Sample records for icd therapy advance-d

  1. Novel ICD Programming and Inappropriate ICD Therapy in CRT-D Versus ICD Patients: A MADIT-RIT Sub-Study.

    PubMed

    Kutyifa, Valentina; Daubert, James P; Schuger, Claudio; Goldenberg, Ilan; Klein, Helmut; Aktas, Mehmet K; McNitt, Scott; Stockburger, Martin; Merkely, Bela; Zareba, Wojciech; Moss, Arthur J

    2016-01-01

    The Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate therapy (MADIT-RIT) trial showed a significant reduction in inappropriate implantable cardioverter defibrillator (ICD) therapy in patients programmed to high-rate cut-off (Arm B) or delayed ventricular tachycardia therapy (Arm C), compared with conventional programming (Arm A). There is limited data on the effect of cardiac resynchronization therapy with a cardioverter defibrillator (CRT-D) on the effect of ICD programming. We aimed to elucidate the effect of CRT-D on ICD programming to reduce inappropriate ICD therapy in patients implanted with CRT-D or an ICD, enrolled in MADIT-RIT. The primary end point of this study was the first inappropriate ICD therapy. Secondary end points were inappropriate anti-tachycardia pacing and inappropriate ICD shock. The study enrolled 742 (49%) patients with an ICD and 757 (51%) patients with a CRT-D. Patients implanted with a CRT-D had 62% lower risk of inappropriate ICD therapy than those with an ICD only (hazard ratio [HR] =0.38, 95% confidence interval: 0.25-0.57; P<0.001). High-rate cut-off or delayed ventricular tachycardia therapy programming significantly reduced the risk of inappropriate ICD therapy compared with conventional ICD programming in ICD (HR=0.14 [B versus A]; HR=0.21 [C versus A]) and CRT-D patients (HR=0.15 [B versus A]; HR=0.23 [C versus A]; P<0.001 for all). There was a significant reduction in inappropriate anti-tachycardia pacings in both group and a significant reduction in inappropriate ICD shock in CRT-D patients. Patients implanted with a CRT-D have lower risk of inappropriate ICD therapy than those with an ICD. Innovative ICD programming significantly reduces the risk of inappropriate ICD therapy in both ICD and CRT-D patients. http://clinicaltrials.gov; Unique identifier: NCT00947310. © 2016 American Heart Association, Inc.

  2. Primary ICD-therapy in patients with advanced heart failure: selection strategies and future trials.

    PubMed

    Frankenstein, Lutz; Zugck, Christian; Nelles, Manfred; Schellberg, Dieter; Remppis, Andrew; Katus, Hugo

    2008-09-01

    For allocation of primary ICD-therapy, a possible lower limit of inclusion criteria--defining overly advanced heart failure--is less well investigated. Also, a multi-variable approach to stratification beyond ejection fraction (LVEF) appears warranted. We examined whether adding a selection limit of peak VO(2) ICD-therapy. All cause mortality was considered as end point. Median follow-up was 45 (18-86) months. ICD was not a significant predictor of outcome either for the entire population, or grouped according to aetiology of CHF. Still, 3-year mortality was 15% (ICD-patients) Vs. 28% (non-ICD-patients); P = 0.05; under combination medical therapy. Inversely, in ICD-patients medical combination therapy conveyed a significant survival benefit (P < 0.001). Consequently, the number-needed-to-treat was eight under combination therapy and the size estimate amounts to 300 patients for a prospective trial in this cohort. A cut-off of LVEF ICD-therapy. Our results indicate the need for a specific randomized trial in this cohort. The according mortality data and a size estimate are provided.

  3. Heart failure severity, inappropriate ICD therapy, and novel ICD programming: a MADIT-RIT substudy.

    PubMed

    Daimee, Usama A; Vermilye, Katherine; Rosero, Spencer; Schuger, Claudio D; Daubert, James P; Zareba, Wojciech; McNitt, Scott; Polonsky, Bronislava; Moss, Arthur J; Kutyifa, Valentina

    2017-12-01

    The effects of heart failure (HF) severity on risk of inappropriate implantable cardioverter-defibrillator (ICD) therapy have not been thoroughly investigated. We aimed to study the association between HF severity and inappropriate ICD therapy in MADIT-RIT. MADIT-RIT randomized 1,500 patients to three ICD programming arms: conventional (Arm A), high-rate cut-off (Arm B: ≥200 beats/min), and delayed therapy (Arm C: 60-second delay for ≥170 beats/min). We evaluated the association between New York Heart Association (NYHA) class III (n = 256) versus class I-II (n = 251) and inappropriate ICD therapy in Arm A patients with ICD-only and cardiac resynchronization therapy with defibrillator (CRT-D). We additionally assessed benefit of novel ICD programming in Arms B and C versus Arm A by NYHA classification. In Arm A, the risk of inappropriate therapy was significantly higher in those with NYHA III versus NYHA I-II for both ICD (hazard ratio [HR] = 2.55, confidence interval [CI]: 1.51-4.30, P < 0.001) and CRT-D patients (HR = 3.73, CI: 1.14-12.23, P = 0.030). This was consistent for inappropriate ATP and inappropriate ICD therapy < 200 beats/min, but not for inappropriate shocks. Novel ICD programming significantly reduced inappropriate therapy in patients with both NYHA III (Arm B vs Arm A: HR = 0.08, P < 0.001; Arm C vs Arm A: HR = 0.17, P < 0.001) and NYHA I-II (Arm B vs Arm A: HR = 0.25, P < 0.001; Arm C vs Arm A: HR = 0.28, P < 0.001). Patients with more severe HF are at increased risk for inappropriate ICD therapy, particularly ATP due to arrhythmias < 200 beats/min. Novel programming with high-rate cut-off or delayed detection reduces inappropriate ICD therapies in both mild and moderate HF. © 2017 Wiley Periodicals, Inc.

  4. The effect of ICD programming on inappropriate and appropriate ICD Therapies in ischemic and nonischemic cardiomyopathy: the MADIT-RIT trial.

    PubMed

    Sedláček, Kamil; Ruwald, Anne-Christine; Kutyifa, Valentina; McNitt, Scott; Thomsen, Poul Erik Bloch; Klein, Helmut; Stockburger, Martin; Wichterle, Dan; Merkely, Bela; DE LA Concha, Joaquin Fernandez; Swissa, Moshe; Zareba, Wojciech; Moss, Arthur J; Kautzner, Josef; Ruwald, Martin H

    2015-04-01

    The MADIT-RIT trial demonstrated reduction of inappropriate and appropriate ICD therapies and mortality by high-rate cut-off and 60-second-delayed VT therapy ICD programming in patients with a primary prophylactic ICD indication. The aim of this analysis was to study effects of MADIT-RIT ICD programming in patients with ischemic and nonischemic cardiomyopathy. First and total occurrences of both inappropriate and appropriate ICD therapies were analyzed by multivariate Cox models in 791 (53%) patients with ischemic and 707 (47%) patients with nonischemic cardiomyopathy. Patients with ischemic and nonischemic cardiomyopathy had similar incidence of first inappropriate (9% and 11%, P = 0.21) and first appropriate ICD therapy (11.6% and 14.1%, P = 0.15). Patients with ischemic cardiomyopathy had higher mortality rate (6.1% vs. 3.3%, P = 0.01). MADIT-RIT high-rate cut-off (arm B) and delayed VT therapy ICD programming (arm C) compared with conventional (arm A) ICD programming were associated with a significant risk reduction of first inappropriate and appropriate ICD therapy in patients with ischemic and nonischemic cardiomyopathy (HR range 0.11-0.34, P < 0.001 for all comparisons). Occurrence of total inappropriate and appropriate ICD therapies was significantly reduced by high-rate cut-off ICD programming and delayed VT therapy ICD programming in both ischemic and nonischemic cardiomyopathy patients. High-rate cut-off and delayed VT therapy ICD programming are associated with significant reduction in first and total inappropriate and appropriate ICD therapy in patients with ischemic and nonischemic cardiomyopathy. © 2014 Wiley Periodicals, Inc.

  5. [Inappropriate ICD therapies: All problems solved with MADIT-RIT?].

    PubMed

    Kolb, Christof

    2015-06-01

    The MADIT-RIT study represents a major trial in implantable cardioverter-defibrillator (ICD) therapy that was recently published. It highlights that different programming strategies (high rate cut-off or delayed therapy versus conventional) reduce inappropriate ICD therapies, leave syncope rates unaltered and can improve patient's survival. The study should motivate cardiologist and electrophysiologists to reconsider their individual programming strategies. However, as the study represents largely patients with ischemic or dilated cardiomyopathy for primary prevention of sudden cardiac death supplied with a dual chamber or cardiac resynchronisation therapy ICD, the results may not easily be transferable to other entities or other device types. Despite the success of the MADIT-RIT study efforts still need to be taken to further optimise device algorithms to avert inappropriate therapies. Optimised ICD therapy also includes the avoidance of unnecessary ICD shocks as well as the treatment of all aspects of the underlying cardiac disease.

  6. Medium voltage therapy for preventing and treating asystole and PEA in ICDs.

    PubMed

    Gilman, Byron L; Brewer, James E; Kroll, Kai; Kroll, Mark W

    2009-01-01

    Sudden cardiac death (SCD) takes up to 500,000 lives each year before a victim can even be treated. To address this the implantable cardioverter defibrillator (ICD) was developed to treat those identified at high risk of SCD. Unfortunately, there are a significant number of cases in which the ICD does not successfully return a victim to normal rhythm and effective perfusion of the blood. The vast majority of cases that are not responsive to the ICD therapy require cardio-pulmonary resuscitation (CPR) according to current resuscitation guidelines. A novel electrical stimulus called medium voltage therapy (MVT) has shown efficacy in producing coronary and carotid blood flow during ventricular fibrillation. This report presents the case that the same stimulus may be effective and feasible for use in ICD patients that do not respond to their ICD therapy, or do not have a rhythm in which, an ICD shock is indicated. The inclusion of MVT technology in implantable devices may be effective in preparing the heart for successful defibrillation or in improving the metabolic condition of the heart to the extent that a pulsatile rhythm may spontaneously develop.

  7. Inadvertent transposition of defibrillator coil terminal pins causing inappropriate ICD therapies.

    PubMed

    Issa, Ziad F

    2008-06-01

    We report the case of a 65-year-old man with chronic atrial fibrillation (AF) and severe ischemic cardiomyopathy who underwent implantation of a prophylactic single-chamber implantable cardioverter-defibrillator (ICD). The patient experienced inappropriate ICD therapies due to oversensing of pectoral muscle myopotential secondary to reversal of the defibrillator coil terminal pins in the ICD header. Recognizing this possibility is important to avoid misinterpretation of spontaneous oversensing as hardware failure (e.g., lead fracture or insulation breech) and potentially unnecessary ICD system surgical intervention, including lead extraction.

  8. Characterization and predictors of first and subsequent inappropriate ICD therapy by heart rate ranges: Result of the MADIT-RIT efficacy analysis.

    PubMed

    Kutyifa, Valentina; Daubert, James P; Olshansky, Brian; Huang, David T; Zhang, Claire; Ruwald, Anne-Christine H; McNitt, Scott; Zareba, Wojciech; Moss, Arthur J; Schuger, Claudio

    2015-09-01

    Data on inappropriate implantable cardioverter-defibrillator (ICD) therapy and effects of programming by heart rate are lacking. We aimed to characterize inappropriate ICD therapy and assess the effects of novel programming by heart rate. Incidence and causes of inappropriate therapy by heart rate range (below or above 200 bpm) were assessed. Predictors of inappropriate therapy and effects of programming by heart rate were evaluated with multivariate Cox regression models. Crossovers were excluded. Inappropriate therapy occurred in 9.2% of the total patient population, with 19% of patients randomized to study arm A, 3.6% in arm B, and 4.7% in arm C. Inappropriate therapies <200 bpm were attributable to supraventricular tachycardia (SVT)/sinus tachycardia (78%) or atrial fibrillation/flutter (20%). Inappropriate therapy ≥200 bpm occurred because of SVT (47%), atrial fibrillation/flutter (41%), or electromagnetic interference (13%). Conventional ICD programming was associated with more inappropriate therapy <200 bpm than high-rate or delayed therapy, as were younger age, history of atrial arrhythmia, advanced New York Heart Association functional class, ICD versus cardiac resynchronization therapy with defibrillator, and absence of diabetes. High-rate and long-delay therapy significantly reduced the risk of inappropriate therapy in the <200 bpm range. Long delay was associated with further reduction of fast (≥200 bpm) inappropriate therapy (P = .032) and a reduction in subsequent inappropriate episodes (P = .006). In MADIT-RIT, inappropriate ICD therapy is most frequent at rates below 200 bpm and can be predicted, and effectively prevented, with high-rate cutoff programming. Long-delay therapy effectively reduces fast inappropriate therapy ≥200 bpm and subsequent events. [ http://clinicaltrials.gov/ct2/show/NCT00947310]. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  9. Contemporary rates of appropriate shock therapy in patients who receive implantable device therapy in a real-world setting: From the Israeli ICD Registry.

    PubMed

    Sabbag, Avi; Suleiman, Mahmoud; Laish-Farkash, Avishag; Samania, Nimer; Kazatsker, Mark; Goldenberg, Ilan; Glikson, Michael; Beinart, Roy

    2015-12-01

    Implantable cardioverter-defibrillators (ICDs) have become the mainstay of preventive measures for sudden cardiac death (SCD). However, there are limited data on rates of appropriate life-saving ICD shock therapies in contemporary real-life settings. The purpose of the study was to evaluate the rate of appropriate life-saving ICD shock therapies in a contemporary registry. The Israeli ICD Registry includes all implants and other ICD operative procedures nationwide. The present study comprises 2349 consecutive cases who were enrolled in the Registry and prospectively followed up for information regarding survival, hospitalizations, and ICD therapies since 2010. Kaplan-Meier survival analysis showed that the rate of appropriate ICD shock therapy at 30-month follow-up was 2.6% among patients who received an ICD for primary prevention compared with 7.4% among those who received a device for secondary prevention (log-rank P < .001). Rates of appropriate ICD shocks among primary prevention patients were 1.1% at 1-year of follow-up and 2.6% at 30 months, whereas the corresponding rates in the secondary prevention group were 3.8% at 1 year and 7.4% at 30 months (log-rank P < .001). A total of 253 patients (4.8%) died during follow-up, 65% of noncardiac causes. Rates of life-saving appropriate ICD shock therapies among patients implanted with a defibrillator for the primary prevention of SCD in a contemporary real-world setting are lower than reported previously. These findings suggest a need for improved risk stratification and patient selection in this population. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  10. The impact of remote monitoring of implanted cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy device (CRT-D) patients on healthcare costs in the Silesian population: three-year follow-up.

    PubMed

    Buchta, Piotr; Tajstra, Mateusz; Kurek, Anna; Skrzypek, Michał; Świetlińska, Małgorzata; Gadula-Gacek, Elżbieta; Wasiak, Michał; Pyka, Łukasz; Gąsior, Mariusz

    2017-01-01

    The population of patients with implanted cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) is constantly growing. The use of remote-monitoring (RM) techniques in this group can significantly improve clinical outcomes, but there are limited data about the impact of RM on healthcare costs from a payer's perspective. The aim of the study was to assess the impact on costs for the healthcare system of RM in patients with ICD or CRT-D. We examined a cohort of 842 patients with ICD or CRT-D. The group was divided into two groups based on RM (or no RM [NRM]), matched according to important clinical characteristics. The subjects were followed for a maximum of three years after implantation (mean follow-up 2.11 ± 0.83 years). The overall costs for the healthcare provider in the follow-up were defined as the primary endpoint. The secondary endpoint was the use of different types of medical contact events: hospitalisation and number of in-clinic and general practitioner visits (without the number of remote transmissions). In the three-year follow-up, the reduction in the costs of treatment for National Health Care in the RM group was 33.5% (median value, p < 0.001). In patients with implanted CRT-D, the reduction reached 42.7% (p = 0.011), and with ICD it was 31.3% (p = 0.007). We observed no significant reduction in the median hospitalisation costs in the three-year follow-up in the RM group (p = NS), despite a 25% drop in the mean value. The costs of outpatient visits were slightly higher in the RM group (p = NS). In the follow-up period, there was no reduction in the number of medical contact events (p = NS). Remote monitoring in patients with implanted ICD or CRT-D devices reduces the cost for the national healthcare provider.

  11. Device Longevity in a Contemporary Cohort of ICD/CRT-D Patients Undergoing Device Replacement.

    PubMed

    Zanon, Francesco; Martignani, Cristian; Ammendola, Ernesto; Menardi, Endrj; Narducci, Maria Lucia; DE Filippo, Paolo; Santamaria, Matteo; Campana, Andrea; Stabile, Giuseppe; Potenza, Domenico Rosario; Pastore, Gianni; Iori, Matteo; LA Rosa, Concetto; Biffi, Mauro

    2016-07-01

    The longevity of defibrillators (ICD) is extremely important from both a clinical and economic perspective. We studied the reasons for device replacement, the longevity of removed ICD, and the existence of possible factors associated with shorter service life. Consecutive patients who underwent ICD replacement from March 2013 to May 2015 in 36 Italian centers were included in this analysis. Data on replaced devices were collected. A total of 953 patients were included in this analysis. In 813 (85%) patients the reason for replacement was battery depletion, while 88 (9%) devices were removed for clinical reasons and the remaining 52 because of system failure (i.e., lead or ICD generator failure or a safety advisory indication). The median service life was 5.9 years (25th-75th percentile, 4.9-6.9) for single- and dual-chamber ICD and 4.9 years (25th-75th percentile, 4.0-5.7) for CRT-D. On multivariate analysis, the factors CRT-D device, SC/DC ICD generator from Biotronik, percentage of ventricular pacing, and the occurrence of a system failure were positively associated with a replacement procedure. By contrast, the device from Boston Scientific was an independent protective factor against replacement. Considerable differences were seen in battery duration in both ICD and CRT-D. Specifically, Biotronik devices showed the shortest longevity among ICD and Boston Scientific showed the longest longevity among CRT-D (log-rank test, P < 0.001 for pairwise comparisons). Several factors were associated with shorter service life of ICD devices: CRT-D, occurrence of system failure and percentage of ventricular pacing. Our results confirmed significant differences among manufacturers. © The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals, Inc.

  12. Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality: The ADVANCE III Trial.

    PubMed

    Gasparini, Maurizio; Lunati, Maurizio G; Proclemer, Alessandro; Arenal, Angel; Kloppe, Axel; Martínez Ferrer, Josè B; Hersi, Ahmad S; Gulaj, Marcin; Wijffels, Maurits C E; Santi, Elisabetta; Manotta, Laura; Varma, Niraj

    2017-11-01

    This study sought to evaluate the effects of programming a long detection in single-chamber (VVI) implantable cardioverter-defibrillators (ICDs) in the multicenter prospective ADVANCE III (Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III) trial. Programming strategies may reduce unnecessary ICD shocks and their adverse effects but to date have been described only for dual-chamber ICDs. A total of 545 subjects (85% male; atrial fibrillation 25%, left ventricular ejection fraction 31%, ischemic etiology 68%, secondary prevention indications 32%) receiving a VVI ICD were randomized to long detection (30 of 40 intervals) or standard programming (18 of 24 intervals) based on device type, atrial fibrillation history, and indication. In both arms, antitachycardia pacing (ATP) therapy during charging was programmed for episodes with cycle length 320 to 200 ms and shock only for cycle length <200 ms. Wavelet and stability functions enabled. Therapies delivered were compared using a negative binomial regression model. A total of 267 patients were randomized to long detection and 278 to the control group. Median follow-up was 12 months. One hundred twelve therapies (shocks and ATP) occurred in the long detection arm versus 257 in the control arm, for a 48% reduction with 30 of 40 intervals (95% confidence interval [CI]: 0.36 to 0.76; p = 0.002). In the long detection arm, overall shocks were reduced by 40% compared to the control arm (48 vs. 24; 95% CI: 0.38 to 0.94; p = 0.026) and appropriate shocks by 51% (34 vs. 74; 95% CI: 0.26 to 0.94; p = 0.033). Syncopal events did not differ between arms, but survival improved in the long detection arm. Among patients implanted with a VVI ICD, programming with the long detection interval significantly reduced appropriate therapies, shocks, and all-cause mortality. (Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III [ADVANCEIII]; NCT00617175). Copyright © 2017 The Authors

  13. A scoping review of ICD-11 adjustment disorder research.

    PubMed

    Kazlauskas, Evaldas; Zelviene, Paulina; Lorenz, Louisa; Quero, Soledad; Maercker, Andreas

    2017-01-01

    Background : Adjustment disorder (AjD) is one of the most used mental disorder diagnoses among mental health professionals. Important revisions of the AjD definition in the 11th edition of the International Classification of Diseases (ICD-11) are proposed. AjD is included in a chapter of disorders specifically associated with stress in ICD-11. Objective : This paper aims to review recent developments in ICD-11 AjD research, and to discuss the available ICD-11 AjD diagnosis validation studies, AjD measures, treatment studies, and outline the future perspectives for AjD research and clinical practice. Methods : In total, 10 empirical studies of AjD ICD-11 were identified and included in this review. We searched for studies in Embase, PubMed, PsycINFO, Scopus, PILOTS, SocINDEX, and via additional search by contacting authors of published empirical studies and reference screening. Results : Review of the studies revealed a lack of validation studies of the ICD-11 AjD symptom structure. AjD validation study findings are ambiguous, and there is still little support for the proposed two symptom structure of AjD for the ICD-11. A self-report AjD measure 'Adjustment Disorder New Module' (ADNM) based on the ICD-11 definition has been developed and used in all 10 reviewed studies. Two self-help interventions have been developed for the ICD-11 AjD, and findings from these studies indicate that self-help low-intensity cognitive-behavioural interventions, delivered via bibliography or internet-based, might be effective treatment of AjD. Conclusions : The AjD definition in ICD-11 with a description of a new symptom profile facilitates AjD measurement and AjD-focused treatment developments. More studies and insights from clinical practice are needed to move the field of AjD research and practice forward.

  14. Results of ENHANCED Implantable Cardioverter Defibrillator Programming to Reduce Therapies and Improve Quality of Life (from the ENHANCED-ICD Study).

    PubMed

    Mastenbroek, Mirjam H; Pedersen, Susanne S; van der Tweel, Ingeborg; Doevendans, Pieter A; Meine, Mathias

    2016-02-15

    Novel implantable cardioverter defibrillator (ICD) discrimination algorithms and programming strategies have significantly reduced the incidence of inappropriate shocks, but there are still gains to be made with respect to reducing appropriate but unnecessary antitachycardia pacing (ATP) and shocks. We examined whether programming a number of intervals to detect (NID) of 60/80 for ventricular tachyarrhythmia (VT)/ventricular fibrillation (VF) detection was safe and the impact of this strategy on (1) adverse events related to ICD shocks and syncopal events; (2) ATPs/shocks; and (3) patient-reported outcomes. The "ENHANCED Implantable Cardioverter Defibrillator programming to reduce therapies and improve quality of life" study (ENHANCED-ICD study) was a prospective, safety-monitoring study enrolling 60 primary and secondary prevention patients at the University Medical Center Utrecht. Patients implanted with any type of ICD with SmartShock technology and aged 18 to 80 years were eligible to participate. In all patients, a prolonged NID 60/80 was programmed. The cycle length for VT/fast VT/VF was 360/330/240 ms, respectively. Programming a NID 60/80 proved safe for ICD patients. Because of the new programming strategy, unnecessary ICD therapy was prevented in 10% of ENHANCED-ICD patients during a median follow-up period of 1.3 years. With respect to patient-reported outcomes, levels of distress were highest and perceived health status lowest at the time of implantation, which both gradually improved during follow-up. In conclusion, the ENHANCED-ICD study demonstrates that programming a NID 60/80 for VT/VF detection is safe for ICD patients and does not negatively impact their quality of life. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Reduced long-term overall mortality in heart failure patients with prolonged QRS treated with CRT combined with ICD vs. heart failure patients with narrow QRS treated with ICD only.

    PubMed

    Palmisano, Pietro; Accogli, Michele; Pisanò, Ennio Carmine Luigi; Zaccaria, Maria; De Blasi, Sergio; Ponzetta, Maria Antonietta; Valsecchi, Sergio; Milanese, Giovanni; Lauretti, Maurelio; Magliari, Francesco

    2016-09-01

    It is not known whether heart failure (HF) patients with prolonged QRS who undergo cardiac resynchronization therapy combined with a defibrillator (CRT-D) have a prognostic advantage over HF patients with narrow QRS (therefore without indication for CRT) treated with an implantable cardioverter defibrillator (ICD) only. The aim of this study was to compare the long-term mortality of a group of HF patients with prolonged QRS receiving CRT-D with that of a similar group of patients with narrow QRS receiving ICD only. A total of 312 patients (mean age 66 ± 13 years; 84% male, mean left ventricular ejection fraction 25 ± 4%, mean New York Heart Association class 2.6 ± 0.5) were included in the analysis. Of these, 138 with a QRS complex duration ≥120 ms received a CRT-D. During follow-up, the time and cause of death were assessed. During a median follow-up of 46 months, CRT-D patients showed significantly lower overall mortality (P = 0.038). Compared with patients receiving ICD only, CRT-D patients showed lower HF mortality (P = 0.003). Coronary mortality, non-cardiac mortality, and sudden mortality were similar in both groups (all P > 0.05). A positive response to CRT was an independent predictor of reduced mortality on multivariate analysis (hazard ratio: 0.27; P = 0.047). In HF patients treated with ICD, the subgroup of patients with prolonged QRS who receive CRT-D displays better long-term survival than narrow QRS ICD recipients, owing to their reduced HF mortality. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  16. Association of psychiatric history and type D personality with symptoms of anxiety, depression, and health status prior to ICD implantation.

    PubMed

    Starrenburg, Annemieke H; Kraaier, Karin; Pedersen, Susanne S; van Hout, Moniek; Scholten, Marcoen; van der Palen, Job

    2013-09-01

    Personality factors and psychiatric history may help explain individual differences in risk of psychological morbidity and poor health outcomes in patients with an implantable cardioverter defibrillator (ICD). We examined associations between previous anxiety and depressive disorder, type D personality, anxiety or depressive symptoms, and health status in ICD patients prior to ICD implantation. Patients (N = 278; 83 % men; mean age = 62.2 years ±11) receiving a first ICD from September 2007 through April 2010 at the Medisch Spectrum Twente, The Netherlands completed validated questionnaires before implantation assessing type D personality (14-item Type D Scale), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale), and health status (36-item Short Form Health Survey). History of anxiety or depressive disorder was assessed with the Mini International Neuropsychiatric Interview structural interview. Previous anxiety or depressive disorder was prevalent in 8 and 19 % of patients, respectively. Type D personality was present in 21 %, depressive symptoms in 15 %, and anxiety in 24 %. In adjusted analyses, type D personality was a dominant correlate of previous depressive disorder (odds ratio (OR) 6.2, p < 0.001) and previous anxiety disorder (OR 3.9, p = 0.004). Type D personality (OR 4.0, p < 0.001), age (OR 1.03, p = 0.043), and gender (OR 2.5, p = 0.013) were associated with anxiety symptoms at baseline. Type D personality (OR 5.9. p < 0.001) was also associated with increased depressive symptoms at baseline. Heart failure and type D personality were related to poorer health status. In ICD patients, prior to ICD implantation, a previous anxiety or depressive disorder, type D personality, and anxiety and depressive symptoms were associated with poorer health status. Type D personality was also independently associated with increased anxiety and depression symptoms.

  17. Effect of supplemented intake of omega-3 fatty acids on arrhythmias in patients with ICD: fish oil therapy may reduce ventricular arrhythmia.

    PubMed

    Weisman, Dalit; Beinart, Roy; Erez, Aharon; Koren-Morag, Nira; Goldenberg, Ilan; Eldar, Michael; Glikson, Michael; Luria, David

    2017-09-01

    The aim of this study was to evaluate the effects of fish oils, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), on ventricular tachyarrhythmic episodes (VTEs) in implantable cardioverter defibrillator (ICD) recipients with ischemic cardiomyopathy. One hundred five ICD recipients with ischemic cardiomyopathy received 3.6 g of EPA and DHA and placebo for 6 months, each at a random order, with a 4-month washout period between treatments. Eighty-seven patients completed the 16-month study protocol. The primary end point was any VTE (including sustained and non-sustained ventricular tachycardias at a rate of >150 bpm) as recorded by the ICDs. Secondary end points included device therapy (anti-tachycardia pacing (ATP) or shocks). During treatment with fish oils, there was a significant increase in EPA and DHA concentrations in red blood cells (RBCs) and subcutaneous fat tissue. Among 87 patients who completed the study protocol, the mean number of VTEs was significantly lower during treatment with fish oil (1.7) vs. placebo (5.6; p = 0.035). Appropriate device therapy for VTE occurred in 18 (21%) patients. Fish oil therapy was associated with a trend toward fewer VTEs terminated with ATP (2.8 ± 13.7 vs. 0.5 ± 2.1, respectively; p = 0.077). VTE terminated by ICD shocks, however, was rare, and rates were similar between both groups (0.11 ± 0.6 vs. 0.10 ± 0.4, p = not significant, respectively). Our data suggest that fish oil therapy may be associated with a reduction in the frequency of VTE in ICD recipients with ischemic cardiomyopathy.

  18. Optimal programming management of ventricular tachycardia storm in ICD patients

    PubMed Central

    Qian, Zhiyong; Guo, Jianghong; Zhang, Zhiyong; Wang, Yao; Hou, Xiaofeng; Zou, Jiangang

    2015-01-01

    Abstract Ventricular tachycardia storm (VTS) is defined as a life-threatening syndrome of three or more separate episodes of ventricular tachycardia (VT) leading to implantable cardioverter defibrillator (ICD) therapy within 24 hours. Patients with VTS have poor outcomes and require immediate medical attention. ICD shocks have been shown to be associated with increased mortality in several studies. Optimal programming in minimization of ICD shocks may decrease mortality. Large controlled trials showed that long detection time and high heart rate detection threshold reduced ICD shock burden without an increase in syncope or death. As a fundamental therapy of ICD, antitachycardia pacing (ATP) can terminate most slow VT with a low risk of acceleration. For fast VT, burst pacing is more effective and less likely to result in acceleration than ramp pacing. One algorithm of optimal programming management during a VTS is presented in the review. PMID:25745473

  19. The Italian subcutaneous implantable cardioverter-defibrillator survey: S-ICD, why not?

    PubMed

    Botto, Giovanni Luca; Forleo, Giovanni B; Capucci, Alessandro; Solimene, Francesco; Vado, Antonello; Bertero, Giovanni; Palmisano, Pietro; Pisanò, Ennio; Rapacciuolo, Antonio; Infusino, Tommaso; Vicentini, Alessandro; Viscusi, Miguel; Ferrari, Paola; Talarico, Antonello; Russo, Giovanni; Boriani, Giuseppe; Padeletti, Luigi; Lovecchio, Mariolina; Valsecchi, Sergio; D'Onofrio, Antonio

    2017-11-01

    A recommendation for a subcutaneous-implantable cardioverter-defibrillator (S-ICD) has been added to recent European Society of Cardiology Guidelines. However, the S-ICD is not ideally suitable for patients who need pacing. The aim of this survey was to analyse the current practice of ICD implantation and to evaluate the actual suitability of S-ICD. The survey 'S-ICD Why Not?' was an independent initiative taken by the Italian Heart Rhythm Society (AIAC). Clinical characteristics, selection criteria, and factors guiding the choice of ICD type were collected in consecutive patients who underwent ICD implantation in 33 Italian centres from September to December 2015. A cardiac resynchronization therapy (CRT) device was implanted in 39% (369 of 947) of patients undergoing de novo ICD implantation. An S-ICD was implanted in 12% of patients with no CRT indication (62 of 510 with available data). S-ICD patients were younger than patients who received transvenous ICD, more often had channelopathies, and more frequently received their device for secondary prevention of sudden death. More frequently, the clinical reason for preferring a transvenous ICD over an S-ICD was the need for pacing (45%) or for antitachycardia pacing (36%). Nonetheless, only 7% of patients fulfilled conditions for recommending permanent pacing, and 4% of patients had a history of monomorphic ventricular tachycardia that might have been treatable with antitachycardia pacing. The vast majority of patients needing ICD therapy are suitable candidates for S-ICD implantation. Nevertheless, it currently seems to be preferentially adopted for secondary prevention of sudden death in young patients with channelopathies. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  20. Reduced appropriate implantable cardioverter-defibrillator therapy after cardiac resynchronization therapy-induced left ventricular function recovery: a meta-analysis and systematic review.

    PubMed

    Chatterjee, Neal A; Roka, Attila; Lubitz, Steven A; Gold, Michael R; Daubert, Claude; Linde, Cecilia; Steffel, Jan; Singh, Jagmeet P; Mela, Theofanie

    2015-11-01

    For patients undergoing cardiac resynchronization therapy (CRT) with implantable cardioverter-defibrillator (ICD; CRT-D), the effect of an improvement in left ventricular ejection fraction (LVEF) on appropriate ICD therapy may have significant implications regarding management at the time of ICD generator replacement. We conducted a meta-analysis to determine the effect of LVEF recovery following CRT on the incidence of appropriate ICD therapy. A search of multiple electronic databases identified 709 reports, of which 6 retrospective cohort studies were included (n = 1740). In patients with post-CRT LVEF ≥35% (study n = 4), the pooled estimated rate of ICD therapy (5.5/100 person-years) was significantly lower than patients with post-CRT LVEF <35% [incidence rate difference (IRD): -6.5/100 person-years, 95% confidence interval (95% CI): -8.8 to -4.2, P < 0.001]. Similarly, patients with post-CRT LVEF ≥45% (study n = 4) demonstrated lower estimated rates of ICD therapy (2.3/100 person-years) compared with patients without such recovery (IRD: -5.8/100 person-years, 95% CI: -7.6 to -4.0, P < 0.001). Restricting analysis to studies discounting ICD therapies during LVEF recovery (study n = 3), patients with LVEF recovery (≥35 or ≥45%) had significantly lower rates of ICD therapy compared with patients without such recovery (P for both <0.001). Patients with primary prevention indication for ICD, regardless of LVEF recovery definition, had very low rates of ICD therapy (0.4 to 0.8/100-person years). Recovery of LVEF post-CRT is associated with significantly reduced appropriate ICD therapy. Patients with improvement of LVEF ≥45% and those with primary prevention indication for ICD appear to be at lowest risk. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  1. Inappropriate ICD discharges due to "triple counting" during normal sinus rhythm.

    PubMed

    Khan, Ejaz; Voudouris, Apostolos; Shorofsky, Stephen R; Peters, Robert W

    2006-11-01

    To describe the clinical course of a patient with multiple ICD shocks in the setting of advanced renal failure and hyperkalemia. The patient was brought to the Electrophysiology Laboratory where the ICD was interrogated. The patient was found to be hyperkalemic (serum potassium 7.6 mg/dl). Analysis of stored intracardiac electrograms from the ICD revealed "triple counting" (twice during his QRS complex and once during the T wave) and multiple inappropriate shocks. Correction of his electrolyte abnormality normalized his electrogram and no further ICD activations were observed. Electrolyte abnormalities can distort the intracardiac electrogram in patients with ICD's and these changes can lead to multiple inappropriate shocks.

  2. Development of an expert based ICD-9-CM and ICD-10-CM map to AIS 2005 update 2008.

    PubMed

    Loftis, Kathryn L; Price, Janet P; Gillich, Patrick J; Cookman, Kathy J; Brammer, Amy L; St Germain, Trish; Barnes, Jo; Graymire, Vickie; Nayduch, Donna A; Read-Allsopp, Christine; Baus, Katherine; Stanley, Patsye A; Brennan, Maureen

    2016-09-01

    allow for ISS calculations for patient data sets. This mapping between ICD and AIS provides a comprehensive, expert-designed solution for analysts to bridge the data gap between the injury descriptions provided in hospital codes (ICD-9-CM, ICD-10-CM) and injury severity codes (AIS08). By applying consistent rules from both the ICD and AIS taxonomies, the expert panel created these definitive maps, which are the only ones endorsed by the Association for the Advancement of Automotive Medicine (AAAM). Initial validation upheld the quality of these maps for the estimation of AIS severity, but future work should include verification of these maps for MAIS and ISS estimations with large data sets. These ICD-AIS maps will support data analysis from databases with injury information classified in these 2 different systems and open new doors for the investigation of injury from traumatic events using large injury data sets.

  3. Application of radiofrequency energy in surgical and interventional procedures: are there interactions with ICDs?

    PubMed

    Fiek, Michael; Dorwarth, Uwe; Durchlaub, Ilka; Janko, Sabine; Von Bary, Christian; Steinbeck, Gerhard; Hoffmann, Ellen

    2004-03-01

    During surgical and interventional procedures, interference may occur between ICDs and electrical cautery or with the application of RF energy. This may lead to the false induction of ICD therapies or could even result in device malfunction, which represents a potential perioperative hazard for the patient. This study analyzed the intraoperative interactions in 45 consecutive ICD patients in reference to different surgical and interventional procedures. A total of 33 surgical operations (general surgery [n = 14], urologic [n = 5], abdominal [n = 10], gynecological [n = 2], thoracic [n = 1], neurosurgical [n = 1]) and 12 interventional therapies (RF catheter ablation [n = 10], endoscopic papillotomy [n = 2]) were performed. The ICD devices were all located in left pectoral position and consisted of 25 single and 20 dual chamber defibrillators. During the procedure, tachyarrhythmia detection (VF 296 +/- 20 ms, VT 376 +/- 49 ms) of the devices was maintained active (monitoring mode), only ICD therapies were inactivated. The indifferent electrode of the electrical cauter/RF generator was placed in standard positions (right/left mid-femoral position [n = 27/8], thoracic spine area [n = 10]). After the procedure, the ICD memory was checked for detections and for changes in the programming. There was no oversensing, reprogramming, or damage of any defibrillator caused by RF energy. Despite the lack of undesired interactions, ICDs should be inactivated preoperatively to assure maximum patient safety. However, should inactivation not be possible, or the achievement uncertain, electromagnetic interference is highly unlikely.

  4. Renal sympathetic denervation guided by renal nerve stimulation to treat ventricular arrhythmia in CKD patients with ICD

    PubMed Central

    Kiuchi, Márcio Galindo; Chen, Shaojie; Rodrigues Paz, Luis Marcelo; Pürerfellner, Helmut

    2017-01-01

    Chronic kidney disease (CKD) patients on stage 4 present greater risk rates for malignant ventricular arrhythmia events. This study examined patients with CKD in stages 1, 2, 3 and 4, left ventricular dysfunction and automatic implantable cardioverter-defibrillator (ICD). Our goal was to record the appropriate therapies, “Anti-tachycardia Therapy Pacing” (ATP) and shock events during the 18 months of follow-up and compare the incidence and severity of these at different stages of CKD, mainly in patients with CKD stage 4 underwent renal sympathetic denervation (RSD) guided by renal nerve stimulation (RNS). One hundred and fifteen patients were evaluated once every three months till 18 months of follow-up. The arrhythmic events were assessed at each follow-up visit. Comparing the groups, we can see the number of ATP and shock events recorded by ICD during 18 months of follow-up, and differences in the number of therapeutic events between the various stages of CKD. The hazard ratio (HR), 95% confidence interval (CI) and P value for ATP and shock events between all the CKD stages were evaluated by the log-rank/Mantel-Haenszel test. At the 18th month of follow-up, 75% of patients with CKD stage 4 received ATP, and 70% were treated with shock while only 20% of the subjects with CKD stage 4 that were submitted to RSD received ATP and 20% were treated with shock, P<0.0001 and P=0.0002, respectively. In our study, a decline occurred in the incidence of arrhythmias, and therefore, appropriate ICD therapies in advanced stages of CKD, reducing the risk rates for these events in patients with CKD on stage 4 after RSD guided by RNS in comparison to the other CKD stages. Our results suggest that RSD can control the higher incidence of malignant arrhythmias in advanced CKD stages. PMID:28415795

  5. [Restrictions for ICD patients in daily life].

    PubMed

    Köbe, Julia; Gradaus, Rainer; Zumhagen, Sven; Böcker, Dirk

    2005-11-01

    Patients with an implantable cardioverter defibrillator (ICD) may experience loss of consciousness. Electromagnetic interference (EMI) may trigger undesired or inhibit necessary therapy in patients with an ICD. Therefore, questions about personal or professional activities for ICD patients arise. Restricting driving or other personal activities has adverse effects on the patient's quality of life. The national Societies of Cardiology provide recommendations for ICD patients concerning driving of motor vehicles. Patients with an ICD that is implanted prophylactically do not have to refrain from driving after recovery from the implantation procedure. Patients with arrhythmias are classified into different groups depending on the risk of recurrence of tachycardias and symptoms. Commercial driving is not allowed for patients with an ICD in Germany except for those with a prophylactic indication without a history of arrhythmias. Those patients may drive small cars but no trucks or busses. Guidelines for medical fitness in commercial or military flying are regulated by the Joint Aviation Authorities (JAA) and ventricular tachycardias are a contraindication for both. Fortunately, loss of consciousness is not dangerous in most jobs. Strong sources of EMI can occur at special workplaces. Patients have to be advised and tested individually concerning their risk for EMI at their employment site before returning safely. Modern life exposes to an increasing amount of EMI. Intact household devices usually do not interfere with ICDs. Mobile phones may interfere with implanted devices. Interaction can be minimized by special precautions like maintaining a distance of minimum 10 cm between mobile phone and ICD. Electronic surveillance systems work differently and have the potential to interact with devices. Patients should be advised to pass those systems with avoiding longer exposure. The presence of an ICD is presently a contraindication for undergoing magnetic resonance imaging

  6. Impact of the introduction of a standardised ICD programming protocol: real-world data from a single centre.

    PubMed

    Sunderland, Nicholas; Kaura, Amit; Li, Anthony; Kamdar, Ravi; Petzer, Ed; Dhillon, Para; Murgatroyd, Francis; Scott, Paul A

    2016-09-01

    Randomised trials have shown that empiric ICD programming, using long detection times and high detection zones, reduces device therapy in ICD recipients. However, there is less data on its effectiveness in a "real-world" setting, especially secondary prevention patients. Our aim was to evaluate the introduction of a standardised programming protocol in a real-world setting of unselected ICD recipients. We analysed 270 consecutive ICD recipients implanted in a single centre-135 implanted prior to protocol implementation (physician-led group) and 135 after (standardised group). The protocol included long arrhythmia detection times (30/40 or equivalent) and high rate detection zones (primary prevention lower treatment zone 200 bpm). Programming in the physician-led group was at the discretion of the implanter. The primary endpoint was time-to-any therapy (ATP or shocks). Secondary endpoints were time-to-inappropriate therapy and time-to-appropriate therapy. The safety endpoints were syncopal episodes, hospital admissions and death. At 12 months follow-up, 47 patients had received any ICD therapy (physician-led group, n = 31 vs. standardised group, n = 16). There was a 47 % risk reduction in any device therapy (p = 0.04) and an 86 % risk reduction in inappropriate therapy (p = 0.009) in the standardised compared to the physician-led group. There was a non-significant 30 % risk reduction in appropriate therapy (p = 0.32). Results were consistent across primary and secondary prevention patients. There were no significant differences in the rates of syncope, hospitalisation, and death. In unselected patients in a real-world setting, introduction of a standardised programming protocol, using long detection times and high detection zones, significantly reduces the burden of ICD therapy without an increase in adverse outcomes.

  7. Development of structured ICD-10 and its application to computer-assisted ICD coding.

    PubMed

    Imai, Takeshi; Kajino, Masayuki; Sato, Megumi; Ohe, Kazuhiko

    2010-01-01

    This paper presents: (1) a framework of formal representation of ICD10, which functions as a bridge between ontological information and natural language expressions; and (2) a methodology to use formally described ICD10 for computer-assisted ICD coding. First, we analyzed and structurized the meanings of categories in 15 chapters of ICD10. Then we expanded the structured ICD10 (S-ICD10) by adding subordinate concepts and labels derived from Japanese Standard Disease Names. The information model to describe formal representation was refined repeatedly. The resultant model includes 74 types of semantic links. We also developed an ICD coding module based on S-ICD10 and a 'Coding Principle,' which achieved high accuracy (>70%) for four chapters. These results not only demonstrate the basic feasibility of our coding framework but might also inform the development of the information model for formal description framework in the ICD11 revision.

  8. The subcutaneous ICD as an alternative to the conventional ICD system: Initial experience in Greece and a review of the literature.

    PubMed

    Sideris, Skevos; Archontakis, Stefanos; Gatzoulis, Konstantinos A; Anastasakis, Aristotelis; Sotiropoulos, Ilias; Arsenos, Petros; Kasiakogias, Alexandros; Terentes, Dimitrios; Trachanas, Konstantinos; Paschalidis, Eleftherios; Tousoulis, Dimitrios; Kallikazaros, Ioannis

    The introduction of an implantable cardioverter defibrillator (ICD) in clinical practice has revolutionized our therapeutic approach for both primary and secondary prevention of sudden cardiac death (SCD), as it has proven to be superior to medical therapy in treating potentially life-threatening ventricular arrhythmias and has resulted in reduced mortality rates. However, implantation of a conventional ICD carries a non-negligible risk of periprocedural and long-term complications associated with the transvenous ICD leads. The entirely subcutaneous implantable cardioverter defibrillator (S-ICD) has recently emerged as a therapeutic alternative to the conventional ICD for patients with various cardiopathies and who are at high risk of SCD. The main advantage is the avoidance of vascular access and thus avoidance of complications associated with transvenous leads. Patients without pacing indications, such as bradycardia, a need for antitachycardia pacing or cardiac resynchronization, as well as those at higher risk of complications from transvenous lead implantation are perfect candidates for this novel technology. The subcutaneous ICD has proven to be equally safe and effective compared to transvenous ICD systems in early clinical trials. Further technical improvements of the system will likely lead to the expansion of indications and widespread use of this technology. In the present review, we discuss the indications for this system, summarize early clinical experiences and highlight the advantages and disadvantages of this novel technology. In addition, we present the first two cases of subcutaneous cardioverter defibrillator system implantation in Greece. Copyright © 2017 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.

  9. Open-access programs for injury categorization using ICD-9 or ICD-10.

    PubMed

    Clark, David E; Black, Adam W; Skavdahl, David H; Hallagan, Lee D

    2018-04-09

    The article introduces Programs for Injury Categorization, using the International Classification of Diseases (ICD) and R statistical software (ICDPIC-R). Starting with ICD-8, methods have been described to map injury diagnosis codes to severity scores, especially the Abbreviated Injury Scale (AIS) and Injury Severity Score (ISS). ICDPIC was originally developed for this purpose using Stata, and ICDPIC-R is an open-access update that accepts both ICD-9 and ICD-10 codes. Data were obtained from the National Trauma Data Bank (NTDB), Admission Year 2015. ICDPIC-R derives CDC injury mechanism categories and an approximate ISS ("RISS") from either ICD-9 or ICD-10 codes. For ICD-9-coded cases, RISS is derived similar to the Stata package (with some improvements reflecting user feedback). For ICD-10-coded cases, RISS may be calculated in several ways: The "GEM" methods convert ICD-10 to ICD-9 (using General Equivalence Mapping tables from CMS) and then calculate ISS with options similar to the Stata package; a "ROCmax" method calculates RISS directly from ICD-10 codes, based on diagnosis-specific mortality in the NTDB, maximizing the C-statistic for predicting NTDB mortality while attempting to minimize the difference between RISS and ISS submitted by NTDB registrars (ISSAIS). Findings were validated using data from the National Inpatient Survey (NIS, 2015). NTDB contained 917,865 cases, of which 86,878 had valid ICD-10 injury codes. For a random 100,000 ICD-9-coded cases in NTDB, RISS using the GEM methods was nearly identical to ISS calculated by the Stata version, which has been previously validated. For ICD-10-coded cases in NTDB, categorized ISS using any version of RISS was similar to ISSAIS; for both NTDB and NIS cases, increasing ISS was associated with increasing mortality. Prediction of NTDB mortality was associated with C-statistics of 0.81 for ISSAIS, 0.75 for RISS using the GEM methods, and 0.85 for RISS using the ROCmax method; prediction of NIS mortality

  10. Refusing Implantable Cardioverter Defibrillator (ICD) Replacement in Elderly Persons-The Same as Giving Up Life: A Qualitative Study.

    PubMed

    Svanholm, Jette Rolf; Nielsen, Jens Cosedis; Mortensen, Peter; Christensen, Charlotte Fuglesang; Birkelund, Regner

    2015-11-01

    More than 20% of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices are implanted in the elderly population aged 80 years or older. In recent scientific literature it is suggested to consider termination of ICD therapy, rather than ICD replacement, in this patient group. The aim of this study was to explore the experiences of persons above 80 years of age concerning replacement of the ICD battery, and the shared communication and decision making with healthcare professionals. We performed a qualitative, explorative study, inspired by Ricoeur's narrative, with a phenomenological-hermeneutic approach, involving 11 ICD patients older than 80 years. The study period was 2011-2012. The meaning of the patients' experiences of living with an ICD was formulated into two themes: (1) "Feeling safe with the ICD" with the subthemes: "The ICD-a life keeper," "The battery level is important," "ICD shock-no problem." (2) "The physician is an authority" with the subthemes: "Being trustful," "Feeling fine knowing nothing," "Criminal act to deactivate the ICD." The elderly ICD recipients tended not to be aware of the option of declining replacement of their ICD. They tended to expect to have their ICD replaced and not to be involved actively in decision making concerning this. Healthcare professionals have an obligation to discuss options and ensure that every patient understands these. More research is needed to change practices and create more realistic, person-centered, ethically acceptable, and constructive healthcare for elderly persons with an ICD. © 2015 Wiley Periodicals, Inc.

  11. Conducting Retrospective Ontological Clinical Trials in ICD-9-CM in the Age of ICD-10-CM.

    PubMed

    Venepalli, Neeta K; Shergill, Ardaman; Dorestani, Parvaneh; Boyd, Andrew D

    2014-01-01

    To quantify the impact of International Classification of Disease 10th Revision Clinical Modification (ICD-10-CM) transition in cancer clinical trials by comparing coding accuracy and data discontinuity in backward ICD-10-CM to ICD-9-CM mapping via two tools, and to develop a standard ICD-9-CM and ICD-10-CM bridging methodology for retrospective analyses. While the transition to ICD-10-CM has been delayed until October 2015, its impact on cancer-related studies utilizing ICD-9-CM diagnoses has been inadequately explored. Three high impact journals with broad national and international readerships were reviewed for cancer-related studies utilizing ICD-9-CM diagnoses codes in study design, methods, or results. Forward ICD-9-CM to ICD-10-CM mapping was performing using a translational methodology with the Motif web portal ICD-9-CM conversion tool. Backward mapping from ICD-10-CM to ICD-9-CM was performed using both Centers for Medicare and Medicaid Services (CMS) general equivalence mappings (GEMs) files and the Motif web portal tool. Generated ICD-9-CM codes were compared with the original ICD-9-CM codes to assess data accuracy and discontinuity. While both methods yielded additional ICD-9-CM codes, the CMS GEMs method provided incomplete coverage with 16 of the original ICD-9-CM codes missing, whereas the Motif web portal method provided complete coverage. Of these 16 codes, 12 ICD-9-CM codes were present in 2010 Illinois Medicaid data, and accounted for 0.52% of patient encounters and 0.35% of total Medicaid reimbursements. Extraneous ICD-9-CM codes from both methods (Centers for Medicare and Medicaid Services general equivalent mapping [CMS GEMs, n = 161; Motif web portal, n = 246]) in excess of original ICD-9-CM codes accounted for 2.1% and 2.3% of total patient encounters and 3.4% and 4.1% of total Medicaid reimbursements from the 2010 Illinois Medicare database. Longitudinal data analyses post-ICD-10-CM transition will require backward ICD-10-CM to ICD-9-CM

  12. ICD defibrillation failure solved in an unusual fashion.

    PubMed

    Oliveira, Ricardo Gil; Madeira, Francisco; Ferreira, Ana Rita; Antunes, Susana; Morais, Carlos; Gil, Victor

    2010-04-01

    An implantable cardioverter defibrillator (ICD) is designed to sense life-threatening ventricular arrhythmias and terminate them, either by rapid pacing or by delivering an electrical shock. Nowadays it is a proven therapy for both primary and secondary prevention of sudden cardiac death. The typical configuration of an ICD consists of a right ventricular sensing/defibrillator lead with two coils (one distal, located in the right ventricle, and one proximal, located at the superior vena cava-right atrium junction) and an active can, the so-called "ventricular triad". Although effective in the vast majority of patients, it could be argued that this is not the most rational arrangement in electrical terms, since the main shock vector is anteriorly displaced in relation to the greater portion of the left ventricular mass. We describe a case of an ICD defibrillation failure that was solved by placing an additional defibrillator lead in a tributary of the coronary sinus.

  13. Educational videos to reduce racial disparities in ICD therapy via innovative designs (VIVID): a randomized clinical trial.

    PubMed

    Thomas, Kevin L; Zimmer, Louise O; Dai, David; Al-Khatib, Sana M; Allen LaPointe, Nancy M; Peterson, Eric D

    2013-07-01

    Black individuals eligible for an implantable cardioverter/defibrillator (ICD) are considerably less likely than white individuals to receive one. This disparity may, in part, be explained by racial differences in patient preferences. We hypothesized that a targeted patient-centered educational video could improve knowledge of sudden cardiac arrest (SCA) and ICDs and reduce racial differences in ICD preferences. We conducted a pilot study to assess the feasibility of testing this hypothesis in a randomized trial. We created a video that included animation, physician commentary, and patient testimonials on SCA and ICDs. The primary outcome was the decision to have an ICD implanted as a function of race and intervention. Between January 1, 2011, and December 31, 2011, 59 patients (37 white and 22 black) were randomized to the video or health care provider counseling/usual care. Relative to white patients, black patients were younger (median age, 55 vs 68 years) and more likely to have attended college or technical school. Baseline SCA and ICD knowledge was similar and improved significantly in both racial groups after the intervention. Black patients viewing the video were as likely as white patients to want an ICD (60.0% vs 79.2%, P = .20); and among those in the usual care arm, black patients were less likely than white patients to want an ICD (42.9% vs 84.6% P = .05). Among individuals eligible for an ICD, a video decision aid increased patient knowledge and reduced racial differences in patient preference for an ICD. Copyright © 2013 Mosby, Inc. All rights reserved.

  14. Mechanical dispersion and global longitudinal strain by speckle tracking echocardiography: Predictors of appropriate implantable cardioverter defibrillator therapy in hypertrophic cardiomyopathy.

    PubMed

    Candan, Ozkan; Gecmen, Cetin; Bayam, Emrah; Guner, Ahmet; Celik, Mehmet; Doğan, Cem

    2017-06-01

    In this study, we investigated whether mechanical dispersion which reflects electrical abnormality and other echocardiographic and clinic parameters predict appropriate ICD shock in patients undergone ICD implantation for hypertrophic cardiomyopathy. Sixty-three patients who received ICD implantation for primary or secondary prevention were included in the study. Patients' clinical, electrocardiographic, 2D classic, and speckle tracking echocardiographic data were collected. Mechanical dispersion was defined as the standard deviation of time to peak negative strain in 18 left ventricular segments. Appropriate ICD therapy was defined as cardioversion or defibrillation due to ventricular tachycardia or fibrillation. Patients were divided into two groups as occurrence or the absence of appropriate ICD therapy. A total of 17 (26.9%) patients were observed to have an appropriate ICD therapy during follow-up periods. In patients who performed appropriate ICD therapy, a larger left atrial volume index, higher sudden cardiac death (SCD)-Risk Score, longer mechanical dispersion, and decreased global longitudinal peak strain (GLPS) were observed. In multivariate logistic regression analysis, including (GLPS, mechanical dispersion, LAVi, and SCD-Risk Score) was used to determine independent predictors of occurrence of appropriate ICD therapy during the follow-up. Mechanical dispersion, GLPS, and SCD-Risk Score were found to be independent predictors of occurrence of appropriate ICD therapy. Mechanical dispersion, GLPS, and SCD-Risk Score were found to be predictive for appropriate ICD therapy in patients receiving ICD implantation. Readily measurable mechanical dispersion and GLPS could be helpful to distinguish patients at high risk who could optimally benefit from ICD therapy. © 2017, Wiley Periodicals, Inc.

  15. Tachycardia detection in ICDs by Boston Scientific : Algorithms, pearls, and pitfalls.

    PubMed

    Zanker, Norbert; Schuster, Diane; Gilkerson, James; Stein, Kenneth

    2016-09-01

    The aim of this study was to summarize how implantable cardioverter defibrillators (ICDs) by Boston Scientific sense, detect, discriminate rhythms, and classify episodes. Modern devices include multiple programming selections, diagnostic features, therapy options, memory functions, and device-related history features. Device operation includes logical steps from sensing, detection, discrimination, therapy delivery to history recording. The program is designed to facilitate the application of the device algorithms to the individual patient's clinical needs. Features and functions described in this article represent a selective excerpt by the authors from Boston Scientific publicly available product resources. Programming of ICDs may affect patient outcomes. Patient-adapted and optimized programming requires understanding of device operation and concepts.

  16. Inappropriate shock and battery switching to "End of Life" in a patient with biventricular ICD during magnetic resonance imaging.

    PubMed

    Atar, İlyas; Bal, Uğur; Ertan, Çağatay; Özin, Bülent; Müderrisoğlu, Haldun

    2016-01-01

    Presence of a cardiac pacemaker or implantable cardioverter defibrillator (ICD) is a relative contraindication to magnetic resonance imaging (MRI). Biventricular ICDs are often used in the treatment of advanced heart failure; however, reports on experience with biventricular ICDs are lacking in the literature. In this case report, we describe a pacemaker-dependent patient with a biventricular ICD on whom an MRI of the lumbar spine was performed without having realized the presence of the ICD.

  17. Comparison of non-directive counselling and cognitive behaviour therapy for patients presenting in general practice with an ICD-10 depressive episode: a randomized control trial.

    PubMed

    King, M; Marston, L; Bower, P

    2014-07-01

    Most evidence in the UK on the effectiveness of brief therapy for depression concerns cognitive behaviour therapy (CBT). In a trial published in 2000, we showed that non-directive counselling and CBT were equally effective in general practice for patients with depression and mixed anxiety and depression. Our results were criticized for including patients not meeting diagnostic criteria for a depressive disorder. In this reanalysis we aimed to compare the effectiveness of the two therapies for patients with an ICD-10 depressive episode. Patients with an ICD-10 depressive episode or mixed anxiety and depression were randomized to counselling, CBT or usual general practitioner (GP) care. Counsellors provided nondirective, interpersonal counselling following a manual that we developed based on the work of Carl Rogers. Cognitive behaviour therapists provided CBT also guided by a manual. Modelling was carried out using generalized estimating equations with the multiply imputed datasets. Outcomes were mean scores on the Beck Depression Inventory, Brief Symptom Inventory, and Social Adjustment Scale at 4 and 12 months. A total of 134 participants were randomized to CBT, 126 to counselling and 67 to usual GP care. We undertook (1) an interaction analysis using all 316 patients who were assigned a diagnosis and (2) a head-to-head comparison using only those 130 (41%) participants who had an ICD-10 depressive episode at baseline. CBT and counselling were both superior to GP care at 4 months but not at 12 months. There was no difference in the effectiveness of the two psychological therapies. We recommend that national clinical guidelines take our findings into consideration in recommending effective alternatives to CBT.

  18. [Addiction in DSM V and ICD-11 state of the art].

    PubMed

    Lesch, O-M

    2009-09-01

    Diagnoses are made for identifying rather homogeneous groups of patients being thereby relevant for research and for therapy. Therefore diagnostic manuals, like the DSM-IV and the ICD-10 are subjected to changing knowledge derived from research on one hand and to changes of clinical necessities. The diagnosis of substance related disorders, published for DSM-IV in 1994 and for the ICD-10 in 1992, has proven of value for epidemiological research and economic validation. In spite of these advantages the concept has prove to be too broad and rather unspecific for research, specific therapeutic strategies and for defining an illness course. During the last 20 years research has yielded many criteria of interest, which never entered DSM IV or ICD-10, remaining therefore on the level of single items, which are nowadays additionally assigned to all patients (like e. g. early versus late onset) or on the level of typologies (like e. g. Lesch's typology) demanding different treatments. To give an example: acamprosate has lasting relapse preventing effects in Lesch types I and II, while naltrexone is effective in types III and IV. For rendering an expertise in Germany, the referring literature recommends to utilize Lesch's typology additionally to the ICD-10 diagnosis, especially when prognosis or therapeutic strategies are demanded. Since 1999 different expert groups strive for including new criteria into DSM IV and ICD-10. The revised manuals should include easily assignable items for severity of different arrays (time illness onset, co-morbidity, withdrawal symptoms, bridge symptoms and neurological sequela). Different therapy stages (e. g. withdrawal or relapse prevention) need a different weighting of individual symptoms (e. g. degree of intoxication, severity of withdrawal is needed for acute treatment, while an assignment of co-morbidity and personality factors is necessary for relapse prevention). This quantifier is rendered by Lesch's typology, which is available in

  19. Contemporary rates and outcomes of single- vs. dual-coil implantable cardioverter defibrillator lead implantation: data from the Israeli ICD Registry.

    PubMed

    Leshem, Eran; Suleiman, Mahmoud; Laish-Farkash, Avishag; Konstantino, Yuval; Glikson, Michael; Barsheshet, Alon; Goldenberg, Ilan; Michowitz, Yoav

    2017-09-01

    Dual-coil leads were traditionally considered standard of care due to lower defibrillation thresholds (DFT). Higher complication rates during extraction with parallel progression in implantable cardioverter defibrillator (ICD) technology raised questions on dual coil necessity. Prior substudies found no significant outcome difference between dual and single coils, although using higher rates of DFT testing then currently practiced. We evaluated the temporal trends in implantation rates of single- vs. dual-coil leads and determined the associated adverse clinical outcomes, using a contemporary nation-wide ICD registry. Between July 2010 and March 2015, 6343 consecutive ICD (n = 3998) or CRT-D (n = 2345) implantation patients were prospectively enrolled in the Israeli ICD Registry. A follow-up of at least 1 year of 2285 patients was available for outcome analysis. The primary endpoint was all-cause mortality. Single-coil leads were implanted in 32% of our cohort, 36% among ICD recipients, and 26% among CRT-D recipients. Secondary prevention indication was associated with an increased rate of dual-coil implantation. A significant decline in dual-coil leads with reciprocal incline of single coils was observed, despite low rates of DFT testing (11.6%) during implantation, which also declined from 31 to 2%. In the multivariate Cox model analysis, dual- vs. single-coil lead implantation was not associated with an increased risk of mortality [hazard ratio (HR) = 1.23; P= 0.33], heart failure hospitalization (HR = 1.34; P=0.13), appropriate (HR = 1.25; P= 0.33), or inappropriate ICD therapy (HR = 2.07; P= 0.12). Real-life rates of single-coil lead implantation are rising while adding no additional risk. These results of single-coil safety are reassuring and obtained, despite low and contemporary rates of DFT testing. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

  20. Simulation of ICD-9 to ICD-10-CM Transition for Family Medicine: Simple or Convoluted?

    PubMed

    Grief, Samuel N; Patel, Jesal; Kochendorfer, Karl M; Green, Lee A; Lussier, Yves A; Li, Jianrong; Burton, Michael; Boyd, Andrew D

    2016-01-01

    The objective of this study was to examine the impact of the transition from International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM), to Interactional Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), on family medicine and to identify areas where additional training might be required. Family medicine ICD-9-CM codes were obtained from an Illinois Medicaid data set (113,000 patient visits and $5.5 million in claims). Using the science of networks, we evaluated each ICD-9-CM code used by family medicine physicians to determine whether the transition was simple or convoluted. A simple transition is defined as 1 ICD-9-CM code mapping to 1 ICD-10-CM code, or 1 ICD-9-CM code mapping to multiple ICD-10-CM codes. A convoluted transition is where the transitions between coding systems is nonreciprocal and complex, with multiple codes for which definitions become intertwined. Three family medicine physicians evaluated the most frequently encountered complex mappings for clinical accuracy. Of the 1635 diagnosis codes used by family medicine physicians, 70% of the codes were categorized as simple, 27% of codes were convoluted, and 3% had no mapping. For the visits, 75%, 24%, and 1% corresponded with simple, convoluted, and no mapping, respectively. Payment for submitted claims was similarly aligned. Of the frequently encountered convoluted codes, 3 diagnosis codes were clinically incorrect, but they represent only <0.1% of the overall diagnosis codes. The transition to ICD-10-CM is simple for 70% or more of diagnosis codes, visits, and reimbursement for a family medicine physician. However, some frequently used codes for disease management are convoluted and incorrect, and for which additional resources need to be invested to ensure a successful transition to ICD-10-CM. © Copyright 2016 by the American Board of Family Medicine.

  1. Simulation of ICD-9 to ICD-10-CM transition for family medicine: simple or convoluted?

    PubMed Central

    Grief, Samuel N.; Patel, Jesal; Lussier, Yves A.; Li, Jianrong; Burton, Michael; Boyd, Andrew D.

    2017-01-01

    Objectives The objective of this study was to examine the impact of the transition from International Classification of Disease Version Nine Clinical Modification (ICD-9-CM) to Interactional Classification of Disease Version Ten Clinical Modification (ICD-10-CM) on family medicine and identify areas where additional training might be required. Methods Family medicine ICD-9-CM codes were obtained from an Illinois Medicaid data set (113,000 patient visits and $5.5 million dollars in claims). Using the science of networks we evaluated each ICD-9-CM code used by family medicine physicians to determine if the transition was simple or convoluted.1 A simple translation is defined as one ICD-9-CM code mapping to one ICD-10-CM code or one ICD-9-CM code mapping to multiple ICD-10-CM codes. A convoluted transition is where the transitions between coding systems is non-reciprocal and complex with multiple codes where definitions become intertwined. Three family medicine physicians evaluated the most frequently encountered complex mappings for clinical accuracy. Results Of the 1635 diagnosis codes used by the family medicine physicians, 70% of the codes were categorized as simple, 27% of the diagnosis codes were convoluted and 3% were found to have no mapping. For the visits, 75%, 24%, and 1% corresponded with simple, convoluted, and no mapping, respectively. Payment for submitted claims were similarly aligned. Of the frequently encountered convoluted codes, 3 diagnosis codes were clinically incorrect, but they represent only < 0.1% of the overall diagnosis codes. Conclusions The transition to ICD-10-CM is simple for 70% or more of diagnosis codes, visits, and reimbursement for a family medicine physician. However, some frequently used codes for disease management are convoluted and incorrect, where additional resources need to be invested to ensure a successful transition to ICD-10-CM. PMID:26769875

  2. The relationship between baseline and follow-up left ventricular ejection fraction with adverse events among primary prevention ICD patients.

    PubMed

    Friedman, Daniel J; Fudim, Marat; Overton, Robert; Shaw, Linda K; Patel, Divyang; Pokorney, Sean D; Velazquez, Eric J; Al-Khatib, Sana M

    2018-07-01

    Left ventricular ejection fraction (LVEF) is used to select patients for primary prevention implantable cardioverter defibrillators (ICDs). The relationship between baseline and long-term follow-up LVEF and clinical outcomes among primary prevention ICD patients remains unclear. We studied 195 patients with a baseline LVEF ≤35% ≤6 months prior to ICD implantation and follow-up LVEF 1-3 years after ICD implantation without intervening left ventricular assist device (LVAD) or transplant. The co-primary study endpoints were: (1) a composite of time to death, LVAD, or transplant and (2) appropriate ICD therapy. We examined multivariable Cox proportional hazard models with a 3-year post-implant landmark view; the LVEF closest to the 3-year mark was considered the follow-up LVEF for analyses. Follow-up LVEF was examined using 2 definitions: (1) ≥10% improvement compared to baseline or (2) actual value of ≥40%. Fifty patients (26%) had a LVEF improvement of ≥10% and 44 (23%) had a follow-up LVEF ≥40%. Neither baseline nor follow-up LVEF was significantly associated with the composite endpoint. In contrast, both baseline and follow-up LVEF were associated with risk for long-term ICD therapies, whether follow-up LVEF was modeled as a ≥10% absolute improvement (baseline LVEF HR 0.87, CI 0.91-0.93, P < .001; follow-up LVEF HR 0.18, CI 0.06-0.53, P = .002) or a ≥40% follow-up value (baseline LVEF HR 0.89, CI 0.83-0.96, P = .001, follow-up LVEF HR 0.26, CI 0.08-0.87, P = .03). Among primary prevention ICD recipients, both baseline and follow-up LVEF were independently associated with long-term risk for appropriate ICD therapy, but they were not associated with time to the composite of LVAD, transplant, or death. Copyright © 2018 Elsevier Inc. All rights reserved.

  3. Intermolecular Coulombic Decay (ICD) Occuring in Triatomic Molecular Dimer

    NASA Astrophysics Data System (ADS)

    Iskandar, Wael; Gatton, Averell; Gaire, Bishwanath; Champenois, Elio; Larsen, Kirk; Shivaram, Niranjan; Moradmand, Ali; Severt, Travis; Williams, Joshua; Slaughter, Daniel; Weber, Thorsten

    2017-04-01

    For over two decades, the production of ICD process has been extensively investigated theoretically and experimentally in different systems bounded by a week force (ex. van-der-Waals or Hydrogen force). Furthermore, the ICD process has been demonstrated a strong implication in biological system (DNA damage and DNA repair mechanism) because of the production of genotoxic low energy electrons during the decay cascade. Studying large complex system such as triatomic molecular dimer may be helpful for further exploration of ``Auger electron driven cancer therapy''. The present experiment investigates the dissociation dynamics happened in collision between a photons and CO2 dimer. We will focus more specifically on the CO2++CO2+ fragmentation channel and the detection in coincidence of the two ionic fragments and the two electrons will be done using a COld Target Recoil Ion Momentum Spectroscopy (COLTRIMS). The measurements of the Kinetic Energy Release of the two fragments and the relative angular distribution of the electrons in the molecular frame reveal that the ICD is the only mechanism responsible for the production of this fragmentation channel.

  4. Questions to Ask Your Doctor--Implantable Cardioverter Defibrillator (ICD)

    MedlinePlus

    ... affect my family member or me because of gender? Does age have any bearing on how the ICD works? Does one kind of therapy ... brief, easy to follow and easy to read. Many topics also available in Spanish . ... 4 Warning Signs of a Heart Attack 5 How to Eat Healthy 6 What are the Symptoms ...

  5. Evidence of distinct profiles of Posttraumatic Stress Disorder (PTSD) and Complex Posttraumatic Stress Disorder (CPTSD) based on the new ICD-11 Trauma Questionnaire (ICD-TQ).

    PubMed

    Karatzias, Thanos; Shevlin, Mark; Fyvie, Claire; Hyland, Philip; Efthymiadou, Erifili; Wilson, Danielle; Roberts, Neil; Bisson, Jonathan I; Brewin, Chris R; Cloitre, Marylene

    2017-01-01

    The WHO International Classification of Diseases, 11th version (ICD-11), has proposed two related diagnoses following exposure to traumatic events; Posttraumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD). We set out to explore whether the newly developed ICD-11 Trauma Questionnaire (ICD-TQ) can distinguish between classes of individuals according to the PTSD and CPTSD symptom profiles as per ICD-11 proposals based on latent class analysis. We also hypothesized that the CPTSD class would report more frequent and a greater number of different types of childhood trauma as well as higher levels of functional impairment. Methods Participants in this study were a sample of individuals who were referred for psychological therapy to a National Health Service (NHS) trauma centre in Scotland (N=193). Participants completed the ICD-TQ as well as measures of life events and functioning. Overall, results indicate that using the newly developed ICD-TQ, two subgroups of treatment-seeking individuals could be empirically distinguished based on different patterns of symptom endorsement; a small group high in PTSD symptoms only and a larger group high in CPTSD symptoms. In addition, CPTSD was more strongly associated with more frequent and a greater accumulation of different types of childhood traumatic experiences and poorer functional impairment. Sample predominantly consisted of people who had experienced childhood psychological trauma or been multiply traumatised in childhood and adulthood. CPTSD is highly prevalent in treatment seeking populations who have been multiply traumatised in childhood and adulthood and appropriate interventions should now be developed to aid recovery from this debilitating condition. Copyright © 2016 Elsevier B.V. All rights reserved.

  6. Introducing ICD-resistant mortality as an end point to evaluate the clinical efficacy of an implantable cardioverter-defibrillator in ischaemic cardiomyopathy.

    PubMed

    Floré, Vincent; Vandenberk, Bert; Belmans, Ann; Garweg, Christophe; Ector, Joris; Willems, Rik

    2018-02-01

    A new end point called ICD-resistant mortality was evaluated to assess the clinical efficacy of ICD implantations. In 302 ICD patients with ischaemic cardiomyopathy, we investigated which clinical parameters predicted useful ICD implantations using cumulative incidence competing risk analysis. Implantation was deemed clinically useful when the ICD provided appropriate therapy and the patient survived implantation by 1 year and the first shock by 30 days. ICD-resistant mortality (ICDRM) was defined as death within 30 days after the first shock, within 1 year of implantation or without previous appropriate ICD therapy. After 5 years, ICDRM occurred in 23% of implantations, while 36% were clinically useful. After multivariable analysis, ICDRM was associated with LVEF <35% (HR: 2.63; p = .005), beta-blocker dose <50% (HR: 2.0; p = .01) and anterior or diffuse infarct location (HR: 3.61; p = .001 and HR: 2.89; p = .02). Useful ICD implantations were associated with beta-blocker dose <50% (HR: 1.64; p = .02) and non-anterior infarct location (HR: 3.22 vs anterior and 1.59 vs diffuse; combined p<.001). Five years after implantation, an ICD could be classified as useful in 1 out of 3, while ICDRM occurred in one out of four patients. At 10 years, up to 80% of implantations could be categorized. Lower LVEF was related with significantly higher incidence of ICDRM. Anterior infarcts were associated with more ICDRM and less useful implantations than non-anterior infarcts. Future risk stratification for ICD should focus more on the discrimination between arrhythmic risk, probably preventable by ICDs and ICD-resistant mortality risk.

  7. An Intervention to Control Vasomotor Symptoms for Advanced PC Patients on Hormone Therapy

    DTIC Science & Technology

    2014-08-01

    Symptoms for Advanced PC Patients on Hormone Therapy PRINCIPAL INVESTIGATOR: Michael A. Diefenbach, Ph.D. CONTRACTING ORGANIZATION...Control Vasomotor Symptoms for Advanced PC Patients on Hormone Therapy 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-11-1-0604 5c...NOTES 14. ABSTRACT Vasomotor Symptom (Hot Flashes) is a common side-effect of hormone therapy for prostate cancer survivors who experience a rising

  8. Association of Single vs. Dual Chamber ICDs with Mortality, Readmissions and Complications among Patients Receiving an ICD for Primary Prevention

    PubMed Central

    Peterson, Pamela N; Varosy, Paul D; Heidenreich, Paul A; Wang, Yongfei; Dewland, Thomas A; Curtis, Jeptha P; Go, Alan S; Greenlee, Robert T; Magid, David J; Normand, Sharon-Lise T; Masoudi, Frederick A

    2013-01-01

    Importance Randomized trials of implantable cardioverter defibrillators (ICDs) for primary prevention predominantly employed single chamber devices. In clinical practice, patients often receive dual chamber ICDs, even without clear indications for pacing. The outcomes of dual versus single chamber devices are uncertain. Objective Compare outcomes of single and dual chamber ICDs for primary prevention of sudden cardiac death. Design, Setting, and Participants Retrospective cohort study. Admissions in the National Cardiovascular Data Registry’s (NCDR®) ICD Registry™ from 2006–2009 that could be linked to CMS fee for service Medicare claims data were identified. Patients were included if they received an ICD for primary prevention and did not have a documented indication for pacing. Main Outcome Measures Adjusted risks of 1-year mortality, all-cause readmission, HF readmission and device-related complications within 90 days were estimated with propensity-score matching based on patient, clinician and hospital factors. Results Among 32,034 patients, 38% (n=12,246) received a single chamber device and 62% (n=19,788) received a dual chamber device. In a propensity-matched cohort, rates of complications were lower for single chamber devices (3.5% vs. 4.7%; p<0.001; risk difference −1.20; 95% CI −1.72, −0.69), but device type was not significantly associated with mortality or hospitalization outcomes (unadjusted rate 9.9% vs. 9.8%; HR 0.99, 95% CI 0.91–1.07; p=0.792 for 1-year mortality; unadjusted rate 43.9% vs. 44.8%; HR 1.00, 95% CI 0.97–1.04; p=0.821 for 1-year all-cause hospitalization; unadjusted rate 14.7% vs. 15.4%; HR 1.05, 95% CI 0.99–1.12; p=0.189 for 1-year HF hospitalization). Conclusions and Relevance Among patients receiving an ICD for primary prevention without indications for pacing, the use of a dual chamber device compared with a single chamber device was associated with a higher risk of device-related complications but not with

  9. Relationship between age and inappropriate implantable cardioverter-defibrillator therapy in MADIT-RIT (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy).

    PubMed

    Biton, Yitschak; Huang, David T; Goldenberg, Ilan; Rosero, Spencer; Moss, Arthur J; Kutyifa, Valentina; McNitt, Scott; Strasberg, Boris; Zareba, Wojciech; Barsheshet, Alon

    2016-04-01

    There is limited data regarding the relationship between age and inappropriate therapy among patients with an implantable cardioverter-defibrillator (ICD) and resynchronization therapy. We aimed to investigate this relationship and the effect of ICD programming on inappropriate therapy by age. In the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) 1500 patients were randomized to 3 ICD programming arms: (A) conventional with ventricular tachycardia (VT) therapy ≥170; (B) high-rate cutoff with VT therapy ≥200, and (C) prolonged 60-second delay for VT therapy ≥170. We investigated the relationship between age, the risk of inappropriate ICD therapy (including antitachycardia pacing [ATP] or shock), and ICD programming. Cumulative incidence function Kaplan-Meier graphs showed an inverse relationship between increasing quartiles of age (Q1: ≤55, Q2: 56-64, Q3: 65-71, and Q4: ≥72 years) and the risk for inappropriate therapy. Multivariate analyses showed that each increasing decade of life was associated with 34% (P < .001), 27% (P < .001), and 26% (P < .001) reduction in the risk of inappropriate shock, inappropriate ATP, and any inappropriate therapy, respectively. Treatment arms B and C as compared with arm A were associated with a significant reduction in the risk of inappropriate therapies across all age quartiles (P < .001 for all). Among patients with a primary prevention indication for an ICD, there is an inverse relationship between age and inappropriate ICD therapy. Innovative ICD programming of high-rate cutoff or prolonged delay for VT therapy is associated with significant reductions in inappropriate therapy among all age groups. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  10. Complex PTSD as proposed for ICD-11: validation of a new disorder in children and adolescents and their response to Trauma-Focused Cognitive Behavioral Therapy.

    PubMed

    Sachser, Cedric; Keller, Ferdinand; Goldbeck, Lutz

    2017-02-01

    To evaluate whether the symptoms of children and adolescents with clinically significant posttraumatic stress symptoms (PTSS) form classes consistent with the diagnostic criteria of complex PTSD (CPTSD) as proposed for the ICD-11, and to relate the emerging classes with treatment outcome of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT). Latent classes analysis (LCA) was used to explore the symptom profiles of the clinical baseline assessment of N = 155 children and adolescents participating in a randomized controlled trial of TF-CBT. The treatment outcomes of patients with posttraumatic stress disorder (PTSD) and of patients with CPTSD were compared by a t-test for depended samples and a repeated-measures ANOVA. The LCA revealed two distinct classes: a PTSD class characterized by elevated core symptoms of PTSD (n = 62) and low symptoms of disturbances in self-organization versus a complex PTSD class with elevated PTSD core symptoms and elevated symptoms of disturbances in self-organization (n = 93). The Group × Time interaction regarding posttraumatic stress symptoms was not significant. Pre-post effect sizes regarding posttraumatic stress symptoms were large for both groups (PTSD: d = 2.81; CPTSD: d = 1.37). For disturbances in self-organization in the CPTSD class, we found medium to large effect sizes (d = 0.40-1.16) after treatment with TF-CBT. The results provide empirical evidence of the ICD-11 CPTSD and PTSD distinction in a clinical sample of children and adolescents. In terms of relative improvement from their respective baseline posttraumatic stress symptoms, patients with PTSD and CPTSD responded equally to TF-CBT; however, those with CPTSD ended treatment with clinically and statistically greater symptoms than those with PTSD. © 2016 Association for Child and Adolescent Mental Health.

  11. [Sudden cardiac death in the youth. Is the new subcutaneous implantable cardioverter defibrillator S-ICD an alternative solution?].

    PubMed

    Roche, N-C; Stefuriac, M; Dumitrescu, N; Charbonnel, A; Godreuil, C; Bonnevie, L

    2015-02-01

    Implantable cardioverter defibrillator (ICD) is well-recognized therapy to prevent sudden cardiac death. Classic ICD need the use of permanent endocavitary leads, which may cause serious troubles (lead dislodgement, ventricular perforation, lead infections, etc.). The subcutaneous implantable cardioverter defibrillator (S-ICD) is a new device provided by only a subcutaneous lead. It has been developed for the last five years and it is becoming at present a real alternative to classic ICD. We report a clinical case of a 34 y.o. woman who presented a sudden cardiac death and who benefited the implantation of this new technology. This paper deals with the potential indications, usefulness benefits, and problems of the S-ICD. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  12. Patient satisfaction and suggestions for improvement of remote ICD monitoring.

    PubMed

    Petersen, Helen Høgh; Larsen, Mie Christa Jensen; Nielsen, Olav Wendelboe; Kensing, Finn; Svendsen, Jesper Hastrup

    2012-09-01

    The study aim was to evaluate patient acceptance and content with remote follow-up (FU) of their implantable cardioverter defibrillator (ICD) and to estimate patients' wish for changes in remote follow-up routines. Four hundred seventy-four ICD patients at the device follow-up clinic at Rigshospitalet using CareLink® (Medtronic) remote follow-up, who had made ≥2 transmissions, received a questionnaire. Three hundred eighty-five patients (81.2%) answered. Mean time with ICD was 56 ± 45 months and mean age was 62 ± 13 years; 80% was male. Diagnosis related to ICD implant was: ischemic heart disease in 56% and dilated cardiomyopathy in 21%. Twenty-six percent had primary prophylactic indication. Mean time on remote FU was 16.4 ± 6.9 months. Mean time spent on in-clinic FU (two-way transport and FU) was 4 h and 36 min ± 7 h and 50 min, excluding 12 patients from Greenland and Faroe Islands. Ninety-five percent of the patients was very content or content with remote FU compared to in-clinic FU; 3% was less content and 2% was not content. For scheduled transmissions, 21% of the patients wished for a faster reply (sms or e-mail) compared to current practice with a letter. Eighty-four percent preferred more detailed information concerning ICD leads, battery status, and ICD therapies. A total of 96 patients (25%) had performed extra unscheduled remote transmissions: 20 due to shock, 20 due to alarm, 35 due to palpitations, and 18 for other or combined reasons. Ninety-five percent of the patients were content with the remote FU. Only 25% had unscheduled transmissions and most unscheduled transmissions were for appropriate reasons. Eighty-four percent of the patients wished for a more detailed response and 21% wished for a faster reply after routine transmissions.

  13. Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study.

    PubMed

    De Simone, Antonio; Leoni, Loira; Luzi, Mario; Amellone, Claudia; Stabile, Giuseppe; La Rocca, Vincenzo; Capucci, Alessandro; D'onofrio, Antonio; Ammendola, Ernesto; Accardi, Francesco; Valsecchi, Sergio; Buja, Gianfranco

    2015-08-01

    Internet-based remote interrogation systems have been shown to reduce emergency department and in-office visits in patients with implantable cardioverter defibrillators (ICDs), resulting in increased efficiency for healthcare providers. Nonetheless, studies sized to demonstrate the impact of remote monitoring on patients' outcome have been lacking. The EFFECT study was a multicentre clinical trial aimed at measuring and comparing the outcome of ICD patients conventionally followed-up by means of in-clinic visits (Standard arm) or by remote monitoring (Remote arm) in the clinical practice of 25 Italian centres. From 2011 to 2013, 987 consecutive patients were enrolled and followed up for at least 12 months. The primary endpoint was the rate of death and cardiovascular hospitalizations. Remote monitoring was adopted by 499 patients. Patients in the Standard and Remote arms did not differ significantly in terms of baseline clinical characteristics, except for a more frequent use of ICD with cardiac resynchronization therapy (CRT-D) in the Remote arm (48 vs. 36%, P < 0.001). One-year rates of the primary combined endpoint were 0.27 events/year for patients in the Standard arm and were 0.15 events/year for those in the Remote arm (incident rate ratio, 0.55; 95% CI, 0.41-0.73; P < 0.001). The endpoint rates in the Standard and Remote arms were 0.27 and 0.08 events/year, respectively, among CRT-D recipients (P < 0.001), and 0.28 vs. 0.21 among ICD patients (P = 0.094). The rates of in-office visits were 1.9 per year in the Standard arm and 1.7 per year in the Remote arm. Compared with the standard follow-up through in-office visits, remote monitoring is associated with reduced death and cardiovascular hospitalizations in patients with ICD in clinical practice. URL: http://clinicaltrials.gov/ Identifier: NCT01723865. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  14. The Use of Advance Directives Among Patients With Implantable Cardioverter Defibrillators

    PubMed Central

    Tajouri, Tanya H.; Ottenberg, Abigale L.; Hayes, David L.; Mueller, Paul S.

    2013-01-01

    Background We aimed to determine the prevalence of advance directives (ADs) among patients with implantable cardioverter defibrillators (ICDs) and of ADs that addressed ICD management at the end of life. Methods The medical records of all patients who underwent ICD implantation during 2007 at a single institution were reviewed retrospectively to determine the number of patients with an AD and the number of ADs mentioning the ICD specifically (ie, ICD management at end of life). Results During 2007, 420 patients (males, 71%) underwent ICD implantation at our institution (mean age [range] at implantation, 63 [1–90] years). Primary prevention was the most common indication for device therapy (254 patients [61%]). Overall, 127 patients (30%) had an AD, with 83 ADs (65%) completed more than 12 months before ICD implantation and 10 (8%) completed after it. Several life-sustaining treatments were mentioned in the ADs: tube feeding, 46 (37%); cardiopulmonary resuscitation, 25 (20%); mechanical ventilation, 22 (17%); and hemodialysis, 9 (7%). Pain control was mentioned in 58 ADs (46%) and comfort measures in 38 (30%). However, only 2 ADs (2%) mentioned the ICD or its deactivation at end of life. Conclusions About one-third of patients with ICDs had an AD, but only a couple ADs mentioned the ICD. These results suggest that clinicians should not only encourage patients with ICDs to complete an AD, but also encourage them to address ICD management specifically. Not addressing ICD management in an AD may result in ethical dilemmas during end-of- life care. PMID:22432897

  15. Posttraumatic Stress Disorder and Complex Posttraumatic Stress Disorder in DSM-5 and ICD-11: Clinical and Behavioral Correlates.

    PubMed

    Hyland, Philip; Shevlin, Mark; Fyvie, Claire; Karatzias, Thanos

    2018-04-01

    The American Psychiatric Association and the World Health Organization provide distinct trauma-based diagnoses in the fifth edition of the Diagnostic and Statistical Manual (DSM-5), and the forthcoming 11th version of the International Classification of Diseases (ICD-11), respectively. The DSM-5 conceptualizes posttraumatic stress disorder (PTSD) as a single, broad diagnosis, whereas the ICD-11 proposes two "sibling" disorders: PTSD and complex PTSD (CPTSD). The objectives of the current study were to: (a) compare prevalence rates of PTSD/CPTSD based on each diagnostic system; (b) identify clinical and behavioral variables that distinguish ICD-11 CPTSD and PTSD diagnoses; and (c) examine the diagnostic associations for ICD-11 CPTSD and DSM-5 PTSD. Participants in a predominately female clinical sample (N = 106) completed self-report scales to measure ICD-11 PTSD and CPTSD, DSM-5 PTSD, and depression, anxiety, borderline personality disorder, dissociation, destructive behaviors, and suicidal ideation and self-harm. Significantly more people were diagnosed with PTSD according to the DSM-5 criteria (90.4%) compared to those diagnosed with PTSD and CPTSD according to the ICD-11 guidelines (79.8%). An ICD-11 CPTSD diagnosis was distinguished from an ICD-11 PTSD diagnosis by higher levels of dissociation (d = 1.01), depression (d = 0.63), and borderline personality disorder (d = 0.55). Diagnostic associations with depression, anxiety, and suicidal ideation and self-harm were higher for ICD-11 CPTSD compared to DSM-5 PTSD (by 10.7%, 4.0%, and 7.0%, respectively). These results have implications for differential diagnosis and for the development of targeted treatments for CPTSD. Copyright © 2018 International Society for Traumatic Stress Studies.

  16. Reduction in depressive symptoms in primary prevention ICD scheduled patients - One year prospective study.

    PubMed

    Amiaz, Revital; Asher, Elad; Rozen, Guy; Czerniak, Efrat; Levi, Linda; Weiser, Mark; Glikson, Michael

    2017-09-01

    Implantable Cardioverter Defibrillators (ICDs), have previously been associated with the onset of depression and anxiety. The aim of this one-year prospective study was to evaluate the rate of new onset psychopathological symptoms after elective ICD implantation. A total of 158 consecutive outpatients who were scheduled for an elective ICD implantation were diagnosed and screened based on the Mini International Neuropsychiatric Interview (MINI). Depression and anxiety were evaluated using the Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A). Patient's attitude toward the ICD device was evaluated using a Visual Analog Scale (VAS). Patients' mean age was 64±12.4years; 134 (85%) were men, with the majority of patients performing the procedure for reasons of 'primary prevention'. According to the MINI diagnosis at baseline, three (2%) patients suffered from major depressive disorder and ten (6%) from dysthymia. Significant improvement in HAM-D mean scores was found between baseline, three months and one year after implantation (6.50±6.4; 4.10±5.3 and 2.7±4.6, respectively F(2100)=16.42; p<0.001). There was a significantly more positive attitude toward the device over time based on the VAS score [F(2122)=53.31, p<0.001]. ICD implantation significantly contributes to the reduction of depressive symptoms, while the overall mindset toward the ICD device was positive and improved during the one-year follow-up. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Depression, psychological distress, and quality of life in patients with cardioverter defibrillator with or without cardiac resynchronization therapy.

    PubMed

    Knackstedt, Christian; Arndt, Marlies; Mischke, Karl; Marx, Nikolaus; Nieman, Fred; Kunert, Hanns Jürgen; Schauerte, Patrick; Norra, Christine

    2014-05-01

    Congestive heart failure is frequent and leads to reduced exercise capacity, reduced quality of life (QoL), and depression in many patients. Cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillators (ICD) offer therapeutic options and may have an impact on QoL and depression. This study was performed to evaluate physical and mental health in patients undergoing ICD or combined CRT/ICD-implantation (CRT-D). Echocardiography, spiroergometry, and psychometric questionnaires [Beck Depression Inventory, General World Health Organization Five Well-being Index (WHO-5), Brief Symptom Inventory and 36-item Short Form (SF-36)] were obtained in 39 patients (ICD: 17, CRT-D: 22) at baseline and 6-month follow-up (FU) after device implantation. CRT-D patients had a higher NYHA class and broader left bundle branch block than ICD patients at baseline. At FU, ejection fraction (EF), peak oxygen uptake, and NYHA class improved significantly in CRT-D patients but remained unchanged in ICD patients. Patients with CRT-D implantation showed higher levels of depressive symptoms, psychological distress, and impairment in QoL at baseline and FU compared to ICD patients. These impairments remained mostly unchanged in all patients after 6 months. Overall, these findings imply that there is a need for careful assessment and treatment of psychological distress and depression in ICD and CRT-D patients in the course of device implantation as psychological burden seems to persist irrespective of physical improvement.

  18. Clinical implications of the proposed ICD-11 PTSD diagnostic criteria.

    PubMed

    Barbano, Anna C; van der Mei, Willem F; Bryant, Richard A; Delahanty, Douglas L; deRoon-Cassini, Terri A; Matsuoka, Yutaka J; Olff, Miranda; Qi, Wei; Ratanatharathorn, Andrew; Schnyder, Ulrich; Seedat, Soraya; Kessler, Ronald C; Koenen, Karestan C; Shalev, Arieh Y

    2018-05-14

    Projected changes to post-traumatic stress disorder (PTSD) diagnostic criteria in the upcoming International Classification of Diseases (ICD)-11 may affect the prevalence and severity of identified cases. This study examined differences in rates, severity, and overlap of diagnoses using ICD-10 and ICD-11 PTSD diagnostic criteria during consecutive assessments of recent survivors of traumatic events. The study sample comprised 3863 survivors of traumatic events, evaluated in 11 longitudinal studies of PTSD. ICD-10 and ICD-11 diagnostic rules were applied to the Clinician-Administered PTSD Scale (CAPS) to derive ICD-10 and ICD-11 diagnoses at different time intervals between trauma occurrence and 15 months. The ICD-11 criteria identified fewer cases than the ICD-10 across assessment intervals (range -47.09% to -57.14%). Over 97% of ICD-11 PTSD cases met concurrent ICD-10 PTSD criteria. PTSD symptom severity of individuals identified by the ICD-11 criteria (CAPS total scores) was 31.38-36.49% higher than those identified by ICD-10 criteria alone. The latter, however, had CAPS scores indicative of moderate PTSD. ICD-11 was associated with similar or higher rates of comorbid mood and anxiety disorders. Individuals identified by either ICD-10 or ICD-11 shortly after traumatic events had similar longitudinal course. This study indicates that significantly fewer individuals would be diagnosed with PTSD using the proposed ICD-11 criteria. Though ICD-11 criteria identify more severe cases, those meeting ICD-10 but not ICD-11 criteria remain in the moderate range of PTSD symptoms. Use of ICD-11 criteria will have critical implications for case identification in clinical practice, national reporting, and research.

  19. Leveraging the NLM map from SNOMED CT to ICD-10-CM to facilitate adoption of ICD-10-CM.

    PubMed

    Cartagena, F Phil; Schaeffer, Molly; Rifai, Dorothy; Doroshenko, Victoria; Goldberg, Howard S

    2015-05-01

    Develop and test web services to retrieve and identify the most precise ICD-10-CM code(s) for a given clinical encounter. Facilitate creation of user interfaces that 1) provide an initial shortlist of candidate codes, ideally visible on a single screen; and 2) enable code refinement. To satisfy our high-level use cases, the analysis and design process involved reviewing available maps and crosswalks, designing the rule adjudication framework, determining necessary metadata, retrieving related codes, and iteratively improving the code refinement algorithm. The Partners ICD-10-CM Search and Mapping Services (PI-10 Services) are SOAP web services written using Microsoft's.NET 4.0 Framework, Windows Communications Framework, and SQL Server 2012. The services cover 96% of the Partners problem list subset of SNOMED CT codes that map to ICD-10-CM codes and can return up to 76% of the 69,823 billable ICD-10-CM codes prior to creation of custom mapping rules. We consider ways to increase 1) the coverage ratio of the Partners problem list subset of SNOMED CT codes and 2) the upper bound of returnable ICD-10-CM codes by creating custom mapping rules. Future work will investigate the utility of the transitive closure of SNOMED CT codes and other methods to assist in custom rule creation and, ultimately, to provide more complete coverage of ICD-10-CM codes. ICD-10-CM will be easier for clinicians to manage if applications display short lists of candidate codes from which clinicians can subsequently select a code for further refinement. The PI-10 Services support ICD-10 migration by implementing this paradigm and enabling users to consistently and accurately find the best ICD-10-CM code(s) without translation from ICD-9-CM. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  20. Neurodevelopmental Disorders (ASD and ADHD): DSM-5, ICD-10, and ICD-11.

    PubMed

    Doernberg, Ellen; Hollander, Eric

    2016-08-01

    Neurodevelopmental disorders, specifically autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) have undergone considerable diagnostic evolution in the past decade. In the United States, the current system in place is the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), whereas worldwide, the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) serves as a general medical system. This review will examine the differences in neurodevelopmental disorders between these two systems. First, we will review the important revisions made from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) to the DSM-5, with respect to ASD and ADHD. Next, we will cover the similarities and differences between ASD and ADHD classification in the DSM-5 and the ICD-10, and how these differences may have an effect on neurodevelopmental disorder diagnostics and classification. By examining the changes made for the DSM-5 in 2013, and critiquing the current ICD-10 system, we can help to anticipate and advise on the upcoming ICD-11, due to come online in 2017. Overall, this review serves to highlight the importance of progress towards complementary diagnostic classification systems, keeping in mind the difference in tradition and purpose of the DSM and the ICD, and that these systems are dynamic and changing as more is learned about neurodevelopmental disorders and their underlying etiology. Finally this review will discuss alternative diagnostic approaches, such as the Research Domain Criteria (RDoC) initiative, which links symptom domains to underlying biological and neurological mechanisms. The incorporation of new diagnostic directions could have a great effect on treatment development and insurance coverage for neurodevelopmental disorders worldwide.

  1. [Impact of attachment style, social support and the number of implantable cardioverter defibrillator (ICD) discharges on psychological strain of ICD patients].

    PubMed

    Simson, Udo; Perings, Christian; Plaskuda, Ariane; Schäfer, Ralf; Brehm, Michael; Bader, Doris; Tress, Wolfgang; Franz, Matthias

    2006-12-01

    OBJECTIVE It is well known fact, that the life of ICD patients is often affected by anxiety and depression. The number of ICD discharges is only a contributing factor explaining the variance of anxiety and depression. There have to be other factors that have more influence on the physical strain of ICD patients. In this study we examined the impact of attachment style and social support in addition to the number of ICD discharges. METHODS 119 out-patients at an out-patient ICD unit were examined consecutively with the following self report scales: (1) the State-Trait-Anxiety Inventory (STAI), (2) the Beck Depression Inventory (BDI), (3) a short form of a social support questionnaire (F-SOZU), (4) the Bielefeld Partnership Expectations Questionnaire (BFPE) and (5) a specifically designed questionnaire for the assessment of sociodemografic data. To determine the frequency and timing of the ICD discharges we analysed the ICD data. RESULTS 38 % of the ICD patients reported enhanced anxiety levels and 37 % reported enhanced depression levels. Only 38 % of the ICD patients received discharges at all. Elevated levels of anxiety and depression were found in patients who showed insecure attachment styles, low social support, long-term treatment in hospital and a higher number of ICD discharges. To explain the variance of anxiety we found social support, attachment style, and the number of ICD storms to be contributing factors. To explain the variance of depression we found social support and time spent in hospital in the previous year to be contributing factors. CONCLUSIONS Almost half of the ICD patients suffer considerably from anxiety and/or depression. These patients have to be identified and treated psychotherapeutically. Patients who show insecure attachment styles, receive low social support, undergo long-term treatment in hospital and receive a higher number of discharges, especially so called ICD storms, bear the highest risk to develop psychological strain

  2. Age-related differences in the effect of psychological distress on mortality: Type D personality in younger versus older patients with cardiac arrhythmias.

    PubMed

    Denollet, Johan; Tekle, Fetene B; van der Voort, Pepijn H; Alings, Marco; van den Broek, Krista C

    2013-01-01

    Mixed findings in biobehavioral research on heart disease may partly be attributed to age-related differences in the prognostic value of psychological distress. This study sought to test the hypothesis that Type D (distressed) personality contributes to an increased mortality risk following implantable cardioverter defibrillator (ICD) treatment in younger patients but not in older patients. The Type D Scale (DS14) was used to assess general psychological distress in 455 younger (≤70 y, m = 59.1) and 134 older (>70 y, m = 74.3) ICD patients. End points were all-cause mortality and cardiac death after a median follow-up of 3.2 years. Older patients had more advanced heart failure and a higher mortality rate (n = 34/25%) than younger patients (n = 60/13%), P = 0.001. Cardiac resynchronization therapy (CRT), but not Type D personality, was associated with increased mortality in older patients. Among younger patients, however, Type D personality was associated with an adjusted hazard ratio = 1.91 (95% CI 1.09-3.34) and 2.26 (95% CI 1.16-4.41) for all-cause and cardiac mortality; other predictors were increasing age, CRT, appropriate shocks, ACE-inhibitors, and smoking. Type D personality was independently associated with all-cause and cardiac mortality in younger ICD patients but not in older patients. Cardiovascular research needs to further explore age-related differences in psychosocial risk.

  3. Recent advances in radiation cancer therapy

    NASA Astrophysics Data System (ADS)

    Ma, C.-M. Charlie

    2007-03-01

    This paper presents the recent advances in radiation therapy techniques for the treatment of cancer. Significant improvement has been made in imaging techniques such as CT, MRI, MRS, PET, ultrasound, etc. that have brought marked advances in tumor target and critical structure delineation for treatment planning and patient setup and target localization for accurate dose delivery in radiation therapy of cancer. Recent developments of novel treatment modalities including intensity-modulated x-ray therapy (IMXT), energy- and intensity modulated electron therapy (MERT) and intensity modulated proton therapy (IMPT) together with the use of advanced image guidance have enabled precise dose delivery for dose escalation and hypofractionation studies that may result in better local control and quality of life. Particle acceleration using laser-induced plasmas has great potential for new cost-effective radiation sources that may have a great impact on the management of cancer using radiation therapy.

  4. [Cause-of-death statistics and ICD, quo vadis?

    PubMed

    Eckert, Olaf; Vogel, Ulrich

    2018-07-01

    The International Statistical Classification of Diseases and Related Health Problems (ICD) is the worldwide binding standard for generating underlying cause-of-death statistics. What are the effects of former revisions of the ICD on underlying cause-of-death statistics and which opportunities and challenges are becoming apparent in a possible transition process from ICD-10 to ICD-11?This article presents the calculation of the exploitation grade of ICD-9 and ICD-10 in the German cause-of-death statistics and quality of documentation. Approximately 67,000 anonymized German death certificates are processed by Iris/MUSE and official German cause-of-death statistics are analyzed.In addition to substantial changes in the exploitation grade in the transition from ICD-9 to ICD-10, regional effects become visible. The rate of so-called "ill-defined" conditions exceeds 10%.Despite substantial improvement of ICD revisions there are long-known deficits in the coroner's inquest, filling death certificates and quality of coding. To make better use of the ICD as a methodological framework for mortality statistics and health reporting in Germany, the following measures are necessary: 1. General use of Iris/MUSE, 2. Establishing multiple underlying cause-of-death statistics, 3. Introduction of an electronic death certificate, 4. Improvement of the medical assessment of cause of death.Within short time the WHO will release the 11th revision of the ICD that will provide additional opportunities for the development of underlying cause-of-death statistics and their use in science, public health and politics. A coordinated effort including participants in the process and users is necessary to meet the related challenges.

  5. Greater Prevalence of Proposed ICD-11 Alcohol and Cannabis Dependence Compared to ICD-10, DSM-IV, and DSM-5 in Treated Adolescents.

    PubMed

    Chung, Tammy; Cornelius, Jack; Clark, Duncan; Martin, Christopher

    2017-09-01

    Proposed International Classification of Diseases, 11th edition (ICD-11), criteria for substance use disorder (SUD) radically simplify the algorithm used to diagnose substance dependence. Major differences in case identification across DSM and ICD impact determinations of treatment need and conceptualizations of substance dependence. This study compared the draft algorithm for ICD-11 SUD against DSM-IV, DSM-5, and ICD-10, for alcohol and cannabis. Adolescents (n = 339, ages 14 to 18) admitted to intensive outpatient addictions treatment completed, as part of a research study, a Structured Clinical Interview for DSM SUDs adapted for use with adolescents and which has been used to assess DSM and ICD SUD diagnoses. Analyses examined prevalence across classification systems, diagnostic concordance, and sources of diagnostic disagreement. Prevalence of any past-year proposed ICD-11 alcohol or cannabis use disorder was significantly lower compared to DSM-IV and DSM-5 (ps < 0.01). However, prevalence of proposed ICD-11 alcohol and cannabis dependence diagnoses was significantly higher compared to DSM-IV, DSM-5, and ICD-10 (ps < 0.01). ICD-11 and DSM-5 SUD diagnoses showed only moderate concordance. For both alcohol and cannabis, youth typically met criteria for an ICD-11 dependence diagnosis by reporting tolerance and much time spent using or recovering from the substance, rather than symptoms indicating impaired control over use. The proposed ICD-11 dependence algorithm appears to "overdiagnose" dependence on alcohol and cannabis relative to DSM-IV and ICD-10 dependence, and DSM-5 moderate/severe use disorder, generating potential "false-positive" cases of dependence. Among youth who met criteria for proposed ICD-11 dependence, few reported impaired control over substance use, highlighting ongoing issues in the conceptualization and diagnosis of SUD. Copyright © 2017 by the Research Society on Alcoholism.

  6. Advances in 4D Treatment Planning for Scanned Particle Beam Therapy — Report of Dedicated Workshops

    PubMed Central

    Bert, Christoph; Graeff, Christian; Riboldi, Marco; Nill, Simeon; Baroni, Guido; Knopf, Antje-Christin

    2014-01-01

    We report on recent progress in the field of mobile tumor treatment with scanned particle beams, as discussed in the latest editions of the 4D treatment planning workshop. The workshop series started in 2009, with about 20 people from 4 research institutes involved, all actively working on particle therapy delivery and development. The first workshop resulted in a summary of recommendations for the treatment of mobile targets, along with a list of requirements to apply these guidelines clinically. The increased interest in the treatment of mobile tumors led to a continuously growing number of attendees: the 2012 edition counted more than 60 participants from 20 institutions and commercial vendors. The focus of research discussions among workshop participants progressively moved from 4D treatment planning to complete 4D treatments, aiming at effective and safe treatment delivery. Current research perspectives on 4D treatments include all critical aspects of time resolved delivery, such as in-room imaging, motion detection, beam application, and quality assurance techniques. This was motivated by the start of first clinical treatments of hepato cellular tumors with a scanned particle beam, relying on gating or abdominal compression for motion mitigation. Up to date research activities emphasize significant efforts in investigating advanced motion mitigation techniques, with a specific interest in the development of dedicated tools for experimental validation. Potential improvements will be made possible in the near future through 4D optimized treatment plans that require upgrades of the currently established therapy control systems for time resolved delivery. But since also these novel optimization techniques rely on the validity of the 4DCT, research focusing on alternative 4D imaging technique, such as MRI based 4DCT generation will continue. PMID:24354749

  7. Comparison of DSM-5 and proposed ICD-11 criteria for PTSD with DSM-IV and ICD-10: changes in PTSD prevalence in military personnel.

    PubMed

    Kuester, Annika; Köhler, Kai; Ehring, Thomas; Knaevelsrud, Christine; Kober, Louisa; Krüger-Gottschalk, Antje; Schäfer, Ingo; Schellong, Julia; Wesemann, Ulrich; Rau, Heinrich

    2017-01-01

    Background: Recently, changes have been introduced to the diagnostic criteria for posttraumatic stress disorder (PTSD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) and the International Classification of Diseases (ICD). Objectives: This study investigated the effect of the diagnostic changes made from DSM-IV to DSM-5 and from ICD-10 to the proposed ICD-11. The concordance of provisional PTSD prevalence between the diagnostic criteria was examined in a convenience sample of 100 members of the German Armed Forces. Method: Based on questionnaire measurements, provisional PTSD prevalence was assessed according to DSM-IV, DSM-5, ICD-10, and proposed ICD-11 criteria. Consistency of the diagnostic status across the diagnostic systems was statistically evaluated. Results: Provisional PTSD prevalence was the same for DSM-IV and DSM-5 (both 56%) and comparable under DSM-5 versus ICD-11 proposal (48%). Agreement between DSM-IV and DSM-5, and between DSM-5 and the proposed ICD-11, was high (both p  < .001). Provisional PTSD prevalence was significantly increased under ICD-11 proposal compared to ICD-10 (30%) which was mainly due to the deletion of the time criterion. Agreement between ICD-10 and the proposed ICD-11 was low ( p  = .014). Conclusion: This study provides preliminary evidence for a satisfactory concordance between provisional PTSD prevalence based on the diagnostic criteria for PTSD that are defined using DSM-IV, DSM-5, and proposed ICD-11. This supports the assumption of a set of PTSD core symptoms as suggested in the ICD-11 proposal, when at the same time a satisfactory concordance between ICD-11 proposal and DSM was given. The finding of increased provisional PTSD prevalence under ICD-11 proposal in contrast to ICD-10 can be of guidance for future epidemiological research on PTSD prevalence, especially concerning further investigations on the impact, appropriateness, and usefulness of the time criterion included in ICD-10

  8. Comparison of DSM-5 and proposed ICD-11 criteria for PTSD with DSM-IV and ICD-10: changes in PTSD prevalence in military personnel

    PubMed Central

    Kuester, Annika; Köhler, Kai; Ehring, Thomas; Knaevelsrud, Christine; Kober, Louisa; Krüger-Gottschalk, Antje; Schäfer, Ingo; Schellong, Julia; Wesemann, Ulrich; Rau, Heinrich

    2017-01-01

    ABSTRACT Background: Recently, changes have been introduced to the diagnostic criteria for posttraumatic stress disorder (PTSD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) and the International Classification of Diseases (ICD). Objectives:This study investigated the effect of the diagnostic changes made from DSM-IV to DSM-5 and from ICD-10 to the proposed ICD-11. The concordance of provisional PTSD prevalence between the diagnostic criteria was examined in a convenience sample of 100 members of the German Armed Forces. Method: Based on questionnaire measurements, provisional PTSD prevalence was assessed according to DSM-IV, DSM-5, ICD-10, and proposed ICD-11 criteria. Consistency of the diagnostic status across the diagnostic systems was statistically evaluated. Results: Provisional PTSD prevalence was the same for DSM-IV and DSM-5 (both 56%) and comparable under DSM-5 versus ICD-11 proposal (48%). Agreement between DSM-IV and DSM-5, and between DSM-5 and the proposed ICD-11, was high (both p < .001). Provisional PTSD prevalence was significantly increased under ICD-11 proposal compared to ICD-10 (30%) which was mainly due to the deletion of the time criterion. Agreement between ICD-10 and the proposed ICD-11 was low (p = .014). Conclusion: This study provides preliminary evidence for a satisfactory concordance between provisional PTSD prevalence based on the diagnostic criteria for PTSD that are defined using DSM-IV, DSM-5, and proposed ICD-11. This supports the assumption of a set of PTSD core symptoms as suggested in the ICD-11 proposal, when at the same time a satisfactory concordance between ICD-11 proposal and DSM was given. The finding of increased provisional PTSD prevalence under ICD-11 proposal in contrast to ICD-10 can be of guidance for future epidemiological research on PTSD prevalence, especially concerning further investigations on the impact, appropriateness, and usefulness of the time criterion included in ICD

  9. Prospective evaluation of defibrillation threshold and postshock rhythm in young ICD recipients.

    PubMed

    Radbill, Andrew E; Triedman, John K; Berul, Charles I; Walsh, Edward P; Alexander, Mark E; Webster, Gregory; Cecchin, Frank

    2012-12-01

    Adaptation of implantable cardioverter defibrillator (ICD) systems to the needs of pediatric and congenital heart patients is problematic due to constraints of vascular and thoracic anatomy. An improved understanding of the defibrillation energy and postshock pacing requirements in such patients may help direct more tailored ICD therapy. We describe the first prospective evaluation of defibrillation threshold (DFT) and postshock rhythm in this population. We prospectively studied patients ≤ 60 kg at time of ICD intervention. DFTs were obtained using a binary search protocol with three VF inductions. Postshock pacing was programmed using a stepwise protocol, lowering the rate prior to each VF induction. Twenty patients were enrolled: 11 had channelopathy, five congenital heart disease, and four cardiomyopathy. The median age was 16 years, median weight 48 kg. Twelve patients had a transvenous high-voltage coil; eight had pericardial +/- subcutaneous coil(s). Median DFT was 7 J (range 3-31 J); 19/20 patients had DFT ≤ 15 J and all patients <25 kg had DFT ≤ 9 J (n = 6). There was no difference in DFT between patients with transvenous versus pericardial +/- subcutaneous coils (median 7 J vs 6 J, P = 0.59). No patient with normal atrioventricular conduction prior to defibrillation required postshock pacing (n = 16). There were no adverse events. These data suggest that many pediatric ICD patients have low DFTs and adequate postshock escape rhythm. This may help determine appropriate parameters for future design of pediatric-specific ICDs. ©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.

  10. Measuring diagnoses: ICD code accuracy.

    PubMed

    O'Malley, Kimberly J; Cook, Karon F; Price, Matt D; Wildes, Kimberly Raiford; Hurdle, John F; Ashton, Carol M

    2005-10-01

    To examine potential sources of errors at each step of the described inpatient International Classification of Diseases (ICD) coding process. The use of disease codes from the ICD has expanded from classifying morbidity and mortality information for statistical purposes to diverse sets of applications in research, health care policy, and health care finance. By describing a brief history of ICD coding, detailing the process for assigning codes, identifying where errors can be introduced into the process, and reviewing methods for examining code accuracy, we help code users more systematically evaluate code accuracy for their particular applications. We summarize the inpatient ICD diagnostic coding process from patient admission to diagnostic code assignment. We examine potential sources of errors at each step and offer code users a tool for systematically evaluating code accuracy. Main error sources along the "patient trajectory" include amount and quality of information at admission, communication among patients and providers, the clinician's knowledge and experience with the illness, and the clinician's attention to detail. Main error sources along the "paper trail" include variance in the electronic and written records, coder training and experience, facility quality-control efforts, and unintentional and intentional coder errors, such as misspecification, unbundling, and upcoding. By clearly specifying the code assignment process and heightening their awareness of potential error sources, code users can better evaluate the applicability and limitations of codes for their particular situations. ICD codes can then be used in the most appropriate ways.

  11. Heart rate turbulence predicts ICD-resistant mortality in ischaemic heart disease.

    PubMed

    Marynissen, Thomas; Floré, Vincent; Heidbuchel, Hein; Nuyens, Dieter; Ector, Joris; Willems, Rik

    2014-07-01

    In high-risk patients, implantable cardioverter-defibrillators (ICDs) can convert the mode of death from arrhythmic to pump failure death. Therefore, we introduced the concept of 'ICD-resistant mortality' (IRM), defined as death (a) without previous appropriate ICD intervention (AI), (b) within 1 month after the first AI, or (c) within 1 year after the initial ICD implantation. Implantable cardioverter-defibrillator implantation in patients with a high risk of IRM should be avoided. Implantable cardioverter-defibrillator patients with ischaemic heart disease were included if a digitized 24 h Holter was available pre-implantation. Demographic, electrocardiographic, echocardiographic, and 24 h Holter risk factors were collected at device implantation. The primary endpoint was IRM. Cox regression analyses were used to test the association between predictors and outcome. We included 130 patients, with a mean left ventricular ejection fraction (LVEF) of 33.6 ± 10.3%. During a follow-up of 52 ± 31 months, 33 patients died. There were 21 cases of IRM. Heart rate turbulence (HRT) was the only Holter parameter associated with IRM and total mortality. A higher New York Heart Association (NYHA) class and a lower body mass index were the strongest predictors of IRM. Left ventricular ejection fraction predicted IRM on univariate analysis, and was the strongest predictor of total mortality. The only parameter that predicted AI was non-sustained ventricular tachycardia. Implantable cardioverter-defibrillator implantation based on NYHA class and LVEF leads to selection of patients with a higher risk of IRM and death. Heart rate turbulence may have added value for the identification of poor candidates for ICD therapy. Available Holter parameters seem limited in their ability to predict AI. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2013. For permissions please email: journals.permissions@oup.com.

  12. Incidence, predictors, and procedural results of upgrade to resynchronization therapy: the RAFT upgrade substudy.

    PubMed

    Essebag, Vidal; Joza, Jacqueline; Birnie, David H; Sapp, John L; Sterns, Laurence D; Philippon, Francois; Yee, Raymond; Crystal, Eugene; Kus, Teresa; Rinne, Claus; Healey, Jeffrey S; Sami, Magdi; Thibault, Bernard; Exner, Derek V; Coutu, Benoit; Simpson, Chris S; Wulffhart, Zaev; Yetisir, Elizabeth; Wells, George; Tang, Anthony S L

    2015-02-01

    The resynchronization-defibrillation for ambulatory heart failure trial (RAFT) study demonstrated that adding cardiac resynchronization therapy (CRT) in selected patients requiring de novo implantable cardiac defibrillators (ICD) reduced mortality as compared with ICD therapy alone, despite an increase in procedure-related adverse events. Data are lacking regarding the management of patients with ICD therapy who develop an indication for CRT upgrade. Participating RAFT centers provided data regarding de novo CRT-D (CRT with ICD) implant, upgrade to CRT-D during RAFT (study upgrade), and upgrade within 6 months after presentation of study results (substudy). Substudy centers enrolled 1346 (74.9%) patients in RAFT, including 644 de novo, 80 study upgrade, and 60 substudy CRT attempts. The success rate (initial plus repeat attempts) was 95.2% for de novo versus 96.3% for study upgrade and 90.0% for substudy CRT attempts (P=0.402). Acute complications occurred among 26.2% of de novo versus 18.8% of study upgrade and 3.4% of substudy CRT implantation attempts (P<0.001). The most common complication was left ventricular lead dislodgement. The principal reasons for not yet attempting upgrade in the substudy were patient preference (31.9%), New York Heart Association Class I (17.0%), and a QRS<150 ms (13.1%). Among a broad group of implant physicians, CRT upgrades were performed in patients with an ICD in situ with no difference in implant success rate and a reduced acute complication rate as compared with a de novo CRT implant. Decisions to upgrade were influenced by predictors of benefit in subgroup analyses of the RAFT study and other trials. © 2014 American Heart Association, Inc.

  13. Does Age Influence Cardiac Resynchronization Therapy Use and Outcome?

    PubMed

    Heidenreich, Paul A; Tsai, Vivian; Bao, Haikun; Curtis, Jeptha; Goldstein, Mary; Curtis, Lesley; Hernandez, Adrian; Peterson, Pamela; Turakhia, Mintu P; Masoudi, Frederick A

    2015-06-01

    This study sought to describe the use of CRT-D and its association with survival for older patients. Many patients who receive cardiac resynchronization therapy with defibrillator (CRT-D) in practice are older than those included in clinical trials. We identified patients undergoing ICD implantation in the National Cardiovascular Disease Registry (NCDR) ICD registry from 2006 to 2009, who also met clinical trial criteria for CRT, including left ventricular ejection fraction (LVEF) ≤35%, QRS ≥120 ms, and New York Heart Association (NYHA) functional class III or IV. NCDR registry data were linked to the social security death index to determine the primary outcome of time to death from any cause. We identified 70,854 patients from 1,187 facilities who met prior trial criteria for CRT-D. The mean age of the 58,147 patients receiving CRT-D was 69.4 years with 6.4% of patients age 85 or older. CRT use was 80% or higher among candidates in all age groups. Follow-up was available for 42,285 patients age ≥65 years at 12 months. Receipt of CRT-D was associated with better survival at 1 year (82.1% vs. 77.1%, respectively) and 4 years (54.0% vs. 46.2% , respectively) than in those receiving only an ICD (p < 0.001). The CRT association with improved survival was not different for different age groups (p = 0.86 for interaction). More than 80% of older patients undergoing ICD implantation who were candidates for a CRT-D received the combined device. Mortality in older patients undergoing ICD implantation was high but was lower for those receiving CRT-D. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  14. Comparative Effectiveness of Cardiac Resynchronization Therapy Defibrillators Versus Standard Implantable Defibrillators in Medicare Patients.

    PubMed

    Zusterzeel, Robbert; Caños, Daniel A; Sanders, William E; Silverman, Henry; MaCurdy, Thomas E; Worrall, Christopher M; Kelman, Jeffrey; Marinac-Dabic, Danica; Strauss, David G

    2015-07-01

    Previous analyses have shown that there is lower mortality with cardiac resynchronization therapy defibrillators (CRT-D) in patients with left bundle branch block (LBBB) but demonstrated mixed results in patients without LBBB. We evaluated the comparative effectiveness of CRT-D versus standard implantable defibrillators (ICDs) separately in patients with LBBB and right bundle branch block (RBBB) using Medicare claims data. Medicare records from CRT-D and ICD recipients from 2002 to 2009 that were followed up for up to 48 months were analyzed. We used propensity scores to match patients with ICD to those with CRT-D. In LBBB, 1:1 matching with replacement resulted in 54,218 patients with CRT-D and 20,763 with ICD, and in RBBB, 1:1 matching resulted in 7,298 patients with CRT-D and 7,298 with ICD. In LBBB, CRT-D had a 12% lower risk of heart failure hospitalization or death (hazard ratio [HR] 0.88, 95% confidence interval 0.86 to 0.90) and 5% lower death risk (HR 0.95, 0.92 to 0.97) compared with ICD. In RBBB, CRT-D had a 15% higher risk of heart failure hospitalization or death (HR 1.15, 1.10 to 1.20) and 13% higher death risk (HR 1.13, 1.07 to 1.18). Sensitivity analysis revealed that accounting for covariates not captured in the Medicare database may lead to increased benefit with CRT-D in LBBB and no difference in RBBB. In conclusion, in a large Medicare population, CRT-D was associated with lower mortality in LBBB but higher mortality in RBBB. The absence of certain covariates, in particular those that determine treatment selection, may affect the results of comparative effectiveness studies using claims data. Published by Elsevier Inc.

  15. Measuring Diagnoses: ICD Code Accuracy

    PubMed Central

    O'Malley, Kimberly J; Cook, Karon F; Price, Matt D; Wildes, Kimberly Raiford; Hurdle, John F; Ashton, Carol M

    2005-01-01

    Objective To examine potential sources of errors at each step of the described inpatient International Classification of Diseases (ICD) coding process. Data Sources/Study Setting The use of disease codes from the ICD has expanded from classifying morbidity and mortality information for statistical purposes to diverse sets of applications in research, health care policy, and health care finance. By describing a brief history of ICD coding, detailing the process for assigning codes, identifying where errors can be introduced into the process, and reviewing methods for examining code accuracy, we help code users more systematically evaluate code accuracy for their particular applications. Study Design/Methods We summarize the inpatient ICD diagnostic coding process from patient admission to diagnostic code assignment. We examine potential sources of errors at each step and offer code users a tool for systematically evaluating code accuracy. Principle Findings Main error sources along the “patient trajectory” include amount and quality of information at admission, communication among patients and providers, the clinician's knowledge and experience with the illness, and the clinician's attention to detail. Main error sources along the “paper trail” include variance in the electronic and written records, coder training and experience, facility quality-control efforts, and unintentional and intentional coder errors, such as misspecification, unbundling, and upcoding. Conclusions By clearly specifying the code assignment process and heightening their awareness of potential error sources, code users can better evaluate the applicability and limitations of codes for their particular situations. ICD codes can then be used in the most appropriate ways. PMID:16178999

  16. Advances in the Immunobiological Therapies for Advanced Melanoma.

    PubMed

    Pérez Gago, M C; Saavedra Santa Gadea, O; de la Cruz-Merino, L

    2017-10-01

    Metastatic or locally advanced unresectable melanoma carries a high morbidity and mortality. However, notable advances have been made in recent years in the systemic treatment of this disease, with the appearance of targeted therapy using tyrosine kinase inhibitors that block the mitogen activated protein kinase pathway, and of modern immunotherapy with immune-modulating monoclonal antibodies. In this paper, we provide an update of available data on new immune therapies and we review the clinical development that led to their approval for use in routine clinical practice. Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. ICD-9-CM and ICD-10-CM mapping of the AAST Emergency General Surgery disease severity grading systems: Conceptual approach, limitations, and recommendations for the future.

    PubMed

    Utter, Garth H; Miller, Preston R; Mowery, Nathan T; Tominaga, Gail T; Gunter, Oliver; Osler, Turner M; Ciesla, David J; Agarwal, Suresh K; Inaba, Kenji; Aboutanos, Michel B; Brown, Carlos V R; Ross, Steven E; Crandall, Marie L; Shafi, Shahid

    2015-05-01

    The American Association for the Surgery of Trauma (AAST) recently established a grading system for uniform reporting of anatomic severity of several emergency general surgery (EGS) diseases. There are five grades of severity for each disease, ranging from I (lowest severity) to V (highest severity). However, the grading process requires manual chart review. We sought to evaluate whether International Classification of Diseases, 9th and 10th Revisions, Clinical Modification (ICD-9-CM, ICD-10-CM) codes might allow estimation of AAST grades for EGS diseases. The Patient Assessment and Outcomes Committee of the AAST reviewed all available ICD-9-CM and ICD-10-CM diagnosis codes relevant to 16 EGS diseases with available AAST grades. We then matched grades for each EGS disease with one or more ICD codes. We used the Official Coding Guidelines for ICD-9-CM and ICD-10-CM and the American Hospital Association's "Coding Clinic for ICD-9-CM" for coding guidance. The ICD codes did not allow for matching all five AAST grades of severity for each of the 16 diseases. With ICD-9-CM, six diseases mapped into four categories of severity (instead of five), another six diseases into three categories of severity, and four diseases into only two categories of severity. With ICD-10-CM, five diseases mapped into four categories of severity, seven diseases into three categories, and four diseases into two categories. Two diseases mapped into discontinuous categories of grades (two in ICD-9-CM and one in ICD-10-CM). Although resolution is limited, ICD-9-CM and ICD-10-CM diagnosis codes might have some utility in roughly approximating the severity of the AAST grades in the absence of more precise information. These ICD mappings should be validated and refined before widespread use to characterize EGS disease severity. In the long-term, it may be desirable to develop alternatives to ICD-9-CM and ICD-10-CM codes for routine collection of disease severity characteristics.

  18. Legal basis of the Advanced Therapies Regulation.

    PubMed

    Jekerle, V; Schröder, C; Pedone, E

    2010-01-01

    Advanced therapy medicinal products consist of gene therapy, somatic cell therapy and tissue engineered products. Due to their specific manufacturing process and mode of action these products require specially tailored legislation. With Regulation (EC) No. 1394/2007, these needs have been met. Definitions of gene therapy, somatic cell therapy and tissue engineered products were laid down. A new committee, the Committee for Advanced Therapies, was founded, special procedures such as the certification procedure for small- and medium-sized enterprises were established and the technical requirements for Marketing Authorisation Applications (quality, non-clinical and clinical) were revised.

  19. Development of the ICD-10 simplified version and field test.

    PubMed

    Paoin, Wansa; Yuenyongsuwan, Maliwan; Yokobori, Yukiko; Endo, Hiroyoshi; Kim, Sukil

    2018-05-01

    The International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) has been used in various Asia-Pacific countries for more than 20 years. Although ICD-10 is a powerful tool, clinical coding processes are complex; therefore, many developing countries have not been able to implement ICD-10-based health statistics (WHO-FIC APN, 2007). This study aimed to simplify ICD-10 clinical coding processes, to modify index terms to facilitate computer searching and to provide a simplified version of ICD-10 for use in developing countries. The World Health Organization Family of International Classifications Asia-Pacific Network (APN) developed a simplified version of the ICD-10 and conducted field testing in Cambodia during February and March 2016. Ten hospitals were selected to participate. Each hospital sent a team to join a training workshop before using the ICD-10 simplified version to code 100 cases. All hospitals subsequently sent their coded records to the researchers. Overall, there were 1038 coded records with a total of 1099 ICD clinical codes assigned. The average accuracy rate was calculated as 80.71% (66.67-93.41%). Three types of clinical coding errors were found. These related to errors relating to the coder (14.56%), those resulting from the physician documentation (1.27%) and those considered system errors (3.46%). The field trial results demonstrated that the APN ICD-10 simplified version is feasible for implementation as an effective tool to implement ICD-10 clinical coding for hospitals. Developing countries may consider adopting the APN ICD-10 simplified version for ICD-10 code assignment in hospitals and health care centres. The simplified version can be viewed as an introductory tool which leads to the implementation of the full ICD-10 and may support subsequent ICD-11 adoption.

  20. Validation of the Combined Comorbidity Index of Charlson and Elixhauser to Predict 30-Day Mortality Across ICD-9 and ICD-10.

    PubMed

    Simard, Marc; Sirois, Caroline; Candas, Bernard

    2018-05-01

    To validate and compare performance of an International Classification of Diseases, tenth revision (ICD-10) version of a combined comorbidity index merging conditions of Charlson and Elixhauser measures against individual measures in the prediction of 30-day mortality. To select a weight derivation method providing optimal performance across ICD-9 and ICD-10 coding systems. Using 2 adult population-based cohorts of patients with hospital admissions in ICD-9 (2005, n=337,367) and ICD-10 (2011, n=348,820), we validated a combined comorbidity index by predicting 30-day mortality with logistic regression. To appreciate performance of the Combined index and both individual measures, factors impacting indices performance such as population characteristics and weight derivation methods were accounted for. We applied 3 scoring methods (Van Walraven, Schneeweiss, and Charlson) and determined which provides best predictive values. Combined index [c-statistics: 0.853 (95% confidence interval: CI, 0.848-0.856)] performed better than original Charlson [0.841 (95% CI, 0.835-0.844)] or Elixhauser [0.841 (95% CI, 0.837-0.844)] measures on ICD-10 cohort. All weight derivation methods provided close high discrimination results for the Combined index (Van Walraven: 0.852, Schneeweiss: 0.851, Charlson: 0.849). Results were consistent across both coding systems. The Combined index remains valid with both ICD-9 and ICD-10 coding systems and the 3 weight derivation methods evaluated provided consistent high performance across those coding systems.

  1. Towards eradication of inappropriate therapies for ICD lead failure by combining comprehensive remote monitoring and lead noise alerts.

    PubMed

    Ploux, Sylvain; Swerdlow, Charles D; Strik, Marc; Welte, Nicolas; Klotz, Nicolas; Ritter, Philippe; Haïssaguerre, Michel; Bordachar, Pierre

    2018-06-02

    Recognition of implantable cardioverter defibrillator (ICD) lead malfunction before occurrence of life threatening complications is crucial. We aimed to assess the effectiveness of remote monitoring associated or not with a lead noise alert for early detection of ICD lead failure. From October 2013 to April 2017, a median of 1,224 (578-1,958) ICD patients were remotely monitored with comprehensive analysis of all transmitted materials. ICD lead failure and subsequent device interventions were prospectively collected in patients with (RMLN) and without (RM) a lead noise alert (Abbott Secure Sense™ or Medtronic Lead Integrity Alert™) in their remote monitoring system. During a follow-up of 4,457 patient years, 64 lead failures were diagnosed. Sixty-one (95%) of the diagnoses were made before any clinical complication occurred. Inappropriate shocks were delivered in only one patient of each group (3%), with an annual rate of 0.04%. All high voltage conductor failures were identified remotely by a dedicated impedance alert in 10 patients. Pace-sense component failures were correctly identified by a dedicated alert in 77% (17 of 22) of the RMLN group versus 25% (8 of 32) of the RM group (P = 0.002). The absence of a lead noise alert was associated with a 16-fold increase in the likelihood of initiating either a shock or ATP (OR: 16.0, 95% CI 1.8-143.3; P = 0.01). ICD remote monitoring with systematic review of all transmitted data is associated with a very low rate of inappropriate shocks related to lead failure. Dedicated noise alerts further reduce inappropriate detection of ventricular arrhythmias. © 2018 Wiley Periodicals, Inc.

  2. Substance use and addictive disorders in DSM-5 and ICD 10 and the draft ICD 11.

    PubMed

    Saunders, John B

    2017-07-01

    The present review compares and contrasts the diagnostic entities and taxonomy of substance use and addictive disorders in the beta draft of the Eleventh Revision of the International Classification of Diseases (ICD 11), which was released in November 2016, and the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), which was published in mid-2013. Recently published papers relevant to these two classification systems are examined. New initiatives in diagnosis and assessment including the addictions neuroclinical assessment are noted. The draft ICD 11 retains substance dependence as the 'master diagnosis' in contrast to the broader and heterogeneous concept of substance use disorder in DSM-5 and there is empirical support for the coherence of substance dependence for alcohol, cannabis, and prescribed opioids. Both systems now include gambling disorder in the addictive disorders section, with it being transferred from the impulse control disorders section. The new diagnosis of Internet gaming disorder is included in DSM-5 as a condition for further study, and gaming disorder is grouped with the substance and gambling disorders in the draft ICD 11. Initiatives from the U.S. National Institutes of Health (NIH) are highlighting the importance of capturing the neurobiological phases of the addictive cycle in clinical diagnosis and assessment. Although most of the changes in the draft ICD 11 and DSM-5 are incremental, the contrast between DSM-5 substance use disorder and substance dependence in the draft ICD 11, and the inclusion of gambling disorder and gaming disorder will generate much discussion and research.

  3. Comprehensive cardiac rehabilitation improves outcome for patients with implantable cardioverter defibrillator. Findings from the COPE-ICD randomised clinical trial.

    PubMed

    Berg, Selina Kikkenborg; Pedersen, Preben U; Zwisler, Ann-Dorthe; Winkel, Per; Gluud, Christian; Pedersen, Birthe D; Svendsen, Jesper H

    2015-02-01

    The aim of this randomised clinical trial was to assess a comprehensive cardiac rehabilitation intervention including exercise training and psycho-education vs 'treatment as usual' in patients treated with an implantable cardioverter defibrillator (ICD). In this study 196 patients with first time ICD implantation (mean age 57.2 (standard deviation (SD)=13.2); 79% men) were randomised (1:1) to comprehensive cardiac rehabilitation vs 'treatment as usual'. Altogether 144 participants completed the 12 month follow-up. The intervention consisted of twelve weeks of exercise training and one year of psycho-educational follow-up focusing on modifiable factors associated with poor outcomes. Two primary outcomes, general health score (Short Form-36 (SF-36)) and peak oxygen uptake (VO₂), were used. Post-hoc analyses included SF-36 and ICD therapy history. Comprehensive cardiac rehabilitation significantly increased VO2 uptake after exercise training to 23.0 (95% confidence interval (CI) 20.9-22.7) vs 20.8 (95% CI 18.9-22.7) ml/min/kg in the control group (p=0.004 (multiplicity p=0.015)). Comprehensive cardiac rehabilitation significantly increased general health; at three months (mean 62.8 (95% CI 58.1-67.5) vs 64.4 (95% CI: 59.6-69.2)) points; at six months (mean 66.7 (95% CI 61.5-72.0) vs 61.9 (95% CI 56.1-67.7) points); and 12 months (mean 63.5 (95% CI 57.7-69.3) vs 62.1 (95% CI 56.2-68.0)) points (p <0.05). Explorative analyses showed a significant difference between groups in favour of the intervention group. No significant difference was seen in ICD therapy history. Comprehensive cardiac rehabilitation combining exercise training and a psycho-educational intervention improves VO₂-uptake and general health. Furthermore, mental health seems improved. No significant difference was found in the number of ICD shocks or anti-tachycardia pacing therapy. © The European Society of Cardiology 2014.

  4. Preparing your organization's training program for ICD-10.

    PubMed

    Carolan, Katie; Reitzel, David

    2011-10-01

    Training for ICD-10 is going to be expensive, though predictions of how expensive vary widely. Healthcare finance executives should create a flexible, multiyear capital and operating budget to prepare for ICD-10 conversion and the training and support that will be required. Healthcare organizations also should assess staff knowledge in the critical ICD-10 areas and begin training now to be ready for go-live by early 2013.

  5. Dollars and sense: Mitigating budget risk for ICD-10.

    PubMed

    Newell, Lucy Mancini; DeSilva, Joseph J

    2013-02-01

    The extended deadline for ICD-10 implementation is time that should not be wasted. Healthcare leaders should keep three things in mind: CFOs should approach the effort knowing the costs of ICD-10 implementation will be high and spread over multiple budget years. Training, productivity, and contractual issues are among key areas that will be challenged by ICD-10 implementation. Healthcare finance leaders should work to improve cash-on-hand and cash reserves prior to the ICD-10 deadline to ensure liquidity post-compliance.

  6. Acute evaluation of transthoracic impedance vectors using ICD leads.

    PubMed

    Gottfridsson, Christer; Daum, Douglas; Kennergren, Charles; Ramuzat, Agnès; Willems, Roger; Edvardsson, Nils

    2009-06-01

    Minute ventilation (MV) has been proven to be very useful in rate responsive pacing. The aim of this study was to evaluate the feasibility of using implantable cardioverter-defibrillator (ICD) leads as part of the MV detection system. At implant in 10 patients, the transthoracic impedance was measured from tripolar ICD, tetrapolar ICD, and atrial lead vectors during normal, deep, and shallow voluntary respiration. MV and respiration rate (RespR) were simultaneously measured through a facemask with a pneumotachometer (Korr), and the correlations with impedance-based measurements were calculated. Air sensitivity was the change in impedance per change in respiratory tidal volume, ohms (Omega)/liter (L), and the signal-to-noise ratio (SNR) was the ratio of the respiratory and cardiac contraction components. The air sensitivity and SNR in tripolar ICD vector were 2.70 +/- 2.73 ohm/L and 2.19 +/- 1.31, respectively, and were not different from tetrapolar. The difference in RespR between tripolar ICD and Korr was 0.2 +/- 1.91 breaths/minute. The regressed correlation coefficient between impedance MV and Korr MV was 0.86 +/- 0.07 in tripolar ICD. The air sensitivity and SNR in tripolar and tetrapolar ICD lead vectors did not differ significantly and were in the range of the values in pacemaker leads currently used as MV sensors. The good correlations between impedance-based and Korr-based RespR and MV measurements imply that ICD leads may be used in MV sensor systems.

  7. Predicting trauma patient mortality: ICD [or ICD-10-AM] versus AIS based approaches.

    PubMed

    Willis, Cameron D; Gabbe, Belinda J; Jolley, Damien; Harrison, James E; Cameron, Peter A

    2010-11-01

    The International Classification of Diseases Injury Severity Score (ICISS) has been proposed as an International Classification of Diseases (ICD)-10-based alternative to mortality prediction tools that use Abbreviated Injury Scale (AIS) data, including the Trauma and Injury Severity Score (TRISS). To date, studies have not examined the performance of ICISS using Australian trauma registry data. This study aimed to compare the performance of ICISS with other mortality prediction tools in an Australian trauma registry. This was a retrospective review of prospectively collected data from the Victorian State Trauma Registry. A training dataset was created for model development and a validation dataset for evaluation. The multiplicative ICISS model was compared with a worst injury ICISS approach, Victorian TRISS (V-TRISS, using local coefficients), maximum AIS severity and a multivariable model including ICD-10-AM codes as predictors. Models were investigated for discrimination (C-statistic) and calibration (Hosmer-Lemeshow statistic). The multivariable approach had the highest level of discrimination (C-statistic 0.90) and calibration (H-L 7.65, P= 0.468). Worst injury ICISS, V-TRISS and maximum AIS had similar performance. The multiplicative ICISS produced the lowest level of discrimination (C-statistic 0.80) and poorest calibration (H-L 50.23, P < 0.001). The performance of ICISS may be affected by the data used to develop estimates, the ICD version employed, the methods for deriving estimates and the inclusion of covariates. In this analysis, a multivariable approach using ICD-10-AM codes was the best-performing method. A multivariable ICISS approach may therefore be a useful alternative to AIS-based methods and may have comparable predictive performance to locally derived TRISS models. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

  8. The Design of the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED).

    PubMed

    Gold, Michael R; Knops, Reinoud; Burke, Martin C; Lambiase, Pier D; Russo, Andrea M; Bongiorni, Maria Grazia; Deharo, Jean-Claude; Aasbo, Johan; El Chami, Mikhael F; Husby, Michael; Carter, Nathan; Boersma, Lucas

    2017-01-01

    The UNTOUCHED study will assess the safety and efficacy of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the most common cohort of patients receiving ICDs. The primary goal is to evaluate the inappropriate shock (IAS)-free rate in primary prevention patients with a reduced ejection fraction (EF) and compare with a historical control of transvenous ICD patients with similar programming. The UNTOUCHED study is a global, multicenter, prospective, nonrandomized study of patients undergoing de novo S-ICD implantation for primary prevention of sudden cardiac death with a left ventricular EF ≤35%. The primary end point of this trial is freedom from IAS at 18 months. The lower 95% confidence bound of the observed incidence will be compared to a performance goal of 91.6%, which was derived from the IAS rate in MADIT-RIT. The secondary end points are all-cause shock-free rate at 18 months, and system- and procedure-related complication-free rate at 1 month and 6 months. Enrollment of a minimum of 1,100 subjects from up to 200 centers worldwide is planned based on power calculations of the primary and principal secondary end points. This trial will provide important data regarding the rates of inappropriate and appropriate shock therapy in real-world use of the S-ICD in the most common group of patients receiving ICDs. © 2016 Wiley Periodicals, Inc.

  9. 76 FR 51985 - ICD-9-CM Coordination and Maintenance Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... and Public Health Data Standards Staff, announces the following meeting. Name: ICD-9-CM Coordination.... 2012 ICD-10-PCS GEM and Reimbursement Map Updates. ICD-10-PCS Official Coding Guidelines. ICD-10 MS... Pickett, Medical Systems Administrator, Classifications and Public Health Data Standards Staff, NCHS, 3311...

  10. Far-Infrared Emission of Intracluster Dust (ICD)

    NASA Astrophysics Data System (ADS)

    Arimoto, N.; Takagi, T.; Hanami, H.

    2000-12-01

    In the young universe, clusters of galaxies could be bright FIR-Submm sources due to the dust emissions from young ellipticals. The intracluster dust (ICD) could also contribute to the FIR-Submm emissions considerably, but the ICD is fragile in the ambient hot ICM. Therefore, a chance to detect the ICD emission would be much smaller than the dust emissions from galaxies. Dust emissions from elliptical galaxies (EROs) in the young Coma cluster at a distance of z=2-3 would be easily detected by a future mission of H2L2 satellite, thus the FIR-Submm survey would become a powerful tool for searching high-z clusters.

  11. Hypochondriasis: considerations for ICD-11.

    PubMed

    van den Heuvel, Odile A; Veale, David; Stein, Dan J

    2014-01-01

    The World Health Organization (WHO) is currently revisiting the ICD. In the 10th version of the ICD, approved in 1990, hypochondriacal symptoms are described in the context of both the primary condition hypochondriacal disorder and as secondary symptoms within a range of other mental disorders. Expansion of the research base since 1990 makes a critical evaluation and revision of both the definition and classification of hypochondriacal disorder timely. This article addresses the considerations reviewed by members of the WHO ICD-11 Working Group on the Classification of Obsessive-Compulsive and Related Disorders in their proposal for the description and classification of hypochondriasis. The proposed revision emphasizes the phenomenological overlap with both anxiety disorders (e.g., fear, hypervigilance to bodily symptoms, and avoidance) and obsessive-compulsive and related disorders (e.g., preoccupation and repetitive behaviors) and the distinction from the somatoform disorders (presence of somatic symptom is not a critical characteristic). This revision aims to improve clinical utility by enabling better recognition and treatment of patients with hypochondriasis within the broad range of global health care settings.

  12. Looking into the Future: Toward Advanced 3D Biomaterials for Stem-Cell-Based Regenerative Medicine.

    PubMed

    Liu, Zhongmin; Tang, Mingliang; Zhao, Jinping; Chai, Renjie; Kang, Jiuhong

    2018-04-01

    Stem-cell-based therapies have the potential to provide novel solutions for the treatment of a variety of diseases, but the main obstacles to such therapies lie in the uncontrolled differentiation and functional engraftment of implanted tissues. The physicochemical microenvironment controls the self-renewal and differentiation of stem cells, and the key step in mimicking the stem cell microenvironment is to construct a more physiologically relevant 3D culture system. Material-based 3D assemblies of stem cells facilitate the cellular interactions that promote morphogenesis and tissue organization in a similar manner to that which occurs during embryogenesis. Both natural and artificial materials can be used to create 3D scaffolds, and synthetic organic and inorganic porous materials are the two main kinds of artificial materials. Nanotechnology provides new opportunities to design novel advanced materials with special physicochemical properties for 3D stem cell culture and transplantation. Herein, the advances and advantages of 3D scaffold materials, especially with respect to stem-cell-based therapies, are first outlined. Second, the stem cell biology in 3D scaffold materials is reviewed. Third, the progress and basic principles of developing 3D scaffold materials for clinical applications in tissue engineering and regenerative medicine are reviewed. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  13. Implementation and impact of ICD-10 (Part II)

    PubMed Central

    Rahmathulla, Gazanfar; Deen, H. Gordon; Dokken, Judith A.; Pirris, Stephen M.; Pichelmann, Mark A.; Nottmeier, Eric W.; Reimer, Ronald; Wharen, Robert E.

    2014-01-01

    Background: The transition from the International Classification of Disease-9th clinical modification to the new ICD-10 was all set to occur on 1 October 2015. The American Medical Association has previously been successful in delaying the transition by over 10 years and has been able to further postpone its introduction to 2015. The new system will overcome many of the limitations present in the older version, thus paving the way to more accurate capture of clinical information. Methods: The benefits of the new ICD-10 system include improved quality of care, potential cost savings, reduction of unpaid claims, and improved tracking of healthcare data. The areas where challenges will be evident include planning and implementation, the cost to transition, a shortage of qualified coders, training and education of the healthcare workforce, and a loss of productivity when this occurs. The impacts include substantial costs to the healthcare system, but the projected long-term savings and benefits will be significant. Improved fraud detection, accurate data entry, ability to analyze cost benefits with procedures, and enhanced quality outcome measures are the most significant beneficial factors with this change. Results: The present Current Procedural Terminology and Healthcare Common Procedure Coding System code sets will be used for reporting ambulatory procedures in the same manner as they have been. ICD-10-PCS will replace ICD-9 procedure codes for inpatient hospital services. The ICD-10-CM will replace the clinical code sets. Our article will focus on the challenges to execution of an ICD change and strategies to minimize risk while transitioning to the new system. Conclusion: With the implementation deadline gradually approaching, spine surgery practices that include multidisciplinary health specialists have to anticipate and prepare for the ICD change in order to mitigate risk. Education and communication is the key to this process in spine practices. PMID:25184098

  14. Implementation and impact of ICD-10 (Part II).

    PubMed

    Rahmathulla, Gazanfar; Deen, H Gordon; Dokken, Judith A; Pirris, Stephen M; Pichelmann, Mark A; Nottmeier, Eric W; Reimer, Ronald; Wharen, Robert E

    2014-01-01

    The transition from the International Classification of Disease-9(th) clinical modification to the new ICD-10 was all set to occur on 1 October 2015. The American Medical Association has previously been successful in delaying the transition by over 10 years and has been able to further postpone its introduction to 2015. The new system will overcome many of the limitations present in the older version, thus paving the way to more accurate capture of clinical information. The benefits of the new ICD-10 system include improved quality of care, potential cost savings, reduction of unpaid claims, and improved tracking of healthcare data. The areas where challenges will be evident include planning and implementation, the cost to transition, a shortage of qualified coders, training and education of the healthcare workforce, and a loss of productivity when this occurs. The impacts include substantial costs to the healthcare system, but the projected long-term savings and benefits will be significant. Improved fraud detection, accurate data entry, ability to analyze cost benefits with procedures, and enhanced quality outcome measures are the most significant beneficial factors with this change. The present Current Procedural Terminology and Healthcare Common Procedure Coding System code sets will be used for reporting ambulatory procedures in the same manner as they have been. ICD-10-PCS will replace ICD-9 procedure codes for inpatient hospital services. The ICD-10-CM will replace the clinical code sets. Our article will focus on the challenges to execution of an ICD change and strategies to minimize risk while transitioning to the new system. With the implementation deadline gradually approaching, spine surgery practices that include multidisciplinary health specialists have to anticipate and prepare for the ICD change in order to mitigate risk. Education and communication is the key to this process in spine practices.

  15. Dietary patterns in patients with advanced cancer: implications for anorexia-cachexia therapy.

    PubMed

    Hutton, Joanne L; Martin, Lisa; Field, Catherine J; Wismer, Wendy V; Bruera, Eduardo D; Watanabe, Sharon M; Baracos, Vickie E

    2006-11-01

    Severe malnutrition and wasting are considered hallmarks of advanced malignant disease, and clinical research into anorexia-cachexia therapy and nutritional support for cancer patients is ongoing. However, information on typical dietary intakes and food choices for this population is notably lacking; proposed therapies for anorexia and wasting are not framed within the context of current intake. The objective of the study was to characterize the food intake patterns of patients with advanced cancer. Patients with advanced cancer (n = 151) recruited from a regional cancer center and palliative-care program completed a 3-d dietary record a mean (+/-SD) 8 +/- 7 mo before death. Food items were categorized according to macronutrient content and dietary use and subsequently entered into cluster analysis. Wide variations in intakes of energy (range: 4-53 kcal . kg body wt(-1) . d(-1); x +/- SD: 25.1 +/- 10.0 kcal . kg body wt(-1) . d(-1)) and protein (range: 0.2-2.7 g . kg body wt(-1) . d(-1); x +/- SD: 1.0 +/- 0.4 g . kg body wt(-1) . d(-1)) were observed. Even the subjects with the highest intakes had a recent history of weight loss, which suggests that the diets of those persons were consistently inadequate for weight maintenance. Cluster analysis found 3 dietary patterns that differed in food choice and caloric intake. Low intakes and a high risk of weight loss were associated with decreased frequency of eating and dietary profiles with little variety and unusually high proportions of liquids. These data provide a glimpse into dietary habits toward the end of life. Unique dietary patterns were found in this nutritionally vulnerable patient population.

  16. [Chronic pain disorder with somatic and psychological factors (F45.41) : Validation criteria on operationalization of the ICD-10-GM diagnosis].

    PubMed

    Arnold, B; Lutz, J; Nilges, P; Pfingsten, M; Rief, Winfried; Böger, A; Brinkschmidt, T; Casser, H-R; Irnich, D; Kaiser, U; Klimczyk, K; Sabatowski, R; Schiltenwolf, M; Söllner, W

    2017-12-01

    In 2009 the diagnosis chronic pain disorder with somatic and psychological factors (F45.41) was integrated into the German version of the International Classification of Diseases, version 10 (ICD-10-GM). In 2010 Paul Nilges and Winfried Rief published operationalization criteria for this diagnosis. In the present publication the ad hoc commission on multimodal interdisciplinary pain therapy of the German Pain Society now presents a formula for a clear validation of these operationalization criteria of the ICD code F45.41.

  17. An evaluation of ICD-11 posttraumatic stress disorder criteria in two samples of adolescents and young adults exposed to mass shootings: factor analysis and comparisons to ICD-10 and DSM-IV.

    PubMed

    Haravuori, Henna; Kiviruusu, Olli; Suomalainen, Laura; Marttunen, Mauri

    2016-05-12

    The proposed posttraumatic stress disorder (PTSD) criteria for the International Classification of Diseases (ICD) 11th revision are simpler than the criteria in ICD-10, DSM-IV or DSM-5. The aim of this study was to evaluate the ICD-11 PTSD factor structure in samples of young people, and to compare PTSD prevalence rates and diagnostic agreement between the different diagnostic systems. Possible differences in clinical characteristics of the PTSD cases identified by ICD-11, ICD-10 and DSM-IV are explored. Two samples of adolescents and young adults were followed after exposure to similar mass shooting incidents in their schools. Semi-structured diagnostic interviews were performed to assess psychiatric diagnoses and PTSD symptom scores (N = 228, mean age 17.6 years). PTSD symptom item scores were used to compose diagnoses according to the different classification systems. Confirmatory factor analyses indicated that the proposed ICD-11 PTSD symptoms represented two rather than three factors; re-experiencing and avoidance symptoms comprised one factor and hyperarousal symptoms the other factor. In the studied samples, the three-factor ICD-11 criteria identified 51 (22.4%) PTSD cases, the two-factor ICD-11 identified 56 (24.6%) cases and the DSM-IV identified 43 (18.9%) cases, while the number of cases identified by ICD-10 was larger, being 85 (37.3%) cases. Diagnostic agreement of the ICD-11 PTSD criteria with ICD-10 and DSM-IV was moderate, yet the diagnostic agreement turned to be good when an impairment criterion was imposed on ICD-10. Compared to ICD-11, ICD-10 identified cases with less severe trauma exposure and posttraumatic symptoms and DSM-IV identified cases with less severe trauma exposure. The findings suggest that the two-factor model of ICD-11 PTSD is preferable to the three-factor model. The proposed ICD-11 criteria are more restrictive compared to the ICD-10 criteria. There were some differences in the clinical characteristics of the PTSD cases

  18. Do physicians' attitudes toward implantable cardioverter defibrillator therapy vary by patient age, gender, or race?

    PubMed

    Al-Khatib, Sana M; Sanders, Gillian D; O'Brien, Sean M; Matlock, Daniel; Zimmer, Louise O; Masoudi, Frederick A; Peterson, Eric

    2011-01-01

    Implantable cardioverter defibrillator (ICD) therapy improves survival of patients with systolic heart failure. We assessed whether physicians' recommendation for ICD therapy varies as a function of patient age, gender, race, and physician's specialty. We surveyed a random sample (n = 9969) of U.S. physicians who are active members of the American College of Cardiology (ACC). We asked participants about their likelihood to recommend ICD therapy in 4 clinical scenarios that randomly varied patient age, gender, race, and ICD indication (guideline Class I, Class IIa, Class III, and Class I in a noncompliant patient). Responses were received from 1210 physicians (response rate 12%), of whom 1127 met the study inclusion criteria. Responders and nonresponders had similar demographics. In responding to hypothetical clinical scenarios, physicians were less likely to recommend an ICD to older patients (≥80 vs 50 years) (P < 0.01) but were unaffected by gender or race for all class indications. Compared with non-electrophysiologists (EPs), EPs were significantly more likely to recommend an ICD for a Class I indication (92.4% vs 81.4%; P < 0.01), but they were not more likely to offer an ICD for a Class III indication (0.4% vs 0.6%; P = 0.95). Based on survey responses, physicians were equally willing to offer an ICD to men and women and to whites and blacks, but were less likely to offer an ICD to an older patient even when indicated by practice guidelines. Electrophysiologists (EPs) more often adhered to practice guideline recommendations on ICD therapy compared with non-EPs. ©2011, Wiley Periodicals, Inc.

  19. Preoperative therapy in locally advanced esophageal cancer.

    PubMed

    Garg, Pankaj Kumar; Sharma, Jyoti; Jakhetiya, Ashish; Goel, Aakanksha; Gaur, Manish Kumar

    2016-10-21

    Esophageal cancer is an aggressive malignancy associated with dismal treatment outcomes. Presence of two distinct histopathological types distinguishes it from other gastrointestinal tract malignancies. Surgery is the cornerstone of treatment in locally advanced esophageal cancer (T2 or greater or node positive); however, a high rate of disease recurrence (systemic and loco-regional) and poor survival justifies a continued search for optimal therapy. Various combinations of multimodality treatment (preoperative/perioperative, or postoperative; radiotherapy, chemotherapy, or chemoradiotherapy) are being explored to lower disease recurrence and improve survival. Preoperative therapy followed by surgery is presently considered the standard of care in resectable locally advanced esophageal cancer as postoperative treatment may not be feasible for all the patients due to the morbidity of esophagectomy and prolonged recovery time limiting the tolerance of patient. There are wide variations in the preoperative therapy practiced across the centres depending upon the institutional practices, availability of facilities and personal experiences. There is paucity of literature to standardize the preoperative therapy. Broadly, chemoradiotherapy is the preferred neo-adjuvant modality in western countries whereas chemotherapy alone is considered optimal in the far East. The present review highlights the significant studies to assist in opting for the best evidence based preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy) for locally advanced esophageal cancer.

  20. ISS mapped from ICD-9-CM by a novel freeware versus traditional coding: a comparative study.

    PubMed

    Di Bartolomeo, Stefano; Tillati, Silvia; Valent, Francesca; Zanier, Loris; Barbone, Fabio

    2010-03-31

    Injury severity measures are based either on the Abbreviated Injury Scale (AIS) or the International Classification of diseases (ICD). The latter is more convenient because routinely collected by clinicians for administrative reasons. To exploit this advantage, a proprietary program that maps ICD-9-CM into AIS codes has been used for many years. Recently, a program called ICDPIC trauma and developed in the USA has become available free of charge for registered STATA users. We compared the ICDPIC calculated Injury Severity Score (ISS) with the one from direct, prospective AIS coding by expert trauma registrars (dAIS). The administrative records of the 289 major trauma cases admitted to the hospital of Udine-Italy from 1 July 2004 to 30 June 2005 and enrolled in the Italian Trauma Registry were retrieved and ICDPIC-ISS was calculated. The agreement between ICDPIC-ISS and dAIS-ISS was assessed by Cohen's Kappa and Bland-Altman charts. We then plotted the differences between the 2 scores against the ratio between the number of traumatic ICD-9-CM codes and the number of dAIS codes for each patient (DIARATIO). We also compared the absolute differences in ISS among 3 groups identified by DIARATIO. The discriminative power for survival of both scores was finally calculated by ROC curves. The scores matched in 33/272 patients (12.1%, k 0.07) and, when categorized, in 80/272 (22.4%, k 0.09). The Bland-Altman average difference was 6.36 (limits: minus 22.0 to plus 34.7). ICDPIC-ISS of 75 was particularly unreliable. The differences increased (p < 0.01) as DIARATIO increased indicating incomplete administrative coding as a cause of the differences. The area under the curve of ICDPIC-ISS was lower (0.63 vs. 0.76, p = 0.02). Despite its great potential convenience, ICPIC-ISS agreed poorly with its conventionally calculated counterpart. Its discriminative power for survival was also significantly lower. Incomplete ICD-9-CM coding was a main cause of these findings. Because this

  1. Time dependence of risks and benefits in pediatric primary prevention implantable cardioverter-defibrillator therapy.

    PubMed

    DeWitt, Elizabeth S; Triedman, John K; Cecchin, Frank; Mah, Doug Y; Abrams, Dominic J; Walsh, Edward P; Gauvreau, Kimberlee; Alexander, Mark E

    2014-12-01

    Implantable cardioverter defibrillators (ICDs) used to prevent sudden cardiac arrest in children not only provide appropriate therapy in 25% of patients but also result in a significant incidence of inappropriate shocks and other device complications. ICDs placed for secondary prevention have higher rates of appropriate therapy than those placed for primary prevention. Pediatric patients with primary prevention ICDs were studied to determine time-dependent incidence of appropriate use and adverse events. A total of 140 patients aged <21 years (median age, 15 years) at first ICD implantation at Boston Children's Hospital (2000-2009) in whom devices were placed for primary prevention were retrospectively identified. Demographics and times to first appropriate shock; adverse events (including inappropriate shock, lead failure, reintervention, and complication); generator replacement and follow-up were noted. During mean follow-up of 4 years, appropriate shock occurred in 19% patients and first adverse event (excluding death/transplant) occurred in 36%. Risk of death or transplant was ≈1% per year and was not related to receiving appropriate therapy. Conditional survival analysis showed rates of appropriate therapy and adverse events decrease soon after implantation, but adverse events are more frequent than appropriate therapy throughout follow-up. Primary prevention ICDs were associated with appropriate therapy in 19% and adverse event in 36% in this cohort. The incidence of both first appropriate therapy and device-related adverse events decreased during longer periods of follow-up after implantation. This suggests that indications for continued device therapy in pediatric primary prevention ICD patients might be reconsidered after a period of nonuse. © 2014 American Heart Association, Inc.

  2. Beta-blocker therapy is not associated with symptoms of depression and anxiety in patients receiving an implantable cardioverter-defibrillator.

    PubMed

    Hoogwegt, Madelein T; Kupper, Nina; Theuns, Dominic A M J; Jordaens, Luc; Pedersen, Susanne S

    2012-01-01

    Beta-blockers are frequently prescribed to implantable cardioverter-defibrillator (ICD) patients. Beta-blocker therapy has been proposed to induce emotional distress such as depression and anxiety, but a paucity of studies has examined the relationship between beta-blockers and distress. We investigated the association between beta-blocker therapy, including type and dosage, and symptoms of anxiety and depression in a consecutive cohort of patients receiving an ICD. Between 2003 and 2010, 448 consecutively implanted ICD patients were enrolled in the prospective Mood and personality as precipitants of arrhythmia in patients with an Implantable cardioverter Defibrillator: A prospective Study (MIDAS), of which 429 completed the Hospital Anxiety and Depression Scale (HADS) and the ICD Patient Concerns questionnaire (ICDC) at baseline. Eighty per cent of all patients received beta-blocker therapy. In univariate analysis, beta-blocker therapy was not significantly associated with symptoms of anxiety, depression, and ICD concerns (β = -0.030, β = 0.007, and β = -0.045, respectively; all P's >0.36). Type of beta-blocker showed a trend towards significance for mean levels of ICD concerns (P = 0.09). No association was found between dosage and emotional distress (all P's >0.21). After adjustment for relevant clinical and demographic variables, the association of beta-blocker therapy and symptoms of anxiety, depression, and ICD concerns remained non-significant (β = 0.009, β = 0.037, and β = 0.019, respectively; all P's >0.47). In patients receiving an ICD, beta-blocker therapy was not associated with symptoms of anxiety, depression, and ICD concerns. Research is warranted that further elucidates the link between beta-blocker therapy and emotional distress in this vulnerable patient group.

  3. Piloting a Collaborative Web-Based System for Testing ICD-11.

    PubMed

    Donada, Marc; Kostanjsek, Nenad; Della Mea, Vincenzo; Celik, Can; Jakob, Robert

    2017-01-01

    The 11th revision of the International Classification of Diseases (ICD-11), for the first time in ICD history, deployed web-based collaboration of experts and ICT tools. To ensure that ICD-11 is working well, it needs to be systematically field tested in different settings, across the world. This will be done by means of a number of experiments. In order to support its implementation, a web-based system (ICDfit) has been designed and developed. The present paper illustrates the current prototype of the system and its technical testing. the system has been designed according to WHO requirements, and implemented using PHP and MySQL. Then, a preliminary technical test has been designed and run in January 2016, involving 8 users. They had to carry out double coding, that is, coding case summaries with both ICD-10 and ICD-11, and answering quick questions on the coding difficulty. the 8 users coded 632 cases each, spending an average of 163 seconds per case. While we found an issue in the mechanism used to record coding times, no further issues were found. the proposed system seems to be technically adequate for supporting future ICD-11 testing.

  4. Traditional Chinese Medicine treatment as maintenance therapy in advanced non-small-cell lung cancer: A randomized controlled trial.

    PubMed

    Jiang, Yi; Liu, Ling-Shuang; Shen, Li-Ping; Han, Zhi-Fen; Jian, Hong; Liu, Jia-Xiang; Xu, Ling; Li, He-Gen; Tian, Jian-Hui; Mao, Zhu-Jun

    2016-02-01

    Maintenance therapy for patients with advanced non-small-cell lung cancer (NSCLC) is an increasingly hot topic in the field of clinical NSCLC research. This study aimed to evaluate the effects of Traditional Chinese Medicine (TCM) treatment as maintenance therapy on time to progression (TTP), quality of life (QOL), overall survival (OS) and 1-year survival rate in patients with advanced NSCLC. This study was conducted as a randomized, controlled, open-label trial. 64 non-progressive patients who responded to initial therapy were randomized 1:1 to the TCM arm (treated with herbal injection (Cinobufacini, 20ml/d, d1-d10), herbal decoction (d1-d21) and Chinese acupoint application (d1-d21), n=32) or to the chemotherapy arm (treated with pemetrexed (non-squamous NSCLC, 500mg/m(2), d1), docetaxel (75mg/m(2), d1) or gemcitabine (1250mg/m(2), d1 and d8), n=32). Each therapy cycle was 21 days. They were repeated until disease progression, unacceptable toxicity, or until the patients requested therapy discontinuation. The primary end point was TTP; the secondary end points were QOL, OS and 1-year survival rate. "Intention-to-treat" analysis included all randomized participants. TCM treatment prolonged median TTP for 0.7 months compared with chemotherapy, but it was not statistically significant (3.0 months vs. 2.3 months, P=0.114). Median OS time for TCM treatment did not offer a significant advantage over for chemotherapy (21.5 months vs. 18.8 months, P=0.601). 1-year survival rate of TCM treatment significantly improved than that of chemotherapy (78.1% vs. 53.1%, P=0.035). TCM treatment can significantly improve QOL when compared to chemotherapy as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 QOL instruments. TCM maintenance treatment had similar effects on TTP and OS compared with maintenance chemotherapy, but it improved patients' QOL and had higher 1-year survival rate. TCM Maintenance treatment is a promising option for advanced NSCLC patients without progression

  5. Atrial therapies reduce atrial arrhythmia burden in defibrillator patients.

    PubMed

    Friedman, P A; Dijkman, B; Warman, E N; Xia, H A; Mehra, R; Stanton, M S; Hammill, S C

    2001-08-28

    Approximately 25% of patients who receive an implantable cardioverter-defibrillator (ICD) to treat ventricular tachyarrhythmias have documented atrial tachyarrhythmias before implantation. This study assessed the ability of device-based prevention and termination therapies to reduce the burden of spontaneous atrial tachyarrhythmias. Patients with a standard indication for the implantation of an ICD and 2 episodes of atrial tachyarrhythmias in the preceding year received a dual-chamber ICD (Medtronic 7250 Jewel AF) that uses pacing and shock therapies for prevention and/or termination of atrial tachyarrhythmias. In a multicenter trial, patients were randomized to 3-month periods with atrial therapies "on" or "off" and subsequently crossed over. Analysis was performed on the 52 of 269 patients who had episodes of atrial tachyarrhythmia and had >/=30 days of follow-up with atrial therapies on and off. The atrial therapies resulted in a reduction of atrial tachyarrhythmia burden from a mean of 58.5 to 7.8 h/mo. A paired analysis (Wilcoxon signed-rank test) showed that the median difference in burden (1.1 h/mo) was highly significant (P=0.007). When the subgroup of 41 patients treated only with atrial pacing therapies was analyzed, the reduction in burden persisted (P=0.01). In this study, patients with a standard ICD indication and atrial tachyarrhythmias had a significant reduction in atrial tachyarrhythmia burden with use of atrial pacing and shock therapies.

  6. The Tragedy of the Implementation of ICD-10-CM as ICD-10: Is the Cart Before the Horse or Is There a Tragic Paradox of Misinformation and Ignorance?

    PubMed

    Manchikanti, Laxmaiah; Kaye, Alan D; Singh, Vijay; Boswell, Mark V

    2015-01-01

    The forced implementation of ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) codes that are specific to the United States, scheduled for implementation October 1, 2015, which is vastly different from ICD-10 (International Classification of Diseases, Tenth Revision), implemented worldwide, which has 14,400 codes, compared to ICD-10-CM with 144,000 codes to be implemented in the United States is a major concern to practicing U.S. physicians and a bonanza for health IT and hospital industry. This implementation is based on a liberal interpretation of the Health Insurance Portability and Accountability Act (HIPAA), which requires an update to ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) and says nothing about ICD-10 or beyond. On June 29, 2015, the Supreme Court ruled that the Environmental Protection Agency unreasonably interpreted the Clean Air Act when it decided to set limits on the emissions of toxic pollutants from power plants, without first considering the costs on the industry. Thus, to do so is applicable to the medical industry with the Centers for Medicare and Medicaid Services (CMS) unreasonably interpreting HIPAA and imposing existent extensive regulations without considering the cost. In the United States, ICD-10-CM with a 10-fold increase in the number of codes has resulted in a system which has become so complicated that it no longer compares with any other country. Moreover, most WHO members use the ICD-10 system (not ICD-10-CM) only to record mortality in 138 countries or morbidity in 99 countries. Currently, only 10 countries employ ICD-10 (not ICD-10-CM) in the reimbursement process, 6 of which have a single payer health care system. Development of ICD-10-CM is managed by 4 non-physician groups, known as cooperating parties. They include the Centers for Disease Control and Prevention (CDC), CMS, the American Hospital Association (AHA), and the American Health

  7. Predicting in-hospital mortality of traffic victims: A comparison between AIS-and ICD-9-CM-related injury severity scales when only ICD-9-CM is reported.

    PubMed

    Van Belleghem, Griet; Devos, Stefanie; De Wit, Liesbet; Hubloue, Ives; Lauwaert, Door; Pien, Karen; Putman, Koen

    2016-01-01

    Injury severity scores are important in the context of developing European and national goals on traffic safety, health-care benchmarking and improving patient communication. Various severity scores are available and are mostly based on Abbreviated Injury Scale (AIS) or International Classification of Diseases (ICD). The aim of this paper is to compare the predictive value for in-hospital mortality between the various severity scores if only International Classification of Diseases, 9th revision, Clinical Modification ICD-9-CM is reported. To estimate severity scores based on the AIS lexicon, ICD-9-CM codes were converted with ICD Programmes for Injury Categorization (ICDPIC) and four AIS-based severity scores were derived: Maximum AIS (MaxAIS), Injury Severity Score (ISS), New Injury Severity Score (NISS) and Exponential Injury Severity Score (EISS). Based on ICD-9-CM, six severity scores were calculated. Determined by the number of injuries taken into account and the means by which survival risk ratios (SRRs) were calculated, four different approaches were used to calculate the ICD-9-based Injury Severity Scores (ICISS). The Trauma Mortality Prediction Model (TMPM) was calculated with the ICD-9-CM-based model averaged regression coefficients (MARC) for both the single worst injury and multiple injuries. Severity scores were compared via model discrimination and calibration. Model comparisons were performed separately for the severity scores based on the single worst injury and multiple injuries. For ICD-9-based scales, estimation of area under the receiver operating characteristic curve (AUROC) ranges between 0.94 and 0.96, while AIS-based scales range between 0.72 and 0.76, respectively. The intercept in the calibration plots is not significantly different from 0 for MaxAIS, ICISS and TMPM. When only ICD-9-CM codes are reported, ICD-9-CM-based severity scores perform better than severity scores based on the conversion to AIS. Copyright © 2015 Elsevier Ltd. All

  8. Identification of ICD Codes Suggestive of Child Maltreatment

    ERIC Educational Resources Information Center

    Schnitzer, Patricia G.; Slusher, Paula L.; Kruse, Robin L.; Tarleton, Molly M.

    2011-01-01

    Objective: In order to be reimbursed for the care they provide, hospitals in the United States are required to use a standard system to code all discharge diagnoses: the International Classification of Disease, 9th Revision, Clinical Modification (ICD-9). Although ICD-9 codes specific for child maltreatment exist, they do not identify all…

  9. Diagnostic Concordance between DSM-5 and ICD-10 Cannabis Use Disorders.

    PubMed

    Proctor, Steven L; Williams, Daniel C; Kopak, Albert M; Voluse, Andrew C; Connolly, Kevin M; Hoffmann, Norman G

    2016-07-01

    With the recent federal mandate that all U.S. health care settings transition to ICD-10 billing codes, empirical evidence is necessary to determine if the DSM-5 designations map to their respective ICD-10 diagnostic categories/billing codes. The present study examined the concordance between DSM-5 and ICD-10 cannabis use disorder diagnoses. Data were derived from routine clinical assessments of 6871 male and 801 female inmates recently admitted to a state prison system from 2000 to 2003. DSM-5 and ICD-10 diagnostic determinations were made from algorithms corresponding to the respective diagnostic formulations. Past 12-month prevalence rates of cannabis use disorders were comparable across classification systems. The vast majority of inmates with no DSM-5 diagnosis continued to have no diagnosis per the ICD-10, and a similar proportion with a DSM-5 severe diagnosis received an ICD-10 dependence diagnosis. Most of the variation in diagnostic classifications was accounted for by those with a DSM-5 moderate diagnosis in that approximately half of these cases received an ICD-10 dependence diagnosis while the remaining cases received a harmful use diagnosis. Although there appears to be a generally high level of agreement between diagnostic classification systems for those with no diagnosis or those evincing symptoms of a more severe condition, concordance between DSM-5 moderate and ICD-10 dependence diagnoses was poor. Additional research is warranted to determine the appropriateness and implications of the current DSM-5 coding guidelines regarding the assignment of an ICD-10 dependence code for those with a DSM-5 moderate diagnosis. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. Prophylactic Catheter Ablation for the Prevention of Defibrillator Therapy

    PubMed Central

    Reddy, Vivek Y.; Reynolds, Matthew R.; Neuzil, Petr; Richardson, Allison W.; Taborsky, Milos; Jongnarangsin, Krit; Kralovec, Stepan; Sediva, Lucie; Ruskin, Jeremy N.; Josephson, Mark E.

    2008-01-01

    BACKGROUND For patients who have a ventricular tachyarrhythmic event, implantable cardioverter–defibrillators (ICDs) are a mainstay of therapy to prevent sudden death. However, ICD shocks are painful, can result in clinical depression, and do not offer complete protection against death from arrhythmia. We designed this randomized trial to examine whether prophylactic radiofrequency catheter ablation of arrhythmogenic ventricular tissue would reduce the incidence of ICD therapy. METHODS Eligible patients with a history of a myocardial infarction underwent defibrillator implantation for spontaneous ventricular tachycardia or fibrillation. The patients did not receive antiarrhythmic drugs. Patients were randomly assigned to defibrillator implantation alone or defibrillator implantation with adjunctive catheter ablation (64 patients in each group). Ablation was performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary end point was survival free from any appropriate ICD therapy. RESULTS The mortality rate 30 days after ablation was zero, and there were no significant changes in ventricular function or functional class during the mean (±SD) follow-up period of 22.5±5.5 months. Twenty-one patients assigned to defibrillator implantation alone (33%) and eight patients assigned to defibrillator implantation plus ablation (12%) received appropriate ICD therapy (antitachycardia pacing or shocks) (hazard ratio in the ablation group, 0.35; 95% confidence interval, 0.15 to 0.78, P = 0.007). Among these patients, 20 in the control group (31%) and 6 in the ablation group (9%) received shocks (P = 0.003). Mortality was not increased in the group assigned to ablation as compared with the control group (9% vs. 17%, P = 0.29). CONCLUSIONS In this randomized trial, prophylactic substrate-based catheter ablation reduced the incidence of ICD therapy in patients with a

  11. Long-term outcomes of three-dimensional conformal radiation therapy combined with neoadjuvant hormonal therapy in Japanese patients with locally advanced prostate cancer.

    PubMed

    Sakamoto, Masato; Mizowaki, Takashi; Mitsumori, Michihide; Takayama, Kenji; Sasai, Keisuke; Norihisa, Yoshiki; Kamoto, Toshiyuki; Nakamura, Eijiro; Ogawa, Osamu; Hiraoka, Masahiro

    2010-12-01

    The outcomes of three-dimensional conformal radiation therapy (3D-CRT) combined with neoadjuvant hormonal therapy (NAHT) in Japanese patients with locally advanced prostate cancer who initiated salvage hormonal therapy (SHT) at a relatively early phase were evaluated. Between April 1998 and April 2003, 70 Japanese patients with T3N0M0 prostate cancer who received radical 3D-CRT treatment were evaluated. The median age, initial prostate-specific antigen (PSA) level, and duration of NAHT were 73 years old, 26.3 ng/ml, and 4 months, respectively. Seventy grays were given in 35 fractions that were confined to the prostate and seminal vesicles. Adjuvant hormonal therapy was not administered after 3D-CRT in any of the cases. The median follow-up period was 64.9 months. The median PSA value at the time of initiation of SHT was 5.0 ng/ml (range 0.1-21.6 ng/ml). Overall, disease-specific, PSA failure-free (based on the Phoenix definition) and SHT-free survival rates at 5 years were 90.3% (95% CI 86.5-94.0), 96.5% (94.0-98.9), 60.5% (48.2-72.7), and 63.5% (57.2-69.8), respectively. Therefore, two-thirds of the patients were still hormone-free at 5 years. PSA control rates in our series of Japanese patients with stage T3N0M0 prostate cancer treated with the standard dose of 3D-CRT combined with NAHT seemed higher than expected. This approach involving 3D-CRT combined with NAHT with the initiation of SHT at PSA values of around 5 ng/ml may be one option for Japanese patients with locally advanced prostate cancer, although further prospective study is required to confirm the validity.

  12. Psychosocial impact of implantable cardioverter defibrillators (ICD) in young adults with Tetralogy of Fallot.

    PubMed

    Opić, Petra; Utens, Elisabeth M W J; Moons, Philip; Theuns, Dominic A M J; van Dijk, Arie P J; Hoendermis, Elke S; Vliegen, Hubert W; de Groot, Natasja M S; Witsenburg, Maarten; Schalij, Martin; Roos-Hesselink, Jolien W

    2012-07-01

    To investigate the psychosocial impact of having an implantable cardioverter defibrillator (ICD) in adults with Tetralogy of Fallot (ToF). Included were 26 ToF-patients with an ICD (age 44 ± 12 years), and two control groups consisting of 28 ToF-patients without an ICD (age 40 ± 10 years) and a group of 35 ICD-patients of older age without ToF (age 72.0 ± 8 years). This last control group was chosen to represent the "older general ICD population" with acquired heart disease seen at the out-patient clinic. Psychosocial functioning encompassed daily functioning, subjective health status, quality of life, anxiety, depression, coping and social support. ToF-patients with ICD showed diminished psychosocial functioning in comparison to ToF-patients without ICD. This was reflected by diminished subjectively perceived physical functioning (p = 0.01), general health perception (p < 0.01) and a lower satisfaction with life (p = 0.02). In comparison to older ICD-patients, ToF-patients with ICD showed less satisfaction with life (p = 0.03), experienced more anxiety (p = 0.01) and showed less favourable coping styles, although physical functioning was better for ToF-patients with ICD than for older ICD-patients (p = 0.01). More inappropriate shocks were found in ToF-patients with ICD compared to the older ICD-patients. In patients with ToF, ICD implantation had a major impact on psychosocial functioning which should be taken into account when considering ICD implantation in these young patients. To help improve psychosocial functioning, psychological counselling attuned to the specific needs of these patients may be useful.

  13. Overview of implantable cardioverter defibrillator and cardiac resynchronisation therapy in heart failure management

    PubMed Central

    Chia, Pow-Li; Foo, David

    2016-01-01

    Clinical trials have established the benefits of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) in the treatment of heart failure patients. As adjuncts to guideline-directed medical therapy, ICDs confer mortality benefits from sudden cardiac arrest, while CRT reduces mortality, hospitalisation rates and improves functional capacity. This review discusses the use of ICDs and CRT devices in heart failure management, outlining the evidence supporting their use, indications and contraindications. PMID:27440409

  14. A Strategic Plan for Integrating ICD-10 in Your Practice and Workflow.

    PubMed

    Bowman, Sue; Cleland, Risë Marie; Staggs, Stuart

    2015-01-01

    The adoption of the International Classification of Disease (ICD) 10th Revision (ICD-10) diagnosis code set in the United States has been legislatively delayed several times with the most recent date for implementation set for October 1, 2015. The transition from ICD-9 to ICD-10 will be a major undertaking that will require a substantial amount of planning. In the following article, we outline the steps to develop and implement a strategic plan for the transition to the new code set, identify training needs throughout the practice, and review the challenges and opportunities associated with the transition to ICD-10.

  15. Cancer and Radiation Therapy: Current Advances and Future Directions

    PubMed Central

    Baskar, Rajamanickam; Lee, Kuo Ann; Yeo, Richard; Yeoh, Kheng-Wei

    2012-01-01

    In recent years remarkable progress has been made towards the understanding of proposed hallmarks of cancer development and treatment. However with its increasing incidence, the clinical management of cancer continues to be a challenge for the 21st century. Treatment modalities comprise of radiation therapy, surgery, chemotherapy, immunotherapy and hormonal therapy. Radiation therapy remains an important component of cancer treatment with approximately 50% of all cancer patients receiving radiation therapy during their course of illness; it contributes towards 40% of curative treatment for cancer. The main goal of radiation therapy is to deprive cancer cells of their multiplication (cell division) potential. Celebrating a century of advances since Marie Curie won her second Nobel Prize for her research into radium, 2011 has been designated the Year of Radiation therapy in the UK. Over the last 100 years, ongoing advances in the techniques of radiation treatment and progress made in understanding the biology of cancer cell responses to radiation will endeavor to increase the survival and reduce treatment side effects for cancer patients. In this review, principles, application and advances in radiation therapy with their biological end points are discussed. PMID:22408567

  16. Cancer and radiation therapy: current advances and future directions.

    PubMed

    Baskar, Rajamanickam; Lee, Kuo Ann; Yeo, Richard; Yeoh, Kheng-Wei

    2012-01-01

    In recent years remarkable progress has been made towards the understanding of proposed hallmarks of cancer development and treatment. However with its increasing incidence, the clinical management of cancer continues to be a challenge for the 21st century. Treatment modalities comprise of radiation therapy, surgery, chemotherapy, immunotherapy and hormonal therapy. Radiation therapy remains an important component of cancer treatment with approximately 50% of all cancer patients receiving radiation therapy during their course of illness; it contributes towards 40% of curative treatment for cancer. The main goal of radiation therapy is to deprive cancer cells of their multiplication (cell division) potential. Celebrating a century of advances since Marie Curie won her second Nobel Prize for her research into radium, 2011 has been designated the Year of Radiation therapy in the UK. Over the last 100 years, ongoing advances in the techniques of radiation treatment and progress made in understanding the biology of cancer cell responses to radiation will endeavor to increase the survival and reduce treatment side effects for cancer patients. In this review, principles, application and advances in radiation therapy with their biological end points are discussed.

  17. Nanotechnology meets 3D in vitro models: tissue engineered tumors and cancer therapies.

    PubMed

    da Rocha, E L; Porto, L M; Rambo, C R

    2014-01-01

    Advances in nanotechnology are providing to medicine a new dimension. Multifunctional nanomaterials with diagnostics and treatment modalities integrated in one nanoparticle or in cooperative nanosystems are promoting new insights to cancer treatment and diagnosis. The recent convergence between tissue engineering and cancer is gradually moving towards the development of 3D disease models that more closely resemble in vivo characteristics of tumors. However, the current nanomaterials based therapies are accomplished mainly in 2D cell cultures or in complex in vivo models. The development of new platforms to evaluate nano-based therapies in parallel with possible toxic effects will allow the design of nanomaterials for biomedical applications prior to in vivo studies. Therefore, this review focuses on how 3D in vitro models can be applied to study tumor biology, nanotoxicology and to evaluate nanomaterial based therapies. © 2013.

  18. ICD-10 classification in Danish child and adolescent psychiatry--have diagnoses changed after the introduction of ICD-10?

    PubMed

    Møller, Lene Ruge; Sørensen, Merete Juul; Thomsen, Per Hove

    2007-01-01

    The aim was to test this in a nationwide register study of diagnoses used in child and adolescents psychiatry in Denmark. A larger number of different diagnoses were expected to be applied after the introduction of the 10th version of the International Classification of Diseases (ICD-10). Reflecting the time trend, we particularly expected an increase in the number of neuropsychiatric diagnoses. From the Danish Psychiatric Central Register data were drawn on clinical discharge diagnoses. All patients aged 0-15 years examined at psychiatric hospitals from 1995-2002 were included; 22,469 children and adolescents with a first contact were registered. The most frequent discharge diagnoses were pervasive development disorders (PDD; 11.9%), adjustment disorders (10.6%), conduct disorder (9.5%), emotional and anxiety disorders (7.6%), hyperkinetic disorders (7.3%), and specific developmental disorders (7.3%). We found a significant increase in the number of neuropsychiatric and affective diagnoses and a significant decrease in the number of adjustment, conduct and anxiety diagnoses during the study period. Of the 22,469 diagnoses, 45% were only partly specified according to ICD-10. Thirty-four per cent had diagnoses unspecified on the four-character level (Fxx.9) and 11% had Z-diagnoses. A larger number of different diagnoses and an increase in the use of neuropsychiatric diagnoses were seen after the introduction of ICD-10. Many diagnoses were only partly specified; consequently, a more detailed specification of the ICD-10 is still required.

  19. Innovation and the future of advanced dosimetry: 2D to 5D

    NASA Astrophysics Data System (ADS)

    Oldham, Mark

    2017-05-01

    Recent years have witnessed a remarkable evolution in the techniques, capabilities and applications of 3D dosimetry. Initially the goal was simple: to innovate new techniques capable of comprehensively measuring and verifying exquisitely intricate dose distributions from a paradigm changing emerging new therapy, IMRT. Basic questions emerged: how well were treatment planning systems modelling the complex delivery, and how could treatments be verified for safe use on patients? Since that time, equally significant leaps of innovation have continued in the technology of treatment delivery. In addition, clinical practice has been transformed by the addition of on-board imaging capabilities, which tend to hypo-fractionation strategies and margin reduction. The net result is a high stakes treatment setting where the clinical morbidity of any unintended treatment deviation is exacerbated by the combination of highly conformal dose distributions given with reduced margins with fractionation regimens unfriendly to healthy tissue. Not surprisingly this scenario is replete with challenges and opportunities for new and improved dosimetry systems. In particular tremendous interest exists in comprehensive 3D dosimetry systems, and systems that can resolve the dose in moving structures (4D) and even in deforming structures (5D). Despite significant progress in the capability of multi-dimensional dosimetry systems, it is striking that true 3D dosimetry systems are today largely found in academic institutions or specialist clinics. The reasons will be explored. We will highlight innovations occurring both in treatment delivery and in advanced dosimetry methods designed to verify them, and explore current and future opportunities for advanced dosimetry tools in clinical practice and translational research.

  20. Harmonisation of ICD-11 and DSM-V: opportunities and challenges.

    PubMed

    First, Michael B

    2009-11-01

    Differences in the ICD-10 and DSM-IV definitions for the same disorder impede international communication and research efforts. The forthcoming parallel development of DSM-V and ICD-11 offers an opportunity to harmonise the two classifications. This paper aims to facilitate the harmonisation process by identifying diagnostic differences between the two systems. DSM-IV-TR criteria sets and the ICD-10 Diagnostic Criteria for Research were compared and categorised into those with identical definitions, those with conceptually based differences and those in which differences are not conceptually based and appear to be unintentional. Of the 176 criteria sets in both systems, only one, transient tic disorder, is identical. Twenty-one per cent had conceptually based differences and 78% had non-conceptually based differences. Harmonisation of criteria sets, especially those with non-conceptually based differences, should be prioritised in the DSM-V and ICD-11 development process. Prior experience with the DSM-IV and ICD-10 harmonisation effort suggests that for the process to be successful steps should be taken as early as possible.

  1. ICD-10: from assessment to remediation to strategic opportunity.

    PubMed

    Dugan, John K

    2012-02-01

    Healthcare finance teams should perform an enterprisewide assessment to determine what ICD-10 means to their organization, strategically, operationally, and financially. CFOs should strategically evaluate the impact of ICD-10 on the organization's entire financial operation. Organizations should have a contingency plan in place across all processes.

  2. Postmortem ICD interrogation in mode of death classification.

    PubMed

    Nikolaidou, Theodora; Johnson, Miriam J; Ghosh, Justin M; Marincowitz, Carl; Shah, Saumil; Lammiman, Michael J; Schilling, Richard J; Clark, Andrew L

    2018-04-01

    The definition of sudden death due to arrhythmia relies on the time interval between onset of symptoms and death. However, not all sudden deaths are due to arrhythmia. In patients with an implantable cardioverter defibrillator (ICD), postmortem device interrogation may help better distinguish the mode of death compared to a time-based definition alone. This study aims to assess the proportion of "sudden" cardiac deaths in patients with an ICD that have confirmed arrhythmia. We conducted a literature search for studies using postmortem ICD interrogation and a time-based classification of the mode of death. A modified QUADAS-2 checklist was used to assess risk of bias in individual studies. Outcome data were pooled where sufficient data were available. Our search identified 22 studies undertaken between 1982 and 2015 with 23,600 participants. The pooled results (excluding studies with high risk of bias) suggest that ventricular arrhythmias are present at the time of death in 76% of "sudden" deaths (95% confidence interval [CI] 67-85; range 42-88). Postmortem ICD interrogation identifies 24% of "sudden" deaths to be nonarrhythmic. Postmortem device interrogation should be considered in all cases of unexplained sudden cardiac death. © 2018 Wiley Periodicals, Inc.

  3. Clashing Diagnostic Approaches: DSM-ICD versus RDoC

    PubMed Central

    Lilienfeld, Scott O.; Treadway, Michael T.

    2016-01-01

    Since at least the middle of the past century, one overarching model of psychiatric classification, namely, that of the Diagnostic and Statistical Manual of Mental Disorders and International Classification of Diseases (DSM-ICD), has reigned supreme. This DSM-ICD approach embraces an Aristotelian view of mental disorders as largely discrete entities that are characterized by distinctive signs, symptoms, and natural histories. Over the past several years, however, a competing vision, namely, the Research Domain Criteria (RDoC) initiative launched by the National Institute of Mental Health, has emerged in response to accumulating anomalies within the DSM-ICD system. In contrast to DSM-ICD, RDoC embraces a Galilean view of psychopathology as the product of dysfunctions in neural circuitry. RDoC appears to be a valuable endeavor that holds out the long-term promise of an alternative system of mental illness classification. We delineate three sets of pressing challenges – conceptual, methodological, and logistical/pragmatic – that must be addressed for RDoC to realize its scientific potential, and conclude with a call for further research, including investigation of a rapprochement between Aristotelian and Galilean approaches to psychiatric classification. PMID:26845519

  4. Stereotyped movement disorder in ICD-11.

    PubMed

    Stein, Dan J; Woods, Douglas W

    2014-01-01

    According to current proposals for ICD-11, stereotyped movement disorder will be classified in the grouping of neurodevelopmental disorders, with a qualifier to indicate whether self-injury is present, similar to the classification of stereotypic movement disorder in DSM-5. At the same time, the WHO ICD-11 Working Group on the Classification of Obsessive-Compulsive and Related Disorders has proposed a grouping of body-focused repetitive behavior disorders within the obsessive-compulsive and related disorders (OCRD) cluster to include trichotillomania and skin-picking disorder. DSM-5 has taken a slightly different approach: trichotillomania and excoriation (skin picking) disorder are included in the OCRD grouping, while body-focused repetitive behavior disorder is listed under other specified forms of OCRD. DSM-5 also includes a separate category of nonsuicidal self-injury in the section on "conditions for further study." There are a number of unresolved nosological questions regarding the relationships among stereotyped movement disorder, body-focused repetitive behavior disorders, and nonsuicidal self-injury. In this article, we attempt to provide preliminary answers to some of these questions as they relate to the ICD-11 classification of mental and behavioral disorders.

  5. Impulse control disorders and related behaviours (ICD-RBs) in Parkinson's disease patients: Assessment using "Questionnaire for impulsive-compulsive disorders in Parkinson's disease" (QUIP).

    PubMed

    Sharma, Ashish; Goyal, Vinay; Behari, Madhuri; Srivastva, Achal; Shukla, Garima; Vibha, Deepti

    2015-01-01

    There is limited data on the prevalence of impulse control disorder and related behaviors (ICD-RBs) in Indian patients with Parkinson's Disease (PD). In the context of potential genetic and environmental factors affecting the expression of ICD-RBs, studying other multiethnic populations may bring in-sights into the mechanisms of these disorders. To ascertain point prevalence estimate of ICD-RBs in Indian PD patients, using the validated "Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease (QUIP)" and to examine their association with Dopamine replacement therapy (DRT). This was a hospital based observational cross-sectional study. After taking informed consent, patients and their informants (spouse, or primary caregiver) were made to complete the QUIP, and were instructed to answer questions based on behaviors that occurred anytime during PD that lasted at least four consecutive weeks. Total of 299 patients participated in the study. At least one ICD-RB was present in 128 (42.8%), at least one Impulse control disorder (ICD) was present in 74 (24.75%) and at least one Impulse control related compulsive behaviour (ICRB) was present in 93 (31.1%) patients. Punding was the most frequent (12.4%) followed by hyper sexuality (11.04%), compulsive hobbyism (9.4%), compulsive shopping (8.4%), compulsive medication use (7.7%), compulsive eating (5.35%), walkabout (4%) and pathological gambling (3.3%). ≥ 2 ICD-RBs were observed in 15.7% of patients. After multivariate analysis, younger age of onset, being unmarried were specifically associated with presence of ICD. Longer disease duration was specifically associated with presence of ICRB. Whereas smoking and higher dopamine levodopa equivalent daily doses (DA LEDD) were associated with both presence of ICD and ICRB. Higher LD LEDD was specifically associated with presence of ICD-RB. Our study revealed a relatively higher frequency of ICD-RBs, probably because of the use of screening instrument and because

  6. Validation of ICD-9 Codes for Stable Miscarriage in the Emergency Department.

    PubMed

    Quinley, Kelly E; Falck, Ailsa; Kallan, Michael J; Datner, Elizabeth M; Carr, Brendan G; Schreiber, Courtney A

    2015-07-01

    International Classification of Disease, Ninth Revision (ICD-9) diagnosis codes have not been validated for identifying cases of missed abortion where a pregnancy is no longer viable but the cervical os remains closed. Our goal was to assess whether ICD-9 code "632" for missed abortion has high sensitivity and positive predictive value (PPV) in identifying patients in the emergency department (ED) with cases of stable early pregnancy failure (EPF). We studied females ages 13-50 years presenting to the ED of an urban academic medical center. We approached our analysis from two perspectives, evaluating both the sensitivity and PPV of ICD-9 code "632" in identifying patients with stable EPF. All patients with chief complaints "pregnant and bleeding" or "pregnant and cramping" over a 12-month period were identified. We randomly reviewed two months of patient visits and calculated the sensitivity of ICD-9 code "632" for true cases of stable miscarriage. To establish the PPV of ICD-9 code "632" for capturing missed abortions, we identified patients whose visits from the same time period were assigned ICD-9 code "632," and identified those with actual cases of stable EPF. We reviewed 310 patient records (17.6% of 1,762 sampled). Thirteen of 31 patient records assigned ICD-9 code for missed abortion correctly identified cases of stable EPF (sensitivity=41.9%), and 140 of the 142 patients without EPF were not assigned the ICD-9 code "632"(specificity=98.6%). Of the 52 eligible patients identified by ICD-9 code "632," 39 cases met the criteria for stable EPF (PPV=75.0%). ICD-9 code "632" has low sensitivity for identifying stable EPF, but its high specificity and moderately high PPV are valuable for studying cases of stable EPF in epidemiologic studies using administrative data.

  7. WE-D-BRD-01: Innovation in Radiation Therapy Delivery: Advanced Digital Linac Features

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

    Xing, L; Wong, J; Li, R

    2014-06-15

    Last few years has witnessed significant advances in linac technology and therapeutic dose delivery method. Digital linacs equipped with high dose rate FFF beams have been clinically implemented in a number of hospitals. Gated VMAT is becoming increasingly popular in treating tumors affected by respiratory motion. This session is devoted to update the audience with these technical advances and to present our experience in clinically implementing the new linacs and dose delivery methods. Topics to be covered include, technical features of new generation of linacs from different vendors, dosimetric characteristics and clinical need for FFF-beam based IMRT and VMAT, respiration-gatedmore » VMAT, the concept and implementation of station parameter optimized radiation therapy (SPORT), beam level imaging and onboard image guidance tools. Emphasis will be on providing fundamental understanding of the new treatment delivery and image guidance strategies, control systems, and the associated dosimetric characteristics. Commissioning and acceptance experience on these new treatment delivery technologies will be reported. Clinical experience and challenges encountered during the process of implementation of the new treatment techniques and future applications of the systems will also be highlighted. Learning Objectives: Present background knowledge of emerging digital linacs and summarize their key geometric and dosimetric features. SPORT as an emerging radiation therapy modality specifically designed to take advantage of digital linacs. Discuss issues related to the acceptance and commissioning of the digital linacs and FFF beams. Describe clinical utility of the new generation of digital linacs and their future applications.« less

  8. Past, present and future of Integrated Child Development Services (I.C.D.S.).

    PubMed

    Lal, S; Sachar, R K

    1993-01-01

    India's Integrated Child Development Services (ICDS) was established in 33 projects in 1975 and is spread over 22 states; 67 additional projects were begun in 1977, and over the next 2 years; 100 additional projects were added. By 1991=92, coverage was almost 50% of the country with 2696 projects; the expectation is for 100% coverage by the year 2000. An infrastructure chart identifies the organization and integration between level and social welfare and health departments. Objectives are clearly identified and the departments functionally linked. Linkages are achieved by shared space and activities at various levels. Over the past 17 years, services have included minimum needs programs, integrated rural development and poverty alleviation, national health policy and education policy, universal immunization, and the development of women and children in rural areas. ICDS is sponsored 100% by the status and uniquely relies on the honorary anganwadi worker (AWW), who is a woman, recruited and chosen by the community, aged 21-45 years and middle-school educated. The AWW was responsibility for 2000 households or 1000 persons in rural areas and 700 persons in tribal areas. The AWW is crucial to the functioning of the program and receives an honorarium of Rs. 225-275/month for implementing the ICDs program; AWWs have helpers who are paid Rs. 110/month. Training over a 3-year period is conducted at the Bal Sevika Training Institute by the Indian Council of Child Welfare. Additional health personnel and their role and the number of persons/per area AWWS are responsible for, equipment, and functions are also described. The AWW is responsible for nonformal preschool education, organization of supplementary nutrition feeding, health and nutrition education of women and families, immunization of women and children, treatment and referral of common illnesses, growing monitoring, and community participation. Presently, there are 2506 central sector projects and 190 state sector

  9. New Methodology for an Expert-Designed Map From International Classification of Diseases (ICD) to Abbreviated Injury Scale (AIS) 3+ Severity Injury.

    PubMed

    Zonfrillo, Mark R; Weaver, Ashley A; Gillich, Patrick J; Price, Janet P; Stitzel, Joel D

    2015-01-01

    There has been a longstanding desire for a map to convert International Classification of Diseases (ICD) injury codes to Abbreviated Injury Scale (AIS) codes to reflect the severity of those diagnoses. The Association for the Advancement of Automotive Medicine (AAAM) was tasked by European Union representatives to create a categorical map classifying diagnoses codes as serious injury (Abbreviated Injury Scale [AIS] 3+), minor/moderate injury (AIS 1/2), or indeterminate. This study's objective was to map injury-related ICD-9-CM (clinical modification) and ICD-10-CM codes to these severity categories. Approximately 19,000 ICD codes were mapped, including injuries from the following categories: amputations, blood vessel injury, burns, crushing injury, dislocations/sprains/strains, foreign body, fractures, internal organ, nerve/spinal cord injury, intracranial, laceration, open wounds, and superficial injury/contusion. Two parallel activities were completed to create the maps: (1) An in-person expert panel and (2) an electronic survey. The panel consisted of expert users of AIS and ICD from North America, the United Kingdom, and Australia. The panel met in person for 5 days, with follow-up virtual meetings to create and revise the maps. Additional qualitative data were documented to resolve potential discrepancies in mapping. The electronic survey was completed by 95 injury coding professionals from North America, Spain, Australia, and New Zealand over 12 weeks. ICD-to-AIS maps were created for: ICD-9-CM and ICD-10-CM. Both maps indicated whether the corresponding AIS 2005/Update 2008 severity score for each ICD code was AIS 3+, 1/2, or indeterminable. Though some ICD codes could be mapped to multiple AIS codes, the maximum severity of all potentially mapped injuries determined the final severity categorization. The in-person panel consisted of 13 experts, with 11 Certified AIS specialists (CAISS) with a median of 8 years and an average of 15 years of coding experience

  10. Photothermal Therapy Generates a Thermal Window of Immunogenic Cell Death in Neuroblastoma.

    PubMed

    Sweeney, Elizabeth E; Cano-Mejia, Juliana; Fernandes, Rohan

    2018-04-17

    A thermal "window" of immunogenic cell death (ICD) elicited by nanoparticle-based photothermal therapy (PTT) in an animal model of neuroblastoma is described. In studies using Prussian blue nanoparticles to administer photothermal therapy (PBNP-PTT) to established localized tumors in the neuroblastoma model, it is observed that PBNP-PTT conforms to the "more is better" paradigm, wherein higher doses of PBNP-PTT generates higher cell/local heating and thereby more cell death, and consequently improved animal survival. However, in vitro analysis of the biochemical correlates of ICD (ATP, high-motility group box 1, and calreticulin) elicited by PBNP-PTT demonstrates that PBNP-PTT triggers a thermal window of ICD. ICD markers are highly expressed within an optimal temperature (thermal dose) window of PBNP-PTT (63.3-66.4 °C) as compared with higher (83.0-83.5 °C) and lower PBNP-PTT (50.7-52.7 °C) temperatures, which both yield lower expression. Subsequent vaccination studies in the neuroblastoma model confirm the in vitro findings, wherein PBNP-PTT administered within the optimal temperature window results in long-term survival (33.3% at 100 d) compared with PBNP-PTT administered within the higher (0%) and lower (20%) temperature ranges, and controls (0%). The findings demonstrate a tunable immune response to heat generated by PBNP-PTT, which should be critically engaged in the administration of PTT for maximizing its therapeutic benefits. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  11. Relationship between improvement in left ventricular dyssynchrony and contractile function and clinical outcome with cardiac resynchronization therapy: the MADIT-CRT trial.

    PubMed

    Pouleur, Anne-Catherine; Knappe, Dorit; Shah, Amil M; Uno, Hajime; Bourgoun, Mikhail; Foster, Elyse; McNitt, Scott; Hall, W Jackson; Zareba, Wojciech; Goldenberg, Ilan; Moss, Arthur J; Pfeffer, Marc A; Solomon, Scott D

    2011-07-01

    To assess long-term effects of cardiac resynchronization therapy (CRT) on left ventricular (LV) dyssynchrony and contractile function, by two-dimensional speckle-tracking echocardiography, compared with implantable cardioverter defibrillator (ICD) only in MADIT-CRT. We studied 761 patients in New York Heart Association I/II, ejection fraction ≤30%, and QRS ≥130 ms [n = 434, CRT-defibrillator (CRT-D), n = 327, ICD] with echocardiographic studies available at baseline and 12 months. Dyssynchrony was determined as the standard deviation of time to peak transverse strain between 12 segments of apical four- and two-chamber views, and contractile function as global longitudinal strain (GLS) by averaging longitudinal strain over these 12 segments. We compared changes in LV dyssynchrony and contractile function between treatment groups and assessed relationships between these changes over the first year and subsequent outcomes (median post 1-year follow-up = 14.9 months). Mean changes in LV dyssynchrony and contractile function measured by GLS in the overall population were, respectively, -29 ± 83 ms and -1 ± 2.9%. However, both LV dyssynchrony (CRT-D: -47 ± 83 ms vs. ICD: -6 ± 76 ms, P < 0.001) and contractile function (CRT-D: -1.4 ± 3.1% vs. ICD: -0.4 ± 2.5%, P < 0.001) improved to a greater extent in the CRT-D group compared with the ICD-only group. A greater improvement in dyssynchrony and contractile function at 1 year was associated with lower rates of the subsequent primary outcome of death or heart failure, adjusting for baseline dyssynchrony and contractile function, treatment arm, ischaemic status, and change in LV end-systolic volume. Each 20 ms decrease in LV dyssynchrony was associated with a 7% reduction in the primary outcome (P = 0.047); each 1% improvement in GLS over the 12-month period was associated with a 24% reduction in the primary outcome (P < 0.001). Cardiac resynchronization therapy resulted in a significant improvement in both LV

  12. Concurrent apatinib and local radiation therapy for advanced gastric cancer

    PubMed Central

    Zhang, Ming; Deng, Weiye; Cao, Xiaoci; Shi, Xiaoming; Zhao, Huanfen; Duan, Zheping; Lv, Bonan; Liu, Bin

    2017-01-01

    Abstract Rationale: Apatinib is a novel anti-angiogenic agent targeting vascular endothelial growth factor receptor-2, which is effective in patients with chemotherapy-refractory gastric cancer. There are no reports of concurrent apatinib with local radiation therapy in elderly patients with advanced gastric cancer. Patient concerns and Diagnoses: we present the first published report of a 70-year-old male patient with advanced gastric cancer who received concurrent apatinib and local radiation therapy after failure of oxaliplatin and S-1 chemotherapy. Interventions and Outcomes: The patient received concurrent apatinib and local radiation therapy and was followed up 7 months after therapy without disease progress, 14 months later indicated extensive metastasis and this patient died of pulmonary infection. Lessons: Elderly patients with advanced gastric cancer may benefit from concurrent apatinib with local radiation therapy when chemotherapy is not tolerated or successful. Further studies are needed to investigate the clinical outcomes and toxicities associated with concurrent apatinib and radiation therapy in gastric cancer. PMID:28248891

  13. Cardiac-resynchronization therapy for mild-to-moderate heart failure.

    PubMed

    Tang, Anthony S L; Wells, George A; Talajic, Mario; Arnold, Malcolm O; Sheldon, Robert; Connolly, Stuart; Hohnloser, Stefan H; Nichol, Graham; Birnie, David H; Sapp, John L; Yee, Raymond; Healey, Jeffrey S; Rouleau, Jean L

    2010-12-16

    Cardiac-resynchronization therapy (CRT) benefits patients with left ventricular systolic dysfunction and a wide QRS complex. Most of these patients are candidates for an implantable cardioverter-defibrillator (ICD). We evaluated whether adding CRT to an ICD and optimal medical therapy might reduce mortality and morbidity among such patients. We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more or a paced QRS duration of 200 msec or more to receive either an ICD alone or an ICD plus CRT. The primary outcome was death from any cause or hospitalization for heart failure. We followed 1798 patients for a mean of 40 months. The primary outcome occurred in 297 of 894 patients (33.2%) in the ICD-CRT group and 364 of 904 patients (40.3%) in the ICD group (hazard ratio in the ICD-CRT group, 0.75; 95% confidence interval [CI], 0.64 to 0.87; P<0.001). In the ICD-CRT group, 186 patients died, as compared with 236 in the ICD group (hazard ratio, 0.75; 95% CI, 0.62 to 0.91; P = 0.003), and 174 patients were hospitalized for heart failure, as compared with 236 in the ICD group (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). However, at 30 days after device implantation, adverse events had occurred in 124 patients in the ICD-CRT group, as compared with 58 in the ICD group (P<0.001). Among patients with NYHA class II or III heart failure, a wide QRS complex, and left ventricular systolic dysfunction, the addition of CRT to an ICD reduced rates of death and hospitalization for heart failure. This improvement was accompanied by more adverse events. (Funded by the Canadian Institutes of Health Research and Medtronic of Canada; ClinicalTrials.gov number, NCT00251251.).

  14. The development, evolution, and modifications of ICD-10: challenges to the international comparability of morbidity data.

    PubMed

    Jetté, Nathalie; Quan, Hude; Hemmelgarn, Brenda; Drosler, Saskia; Maass, Christina; Moskal, Lori; Paoin, Wansa; Sundararajan, Vijaya; Gao, Song; Jakob, Robert; Ustün, Bedihran; Ghali, William A

    2010-12-01

    The United States is about to make a major nationwide transition from ICD-9-CM coding of hospital discharges to ICD-10-CM, a country-specific modification of the World Health Organization's ICD-10. As this transition occurs, the WHO is already in the midst of developing ICD-11. Given this context, we undertook this review to discuss: (1) the history of the International Classification of Diseases (a core information "building block" for health systems everywhere) from its introduction to the current era of ICD-11 development; (2) differences across country-specific ICD-10 clinical modifications and the challenges that these differences pose to the international comparability of morbidity data; (3) potential strategic approaches to achieving better international ICD-11 comparability. A literature review and stakeholder consultation was carried out. The various ICD-10 clinical modifications (ICD-10-AM [Australia], ICD-10-CA [Canada], ICD-10-GM [Germany], ICD-10-TM [Thailand], ICD-10-CM [United States]) were compared. These ICD-10 modifications differ in their number of codes, chapters, and subcategories. Specific conditions are present in some but not all of the modifications. ICD-11, with a similar structure to ICD-10, will function in an electronic health records environment and also provide disease descriptive characteristics (eg, causal properties, functional impact, and treatment). The threat to the comparability of international clinical morbidity is growing with the development of many country-specific ICD-10 versions. One solution to this threat is to develop a meta-database including all country-specific modifications to ensure more efficient use of people and resources, decrease omissions and errors but most importantly provide a platform for future ICD updates.

  15. Neutrophil to lymphocyte ratio predicts appropriate therapy in idiopathic dilated cardiomyopathy patients with primary prevention implantable cardioverter defibrillator

    PubMed Central

    Uçar, Fatih M.; Açar, Burak

    2017-01-01

    Objectives: To investigate whether an inflammatory marker of neutrophil to lymphocyte ratio (NLR) predicts appropriate implantable cardioverter defibrillator (ICD) therapy (shock or anti tachycardia pacing) in idiopathic dilated cardiomyopathy (IDC) patients. Methods: We retrospectively examined IDC patients (mean age: 58.3 ± 11.8 years, 81.5% male) with ICD who admitted to outpatient clinic for pacemaker control at 2 tertiary care hospitals in Ankara and Edirne, Turkey from January 2013-2015. All ICDs were implanted for primary prevention. Hematological and biochemical parameters were measured prior procedure. Results: Over a median follow-up period of 43 months (Range 7-125), 68 (33.1%) patients experienced appropriate ICD therapy. The NLR was increased in patients that received appropriate therapy (4.39 ± 2.94 versus 2.96 ± 1.97, p<0.001). To identify independent risk factors for appropriate therapy, a multivariate linear regression model was conducted and age (β=0.163, p=0.013), fasting glucose (β=0.158, p=0.017), C-reactive protein (CRP) (β=0.289, p<0.001) and NLR (β=0.212, p<0.008) were found to be independent risk factors for appropriate ICD therapy. Conclusions: Before ICD implantation by using NLR and CRP, arrhythmic episodes may be predictable and better antiarrhythmic medical therapy optimization may protect these IDC patients from unwanted events. PMID:28133686

  16. Outcomes in African Americans undergoing cardioverter-defibrillator implantation for primary prevention of sudden cardiac death: findings from the Prospective Observational Study of Implantable Cardioverter-Defibrillators (PROSE-ICD).

    PubMed

    Zhang, Yiyi; Kennedy, Robert; Blasco-Colmenares, Elena; Butcher, Barbara; Norgard, Sanaz; Eldadah, Zayd; Dickfeld, Timm; Ellenbogen, Kenneth A; Marine, Joseph E; Guallar, Eliseo; Tomaselli, Gordon F; Cheng, Alan

    2014-08-01

    Implantable cardioverter-defibrillators (ICDs) reduce the risk of death in patients with left ventricular dysfunction. Little is known regarding the benefit of this therapy in African Americans (AAs). The purpose of this study was to determine the association between AA race and outcomes in a cohort of primary prevention ICD patients. We conducted a prospective cohort study of patients with systolic heart failure who underwent ICD implantation for primary prevention of sudden cardiac death. The primary end-point was appropriate ICD shock defined as a shock for rapid ventricular tachyarrhythmias. The secondary end-point was all-cause mortality. There were 1189 patients (447 AAs and 712 non-AAs) enrolled. Over a median follow-up of 5.1 years, a total of 137 patients experienced an appropriate ICD shock, and 343 died (294 of whom died without receiving an appropriate ICD shock). The multivariate adjusted hazard ratio (95% confidence interval) comparing AAs vs non-AAs were 1.24 (0.96-1.59) for all-cause mortality, 1.33 (1.02, 1.74) for all-cause mortality without receiving appropriate ICD shock, and 0.78 (0.51, 1.19) for appropriate ICD shock. Ejection fraction, diabetes, and hypertension appeared to explain 24.1% (10.1%-69.5%), 18.7% (5.3%-58.0%), and 13.6% (3.8%-53.6%) of the excess risk of mortality in AAs, with a large proportion of the mortality difference remaining unexplained. In patients with primary prevention ICDs, AAs had an increased risk of dying without receiving an appropriate ICD shock compared to non-AAs. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  17. Impulse control disorders and related behaviours (ICD-RBs) in Parkinson's disease patients: Assessment using “Questionnaire for impulsive-compulsive disorders in Parkinson's disease” (QUIP)

    PubMed Central

    Sharma, Ashish; Goyal, Vinay; Behari, Madhuri; Srivastva, Achal; Shukla, Garima; Vibha, Deepti

    2015-01-01

    Background: There is limited data on the prevalence of impulse control disorder and related behaviors (ICD-RBs) in Indian patients with Parkinson's Disease (PD). In the context of potential genetic and environmental factors affecting the expression of ICD-RBs, studying other multiethnic populations may bring in-sights into the mechanisms of these disorders. Objectives: To ascertain point prevalence estimate of ICD-RBs in Indian PD patients, using the validated “Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease (QUIP)” and to examine their association with Dopamine replacement therapy (DRT). Materials and Methods: This was a hospital based observational cross-sectional study. After taking informed consent, patients and their informants (spouse, or primary caregiver) were made to complete the QUIP, and were instructed to answer questions based on behaviors that occurred anytime during PD that lasted at least four consecutive weeks. Results: Total of 299 patients participated in the study. At least one ICD-RB was present in 128 (42.8%), at least one Impulse control disorder (ICD) was present in 74 (24.75%) and at least one Impulse control related compulsive behaviour (ICRB) was present in 93 (31.1%) patients. Punding was the most frequent (12.4%) followed by hyper sexuality (11.04%), compulsive hobbyism (9.4%), compulsive shopping (8.4%), compulsive medication use (7.7%), compulsive eating (5.35%), walkabout (4%) and pathological gambling (3.3%). ≥ 2 ICD-RBs were observed in 15.7% of patients. After multivariate analysis, younger age of onset, being unmarried were specifically associated with presence of ICD. Longer disease duration was specifically associated with presence of ICRB. Whereas smoking and higher dopamine levodopa equivalent daily doses (DA LEDD) were associated with both presence of ICD and ICRB. Higher LD LEDD was specifically associated with presence of ICD-RB. Conclusions: Our study revealed a relatively higher frequency of

  18. Psychotic disorders in DSM-5 and ICD-11.

    PubMed

    Biedermann, Falko; Fleischhacker, W Wolfgang

    2016-08-01

    The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) was published by the American Psychiatric Association (APA) in 2013, and the Work Group on the Classification of Psychotic disorders (WGPD), installed by the World Health Organization (WHO), is expected to publish the new chapter about schizophrenia and other primary psychotic disorders in 2017. We reviewed the available literature to summarize the major changes, innovations, and developments of both manuals. If available and possible, we outline the theoretical background behind these changes. Due to the fact that the development of ICD-11 has not yet been completed, the details about ICD-11 are still proposals under ongoing revision. In this ongoing process, they may be revised and therefore have to be seen as proposals. DSM-5 has eliminated schizophrenia subtypes and replaced them with a dimensional approach based on symptom assessments. ICD-11 will most likely go in a similar direction, as both manuals are planned to be more harmonized, although some differences will remain in details and the conceptual orientation. Next to these modifications, ICD-11 will provide a transsectional diagnostic criterion for schizoaffective disorders and a reorganization of acute and transient psychotic and delusional disorders. In this manuscript, we will compare the 2 classification systems.

  19. Body-focused repetitive behavior disorders in ICD-11.

    PubMed

    Grant, Jon E; Stein, Dan J

    2014-01-01

    This article addresses the question of how body-focused repetitive behavior disorders (e.g., trichotillomania and skin-picking disorder) should be characterized in ICD-11. The article reviews the historical nosology of the two disorders and the current approaches in DSM-5 and ICD-10. Although data are limited and mixed regarding the optimal relationship between body-focused repetitive behavior disorders and nosological categories, these conditions should be included within the obsessive-compulsive and related disorders category, as this is how most clinicians see these behaviors, and as this may optimize clinical utility. The descriptions of these disorders should largely mirror those in DSM-5, given the evidence from recent field surveys. The recommendations regarding ICD-11 and body-focused repetitive behavior disorders should promote the global identification and treatment of these conditions in primary care settings.

  20. Advances of Molecular Targeted Therapy in Gastric Cancer.

    PubMed

    Cetin, Bulent; Gumusay, Ozge; Cengiz, Mustafa; Ozet, Ahmet

    2016-06-01

    Gastric cancer is the second most common cause of cancer-related death in the world, and its prognosis remains poor with a median overall survival of 12 months for advanced disease. Advances in the understanding of molecular genetics have led to the development of directed molecular targeted therapy in gastric cancer, leading to improve patient outcomes and quality of life. In the treatment of human epidermal growth factor receptor 2 (HER2)-positive gastric cancer, the addition of trastuzumab significantly improves survival in the first-line setting of therapy. Ramucirumab, an antibody directed against vascular endothelial growth factor receptor 2, significantly improved progression-free and overall survival and has been approved for second-line treatment of gastric cancer. Anti-mesenchymal-epithelial transition (c-MET), mammalian target of rapamycin inhibitors, and polo-like kinase 1 inhibitors are under investigation as a novel therapeutic option for the treatment of gastric cancer. The novel therapies target the key immune checkpoint interaction between a T cell co-inhibitory receptor called programmed death 1 (PD-1) and one of its immunosuppressive ligands, PD-L1. This article reviews molecular targeted therapies in gastric cancer, in light of recent advances.

  1. Advances in intravesical therapy for urinary tract disorders

    PubMed Central

    Tyagi, Pradeep; Kashyap, Mahendra; Hensley, Harvey; Yoshimura, Naoki

    2016-01-01

    Introduction Intravesical therapy is a valuable option in the clinical management of urinary tract disorders such as interstitial cystitis/ painful bladder syndrome (IC/PBS) and refractory overactive bladder. This review will cover the latest advances in this field using polymer and liposomes as delivery platform for drugs, protein and nucleic acids. Areas covered This review summarizes the significance of intravesical therapy for lower urinary tract disorders. The recent advancement of liposomes as a drug delivery platform for botulinum toxin, tacrolimus and small interfering RNA is discussed. The importance of polymers forming indwelling devices and hydrogels are also discussed, where all preparations improved efficacy parameters in rodent models. Clinical experience of treating IC/PBS with indwelling devices and liposomes are summarized and preclinical evidence about the downregulation of target gene expression in rodent bladder with liposomes complexed with siRNA is also reviewed. Expert opinion There have been several advances in the field of intravesical therapy for improving clinical outcomes. One of the most promising research avenues is the repurposing of drugs, given previously by other routes of administration, such as tacrolimus. Intravesical therapy also opens up novel therapeutic targets with improved efficacy and safety for underactive bladder. PMID:26479968

  2. Surgical resection after TNFerade therapy for locally advanced pancreatic cancer.

    PubMed

    Chadha, Manpreet K; Litwin, Alan; Levea, Charles; Iyer, Renuka; Yang, Gary; Javle, Milind; Gibbs, John F

    2009-09-04

    Treatment of pancreatic cancer remains a major oncological challenge and survival is dismal. Most patients, present with advanced disease at diagnosis and are not candidates for curative resection. Preoperative chemoradiation may downstage and improve survival in locally advanced pancreatic cancer. This has prompted investigators to look for novel neoadjuvant therapies. Gene therapy for pancreatic cancer is a novel investigational approach that may have promise. TNFerade is a replication deficient adenovirus vector carrying the human tumor necrosis factor (TNF)-alpha gene regulated under control of a radiation-inducible gene promoter. Transfection of tumor cells with TNFerade maximizes the antitumor effect of TNF-alpha under influence of radiation leading to synergistic effects in preclinical studies. We describe a case of locally advanced unresectable pancreatic cancer treated with a novel multimodal approach utilizing gene therapy with TNFerade and concurrent chemoradiation that was followed by successful surgical resection. Neoadjuvant TNFerade based chemoradiation therapy may be a useful adjunct to treatment of locally advanced pancreatic cancer.

  3. 77 FR 48985 - Notice of Meeting of the ICD-9-CM Coordination and Maintenance Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

    ... Topics: ICD-10 Implementation Announcements Expansion of Thoracic Aorta Body Part Under Heart and Great... from thoracic aorta to abdominal aorta) ICD-10 MS-DRGs ICD-10 HAC Translations ICD-10 MCE Translations...

  4. Reliability and Validity of the Self Efficacy Expectations and Outcome Expectations After ICD Implantation Scales

    PubMed Central

    Dougherty, Cynthia M.; Johnston, Sandra K.; Thompson, Elaine Adams

    2009-01-01

    The purpose of this study was to assess the reliability and validity characteristics of two new scales that measure self-efficacy expectations (SE-ICD) and outcome expectations (OE-ICD) in survivors (n=168) of sudden cardiac arrest (SCA), all of whom received an implantable cardioverter defibrillator (ICD). Cronbach's alpha reliability demonstrated good internal consistency (SE-ICD α = 0.93 and OE-ICD α = 0.81). Correlations with other self-efficacy instruments (general self-efficacy and social self-efficacy) were consistently high. The instruments were responsive to change across time with effect sizes of 0.46 for SE-ICD, and 0.26 for OE-ICD. These reliable, valid, and responsive instruments for measurement of self-efficacy expectations and outcome expectations after an ICD can be used in research and clinical settings. PMID:17693214

  5. Long-term single-center experience of defibrillator therapy in children and adolescents.

    PubMed

    Frommeyer, Gerrit; Feder, Sebastian; Bettin, Markus; Debus, Volker; Köbe, Julia; Reinke, Florian; Uebing, Anselm; Eckardt, Lars; Kehl, Hans Gerd

    2018-06-01

    Implantable cardioverter-defibrillator (ICD) systems are established therapy for prevention of sudden cardiac death. Long-term data on ICD systems in children and adolescents is rare. The present study displays a long-term single-center follow-up of children and adolescents with ICD systems. The present study represents a single-center experience of patients younger than 18 years who received an ICD (n = 58). Follow-up data included in-house follow-up as well as examinations of collaborating specialists. Mean age at implantation was 14.0 ± 3.3 years and 33 patients (56.9%) were male. A transvenous ICD system was implanted in 54 patients (93.1%). In 33 patients (56.9%) electrical heart disease or idiopathic ventricular fibrillation represented the underlying condition of ICD implantation. Median follow-up duration was 70 months (45; 94). 3 patients (5.2%) died during the observation period. None of these deaths was associated with ICD failure. Appropriate shocks occurred in 32 patients (55.2%). Inappropriate shock delivery was recorded in 17 patients (29.3%). Supraventricular tachycardia represented the most frequent cause of inappropriate shock delivery (9 patients, 52.9%). T-wave oversensing led to inappropriate shock delivery in 3 patients (17.6%). In 5 patients (29.4%), lead failure caused inappropriate shock delivery. Of note, during follow-up lead failure was reported in 15 patients (25.9%) leading to surgical revision. ICD therapy in children and adolescents is effective for prevention of sudden cardiac death. The rate of appropriate shock deliveries was significantly higher as compared with large ICD trials. Inappropriate therapies occurred frequently. In particular supraventricular tachycardia, T-wave oversensing and lead failures were responsible for these episodes. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. An evaluation of comparability between NEISS and ICD-9-CM injury coding.

    PubMed

    Thompson, Meghan C; Wheeler, Krista K; Shi, Junxin; Smith, Gary A; Xiang, Huiyun

    2014-01-01

    To evaluate the National Electronic Injury Surveillance System's (NEISS) comparability with a data source that uses ICD-9-CM coding. A sample of NEISS cases from a children's hospital in 2008 was selected, and cases were linked with their original medical record. Medical records were reviewed and an ICD-9-CM code was assigned to each case. Cases in the NEISS sample that were non-injuries by ICD-9-CM standards were identified. A bridging matrix between the NEISS and ICD-9-CM injury coding systems, by type of injury classification, was proposed and evaluated. Of the 2,890 cases reviewed, 13.32% (n = 385) were non-injuries according to the ICD-9-CM diagnosis. Using the proposed matrix, the comparability of the NEISS with ICD-9-CM coding was favorable among injury cases (κ = 0.87, 95% CI: 0.85-0.88). The distribution of injury types among the entire sample was similar for the two systems, with percentage differences ≥1% for only open wounds or amputation, poisoning, and other or unspecified injury types. There is potential for conducting comparable injury research using NEISS and ICD-9-CM data. Due to the inclusion of some non-injuries in the NEISS and some differences in type of injury definitions between NEISS and ICD-9-CM coding, best practice for studies using NEISS data obtained from the CPSC should include manual review of case narratives. Use of the standardized injury and injury type definitions presented in this study will facilitate more accurate comparisons in injury research.

  7. A self-report measure for the ICD-11 dimensional trait model proposal: The personality inventory for ICD-11.

    PubMed

    Oltmanns, Joshua R; Widiger, Thomas A

    2018-02-01

    Proposed for the 11th edition of the World Health Organization's International Classification of Diseases (ICD-11) is a dimensional trait model for the classification of personality disorder (Tyrer, Reed, & Crawford, 2015). The ICD-11 proposal consists of 5 broad domains: negative affective, detachment, dissocial, disinhibition, and anankastic (Mulder, Horwood, Tyrer, Carter, & Joyce, 2016). Several field trials have examined this proposal, yet none has included a direct measure of the trait model. The purpose of the current study was to develop and provide initial validation for the Personality Inventory for ICD-11 (PiCD), a self-report measure of this proposed 5-domain maladaptive trait model. Item selection and scale construction proceeded through 3 initial data collections assessing potential item performance. Two subsequent studies were conducted for scale validation. In Study 1, the PiCD was evaluated in a sample of 259 MTurk participants (who were or had been receiving mental health treatment) with respect to 2 measures of general personality structure: The Eysenck Personality Questionnaire-Revised and the 5-Dimensional Personality Test. In Study 2, the PiCD was evaluated in an additional sample of 285 participants with respect to 2 measures of maladaptive personality traits: The Personality Inventory for DSM-5 and the Computerized Adaptive Test for Personality Disorders. Study 3 provides an item-level exploratory structural equation model with the combined samples from Studies 1 and 2. The results are discussed with respect to the validity of the measure and the potential benefits for future research in having a direct, self-report measure of the ICD-11 trait proposal. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

  8. SU-E-T-169: Characterization of Pacemaker/ICD Dose in SAVI HDR Brachytherapy

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

    Kalavagunta, C; Lasio, G; Yi, B

    2015-06-15

    Purpose: It is important to estimate dose to pacemaker (PM)/Implantable Cardioverter Defibrillator (ICD) before undertaking Accelerated Partial Breast Treatment using High Dose Rate (HDR) brachytherapy. Kim et al. have reported HDR PM/ICD dose using a single-source balloon applicator. To the authors knowledge, there have so far not been any published PM/ICD dosimetry literature for the Strut Adjusted Volume Implant (SAVI, Cianna Medical, Aliso Viejo, CA). This study aims to fill this gap by generating a dose look up table (LUT) to predict maximum dose to the PM/ICD in SAVI HDR brachytherapy. Methods: CT scans for 3D dosimetric planning were acquiredmore » for four SAVI applicators (6−1-mini, 6−1, 8−1 and 10−1) expanded to their maximum diameter in air. The CT datasets were imported into the Elekta Oncentra TPS for planning and each applicator was digitized in a multiplanar reconstruction window. A dose of 340 cGy was prescribed to the surface of a 1 cm expansion of the SAVI applicator cavity. Cartesian coordinates of the digitized applicator were determined in the treatment leading to the generation of a dose distribution and corresponding distance-dose prediction look up table (LUT) for distances from 2 to 15 cm (6-mini) and 2 to 20 cm (10–1).The deviation between the LUT doses and the dose to the cardiac device in a clinical case was evaluated. Results: Distance-dose look up table were compared to clinical SAVI plan and the discrepancy between the max dose predicted by the LUT and the clinical plan was found to be in the range (−0.44%, 0.74%) of the prescription dose. Conclusion: The distance-dose look up tables for SAVI applicators can be used to estimate the maximum dose to the ICD/PM, with a potential usefulness for quick assessment of dose to the cardiac device prior to applicator placement.« less

  9. Results from the Veterans Health Administration ICD-10-CM/PCS Coding Pilot Study.

    PubMed

    Weems, Shelley; Heller, Pamela; Fenton, Susan H

    2015-01-01

    The Veterans Health Administration (VHA) of the US Department of Veterans Affairs has been preparing for the October 1, 2015, conversion to the International Classification of Diseases, Tenth Revision, Clinical Modification and Procedural Coding System (ICD-10-CM/PCS) for more than four years. The VHA's Office of Informatics and Analytics ICD-10 Program Management Office established an ICD-10 Learning Lab to explore expected operational challenges. This study was conducted to determine the effects of the classification system conversion on coding productivity. ICD codes are integral to VHA business processes and are used for purposes such as clinical studies, performance measurement, workload capture, cost determination, Veterans Equitable Resource Allocation (VERA) determination, morbidity and mortality classification, indexing of hospital records by disease and operations, data storage and retrieval, research purposes, and reimbursement. The data collection for this study occurred in multiple VHA sites across several months using standardized methods. It is commonly accepted that coding productivity will decrease with the implementation of ICD-10-CM/PCS. The findings of this study suggest that the decrease will be more significant for inpatient coding productivity (64.5 percent productivity decrease) than for ambulatory care coding productivity (6.7 percent productivity decrease). This study reveals the following important points regarding ICD-10-CM/PCS coding productivity: 1. Ambulatory care ICD-10-CM coding productivity is not expected to decrease as significantly as inpatient ICD-10-CM/PCS coding productivity. 2. Coder training and type of record (inpatient versus outpatient) affect coding productivity. 3. Inpatient coding productivity is decreased when a procedure requiring ICD-10-PCS coding is present. It is highly recommended that organizations perform their own analyses to determine the effects of ICD-10-CM/PCS implementation on coding productivity.

  10. Results from the Veterans Health Administration ICD-10-CM/PCS Coding Pilot Study

    PubMed Central

    Weems, Shelley; Heller, Pamela; Fenton, Susan H.

    2015-01-01

    The Veterans Health Administration (VHA) of the US Department of Veterans Affairs has been preparing for the October 1, 2015, conversion to the International Classification of Diseases, Tenth Revision, Clinical Modification and Procedural Coding System (ICD-10-CM/PCS) for more than four years. The VHA's Office of Informatics and Analytics ICD-10 Program Management Office established an ICD-10 Learning Lab to explore expected operational challenges. This study was conducted to determine the effects of the classification system conversion on coding productivity. ICD codes are integral to VHA business processes and are used for purposes such as clinical studies, performance measurement, workload capture, cost determination, Veterans Equitable Resource Allocation (VERA) determination, morbidity and mortality classification, indexing of hospital records by disease and operations, data storage and retrieval, research purposes, and reimbursement. The data collection for this study occurred in multiple VHA sites across several months using standardized methods. It is commonly accepted that coding productivity will decrease with the implementation of ICD-10-CM/PCS. The findings of this study suggest that the decrease will be more significant for inpatient coding productivity (64.5 percent productivity decrease) than for ambulatory care coding productivity (6.7 percent productivity decrease). This study reveals the following important points regarding ICD-10-CM/PCS coding productivity: Ambulatory care ICD-10-CM coding productivity is not expected to decrease as significantly as inpatient ICD-10-CM/PCS coding productivity.Coder training and type of record (inpatient versus outpatient) affect coding productivity.Inpatient coding productivity is decreased when a procedure requiring ICD-10-PCS coding is present. It is highly recommended that organizations perform their own analyses to determine the effects of ICD-10-CM/PCS implementation on coding productivity. PMID:26396553

  11. Anti-angiogenesis target therapy for advanced osteosarcoma

    PubMed Central

    Xie, Lu; Ji, Tao; Guo, Wei

    2017-01-01

    Osteosarcomas (OS), especially those with metastatic or unresectable disease, have limited treatment options. The greatest advancement in treatments occurred in the 1980s when multi-agent chemotherapy, including doxorubicin, cisplatin, high-dose methotrexate, and, in some regimens, ifosfamide, was demonstrated to improve overall survival compared with surgery alone. However, standard chemotherapeutic options have been limited by poor response rates in patients with relapsed or advanced cases. It has been reported that VEGFR expression correlates with the outcome of patients with osteosarcoma and circulating VEGF level has been associated with the development of lung metastasis. At present, it seems to us that progress has not been made since Grignani reported a phase II cohort trial of sorafenib and sorafenib combined with everolimus for advanced osteosarcoma, which, in a sense, have become a milestone as a second-line therapy for osteosarcoma. Although the recognization of muramyltripepetide phosphatidyl-ethanolamine has made some progress based on its combination with standard chemotherapy, its effect on refractory cases is controversial. Personalized comprehensive molecular profiling of high-risk osteosarcoma up to now has not changed the therapeutic prospect of advanced osteosarcoma significantly. Thus, how far have we moved forward and what therapeutic strategy should we prefer for anti-angiogenesis therapy? This review provides an overview of the most updated anti-angiogenesis therapy in OS and discusses some clinical options in order to maintain or even improve progression-free survival. PMID:28656259

  12. Targeting the undruggable: Advances and obstacles in current RNAi therapy

    PubMed Central

    Wu, Sherry Y.; Lopez-Berestein, Gabriel; Calin, George A.; Sood, Anil K.

    2014-01-01

    RNA interference (RNAi) therapeutics represents a rapidly emerging platform for personalized cancer treatment. Recent advances in delivery, target selection, and safety of RNAi cancer therapy provide unprecedented opportunities for clinical translation. Here, we discuss these advances and present strategies for making RNAi-based therapy a viable part of cancer management. PMID:24920658

  13. An Evaluation of Comparability between NEISS and ICD-9-CM Injury Coding

    PubMed Central

    Thompson, Meghan C.; Wheeler, Krista K.; Shi, Junxin; Smith, Gary A.; Xiang, Huiyun

    2014-01-01

    Objective To evaluate the National Electronic Injury Surveillance System’s (NEISS) comparability with a data source that uses ICD-9-CM coding. Methods A sample of NEISS cases from a children’s hospital in 2008 was selected, and cases were linked with their original medical record. Medical records were reviewed and an ICD-9-CM code was assigned to each case. Cases in the NEISS sample that were non-injuries by ICD-9-CM standards were identified. A bridging matrix between the NEISS and ICD-9-CM injury coding systems, by type of injury classification, was proposed and evaluated. Results Of the 2,890 cases reviewed, 13.32% (n = 385) were non-injuries according to the ICD-9-CM diagnosis. Using the proposed matrix, the comparability of the NEISS with ICD-9-CM coding was favorable among injury cases (κ = 0.87, 95% CI: 0.85–0.88). The distribution of injury types among the entire sample was similar for the two systems, with percentage differences ≥1% for only open wounds or amputation, poisoning, and other or unspecified injury types. Conclusions There is potential for conducting comparable injury research using NEISS and ICD-9-CM data. Due to the inclusion of some non-injuries in the NEISS and some differences in type of injury definitions between NEISS and ICD-9-CM coding, best practice for studies using NEISS data obtained from the CPSC should include manual review of case narratives. Use of the standardized injury and injury type definitions presented in this study will facilitate more accurate comparisons in injury research. PMID:24658100

  14. Recent Advances in Targeted Therapy for Glioma.

    PubMed

    Lin, Lin; Cai, Jinquan; Jiang, Chuanlu

    2017-01-01

    Gliomas are the most common primary malignant brain tumors, which have a universally fatal outcome. Current standard treatment for glioma patients is surgical removal followed by radiotherapy and adjuvant chemotherapy. Due to therapeutic resistance and tumor recurrence, efforts are ongoing to identify the molecules that are fundamental to regulate the tumor progression and provide additional methods for individual treatment of glioma patients. By studying the initiation and maintenance of glioma, studies focused on the targets of tyrosine kinase receptors including EGFR, PDGFR and other crucial signal pathways such as PI3K/AKT and RAS/RAF/MAPK pathway. Furthermore, recent advances in targeting immunotherapy and stem cell therapy also brought numerous strategies to glioma treatment. This article reviewed the researches focused on the advanced strategies of various target therapies for improving the glioma treatment efficacy, and discussed the challenges and future directions for glioma therapy. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  15. The effect of cost construction based on either DRG or ICD-9 codes or risk group stratification on the resulting cost-effectiveness ratios.

    PubMed

    Chumney, Elinor C G; Biddle, Andrea K; Simpson, Kit N; Weinberger, Morris; Magruder, Kathryn M; Zelman, William N

    2004-01-01

    As cost-effectiveness analyses (CEAs) are increasingly used to inform policy decisions, there is a need for more information on how different cost determination methods affect cost estimates and the degree to which the resulting cost-effectiveness ratios (CERs) may be affected. The lack of specificity of diagnosis-related groups (DRGs) could mean that they are ill-suited for costing applications in CEAs. Yet, the implications of using International Classification of Diseases-9th edition (ICD-9) codes or a form of disease-specific risk group stratification instead of DRGs has yet to be clearly documented. To demonstrate the implications of different disease coding mechanisms on costs and the magnitude of error that could be introduced in head-to-head comparisons of resulting CERs. We based our analyses on a previously published Markov model for HIV/AIDS therapies. We used the Healthcare Cost and Utilisation Project Nationwide Inpatient Sample (HCUP-NIS) data release 6, which contains all-payer data on hospital inpatient stays from selected states. We added costs for the mean number of hospitalisations, derived from analyses based on either DRG or ICD-9 codes or risk group stratification cost weights, to the standard outpatient and prescription drug costs to yield an estimate of total charges for each AIDS-defining illness (ADI). Finally, we estimated the Markov model three times with the appropriate ADI cost weights to obtain CERs specific to the use of either DRG or ICD-9 codes or risk group. Contrary to expectations, we found that the choice of coding/grouping assumptions that are disease-specific by either DRG codes, ICD-9 codes or risk group resulted in very similar CER estimates for highly active antiretroviral therapy. The large variations in the specific ADI cost weights across the three different coding approaches was especially interesting. However, because no one approach produced consistently higher estimates than the others, the Markov model's weighted

  16. Impulse control disorders and compulsive behaviors associated with dopaminergic therapies in Parkinson disease

    PubMed Central

    Marsh, Laura

    2012-01-01

    Summary Impulse control disorders (ICD) (most commonly pathologic gambling, hypersexuality, and uncontrollable spending) and compulsive behaviors can be triggered by dopaminergic therapies in Parkinson disease (PD). ICD are especially prevalent in patients receiving a dopamine agonist as part of their treatment regimen for PD, and have also been reported when dopamine agonists are used for other indications (e.g., restless legs syndrome). Although these iatrogenic disorders are common, affecting 1 in 7 patients with PD on dopamine agonists, they often elude detection by the treating physician. ICD lead to serious consequences, causing significant financial loss and psychosocial morbidity for many patients and families. ICD can appear at any time during treatment with dopamine agonists, sometimes within the first few months, but most often after years of treatment, particularly when patients receive dopamine agonists and levodopa together. In most cases ICD resolve if the dopamine agonist is withdrawn, and PD motor symptoms are managed with levodopa monotherapy. Familiarity with the clinical aspects, risk factors, pathophysiology, and management of ICD is essential for physicians using dopaminergic therapies to treat PD and other disorders. PMID:23634371

  17. Intracellular fragment of NLRR3 (NLRR3-ICD) stimulates ATRA-dependent neuroblastoma differentiation

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

    Akter, Jesmin; Takatori, Atsushi, E-mail: atakatori@chiba-cc.jp; Islam, Md. Sazzadul

    2014-10-10

    Highlights: • NLRR3 is a membrane protein highly expressed in favorable neuroblastoma. • NLRR3-ICD was produced through proteolytic processing by secretases. • NLRR3-ICD was induced to be translocated into cell nucleus following ATRA exposure. • NLRR3-ICD plays a pivotal role in ATRA-mediated neuroblastoma differentiation. - Abstract: We have previously identified neuronal leucine-rich repeat protein-3 (NLRR3) gene which is preferentially expressed in favorable human neuroblastomas as compared with unfavorable ones. In this study, we have found for the first time that NLRR3 is proteolytically processed by secretases and its intracellular domain (NLRR3-ICD) is then released to translocate into cell nucleus duringmore » ATRA-mediated neuroblastoma differentiation. According to our present observations, NLRR3-ICD was induced to accumulate in cell nucleus of neuroblastoma SH-SY5Y cells following ATRA treatment. Since the proteolytic cleavage of NLRR3 was blocked by α- or γ-secretase inhibitor, it is likely that NLRR3-ICD is produced through the secretase-mediated processing of NLRR3. Intriguingly, forced expression of NLRR3-ICD in neuroblastoma SK-N-BE cells significantly suppressed their proliferation as examined by a live-cell imaging system and colony formation assay. Similar results were also obtained in neuroblastoma TGW cells. Furthermore, overexpression of NLRR3-ICD stimulated ATRA-dependent neurite elongation in SK-N-BE cells. Together, our present results strongly suggest that NLRR3-ICD produced by the secretase-mediated proteolytic processing of NLRR3 plays a crucial role in ATRA-mediated neuronal differentiation, and provide a clue to develop a novel therapeutic strategy against aggressive neuroblastomas.« less

  18. Female-specific education, management, and lifestyle enhancement for implantable cardioverter defibrillator patients: the FEMALE-ICD study.

    PubMed

    Vazquez, Lauren D; Conti, Jamie B; Sears, Samuel F

    2010-09-01

    Significant rates of psychological distress occur in implantable cardioverter defibrillator (ICD) patients. Research has demonstrated that women are particularly at risk for developing distress and warrant psychosocial attention. The major objectives were to implement and test the effectiveness of a female-specific psychosocial group intervention on disease-specific quality of life outcomes in outpatient female ICD recipients versus a wait-list control group. Twenty-nine women were recruited for the study. Fourteen women were randomized to the intervention group and participated in a psychosocial intervention focused on female-specific issues; 15 were randomized to the wait-list control group. All women completed individual psychological batteries at baseline and at 1-month follow-up measuring shock anxiety and device acceptance. Pre-post measures of shock anxiety demonstrated a significant time by group interaction effect with the intervention group having a significantly greater decrease (Pillai's trace = 5.58, P = 0.026). A significant interaction effect (Pillai's trace = 5.05, P = 0.046) was found, such that women under the age of 50 experienced greater reduction in shock anxiety than their middle-aged cohorts. Pre-post measures of device acceptance revealed a significant time by group interaction effect with the intervention group having significantly greater increases (Pillai's trace = 5.80, P = 0.023). Structured interventions for female ICD patients involving ICD-specific education, cognitive behavioral therapy strategies, and group social support provide improvements in shock anxiety and device acceptance at 1-month re-assessment. Young women appear to be an at-risk subgroup of this population and may experience more benefit from psychosocial treatment targeting device-specific concerns. ©2010, The Authors. Journal compilation ©2010 Wiley Periodicals, Inc.

  19. Combination Therapy for Advanced Kaposi Sarcoma

    Cancer.gov

    In this clinical trial, adult patients with any form of advanced Kaposi sarcoma will be treated with liposomal doxorubicin and bevacizumab every 3 weeks for a maximum of six treatments.  Patients who respond to this therapy or have stable disease will rec

  20. NExT: Advancing Promising Cancer Therapies

    Cancer.gov

    The NCI Experimental Therapeutics (NExT) program works with researchers and top scientific experts to advance promising or novel cancer therapies from the earliest stages of research to clinical trials. Learn about recent successes from NExT in this Cancer Currents blog post.

  1. ICD-10 procedure codes produce transition challenges

    PubMed Central

    Boyd, Andrew D.; Li, Jianrong ‘John’; Kenost, Colleen; Zaim, Samir Rachid; Krive, Jacob; Mittal, Manish; Satava, Richard A.; Burton, Michael; Smith, Jacob; Lussier, Yves A.

    2018-01-01

    The transition of procedure coding from ICD-9-CM-Vol-3 to ICD-10-PCS has generated problems for the medical community at large resulting from the lack of clarity required to integrate two non-congruent coding systems. We hypothesized that quantifying these issues with network topology analyses offers a better understanding of the issues, and therefore we developed solutions (online tools) to empower hospital administrators and researchers to address these challenges. Five topologies were identified: “identity”(I), “class-to-subclass”(C2S), “subclass-toclass”(S2C), “convoluted(C)”, and “no mapping”(NM). The procedure codes in the 2010 Illinois Medicaid dataset (3,290 patients, 116 institutions) were categorized as C=55%, C2S=40%, I=3%, NM=2%, and S2C=1%. Majority of the problematic and ambiguous mappings (convoluted) pertained to operations in ophthalmology cardiology, urology, gyneco-obstetrics, and dermatology. Finally, the algorithms were expanded into a user-friendly tool to identify problematic topologies and specify lists of procedural codes utilized by medical professionals and researchers for mitigating error-prone translations, simplifying research, and improving quality.http://www.lussiergroup.org/transition-to-ICD10PCS PMID:29888037

  2. ICD-10 procedure codes produce transition challenges.

    PubMed

    Boyd, Andrew D; Li, Jianrong 'John'; Kenost, Colleen; Zaim, Samir Rachid; Krive, Jacob; Mittal, Manish; Satava, Richard A; Burton, Michael; Smith, Jacob; Lussier, Yves A

    2018-01-01

    The transition of procedure coding from ICD-9-CM-Vol-3 to ICD-10-PCS has generated problems for the medical community at large resulting from the lack of clarity required to integrate two non-congruent coding systems. We hypothesized that quantifying these issues with network topology analyses offers a better understanding of the issues, and therefore we developed solutions (online tools) to empower hospital administrators and researchers to address these challenges. Five topologies were identified: "identity"(I), "class-to-subclass"(C2S), "subclass-toclass"(S2C), "convoluted(C)", and "no mapping"(NM). The procedure codes in the 2010 Illinois Medicaid dataset (3,290 patients, 116 institutions) were categorized as C=55%, C2S=40%, I=3%, NM=2%, and S2C=1%. Majority of the problematic and ambiguous mappings (convoluted) pertained to operations in ophthalmology cardiology, urology, gyneco-obstetrics, and dermatology. Finally, the algorithms were expanded into a user-friendly tool to identify problematic topologies and specify lists of procedural codes utilized by medical professionals and researchers for mitigating error-prone translations, simplifying research, and improving quality.http://www.lussiergroup.org/transition-to-ICD10PCS.

  3. Advanced therapies for the treatment of hemophilia: future perspectives.

    PubMed

    Liras, Antonio; Segovia, Cristina; Gabán, Aline S

    2012-12-13

    Monogenic diseases are ideal candidates for treatment by the emerging advanced therapies, which are capable of correcting alterations in protein expression that result from genetic mutation. In hemophilia A and B such alterations affect the activity of coagulation factors VIII and IX, respectively, and are responsible for the development of the disease. Advanced therapies may involve the replacement of a deficient gene by a healthy gene so that it generates a certain functional, structural or transport protein (gene therapy); the incorporation of a full array of healthy genes and proteins through perfusion or transplantation of healthy cells (cell therapy); or tissue transplantation and formation of healthy organs (tissue engineering). For their part, induced pluripotent stem cells have recently been shown to also play a significant role in the fields of cell therapy and tissue engineering. Hemophilia is optimally suited for advanced therapies owing to the fact that, as a monogenic condition, it does not require very high expression levels of a coagulation factor to reach moderate disease status. As a result, significant progress has been possible with respect to these kinds of strategies, especially in the fields of gene therapy (by using viral and non-viral vectors) and cell therapy (by means of several types of target cells). Thus, although still considered a rare disorder, hemophilia is now recognized as a condition amenable to gene therapy, which can be administered in the form of lentiviral and adeno-associated vectors applied to adult stem cells, autologous fibroblasts, platelets and hematopoietic stem cells; by means of non-viral vectors; or through the repair of mutations by chimeric oligonucleotides. In hemophilia, cell therapy approaches have been based mainly on transplantation of healthy cells (adult stem cells or induced pluripotent cell-derived progenitor cells) in order to restore alterations in coagulation factor expression.

  4. Design, development and first validation of a transcoding system from ICD-9-CM to ICD-10 in the IT.DRG Italian project.

    PubMed

    Della Mea, Vincenzo; Vuattolo, Omar; Frattura, Lucilla; Munari, Flavia; Verdini, Eleonora; Zanier, Loris; Arcangeli, Laura; Carle, Flavia

    2015-01-01

    In Italy, ICD-9-CM is currently used for coding health conditions at hospital discharge, but ICD-10 is being introduced thanks to the IT-DRG Project. In this project, one needed component is a set of transcoding rules and associated tools for easing coders work in the transition. The present paper illustrates design and development of those transcoding rules, and their preliminary testing on a subset of Italian hospital discharge data.

  5. Advances in pediatric dehydration therapy.

    PubMed

    Niescierenko, Michelle; Bachur, Richard

    2013-06-01

    To review the advances in the assessment, treatment, and evaluation of care for pediatric dehydration. Recent studies have added new information across the spectrum of care for dehydration. Advances in the assessment of dehydration allow more accurate clinical evaluation, but do not help predict the treatment outcomes. Antiemetics as an adjunct to oral rehydration therapy have been proven well tolerated, efficacious, and cost-effective. Rapid, large-volume intravenous rehydration for outpatients with dehydration did not show any benefit over more standard regimens. Clinical guidelines incorporate all these aspects of care; however, physicians show poor adherence to the guidelines despite the evidence that guidelines improve outcomes and reduce cost. Dehydration burdens the healthcare system worldwide. Through advances in its assessment, treatment with antiemetics and intravenous fluids, and standardization of practice with clinical guidelines, this burden could be reduced.

  6. New advances in focal therapy for early stage prostate cancer.

    PubMed

    Tay, Kae Jack; Schulman, Ariel A; Sze, Christina; Tsivian, Efrat; Polascik, Thomas J

    2017-08-01

    Prostate focal therapy offers men the opportunity to achieve oncological control while preserving sexual and urinary function. The prerequisites for successful focal therapy are to accurately identify, localize and completely ablate the clinically significant cancer(s) within the prostate. We aim to evaluate the evidence for current and upcoming technologies that could shape the future of prostate cancer focal therapy in the next five years. Areas covered: Current literature on advances in patient selection using imaging, biopsy and biomarkers, ablation techniques and adjuvant treatments for focal therapy are summarized. A literature search of major databases was performed using the search terms 'focal therapy', 'focal ablation', 'partial ablation', 'targeted ablation', 'image guided therapy' and 'prostate cancer'. Expert commentary: Advanced radiological tools such as multiparametric magnetic resonance imaging (mpMRI), multiparametric ultrasound (mpUS), prostate-specific-membrane-antigen positron emission tomography (PSMA-PET) represent a revolution in the ability to understand cancer function and biology. Advances in ablative technologies now provide a menu of modalities that can be rationalized based on lesion location, size and perhaps in the near future, pre-determined resistance to therapy. However, these need to be carefully studied to establish their safety and efficacy parameters. Adjuvant strategies to enhance focal ablation are under development.

  7. Generator replacement is associated with an increased rate of ICD lead alerts.

    PubMed

    Lovelock, Joshua D; Cruz, Cesar; Hoskins, Michael H; Jones, Paul; El-Chami, Mikhael F; Lloyd, Michael S; Leon, Angel; DeLurgio, David B; Langberg, Jonathan J

    2014-10-01

    Lead malfunction is an important cause of morbidity and mortality in patients with an implantable cardioverter-defibrillator (ICD). We have shown that the failure of recalled high-voltage leads significantly increases after ICD generator replacement. However, generator replacement has not been recognized as a predictor of lead failure in general. The purpose of this study is to assess the effect of ICD generator exchange on the rate of ICD lead alerts. A time-dependent Cox proportional hazards model was used to analyze a database of remotely monitored ICDs. The model assessed the impact of generator exchange on the rate of lead alerts after ICD generator replacement. The analysis included 60,219 patients followed for 37 ± 19 months. The 5-year lead survival was 99.3% (95% confidence interval 99.2%-99.4%). Of 60,219 patients, 7458 patients (12.9%) underwent ICD generator exchange without lead replacement. After generator replacement, the rate of lead alerts was more than 5-fold higher than in controls with leads of the same age without generator replacement (hazard ratio 5.19; 95% confidence interval 3.45-7.84). A large number of lead alerted within 3 months of generator replacement. Lead alerts were more common in patients with single- vs dual-chamber ICDs and in younger patients. Sex was not associated with lead alerts. Routine generator replacement is associated with a 5-fold higher risk of lead alert compared to age-matched leads without generator replacement. This suggests the need for intense surveillance after generator replacement and the development of techniques to minimize the risk of lead damage during generator replacement. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  8. Mortality reduction in relation to implantable cardioverter defibrillator programming in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT).

    PubMed

    Ruwald, Anne-Christine; Schuger, Claudio; Moss, Arthur J; Kutyifa, Valentina; Olshansky, Brian; Greenberg, Henry; Cannom, David S; Estes, N A Mark; Ruwald, Martin H; Huang, David T; Klein, Helmut; McNitt, Scott; Beck, Christopher A; Goldstein, Robert; Brown, Mary W; Kautzner, Josef; Shoda, Morio; Wilber, David; Zareba, Wojciech; Daubert, James P

    2014-10-01

    The benefit of novel implantable cardioverter defibrillator (ICD) programming in reducing inappropriate ICD therapy and mortality was demonstrated in Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT). However, the cause of mortality reduction remains incompletely evaluated. We aimed to identify factors associated with mortality, with focus on ICD therapy and programming in the MADIT-RIT population. In MADIT-RIT, 1500 patients with a primary prophylactic indication for ICD or cardiac resynchronization therapy with defibrillator were randomized to 1 of 3 different ICD programming arms: conventional programming (ventricular tachycardia zone ≥170 beats per minute), high-rate programming (ventricular tachycardia zone ≥200 beats per minute), and delayed programming (60-second delay before therapy ≥170 beats per minute). Multivariate Cox models were used to assess the influence of time-dependent appropriate and inappropriate ICD therapy (shock and antitachycardia pacing) and randomized programming arm on all-cause mortality. During an average follow-up of 1.4±0.6 years, 71 of 1500 (5%) patients died: cardiac in 40 patients (56.3%), noncardiac in 23 patients (32.4%), and unknown in 8 patients (11.3%). Appropriate shocks (hazard ratio, 6.32; 95% confidence interval, 3.13-12.75; P<0.001) and inappropriate therapy (hazard ratio, 2.61; 95% confidence interval, 1.28-5.31; P=0.01) were significantly associated with an increased mortality risk. There was no evidence of increased mortality risk in patients who experienced appropriate antitachycardia pacing only (hazard ratio, 1.02; 95% confidence interval, 0.36-2.88; P=0.98). Randomization to conventional programming was identified as an independent predictor of death when compared with patients randomized to high-rate programming (hazard ratio, 2.0; 95% confidence interval, 1.06-3.71; P=0.03). In MADIT-RIT, appropriate shocks, inappropriate ICD therapy, and randomization to

  9. Advanced Heart Failure Therapies for Cancer Therapeutics-Related Cardiac Dysfunction.

    PubMed

    Bianco, Christopher M; Al-Kindi, Sadeer G; Oliveira, Guilherme H

    2017-04-01

    End-stage heart failure in cancer survivors may result from cardiotoxic chemotherapy and/or chest radiation and require advanced therapies, including left ventricular assist devices (LVADs) and transplantation. Traditionally, such therapies have been underutilized in cancer survivors owing to lack of experience and perceived risk of cancer recurrence. Recent data from large registries, however, have shown excellent outcomes of LVADs and transplantation in cancer survivors, albeit subject to careful selection and special considerations. This article summarizes all aspects of advanced heart failure therapies in patients with cancer therapy-related cardiac dysfunction and underscores the need for careful selection of these candidates. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Advances in Breast Cancer Therapy

    DTIC Science & Technology

    2012-09-01

    cancer diagnosed by core needle biopsy will be eligible for this study. Additional tumor specimens will be obtained prior to the start of...chemotherapy via core needle biopsies to be used for the ex vivo chemoresponse assay and tumor genomic analysis (gene expression), respectively. All...AD_________________ Award Number: W81XWH-06-2-0021 TITLE: Advances in Breast Cancer Therapy

  11. Radiation Dose-Response Model for Locally Advanced Rectal Cancer After Preoperative Chemoradiation Therapy

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

    Appelt, Ane L., E-mail: ane.lindegaard.appelt@slb.regionsyddanmark.dk; University of Southern Denmark, Odense; Ploen, John

    2013-01-01

    Purpose: Preoperative chemoradiation therapy (CRT) is part of the standard treatment of locally advanced rectal cancers. Tumor regression at the time of operation is desirable, but not much is known about the relationship between radiation dose and tumor regression. In the present study we estimated radiation dose-response curves for various grades of tumor regression after preoperative CRT. Methods and Materials: A total of 222 patients, treated with consistent chemotherapy and radiation therapy techniques, were considered for the analysis. Radiation therapy consisted of a combination of external-beam radiation therapy and brachytherapy. Response at the time of operation was evaluated from themore » histopathologic specimen and graded on a 5-point scale (TRG1-5). The probability of achieving complete, major, and partial response was analyzed by ordinal logistic regression, and the effect of including clinical parameters in the model was examined. The radiation dose-response relationship for a specific grade of histopathologic tumor regression was parameterized in terms of the dose required for 50% response, D{sub 50,i}, and the normalized dose-response gradient, {gamma}{sub 50,i}. Results: A highly significant dose-response relationship was found (P=.002). For complete response (TRG1), the dose-response parameters were D{sub 50,TRG1} = 92.0 Gy (95% confidence interval [CI] 79.3-144.9 Gy), {gamma}{sub 50,TRG1} = 0.982 (CI 0.533-1.429), and for major response (TRG1-2) D{sub 50,TRG1} and {sub 2} = 72.1 Gy (CI 65.3-94.0 Gy), {gamma}{sub 50,TRG1} and {sub 2} = 0.770 (CI 0.338-1.201). Tumor size and N category both had a significant effect on the dose-response relationships. Conclusions: This study demonstrated a significant dose-response relationship for tumor regression after preoperative CRT for locally advanced rectal cancer for tumor dose levels in the range of 50.4-70 Gy, which is higher than the dose range usually considered.« less

  12. PS3-11: Beyond General Equivalency Mappings (GEMs): Understanding the Implications of ICD 10 in Research

    PubMed Central

    Riordan, Rick

    2013-01-01

    Background/Aims With the implementation of ICD 10 CM and ICD 10 PCS less than two years away, there are still unanswered questions as to how research teams will effectively translate or use ICD 10 codes in research. Approximately 84% of the ICD 10 codes have only approximate matches with 10% having multiple matches and only 5% have exact one-to-one matches between ICD 9 and ICD 10. With the number of codes increasing five-fold, this offers additional opportunities and risks when pulling data. Methods Besides looking at the General Equivalency Mappings and other tools that are used to translate ICD 9 codes to ICD 10 codes, we will examine some common research areas where only approximate matches between ICD 9 and ICD 10 exist. We will also discuss how the finer level of detail that ICD 10 gives allows research teams to pinpoint exactly what type of asthma, Crohn’s disease, and diabetic retinopathy they wish to study without including some of the other cases that do not meet their research criteria. Results There are significant ambiguities and irregularity in several common areas such as diabetes, mental health, asthma, and gastroenterology due to approximate, multiple, or combination matches. Even in the case of exact matches such as an old myocardial infarction where there is an exact match, the definition of when a myocardial infarction becomes “old” is different. Conclusions ICD 10 offers a finer level of detail and a higher level of specificity, thereby allowing research teams to be more targeted when pulling data. On the other hand, research teams need to exercise caution when using GEMs and other tools to translate ICD 9 codes into ICD 10 codes and vice versa, especially if they are looking at data that overlaps the implementation date of October 1, 2014.

  13. Comparison of the performance of mental health, drug and alcohol comorbidities based on ICD-10-AM and medical records for predicting 12-month outcomes in trauma patients.

    PubMed

    Nguyen, Tu Q; Simpson, Pamela M; Braaf, Sandra C; Cameron, Peter A; Judson, Rodney; Gabbe, Belinda J

    2018-06-05

    Many outcome studies capture the presence of mental health, drug and alcohol comorbidities from administrative datasets and medical records. How these sources compare as predictors of patient outcomes has not been determined. The purpose of the present study was to compare mental health, drug and alcohol comorbidities based on ICD-10-AM coding and medical record documentation for predicting longer-term outcomes in injured patients. A random sample of patients (n = 500) captured by the Victorian State Trauma Registry was selected for the study. Retrospective medical record reviews were conducted to collect data about documented mental health, drug and alcohol comorbidities while ICD-10-AM codes were obtained from routinely collected hospital data. Outcomes at 12-months post-injury were the Glasgow Outcome Scale - Extended (GOS-E), European Quality of Life Five Dimensions (EQ-5D-3L), and return to work. Linear and logistic regression models, adjusted for age and gender, using medical record derived comorbidity and ICD-10-AM were compared using measures of calibration (Hosmer-Lemeshow statistic) and discrimination (C-statistic and R 2 ). There was no demonstrable difference in predictive performance between the medical record and ICD-10-AM models for predicting the GOS-E, EQ-5D-3L utility sore and EQ-5D-3L mobility, self-care, usual activities and pain/discomfort items. The area under the receiver operating characteristic (AUC) for models using medical record derived comorbidity (AUC 0.68, 95% CI: 0.63, 0.73) was higher than the model using ICD-10-AM data (AUC 0.62, 95% CI: 0.57, 0.67) for predicting the EQ-5D-3L anxiety/depression item. The discrimination of the model for predicting return to work was higher with inclusion of the medical record data (AUC 0.69, 95% CI: 0.63, 0.76) than the ICD-10-AM data (AUC 0.59, 95% CL: 0.52, 0.65). Mental health, drug and alcohol comorbidity information derived from medical record review was not clearly superior for

  14. Malfunction of subpectorally implanted cardiac resynchronization therapy defibrillators due to weakened header bond.

    PubMed

    Hayat, Sajad A; Kojodjojo, Pipin; Mason, Anthony; Benfield, Ann; Wright, Ian; Whinnett, Zachary; Lim, Phang Boon; Davies, D Wyn; Lefroy, David; Peters, Nicholas S; Kanagaratnam, Prapa

    2013-03-01

    Implantable cardioverter defibrillator (ICD) implantation has increased significantly over the last 10 years. Concerns about the safety and reliability of ICD systems have been raised, with premature lead failure and battery malfunctions accounting for the majority of reported adverse events. We describe the unique mode of presentation, diagnosis, and management of cardiac resynchronization therapy defibrillators (CRT-D) malfunctions that were caused by weakened bonding between the generator and header. Between June 2008 and December 2009, 22 Teligen™ ICDs and 24 Cognis™ CRT-Ds were implanted subpectorally at our institution, until a product advisory was issued. Of 24 Cognis™ CRT-D implants, 3 patients presented with CRT-D malfunctions. All our cases presented with initially intermittent and then persisting increases in shock lead impedance, associated with nonphysiological noise in the shock electrogram channels. These issues were rectified by generator change. Postexplant laboratory analysis confirmed inadequate bonding between device header and titanium casing in all cases, resulting in loosening and rocking of the header followed by fatigue-induced fracture of the shock circuitry. Weakened bonding between the header and generator casing of subpectorally implanted CRT-Ds can result in fractures and malfunction of the HV circuit. Physicians monitoring patients with devices affected by the product advisory should remain vigilant in order to diagnose and manage similar device malfunction expediently. © 2012 Wiley Periodicals, Inc.

  15. Impact of programming strategies aimed at reducing nonessential implantable cardioverter defibrillator therapies on mortality: a systematic review and meta-analysis.

    PubMed

    Tan, Vern Hsen; Wilton, Stephen B; Kuriachan, Vikas; Sumner, Glen L; Exner, Derek V

    2014-02-01

    Patients who receive implantable cardioverter defibrillator therapies are at higher risk of death versus those who do not. Programmed settings to reduce nonessential implantable cardioverter defibrillator therapies (therapy reduction programming) have been developed but may have adverse effects. This systematic review and meta-analysis assessed the relationship between therapy reduction programming with the risks of death from any cause, implantable cardioverter defibrillator shocks, and syncope. MEDLINE, EMBASE, and clinicaltrials.gov databases were searched to identify relevant studies. Those that followed patients for ≥6 months and reported mortality were included. Six met the inclusion criteria; 4 randomized (Comparison of Empiric to Physician-Tailored Programming of ICDs [EMPIRIC], Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy [MADIT-RIT], Avoid Delivering Therapies for Non-sustained Arrhythmias in ICD Patients III [ADVANCE III], and Programming Implantable Cardioverter-Defibrillators in Patients with Primary Prevention Indication to Prolong Time to First Shock [PROVIDE]) and 2 prospective studies (Role of Long Detection Window Programming in Patients With Left Ventricular Dysfunction, Non-ischemic Etiology in Primary Prevention Treated with a Biventricular ICD [RELEVANT] and Primary Prevention Parameters Evaluation [PREPARE]). These 6 studies included 7687 (3598 conventional and 4089 therapy reduction programming) patients. Most (77%) participants were men, had a history of ischemic heart disease (56%), and were prescribed β-blockers (84%). Therapy reduction programming was associated with a 30% relative reduction in mortality (95% confidence interval, 16%-41%; P<0.001). No significant heterogeneity among studies was observed (P=0.6). A similar 26% reduction in mortality was observed when only the 4 randomized trials were included (95% confidence interval, 11%-40%; P=0.002). These results were not significantly altered

  16. Increasing sex differences in the use of cardiac resynchronization therapy with or without implantable cardioverter-defibrillator

    PubMed Central

    Chatterjee, Neal A.; Borgquist, Rasmus; Chang, Yuchiao; Lewey, Jennifer; Jackson, Vicki A.; Singh, Jagmeet P.; Metlay, Joshua P.; Lindvall, Charlotta

    2017-01-01

    Aims Previous studies have identified sex disparities in the use of cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillators (ICD), although the basis of underutilization in women remains poorly understood. The aim of this study was to assess sex differences in patterns of CRT use with our without ICD. Methods and results In this cross-sectional study using the National Inpatient Sample database we identified 311 009 patients undergoing CRT implantation in the United States between 2006 and 2012. Demographic and clinical characteristics were compared between men and women undergoing CRT implantation, with special attention to clinical predictors of left ventricular reverse remodelling (CRT response, score range: 0–4) and reduced ICD efficacy (score range: 0–7). When compared to men, women undergoing CRT implantation were significantly more likely to have ≥ 3 predictors of CRT response (47.3 vs. 33.2%, P < 0.001) and less likely to have ≥3 predictors of reduced ICD efficacy (27.0 vs. 37.3%, P < 0.001). Despite this, men were significantly more likely to undergo CRT with ICD (CRT-D) as the type of CRT (88.6 vs. 80.1% of all CRT implants). Compared to those with the greatest likelihood of CRT response (score ≥ 3), those with the least likelihood of CRT response had a significant decreased odds of CRT-D implant (adj odds ratio 0.27 [0.24–0.31], P < 0.001), with a greater decreased odds in women compared to men (P, for sex interaction <0.001). The difference in the % of CRT-D implant in men vs. women increased over the study period (P, sex Δ time trend = 0.012). Conclusion In this large, contemporary cohort, sex differences in CRT-D implantation were inversely related to predicted CRT efficacy and have increased over time. Future efforts to narrow the gap in CRT-D implantation in men and women may help better align device selection with those most likely to benefit. PMID:28065904

  17. CAT--the new committee for advanced therapies at the European Medicines Agency.

    PubMed

    Celis, P

    2010-01-01

    The Regulation on Advanced Therapies (Regulation (EC) 1394/2007) establishes a new scientific committee, the Committee for Advanced Therapies (CAT), at the European Medicines Agency. The CAT is composed of experts in the field of Advanced Therapy Medicinal Products (ATMPs)--gene and cell therapy and tissue engineered products--and is responsible for the evaluation of the marketing authorisation applications for this novel class of products. The CAT is also involved in all scientific advice on ATMPs and in two new regulatory procedures for ATMPs, the classification and the certification procedures. The CAT will also play a key role in early contacts with developers of ATMPs.

  18. Socio-economic analysis of cardiac resynchronization therapy.

    PubMed

    Field, Michael E; Sweeney, Michael O

    2006-12-01

    The field of electrical device therapy has benefited from two basically independent lines of investigation demonstrating mortal benefit from either cardiac resynchronization therapy (CRT) or implantable cardioverter-defibrillator (ICD) therapy in patients with heart failure. Current clinical evidence data is insufficient to conclude that CRT-defibrillation (CRTD) offers an advantage over CRT-pacing (CRTP) alone. The cost of adding a defibrillator to the CRTP device is substantial and will act as a barrier to wide scale penetration. Annualized sudden death rates are very low in certain primary prevention populations. Consequently, the potential for overtreatment is very large and the negative costs of ICD therapy are distributed equally among those patients who will have a life saving benefit and those who were "destined" never to require the therapy. The perception that these costs are acceptable if lives are saved is commonly cited as justification for expensive therapy on a population scale, but there is an important and practical difference between costs per unit life saved and costs among patients who really never needed the device. Until the a priori predictors of volumetric response to CRT are better understood, the use of CRTD in class IV patients should be discouraged since ICD therapy is unlikely to extend life in volumetric non-responders. Similarly, the use of CRTD in patients who are "destined" for significant volumetric response is probably unwise since their risk of sudden death is minimized due to favorable substrate modification. Clinical trials comparing conventional ICDs, CRTP and CRTD are necessary to rationalize use of expensive hardware resources among different patient populations. Additionally, the importance of patient preference regarding end of life care should receive greater emphasis. While CRTP may be considered palliative in terminal heart failure, the decision to offer CRTD must include a discussion with the patient regarding mode of

  19. Battery longevity of implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators: technical, clinical and economic aspects. An expert review paper from EHRA.

    PubMed

    Boriani, Giuseppe; Merino, Josè; Wright, David J; Gadler, Fredrik; Schaer, Beat; Landolina, Maurizio

    2018-05-10

    In recent years an extension of devices longevity has been obtained for implantable cardioverter-defibrillators (ICDs), including ICDs for cardiac resynchronization therapy (CRT-D) through improved battery chemistry and device technology and this implies important clinical benefits (reduced need for device replacements and associated complications, particularly infections), as well as economic benefits, in line with patient preferences and needs. From a clinical point of view, the availability of this improvement in technology allows to better tune the choice of the device to be implanted, taking into account that the reasons supporting the value of an extended device longevity as a clinical priority may differ according to the clinical setting (purely electrical diseases or left ventricular dysfunction/heart failure, respectively). From an economic point of view, extension of device longevity may have an important impact in reducing long-term costs of device therapy, with substantial daily savings in favour of devices with extended longevity, up to 30%, depending on clinical scenarios. In studies based on projections, an extension of device longevity allowed to calculate that the cost per day of ICDs may be substantially reduced, and this allows to overcome the frequent perception of ICD and CRT-D devices as treatments with unaffordable costs and to overturn the misconception that up-front costs are the only metric with which to value device treatments. In view of its clinical and economic value, device longevity should be a determining factor in device choice by physicians and healthcare commissioners and should be appropriately considered and valued in comparative tenders.

  20. Dutch outcome in implantable cardioverter-defibrillator therapy (DO-IT): registry design and baseline characteristics of a prospective observational cohort study to predict appropriate indication for implantable cardioverter-defibrillator.

    PubMed

    van Barreveld, M; Dijkgraaf, M G W; Hulleman, M; Boersma, L V A; Delnoy, P P H M; Meine, M; Tuinenburg, A E; Theuns, D A M J; van der Voort, P H; Kimman, G P; Buskens, E; Tijssen, J P G; Bruinsma, N; Verstraelen, T E; Zwinderman, A H; van Dessel, P H F M; Wilde, A A M

    2017-10-01

    Implantable cardioverter-defibrillators (ICDs) are widely used for the prevention of sudden cardiac death. At present, both clinical benefit and cost-effectiveness of ICD therapy in primary prevention patients are topics of discussion, as only a minority of these patients will eventually receive appropriate ICD therapy. The DO-IT Registry is a nationwide prospective cohort with a target enrolment of 1,500 primary prevention ICD patients with reduced left ventricular function in a setting of structural heart disease. The primary outcome measures are death and appropriate ICD therapy for ventricular tachyarrhythmias. Secondary outcome measures are inappropriate ICD therapy, death of any cause, hospitalisation for ICD related complications and for cardiovascular reasons. As of December 2016, data on demographic, clinical, and ICD characteristics of 1,468 patients have been collected. Follow-up will continue up to 24 months after inclusion of the last patient. During follow-up, clinical and ICD data are collected based on the normal follow-up of these patients, assuming ICD interrogations take place every six months and clinical follow-up is once a year. At baseline, the mean age was 66 (standard deviation [SD] 10) years and 27% were women. The DO-IT Registry represents a real-world nationwide cohort of patients receiving ICDs for primary prevention of sudden cardiac death with reduced left ventricular function in a setting of structural heart disease. The registry investigates the efficacy of the current practice and aims to develop prediction rules to identify subgroups who will not (sufficiently) benefit from ICD implantation and to provide results regarding costs and budget impact of targeted supply of primary preventions ICDs.

  1. Physicians’ Outlook on ICD-10-CM/PCS and Its Effect on Their Practice

    PubMed Central

    Watzlaf, Valerie; Alkarwi, Zahraa; Meyers, Sandy; Sheridan, Patty

    2015-01-01

    Background The United States is one of the last countries to change from ICD-9-CM to ICD-10-CM/PCS. The compliance date for implementation of ICD-10-CM/PCS is expected to fall on October 1, 2015. Objectives Evaluate physicians’ perceptions on the change from ICD-9-CM to ICD-10-CM/PCS and its effect on their practice, determine how HIM professionals can assist in this transition, and assess what resources are needed to aid in the transition. Results Twenty physicians were asked to participate in one of three focus groups. Twelve physicians (60 percent) agreed to participate. Top concerns included electronic health record software readiness, increase in documentation specificity and time, ability of healthcare professionals to learn a new language, and inadequacy of current training methods and content. Conclusion Physicians expressed that advantages of ICD-10-CM/PCS were effective data analytics and complexity of patient cases with more specific codes. Health information management professionals were touted as needed during the transition to create simple, clear specialty guides and crosswalks as well as education and training tools specific for physicians. PMID:26807074

  2. MW-assisted synthesis of SVO for ICD primary batteries

    NASA Astrophysics Data System (ADS)

    Beninati, Sabina; Fantuzzi, Matteo; Mastragostino, Marina; Soavi, Francesca

    An Ag 2V 4O 11 (SVO) cathode material prepared by microwave (MW)-assisted solid-state synthesis (MW-SVO) was developed for lithium primary batteries for implantable cardioverter/defibrillators (ICDs). This paper presents the results of physical-chemical and electrochemical characterizations of MW-SVO as well as those of SVO prepared by conventional thermal route (T-SVO). A specific effect of MWs which accelerates the synthesis reaction and contributes to yield a material of different morphology and degree of crystallinity compared with those of T-SVO was observed. The results of pulsed electrochemical tests carried out at 37 °C in operative conditions of ICDs on Li/MW-SVO batteries with cathode mass loading sized for practical use are also reported. These tests demonstrated that MW-SVO can be used for high performing lithium primary battery delivering in few seconds the specific energy values required by ICD application.

  3. Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

    PubMed

    Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

    2015-01-01

    In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

  4. Adjuvant neutron therapy in complex treatment of patients with locally advanced breast cancer

    NASA Astrophysics Data System (ADS)

    Lisin, V. A.; Velikaya, V. V.; Startseva, Zh. A.; Popova, N. O.; Goldberg, V. E.

    2017-09-01

    The study included 128 patients with stage T2-4N0-3M0 locally advanced breast cancer. All patients were divided into two groups. Group I (study group) consisted of 68 patients, who received neutron therapy, and group II (control group) comprised 60 patients, who received electron beam therapy. Neutron therapy was well tolerated by the patients and 1-2 grade radiation skin reactions were the most common. Neutron therapy was shown to be effective in multimodality treatment of the patients with locally advanced breast cancer. The 8-year recurrence-free survival rate in the patients with locally advanced breast cancer was 94.5 ± 4.1% after neutron therapy and 81.4 ± 5.9% after electron beam therapy (p = 0.05).

  5. Obsessive-compulsive disorder for ICD-11: proposed changes to the diagnostic guidelines and specifiers

    PubMed Central

    Simpson, Helen Blair; Reddy, Y. C. Janardhan

    2016-01-01

    Since the approval of the ICD-10 by the World Health Organization (WHO) in 1990, global research on obsessive-compulsive disorder (OCD) has expanded dramatically. This article evaluates what changes may be needed to enhance the scientific validity, clinical utility, and global applicability of OCD diagnostic guidelines in preparation for ICD-11. Existing diagnostic guidelines for OCD were compared. Key issues pertaining to clinical description, differential diagnosis, and specifiers were identified and critically reviewed on the basis of the current literature. Specific modifications to ICD guidelines are recommended, including: clarifying the definition of obsessions (i.e., that obsessions can be thoughts, images, or impulses/urges) and compulsions (i.e., clarifying that these can be behaviors or mental acts and not calling these “stereotyped”); stating that compulsions are often associated with obsessions; and removing the ICD-10 duration requirement of at least 2 weeks. In addition, a diagnosis of OCD should no longer be excluded if comorbid with Tourette syndrome, schizophrenia, or depressive disorders. Moreover, the ICD-10 specifiers (i.e., predominantly obsessional thoughts, compulsive acts, or mixed) should be replaced with a specifier for insight. Based on new research, modifications to the ICD-10 diagnostic guidelines for OCD are recommended for ICD-11. PMID:25388607

  6. Current advancement in radiation therapy for uterine cervical cancer.

    PubMed

    Nakano, Takashi; Ohno, Tatsuya; Ishikawa, Hitoshi; Suzuki, Yoshiyuki; Takahashi, Takeo

    2010-01-01

    Radiation therapy is one of the effective curative treatments for uterine cervical cancer. However poor clinical results for the advanced stages require further improvement of the treatment. Intensive studies on basic and clinical research have been made to improve local control, primarily important for long term survival in radiation therapy. Regarding current advancement in radiation therapy for uterine cervical cancer, the following three major subjects are pointed out; technological development to improve dose distribution by image guided radiation therapy technology, the concomitant anticancer chemotherapy with combination of radiation therapy, and radiation biological assessment of the radiation resistance of tumors. The biological factors overviewed in this article include hypoxia relating factors of HIF-1alpha, SOD, cell cycle parameters of pMI, proliferation factors of Ki67, EGFR, cerbB2, COX-2, cycle regulation proteins p53, p21, apoptosis regulation proteins Bcl2 and Bax and so on. Especially, the variety of these radiation biological factors is important for the selection of an effective treatment method for each patient to maximize the treatment benefit.

  7. Implementation of ICD-10 in Canada: how has it impacted coded hospital discharge data?

    PubMed Central

    2012-01-01

    Background The purpose of this study was to assess whether or not the change in coding classification had an impact on diagnosis and comorbidity coding in hospital discharge data across Canadian provinces. Methods This study examined eight years (fiscal years 1998 to 2005) of hospital records from the Hospital Person-Oriented Information database (HPOI) derived from the Canadian national Discharge Abstract Database. The average number of coded diagnoses per hospital visit was examined from 1998 to 2005 for provinces that switched from International Classifications of Disease 9th version (ICD-9-CM) to ICD-10-CA during this period. The average numbers of type 2 and 3 diagnoses were also described. The prevalence of the Charlson comorbidities and distribution of the Charlson score one year before and one year after ICD-10 implementation for each of the 9 provinces was examined. The prevalence of at least one of the seventeen Charlson comorbidities one year before and one year after ICD-10 implementation were described by hospital characteristics (teaching/non-teaching, urban/rural, volume of patients). Results Nine Canadian provinces switched from ICD-9-CM to ICD-I0-CA over a 6 year period starting in 2001. The average number of diagnoses coded per hospital visit for all code types over the study period was 2.58. After implementation of ICD-10-CA a decrease in the number of diagnoses coded was found in four provinces whereas the number of diagnoses coded in the other five provinces remained similar. The prevalence of at least one of the seventeen Charlson conditions remained relatively stable after ICD-10 was implemented, as did the distribution of the Charlson score. When stratified by hospital characteristics, the prevalence of at least one Charlson condition decreased after ICD-10-CA implementation, particularly for low volume hospitals. Conclusion In conclusion, implementation of ICD-10-CA in Canadian provinces did not substantially change coding practices, but

  8. Radiation Therapy for Locally Advanced Esophageal Cancer.

    PubMed

    Chun, Stephen G; Skinner, Heath D; Minsky, Bruce D

    2017-04-01

    The treatment of locally advanced esophageal cancer is controversial. For patients who are candidates for surgical resection, multiple prospective clinical trials have demonstrated the advantages of neoadjuvant chemoradiation. For patients who are medically inoperable, definitive chemoradiation is an alternative approach with survival rates comparable to trimodality therapy. Although trials of dose escalation are ongoing, the standard radiation dose remains 50.4 Gy. Modern radiotherapy techniques such as image-guided radiation therapy with motion management and intensity-modulated radiation therapy are strongly encouraged with a planning objective to maximize conformity to the intended target volume while reducing dose delivered to uninvolved normal tissues. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Gender incongruence of childhood in the ICD-11: controversies, proposal, and rationale.

    PubMed

    Drescher, Jack; Cohen-Kettenis, Peggy T; Reed, Geoffrey M

    2016-03-01

    As part of the development of the eleventh revision of the International Classification of Diseases (ICD-11), WHO appointed a Working Group on Sexual Disorders and Sexual Health to recommend changes necessary in the classification of mental and behavioural disorders in ICD-10 that are related to sexuality and gender identity. This Personal View focuses on the Working Group's proposals to include the diagnosis gender incongruence of childhood in ICD-11 and to move gender incongruence of childhood out of the mental and behavioural disorders chapter of ICD-11. We outline the history of ICD and DSM child gender diagnoses, expert consensus, knowledge gaps, and controversies related to the diagnosis and treatment of extremely gender-variant children. We argue that retaining the gender incongruence of childhood category is justified as a basis to structure clinical care and to ensure access to appropriate services for this vulnerable population, which provides opportunities for education and informed consent, the development of standards and pathways of care to help guide clinicians and family members, and a basis for future research efforts. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. Effects of nonsurgical periodontal therapy on C-reactive protein and serum lipids in Jordanian adults with advanced periodontitis.

    PubMed

    Kamil, W; Al Habashneh, R; Khader, Y; Al Bayati, L; Taani, D

    2011-10-01

    Data on whether periodontal therapy affects serum CRP levels are inconclusive. The aim of this study was to determine if nonsurgical periodontal therapy has any effect on CRP and serum lipid levels in patients with advanced periodontitis. Thirty-six systemically healthy patients, ≥ 40 years of age and with advanced periodontitis, were recruited for the study. Patients were randomized consecutively to one of two groups: the treatment group (n = 18) or the control group (n = 18). Treated subjects received nonsurgical periodontal therapy, which included oral hygiene instructions and subgingival scaling and root planing. Systemic levels of inflammatory markers [C-reactive protein (CRP) and the lipid profile] were measured at baseline and 3 mo after periodontal therapy. Nonsurgical periodontal therapy in the treatment group resulted in a significant reduction in the serum CRP level. The average CRP level decreased from 2.3 mg/dL at baseline to 1.8 mg/dL (p < 0.005) after 3 mo of periodontal therapy. The average reduction (95% confidence interval) in CRP was 0.498 (95% confidence interval = 0.265-0.731). In the treatment group, the reduction in CRP was significantly, linearly and directly correlated with the reduction in the plaque index, the gingival index and the percentage of sites with pocket depth ≥ 7 mm (Pearson correlation coefficient = 0.746, 0.425 and 0.621, respectively). Nonsurgical periodontal therapy had no effect on the lipid parameters. This study demonstrated that nonsurgical periodontal therapy results in a significant reduction in the serum CRP level. The effect of this outcome on systemic disease is still unknown. © 2011 John Wiley & Sons A/S.

  11. Adjuvant therapy for advanced renal cell carcinoma.

    PubMed

    Meissner, Matthew A; McCormick, Barrett Z; Karam, Jose A; Wood, Christopher G

    2018-07-01

    Locally advanced, non-metastatic renal cell carcinoma (RCC) is conventionally managed with surgery. However, patients are at a high risk of RCC recurrence and have poor survival outcomes. An effective adjuvant systemic treatment is needed to improve on these outcomes. Targeted molecular and immune-based therapies have been investigated, or are under investigation, but their role in this setting remains unclear. Areas covered: A comprehensive search of PubMed and ClinicalTrials.gov was performed for relevant literature. The following topics pertinent to adjuvant therapy in RCC were evaluated: strategies for patient selection, cytokine-based immunotherapy, vaccine therapy, VEGF and non-VEGF targeted molecular agents, and immune checkpoint inhibitors. Expert commentary: Strong evidence for the incorporation of adjuvant therapy in high-risk RCC is lacking. Multiple targeted molecular therapies have been examined with only one approved for use. Genetic and molecular-based prognostic models are needed to determine who may benefit from adjuvant therapy. Developing adjuvant therapy strategies in the future depends on the results of important ongoing trials with immunotherapy and targeted agents.

  12. Intellectual developmental disorders: towards a new name, definition and framework for "mental retardation/intellectual disability" in ICD-11.

    PubMed

    Salvador-Carulla, Luis; Reed, Geoffrey M; Vaez-Azizi, Leila M; Cooper, Sally-Ann; Martinez-Leal, Rafael; Bertelli, Marco; Adnams, Colleen; Cooray, Sherva; Deb, Shoumitro; Akoury-Dirani, Leyla; Girimaji, Satish Chandra; Katz, Gregorio; Kwok, Henry; Luckasson, Ruth; Simeonsson, Rune; Walsh, Carolyn; Munir, Kemir; Saxena, Shekhar

    2011-10-01

    Although "intellectual disability" has widely replaced the term "mental retardation", the debate as to whether this entity should be conceptualized as a health condition or as a disability has intensified as the revision of the World Health Organization (WHO)'s International Classification of Diseases (ICD) advances. Defining intellectual disability as a health condition is central to retaining it in ICD, with significant implications for health policy and access to health services. This paper presents the consensus reached to date by the WHO ICD Working Group on the Classification of Intellectual Disabilities. Literature reviews were conducted and a mixed qualitative approach was followed in a series of meetings to produce consensus-based recommendations combining prior expert knowledge and available evidence. The Working Group proposes replacing mental retardation with intellectual developmental disorders, defined as "a group of developmental conditions characterized by significant impairment of cognitive functions, which are associated with limitations of learning, adaptive behaviour and skills". The Working Group further advises that intellectual developmental disorders be incorporated in the larger grouping (parent category) of neurodevelopmental disorders, that current subcategories based on clinical severity (i.e., mild, moderate, severe, profound) be continued, and that problem behaviours be removed from the core classification structure of intellectual developmental disorders and instead described as associated features.

  13. Updating Allergy and/or Hypersensitivity Diagnostic Procedures in the WHO ICD-11 Revision.

    PubMed

    Tanno, Luciana Kase; Calderon, Moises A; Li, James; Casale, Thomas; Demoly, Pascal

    2016-01-01

    The classification of allergy and/or hypersensitivity conditions for the World Health Organization (WHO) International Classification of Diseases (ICD)-11 provides the appropriate corresponding codes for allergic diseases, assuming that the final diagnosis is correct. This classification should be linked to in vitro and in vivo diagnostic procedures. Considering the impact for our specialty, we decided to review the codification of these procedures into the ICD aiming to have a baseline and to suggest changes and/or submit new proposals. For that, we prepared a list of the relevant allergy and/or hypersensitivity diagnostic procedures that health care professionals are dealing with on a daily basis. This was based on the main current guidelines and selected all possible and relevant corresponding terms from the ICD-10 (2015 version) and the ICD-11 β phase foundation (June 2015 version). More than 90% of very specific and important diagnostic procedures currently used by the allergists' community on a daily basis are missing. We observed that some concepts usually used by the allergist community on a daily basis are not fully recognized by other specialties. The whole scheme and the correspondence in the ICD-10 (2015 version) and ICD-11 foundation (June 2015 version) provided us a big picture of the missing or imprecise terms and how they are scattered in the current ICD-11 framework, allowing us to submit new proposals to increase the visibility of the allergy and/or hypersensitivity conditions and diagnostic procedures. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. All rights reserved.

  14. Mental and behavioural disorders in the ICD-11: concepts, methodologies, and current status.

    PubMed

    Gaebel, Wolfgang; Zielasek, Jürgen; Reed, Geoffrey M

    2017-04-30

    This review provides an overview of the concepts, methods and current status of the development of the Eleventh Revision of the Mental and Behavioural Disorders chapter of the International Classification of Diseases and Related Health Problems (ICD-11) by the World Health Organization (WHO). Given the global use of the current version (ICD-10) for a wide range of applications in clinical practice and health statistics, a major aim of the development process for ICD-11 has been to increase the utility of the classification system. Expert working groups with responsibility for specific disorder groupings first suggested a set of revised diagnostic guidelines. Then surveys were performed to obtain suggestions for revisions from practicing health professionals. A completely revised structure for the classification of mental and behavioural disorders was developed and major revisions were suggested, for example, for schizophrenia and other primary psychotic disorders, substance use disorders, affective disorders and personality disorders. A new category of "gaming disorder" has been proposed and conditions related to sexual health and gender identity will be classified separately from mental disorders. An ICD-11 beta draft is freely available on the internet and public comments are invited. Field studies of the revised diagnostic guidelines are in process to obtain additional information about necessary improvements. A tabulated crosswalk from previous ICD-10 to then ICD-11 criteria will be necessary to ascertain the continuity of diagnoses for epidemiological and other statistical purposes. The final version of ICD-11 is currently scheduled for release by the World Health Assembly in 2018.

  15. Effect of Sleep-Disordered Breathing on Appropriate Implantable Cardioverter-defibrillator Therapy in Patients With Heart Failure

    PubMed Central

    Kwon, Younghoon; Koene, Ryan J.; Kwon, Osung; Kealhofer, Jessica V.; Adabag, Selcuk; Duval, Sue

    2017-01-01

    Background Patients with heart failure and reduced ejection fraction are at increased risk of malignant ventricular arrhythmias. Implantable cardioverter-defibrillator (ICD) is recommended to prevent sudden cardiac death in some of these patients. Sleep-disordered breathing (SDB) is highly prevalent in this population and may impact arrhythmogenicity. We performed a systematic review and meta-analysis of prospective studies that assessed the impact of SDB on ICD therapy. Methods and Results Relevant prospective studies were identified in the Ovid MEDLINE, EMBASE, and Google Scholar databases. Weighted risk ratios of the association between SDB and appropriate ICD therapies were estimated using random effects meta-analysis. Nine prospective cohort studies (n=1274) were included in this analysis. SDB was present in 52% of the participants. SDB was associated with a 55% higher risk of appropriate ICD therapies (45% versus 28%; risk ratio, 1.55; 95% confidence interval, 1.32–1.83). In a subgroup analysis based on the subtypes of SDB, the risk was higher in both central (risk ratio, 1.50; 95% confidence interval, 1.11–2.02) and obstructive (risk ratio, 1.43; 95% confidence interval, 1.01–2.03) sleep apnea. Conclusions SDB is associated with an increased risk of appropriate ICD therapy in patients with heart failure and reduced ejection fraction. PMID:28213507

  16. Impact of new X-ray technology on patient dose in pacemaker and implantable cardioverter defibrillator (ICD) implantations.

    PubMed

    van Dijk, Joris D; Ottervanger, Jan Paul; Delnoy, Peter Paul H M; Lagerweij, Martine C M; Knollema, Siert; Slump, Cornelis H; Jager, Pieter L

    2017-01-01

    New X-ray technology providing new image processing techniques may reduce radiation exposure. The aim of this study was to quantify this radiation exposure reduction for patients during pacemaker and implantable cardioverter defibrillator (ICD) implantation. In this retrospective study, 1185 consecutive patients who had undergone de novo pacemaker or ICD implantation during a 2-year period were included. All implantations in the first year were performed using the reference technology (Allura Xper), whereas in the second year, the new X-ray technology (AlluraClarity) was used. Radiation exposure, expressed as the dose area product (DAP), was compared between the two time periods to determine the radiation exposure reduction for pacemaker and ICD implantations without cardiac resynchronization therapy (CRT) and with CRT. Procedure duration and contrast volume were used as measures to compare complexity and image quality. The study population consisted of 591 patients who had undergone an implantation using the reference technology, and 594 patients with the new X-ray technology. The two groups did not differ in age, gender, or body mass index. The DAP decreased with 69 % from 16.4 ± 18.5 to 5.2 ± 6.6 Gy cm 2 for the non-CRT implantations (p < 0.001). The DAP decreased with 75 % from 72.1 ± 60.0 to 17.8 ± 17.4 Gy cm 2 for the CRT implantations (p < 0.001). Nevertheless, procedure duration and contrast volume did not differ when using the new technology (p = 0.09 and p = 0.20, respectively). Introduction of new X-ray technology resulted in a radiation exposure reduction of more than 69 % for patients during pacemaker and ICD implantation while image quality was unaffected.

  17. Steps through the revision process of reproductive health sections of ICD-11.

    PubMed

    Chou, Doris; Tunçalp, Özge; Hotamisligil, Selen; Norman, Jane; Say, Lale; Volkmer, Björn; Pattinson, Bob; Rooney, Cleo; Serour, Gamal; de Mouzon, Jacques; Gardosi, Jason; Thueroff, Joachim; Mark, Morgan; D'Hooghe, Thomas

    2012-01-01

    In 2007, the WHO initiated an organizational structure for the 11th revision of the International Classification of Diseases (ICD). Effective deployment of ICD-derived tools facilitates the use and collection of health information in a variety of resource settings, promoting quantitatively informed decisions. They also facilitate comparison of disease incidence and outcomes between different countries and different health care systems around the world. The Department of Reproductive Health and Research (RHR) coordinates the revision of chapters 14 (diseases of the genitourinary system), 15 (pregnancy, childbirth, and puerperium), and 16 (conditions originating in the perinatal period). RHR convened a technical advisory group (TAG), the Genito-Urinary Reproductive Medicine (GURM) TAG, for the ICD revision. The TAG's work reflects the collective understanding of sexual and reproductive health and is now available for review within the ICD-11 revision process. Copyright © 2012 S. Karger AG, Basel.

  18. Comparison of pharmacological treatment alone vs. treatment combined with implantable cardioverter defibrillator therapy in patients older than 75 years.

    PubMed

    Cortés, Marcelino; Palfy, Julia Anna; Lopez, Marta; Martínez, Juan; Rivero, Ana Lucia; Devesa, Ana; Franco-Peláez, Juan Antonio; Briongos, Sem; Taibo-Urquia, Mikel; Benezet, Juan; Rubio, Jose-Manuel

    2018-06-24

    Implantable cardioverter defibrillator (ICD) reduces mortality in selected patients. However, its role in patients older than 75 years is not well established. We performed a retrospective, non-randomized study using a historical cohort from a single centre. Between January 2008 and July 2014, we assessed patients aged ≥75 years with left ventricular ejection fraction ≤ 35%, identifying 385 patients with a Class I or IIa recommendation for ICD implantation. At the decision of the patient or attending cardiologists, 92 patients received an ICD. To avoid potential confounding factors, we used propensity-score matching. Finally, 126 patients were included (63 with ICD). The mean age was 79.1 ± 3.1 years (86.5% male). As compared with the medical therapy group, the ICD patients had a lower percentage of chronic obstructive pulmonary disease (19.0% vs. 38.1%, P < 0.05) and more frequent use of beta-blockers (BBs) (85.7 vs. 70.0%, P < 0.05). Other treatments were otherwise similar in both groups. There were no differences related to age, aetiology, or other co-morbidities. During follow-up (39.2 ± 22.4 months), total mortality was 46.0% and cardiovascular events (death or hospitalization) occurred in 66.7% of the patients. A multivariate analysis revealed that only BB therapy was shown to be an independent protective variable with respect to mortality [hazard ratio 0.4 (0.2-0.7)]. ICD therapy did not reduce overall mortality or the rate of cardiovascular events. According to our results, the use of ICD, as compared with medical therapy, in patients older than 75 years did not demonstrate any benefit. Well-designed randomized controlled studies in patients older than 75 years are needed to ascertain the value of ICD therapy. © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

  19. Minding the body: situating gender identity diagnoses in the ICD-11.

    PubMed

    Drescher, Jack; Cohen-Kettenis, Peggy; Winter, Sam

    2012-12-01

    The World Health Organization (WHO) is in the process of revising the International Statistical Classification of Diseases and Related Health Problems (ICD) and ICD-11 has an anticipated publication date of 2015. The Working Group on the Classification of Sexual Disorders and Sexual Health (WGSDSH) is charged with evaluating clinical and research data to inform the revision of diagnostic categories related to sexuality and gender identity that are currently included in the mental and behavioural disorders chapter of ICD-10, and making initial recommendations regarding whether and how these categories should be represented in the ICD-11. The diagnostic classification of disorders related to (trans)gender identity is an area long characterized by lack of knowledge, misconceptions and controversy. The placement of these categories has shifted over time within both the ICD and the American Psychiatric Association's Diagnostic and Statistical Manual (DSM), reflecting developing views about what to call these diagnoses, what they mean and where to place them. This article reviews several controversies generated by gender identity diagnoses in recent years. In both the ICD-11 and DSM-5 development processes, one challenge has been to find a balance between concerns related to the stigmatization of mental disorders and the need for diagnostic categories that facilitate access to healthcare. In this connection, this article discusses several human rights issues related to gender identity diagnoses, and explores the question of whether affected populations are best served by placement of these categories within the mental disorders section of the classification. The combined stigmatization of being transgender and of having a mental disorder diagnosis creates a doubly burdensome situation for this group, which may contribute adversely to health status and to the attainment and enjoyment of human rights. The ICD-11 Working Group on the Classification of Sexual Disorders and

  20. [Advanced radiation therapy project for cancer treatment--from Hokkaido to the world, the world access to Hokkaido].

    PubMed

    Shimizu, Shinichi; Tsuchiya, Kazuhiko; Takao, Seishin; Shirato, Hiroki

    2014-05-01

    Cancer is the most major cause of death in Japan recently. In this symposium, we explained advanced treatment technology for cancer treatment, now used and that will be used in near future at the Hokkaido University Hospital. Intensity Moderated Radiation Therapy (IMRT) and Proton Beam Therapy (PBT) are considered to be the most promising and advanced technologies for cancer treatment. Various kinds of radiation treatment equipment and methods have been developed and constructed at the Hokkaido University. One of the most worlds wide famous one is the real time tumor tracking radiotherapy system. The FIRST (Funding for World-Leading Innovative R&D on Science and Technology) Program has been supporting us to produce cutting-edge technology. We hope that this symposium would help the audience to understand the latest technology for cancer treatment especially in the field of radiation therapy and also we wish the audience would recognize the importance of the research aspect that have been performed at Hokkaido University and its Hospital.

  1. Refining Preoperative Therapy for Locally Advanced Rectal Cancer

    Cancer.gov

    In the PROSPECT trial, patients with locally advanced, resectable rectal cancer will be randomly assigned to receive either standard neoadjuvant chemoradiation therapy or neoadjuvant FOLFOX chemotherapy, with chemoradiation reserved for nonresponders.

  2. Collaboration between specialties for respiratory allergies in the International Classification of Diseases (ICD)-11.

    PubMed

    Tanno, Luciana Kase; Calderon, Moises; Linzer, Jeffrey F; Chalmers, Robert J G; Demoly, Pascal

    2017-02-10

    The International Classification of Diseases (ICD) has been grouping the allergic and hypersensitivity disorders involving the respiratory tract under topographic distribution, regardless of the underlying mechanisms, triggers or concepts currently in use for allergic and hypersensitivity conditions. In order to strengthen awareness and deliberate the creation of the new "Allergic or hypersensitivity disorders involving the respiratory tract" section of the ICD-11, we here propose make the building process public. The new frame has been constructed to cover the gaps previously identified and was based on consensus academic reports and ICD-11 principles. Constant and bilateral discussion was kept with relevant groups representing specialties and resulted in proposals submission into the ICD-11 online platform. The "Allergic or hypersensitivity disorders involving the respiratory tract" section covers 64 entities distributed across five main categories. All the 79 proposals submitted resulted from an intensive collaboration of the Allergy working group, relevant Expert working groups and the WHO ICD governance. The establishment of the ICD-11 "Allergic or hypersensitivity disorders involving the respiratory tract" section will allow the dissemination of the updated concepts to be used in clinical practice by many different specialties and health professionals.

  3. Intracellular fragment of NLRR3 (NLRR3-ICD) stimulates ATRA-dependent neuroblastoma differentiation.

    PubMed

    Akter, Jesmin; Takatori, Atsushi; Islam, Md Sazzadul; Nakazawa, Atsuko; Ozaki, Toshinori; Nagase, Hiroki; Nakagawara, Akira

    2014-10-10

    We have previously identified neuronal leucine-rich repeat protein-3 (NLRR3) gene which is preferentially expressed in favorable human neuroblastomas as compared with unfavorable ones. In this study, we have found for the first time that NLRR3 is proteolytically processed by secretases and its intracellular domain (NLRR3-ICD) is then released to translocate into cell nucleus during ATRA-mediated neuroblastoma differentiation. According to our present observations, NLRR3-ICD was induced to accumulate in cell nucleus of neuroblastoma SH-SY5Y cells following ATRA treatment. Since the proteolytic cleavage of NLRR3 was blocked by α- or γ-secretase inhibitor, it is likely that NLRR3-ICD is produced through the secretase-mediated processing of NLRR3. Intriguingly, forced expression of NLRR3-ICD in neuroblastoma SK-N-BE cells significantly suppressed their proliferation as examined by a live-cell imaging system and colony formation assay. Similar results were also obtained in neuroblastoma TGW cells. Furthermore, overexpression of NLRR3-ICD stimulated ATRA-dependent neurite elongation in SK-N-BE cells. Together, our present results strongly suggest that NLRR3-ICD produced by the secretase-mediated proteolytic processing of NLRR3 plays a crucial role in ATRA-mediated neuronal differentiation, and provide a clue to develop a novel therapeutic strategy against aggressive neuroblastomas. Copyright © 2014 Elsevier Inc. All rights reserved.

  4. Implantable cardioverter-defibrillator therapy in Brugada syndrome: a 20-year single-center experience.

    PubMed

    Conte, Giulio; Sieira, Juan; Ciconte, Giuseppe; de Asmundis, Carlo; Chierchia, Gian-Battista; Baltogiannis, Giannis; Di Giovanni, Giacomo; La Meir, Mark; Wellens, Francis; Czapla, Jens; Wauters, Kristel; Levinstein, Moises; Saitoh, Yukio; Irfan, Ghazala; Julià, Justo; Pappaert, Gudrun; Brugada, Pedro

    2015-03-10

    Patients with Brugada syndrome and aborted sudden cardiac death or syncope have higher risks for ventricular arrhythmias (VAs) and should undergo implantable cardioverter-defibrillator (ICD) placement. Device-based management of asymptomatic patients is controversial. ICD therapy is associated with high rates of inappropriate shocks and device-related complications. The objective of this study was to investigate clinical features, management, and long-term follow-up of ICD therapy in patients with Brugada syndrome. Patients presenting with spontaneous or drug-induced Brugada type 1 electrocardiographic findings, who underwent ICD implantation and continuous follow-up at a single institution, were eligible for this study. A total of 176 consecutive patients were included. During a mean follow-up period of 83.8 ± 57.3 months, spontaneous sustained VAs occurred in 30 patients (17%). Eight patients (4.5%) died. Appropriate ICD shocks occurred in 28 patients (15.9%), and 33 patients (18.7%) had inappropriate shocks. Electrical storm occurred in 4 subjects (2.3%). Twenty-eight patients (15.9%) experienced device-related complications. In multivariate Cox regression analysis, aborted sudden cardiac death and VA inducibility on electrophysiologic studies were independent predictors of appropriate shock occurrence. ICD therapy was an effective strategy in Brugada syndrome, treating potentially lethal arrhythmias in 17% of patients during long-term follow-up. Appropriate shocks were significantly associated with the presence of aborted sudden cardiac death but also occurred in 13% of asymptomatic patients. Risk stratification by electrophysiologic study may identify asymptomatic patients at risk for arrhythmic events and could be helpful in investigating syncope not related to VAs. ICD placement is frequently associated with device-related complications, and rates of inappropriate shocks remain high regardless of careful device programming. Copyright © 2015 American

  5. Advances in gene therapy for heart failure.

    PubMed

    Fish, Kenneth M; Ishikawa, Kiyotake

    2015-04-01

    Chronic heart failure is expected to increase its social and economic burden as a consequence of improved survival in patients with acute cardiac events. Cardiac gene therapy holds significant promise in heart failure treatment for patients with currently very limited or no treatment options. The introduction of adeno-associated virus (AAV) gene vector changed the paradigm of cardiac gene therapy, and now it is the primary vector of choice for chronic heart failure gene therapy in clinical and preclinical studies. Recently, there has been significant progress towards clinical translation in this field spearheaded by AAV-1 mediated sarcoplasmic reticulum Ca2+ ATPase (SERCA2a) gene therapy targeting chronic advanced heart failure patients. Meanwhile, several independent laboratories are reporting successful gene therapy approaches in clinically relevant large animal models of heart failure and some of these approaches are expected to enter clinical trials in the near future. This review will focus on gene therapy approaches targeting heart failure that is in clinical trials and those close to its initial clinical trial application.

  6. Battery longevity in cardiac resynchronization therapy implantable cardioverter defibrillators.

    PubMed

    Alam, Mian Bilal; Munir, Muhammad Bilal; Rattan, Rohit; Flanigan, Susan; Adelstein, Evan; Jain, Sandeep; Saba, Samir

    2014-02-01

    Cardiac resynchronization therapy (CRT) implantable cardioverter defibrillators (ICDs) deliver high burden ventricular pacing to heart failure patients, which has a significant effect on battery longevity. The aim of this study was to investigate whether battery longevity is comparable for CRT-ICDs from different manufacturers in a contemporary cohort of patients. All the CRT-ICDs implanted at our institution from 1 January 2008 to 31 December 2010 were included in this analysis. Baseline demographic and clinical data were collected on all patients using the electronic medical record. Detailed device information was collected on all patients from scanned device printouts obtained during routine follow-up. The primary endpoint was device replacement for battery reaching the elective replacement indicator (ERI). A total of 646 patients (age 69 ± 13 years), implanted with CRT-ICDs (Boston Scientific 173, Medtronic 416, and St Jude Medical 57) were included in this analysis. During 2.7 ± 1.5 years follow-up, 113 (17%) devices had reached ERI (Boston scientific 4%, Medtronic 25%, and St Jude Medical 7%, P < 0.001). The 4-year survival rate of device battery was significantly worse for Medtronic devices compared with devices from other manufacturers (94% for Boston scientific, 67% for Medtronic, and 92% for St Jude Medical, P < 0.001). The difference in battery longevity by manufacturer was independent of pacing burden, lead parameters, and burden of ICD therapy. There are significant discrepancies in CRT-ICD battery longevity by manufacturer. These data have important implications on clinical practice and patient outcomes.

  7. Effective Identification of Similar Patients Through Sequential Matching over ICD Code Embedding.

    PubMed

    Nguyen, Dang; Luo, Wei; Venkatesh, Svetha; Phung, Dinh

    2018-04-11

    Evidence-based medicine often involves the identification of patients with similar conditions, which are often captured in ICD (International Classification of Diseases (World Health Organization 2013)) code sequences. With no satisfying prior solutions for matching ICD-10 code sequences, this paper presents a method which effectively captures the clinical similarity among routine patients who have multiple comorbidities and complex care needs. Our method leverages the recent progress in representation learning of individual ICD-10 codes, and it explicitly uses the sequential order of codes for matching. Empirical evaluation on a state-wide cancer data collection shows that our proposed method achieves significantly higher matching performance compared with state-of-the-art methods ignoring the sequential order. Our method better identifies similar patients in a number of clinical outcomes including readmission and mortality outlook. Although this paper focuses on ICD-10 diagnosis code sequences, our method can be adapted to work with other codified sequence data.

  8. Ethical challenges of deactivation of cardiac devices in advanced heart failure.

    PubMed

    Chamsi-Pasha, Hassan; Chamsi-Pasha, Mohammed A; Albar, Mohammed Ali

    2014-06-01

    More than 23 million adults worldwide have heart failure (HF). Although survival after heart failure diagnosis has improved over time, mortality from heart failure remains high. At the end of life, the chronic HF patient often becomes increasingly symptomatic, and may have other life-limiting comorbidities as well. Multiple trials have shown a clear mortality benefit with the use of implantable cardioverter defibrillators (ICDs) in patients with cardiomyopathy and ventricular arrhythmia. However, patients who have an ICD may be denied the chance of a sudden cardiac death, and instead are committed to a slower terminal decline, with frequent DC shocks that can be painful and decrease the quality of life, greatly contributing to their distress and that of their families during this period. While patients with ICDs are routinely counseled with regard to the benefits of ICDs, they have a poor understanding of the options for device deactivation and related ethical and legal implications. Deactivating an ICD or not performing a generator change is both legal and ethical, and is supported by guidelines from both sides of the Atlantic. Patient autonomy is paramount, and no patient is committed to any therapy that they no longer wish to receive. Left ventricular assist devices (LVADs) were initially used as bridge in patients awaiting heart transplantation, but they are currently implanted as destination therapy (DT) in patients with end-stage heart failure who have failed to respond to optimal medical therapy and who are ineligible for cardiac transplantation. The decision-making process for initiation and deactivation of LVAD is becoming more and more ethically and clinically challenging, particularly for elderly patients.

  9. The impact of proposed changes to ICD-11 on estimates of PTSD prevalence and comorbidity.

    PubMed

    Wisco, Blair E; Miller, Mark W; Wolf, Erika J; Kilpatrick, Dean; Resnick, Heidi S; Badour, Christal L; Marx, Brian P; Keane, Terence M; Rosen, Raymond C; Friedman, Matthew J

    2016-06-30

    The World Health Organization's posttraumatic stress disorder (PTSD) work group has published a proposal for the forthcoming edition of the International Classification of Diseases (ICD-11) that would yield a very different diagnosis relative to DSM-5. This study examined the impact of the proposed ICD-11 changes on PTSD prevalence relative to the ICD-10 and DSM-5 definitions and also evaluated the extent to which these changes would accomplish the stated aim of reducing the comorbidity associated with PTSD. Diagnostic prevalence estimates were compared using a U.S. national community sample and two U.S. Department of Veterans Affairs clinical samples. The ICD-11 definition yielded prevalence estimates 10-30% lower than DSM-5 and 25% and 50% lower than ICD-10 with no reduction in the prevalence of common comorbidities. Findings suggest that by constraining the diagnosis to a narrower set of symptoms, the proposed ICD-11 criteria set would substantially reduce the number of individuals with the disorder. These findings raise doubt about the extent to which the ICD-11 proposal would achieve the aim of reducing comorbidity associated with PTSD and highlight the public health and policy implications of such a redefinition. Published by Elsevier Ireland Ltd.

  10. Proton therapy for locally advanced breast cancer: A systematic review of the literature.

    PubMed

    Kammerer, Emmanuel; Guevelou, Jennifer Le; Chaikh, Abdulhamid; Danhier, Serge; Geffrelot, Julien; Levy, Christelle; Saloux, Eric; Habrand, Jean-Louis; Thariat, Juliette

    2018-02-01

    Radiation therapy plays a major role in the management of adjuvant breast cancer with nodal involvement, with an iatrogenic increase of cardio-vascular risk. Photon therapy, even with intensity modulation, has the downsides of high mean heart dose and heterogeneous target coverage, particularly in the case of internal mammary irradiation. This systematic review of the literature aims to evaluate proton therapy in locally advanced breast cancer. PubMed was searched for original full-text articles with the following search terms: «Proton Therapy» and «Breast Cancer». On-going trials were collected using the words "Breast Cancer" and "Protons". 13 articles met the criteria: 6 with passive proton therapy (Double Scattering), 5 with Pencil Beam Scanning (PBS) and 2 with a combination of both. Proton therapy offered a better target coverage than photons, even compared with intensity modulation radiation therapy (including static or rotational IMRT or tomotherapy). With proton therapy, volumes receiving 95% of the dose were around 98%, with low volumes receiving 105% of the dose. Proton therapy often decreased mean heart dose by a factor of 2 or 3, i.e. 1 Gy with proton therapy versus 3 Gy with conventional 3D, and 6 Gy for IMRT. Lungs were better spared with proton therapy than with photon therapy. Cutaneous toxicity observed with double scattering is improved with PBS. Proton therapy reduces mean heart dose in breast cancer irradiation, probably reducing late cardio-vascular toxicity. Large clinical studies will likely confirm a clinical benefit of proton therapy. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

    PubMed

    Timofeeva, A A

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

  12. Reconstruction of an 8-lead surface ECG from two subcutaneous ICD vectors.

    PubMed

    Wilson, David G; Cronbach, Peter L; Panfilo, D; Greenhut, Saul E; Stegemann, Berthold P; Morgan, John M

    2017-06-01

    Techniques exist which allow surface ECGs to be reconstructed from reduced lead sets. We aimed to reconstruct an 8-lead ECG from two independent S-ICD sensing electrodes vectors as proof of this principle. Participants with ICDs (N=61) underwent 3minute ECGs using a TMSi Porti7 multi-channel signal recorder (TMS international, The Netherlands) with electrodes in the standard S-ICD and 12-lead positions. Participants were randomised to either a training (N=31) or validation (N=30) group. The transformation used was a linear combination of the 2 independent S-ICD vectors to each of the 8 independent leads of the 12-lead ECG, with coefficients selected that minimized the root mean square error (RMSE) between recorded and derived ECGs when applied to the training group. The transformation was then applied to the validation group and agreement between the recorded and derived lead pairs was measured by Pearson correlation coefficient (r) and normalised RMSE (NRMSE). In total, 27 patients with complete data sets were included in the validation set consisting of 57,888 data points from 216 full lead sets. The distribution of the r and NRMSE were skewed. Mean r=0.770 (SE 0.024), median r=0.925. NRMSE mean=0.233 (SE 0.015) median=0.171. We have demonstrated that the reconstruction of an 8-lead ECG from two S-ICD vectors is possible. If perfected, the ability to generate accurate multi-lead surface ECG data from an S-ICD would potentially allow recording and review of clinical arrhythmias at follow-up. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Gene therapy: advances, challenges and perspectives

    PubMed Central

    Gonçalves, Giulliana Augusta Rangel; Paiva, Raquel de Melo Alves

    2017-01-01

    ABSTRACT The ability to make site-specific modifications to the human genome has been an objective in medicine since the recognition of the gene as the basic unit of heredity. Thus, gene therapy is understood as the ability of genetic improvement through the correction of altered (mutated) genes or site-specific modifications that target therapeutic treatment. This therapy became possible through the advances of genetics and bioengineering that enabled manipulating vectors for delivery of extrachromosomal material to target cells. One of the main focuses of this technique is the optimization of delivery vehicles (vectors) that are mostly plasmids, nanostructured or viruses. The viruses are more often investigated due to their excellence of invading cells and inserting their genetic material. However, there is great concern regarding exacerbated immune responses and genome manipulation, especially in germ line cells. In vivo studies in in somatic cell showed satisfactory results with approved protocols in clinical trials. These trials have been conducted in the United States, Europe, Australia and China. Recent biotechnological advances, such as induced pluripotent stem cells in patients with liver diseases, chimeric antigen receptor T-cell immunotherapy, and genomic editing by CRISPR/Cas9, are addressed in this review. PMID:29091160

  14. T wave alternans as a predictor of recurrent ventricular tachyarrhythmias in ICD recipients: prospective comparison with conventional risk markers

    NASA Technical Reports Server (NTRS)

    Hohnloser, S. H.; Klingenheben, T.; Li, Y. G.; Zabel, M.; Peetermans, J.; Cohen, R. J.

    1998-01-01

    INTRODUCTION: The current standard for arrhythmic risk stratification is electrophysiologic (EP) testing, which, due to its invasive nature, is limited to patients already known to be at high risk. A number of noninvasive tests, such as determination of left ventricular ejection fraction (LVEF) or heart rate variability, have been evaluated as additional risk stratifiers. Microvolt T wave alternans (TWA) is a promising new risk marker. Prospective evaluation of noninvasive risk markers in low- or moderate-risk populations requires studies involving very large numbers of patients, and in such studies, documentation of the occurrence of ventricular tachyarrhythmias is difficult. In the present study, we identified a high-risk population, recipients of an implantable cardioverter defibrillator (ICD), and prospectively compared microvolt TWA with invasive EP testing and other risk markers with respect to their ability to predict recurrence of ventricular tachyarrhythmias as documented by ICD electrograms. METHODS AND RESULTS: Ninety-five patients with a history of ventricular tachyarrhythmias undergoing implantation of an ICD underwent EP testing, assessment of TWA, as well as determination of LVEF, baroreflex sensitivity, signal-averaged ECG, analysis of 24-hour Holter monitoring, and QT dispersion from the 12-lead surface ECG. The endpoint of the study was first appropriate ICD therapy for electrogram-documented ventricular fibrillation or tachycardia during follow-up. Kaplan-Meier survival analysis revealed that TWA (P < 0.006) and LVEF (P < 0.04) were the only significant univariate risk stratifiers. EP testing was not statistically significant (P < 0.2). Multivariate Cox regression analysis revealed that TWA was the only statistically significant independent risk factor. CONCLUSIONS: Measurement of microvolt TWA compared favorably with both invasive EP testing and other currently used noninvasive risk assessment methods in predicting recurrence of ventricular

  15. Linking neuroscience with modern concepts of impulse control disorders in Parkinson’s disease

    PubMed Central

    Napier, T. Celeste; Corvol, Jean-Christophe; Grace, Anthony A.; Roitman, Jamie D.; Rowe, James; Voon, Valerie; Strafella, Antonio P.

    2014-01-01

    Patients with Parkinson’s disease (PD) may experience impulse control disorders (ICDs) when on dopamine agonist therapy for their motor symptoms. In the last few years, there has been a rapid growth of interest for the recognition of these aberrant behaviors and their neurobiological correlates. Recent advances in neuroimaging are helping to identify the neuroanatomical networks responsible for these ICDs, and together with psychopharmacological assessments are providing new insights into the brain status of impulsive behavior. The genetic associations that may be unique to ICDs in PD are also being identified. Complementing human studies, electrophysiological and biochemical studies in animal models are providing insights into neuropathological mechanisms associated with these disorders. New animal models of ICDs in PD patients are being implemented that should provide critical means to identify efficacious therapies for PD-related motor deficits while avoiding ICD side effects. Here, we provide an overview of these recent advances, with a particular emphasis on the neurobiological correlates reported in animal models and patients along with their genetic underpinnings. PMID:25476402

  16. Trends in Gastroenteritis-associated Mortality in the United States 1985-2005: Variations by ICD-9 and ICD-10 Codes

    EPA Science Inventory

    BackgroundTrends in gastroenteritis-associated mortality are changing over time with development of antibiotic resistant strains of certain pathogens, improved diagnostic methods, and changing healthcare. In 1999, ICD-10 coding was introduced for mortality records which can also ...

  17. Metrics and tools for consistent cohort discovery and financial analyses post-transition to ICD-10-CM.

    PubMed

    Boyd, Andrew D; Li, Jianrong John; Kenost, Colleen; Joese, Binoy; Yang, Young Min; Kalagidis, Olympia A; Zenku, Ilir; Saner, Donald; Bahroos, Neil; Lussier, Yves A

    2015-05-01

    In the United States, International Classification of Disease Clinical Modification (ICD-9-CM, the ninth revision) diagnosis codes are commonly used to identify patient cohorts and to conduct financial analyses related to disease. In October 2015, the healthcare system of the United States will transition to ICD-10-CM (the tenth revision) diagnosis codes. One challenge posed to clinical researchers and other analysts is conducting diagnosis-related queries across datasets containing both coding schemes. Further, healthcare administrators will manage growth, trends, and strategic planning with these dually-coded datasets. The majority of the ICD-9-CM to ICD-10-CM translations are complex and nonreciprocal, creating convoluted representations and meanings. Similarly, mapping back from ICD-10-CM to ICD-9-CM is equally complex, yet different from mapping forward, as relationships are likewise nonreciprocal. Indeed, 10 of the 21 top clinical categories are complex as 78% of their diagnosis codes are labeled as "convoluted" by our analyses. Analysis and research related to external causes of morbidity, injury, and poisoning will face the greatest challenges due to 41 745 (90%) convolutions and a decrease in the number of codes. We created a web portal tool and translation tables to list all ICD-9-CM diagnosis codes related to the specific input of ICD-10-CM diagnosis codes and their level of complexity: "identity" (reciprocal), "class-to-subclass," "subclass-to-class," "convoluted," or "no mapping." These tools provide guidance on ambiguous and complex translations to reveal where reports or analyses may be challenging to impossible.Web portal: http://www.lussierlab.org/transition-to-ICD9CM/Tables annotated with levels of translation complexity: http://www.lussierlab.org/publications/ICD10to9. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  18. Metrics and tools for consistent cohort discovery and financial analyses post-transition to ICD-10-CM

    PubMed Central

    Boyd, Andrew D; ‘John’ Li, Jianrong; Kenost, Colleen; Joese, Binoy; Min Yang, Young; Kalagidis, Olympia A; Zenku, Ilir; Saner, Donald; Bahroos, Neil; Lussier, Yves A

    2015-01-01

    In the United States, International Classification of Disease Clinical Modification (ICD-9-CM, the ninth revision) diagnosis codes are commonly used to identify patient cohorts and to conduct financial analyses related to disease. In October 2015, the healthcare system of the United States will transition to ICD-10-CM (the tenth revision) diagnosis codes. One challenge posed to clinical researchers and other analysts is conducting diagnosis-related queries across datasets containing both coding schemes. Further, healthcare administrators will manage growth, trends, and strategic planning with these dually-coded datasets. The majority of the ICD-9-CM to ICD-10-CM translations are complex and nonreciprocal, creating convoluted representations and meanings. Similarly, mapping back from ICD-10-CM to ICD-9-CM is equally complex, yet different from mapping forward, as relationships are likewise nonreciprocal. Indeed, 10 of the 21 top clinical categories are complex as 78% of their diagnosis codes are labeled as “convoluted” by our analyses. Analysis and research related to external causes of morbidity, injury, and poisoning will face the greatest challenges due to 41 745 (90%) convolutions and a decrease in the number of codes. We created a web portal tool and translation tables to list all ICD-9-CM diagnosis codes related to the specific input of ICD-10-CM diagnosis codes and their level of complexity: “identity” (reciprocal), “class-to-subclass,” “subclass-to-class,” “convoluted,” or “no mapping.” These tools provide guidance on ambiguous and complex translations to reveal where reports or analyses may be challenging to impossible. Web portal: http://www.lussierlab.org/transition-to-ICD9CM/ Tables annotated with levels of translation complexity: http://www.lussierlab.org/publications/ICD10to9 PMID:25681260

  19. Training and support to improve ICD coding quality: A controlled before-and-after impact evaluation.

    PubMed

    Dyers, Robin; Ward, Grant; Du Plooy, Shane; Fourie, Stephanus; Evans, Juliet; Mahomed, Hassan

    2017-05-24

    The proposed National Health Insurance policy for South Africa (SA) requires hospitals to maintain high-quality International Statistical Classification of Diseases (ICD) codes for patient records. While considerable strides had been made to improve ICD coding coverage by digitising the discharge process in the Western Cape Province, further intervention was required to improve data quality. The aim of this controlled before-and-after study was to evaluate the impact of a clinician training and support initiative to improve ICD coding quality. To compare ICD coding quality between two central hospitals in the Western Cape before and after the implementation of a training and support initiative for clinicians at one of the sites. The difference in differences in data quality between the intervention site and the control site was calculated. Multiple logistic regression was also used to determine the odds of data quality improvement after the intervention and to adjust for potential differences between the groups. The intervention had a positive impact of 38.0% on ICD coding completeness over and above changes that occurred at the control site. Relative to the baseline, patient records at the intervention site had a 6.6 (95% confidence interval 3.5 - 16.2) adjusted odds ratio of having a complete set of ICD codes for an admission episode after the introduction of the training and support package. The findings on impact on ICD coding accuracy were not significant. There is sufficient pragmatic evidence that a training and support package will have a considerable positive impact on ICD coding completeness in the SA setting.

  20. Cardiovascular risk in advanced naïve HIV-infected patients starting antiretroviral therapy: Comparison of three different regimens - PREVALEAT II cohort.

    PubMed

    Maggi, Paolo; Bellacosa, Chiara; Leone, Armando; Volpe, Anna; Ricci, Elena Delfina; Ladisa, Nicoletta; Cicalini, Stefania; Grilli, Elisabetta; Viglietti, Rosaria; Chirianni, Antonio; Bellazzi, Lara Ines; Maserati, Renato; Martinelli, Canio; Corsi, Paola; Celesia, Benedetto Maurizio; Sozio, Federica; Angarano, Gioacchino

    2017-08-01

    PREVALEAT (PREmature VAscular LEsions and Antiretroviral Therapy) II is a multicenter, longitudinal cohort study aimed at the evaluation of cardiovascular risk among advanced HIV-positive, treatment-naïve patients starting their first therapy. We hypothesized that these patients, present a higher cardiovascular (CV) risk. The study included all consecutive naïve patients with less than 200 CD4 cells/ml starting antiretroviral therapy. Our primary objective was to evaluate changes in carotid intima- media thickness (IMT). Secondary endpoints included changes in flow mediated vasodilation (FMD), inflammatory markers, triglycerides and cholesterol. Patients were evaluated at time 0, and after 3, 6 and 12 months. We enrolled 119 patients, stratified into three different groups: patients receiving atazanavir/ritonavir boosted (ATV/r) based regimens, efavirenz (EFV) based regimens and darunavir/ritonavir boosted (DRV/r) based regimens. At baseline, advanced naïve patients showed a relevant deterioration of CV conditions in terms of traditional CV risk factors, endothelial dysfunction and serum biomarkers. During the 12-month follow up period, mean blood lipids significantly increased: total cholesterol from 159 to 190 mg/dL, HDL-C from 31 to 41 mg/dL, and LDL-C from 99 to 117 mg/dL. D-dimers steadily decreased (median level 624 at baseline and 214 at T3), whereas ICAM and VCAM consistently raised. DRV/r and ATV/r determined a more marked decrease of D-dimers as compared to EFV. Regarding the epi-aortic changes (IMT >1 mm or presence of atherosclerotic plaques), patients in the DRV/r group were at risk of developing pathological IMT during the study (OR 6.0, 95% CI 0.9-36.9), as compared to EFV ones. CV risk was elevated in advanced naïve patients and tended to remain high in the first year of therapy. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Radiofrequency ablation of fast ventricular tachycardia causing an ICD storm in an infant with hypertrophic cardiomyopathy.

    PubMed

    Ergul, Yakup; Ozyilmaz, Isa; Bilici, Meki; Ozturk, Erkut; Haydin, Sertaç; Guzeltas, Alper

    2018-04-01

    An implantable cardioverter defibrillator (ICD) storm involves very frequent arrhythmia episodes and ICD shocks, and it is associated with poor short-term and long-term prognosis. Radiofrequency catheter ablation can be used as an effective rescue treatment for patients with an ICD storm. To our knowledge, this is the first report of an infant with hypertrophic cardiomyopathy presenting with an ICD storm and undergoing successful radiofrequency catheter ablation salvage treatment for the fast left posterior fascicular ventricular tachycardia. © 2017 Wiley Periodicals, Inc.

  2. Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial.

    PubMed

    Weaver, Frances M; Follett, Kenneth; Stern, Matthew; Hur, Kwan; Harris, Crystal; Marks, William J; Rothlind, Johannes; Sagher, Oren; Reda, Domenic; Moy, Claudia S; Pahwa, Rajesh; Burchiel, Kim; Hogarth, Penelope; Lai, Eugene C; Duda, John E; Holloway, Kathryn; Samii, Ali; Horn, Stacy; Bronstein, Jeff; Stoner, Gatana; Heemskerk, Jill; Huang, Grant D

    2009-01-07

    Deep brain stimulation is an accepted treatment for advanced Parkinson disease (PD), although there are few randomized trials comparing treatments, and most studies exclude older patients. To compare 6-month outcomes for patients with PD who received deep brain stimulation or best medical therapy. Randomized controlled trial of patients who received either deep brain stimulation or best medical therapy, stratified by study site and patient age (< 70 years vs > or = 70 years) at 7 Veterans Affairs and 6 university hospitals between May 2002 and October 2005. A total of 255 patients with PD (Hoehn and Yahr stage > or = 2 while not taking medications) were enrolled; 25% were aged 70 years or older. The final 6-month follow-up visit occurred in May 2006. Bilateral deep brain stimulation of the subthalamic nucleus (n = 60) or globus pallidus (n = 61). Patients receiving best medical therapy (n = 134) were actively managed by movement disorder neurologists. The primary outcome was time spent in the "on" state (good motor control with unimpeded motor function) without troubling dyskinesia, using motor diaries. Other outcomes included motor function, quality of life, neurocognitive function, and adverse events. Patients who received deep brain stimulation gained a mean of 4.6 h/d of on time without troubling dyskinesia compared with 0 h/d for patients who received best medical therapy (between group mean difference, 4.5 h/d [95% CI, 3.7-5.4 h/d]; P < .001). Motor function improved significantly (P < .001) with deep brain stimulation vs best medical therapy, such that 71% of deep brain stimulation patients and 32% of best medical therapy patients experienced clinically meaningful motor function improvements (> or = 5 points). Compared with the best medical therapy group, the deep brain stimulation group experienced significant improvements in the summary measure of quality of life and on 7 of 8 PD quality-of-life scores (P < .001). Neurocognitive testing revealed small

  3. Revisiting Desensitization and Allergen Immunotherapy Concepts for the International Classification of Diseases (ICD)-11.

    PubMed

    Tanno, Luciana Kase; Calderon, Moises A; Papadopoulos, Nikolaos G; Sanchez-Borges, Mario; Rosenwasser, Lanny J; Bousquet, Jean; Pawankar, Ruby; Sisul, Juan Carlos; Cepeda, Alfonso Mario; Li, James; Muraro, Antonella; Fineman, Stanley; Sublett, James L; Katelaris, Constance H; Chang, Yoon-Seok; Moon, Hee-Bom; Casale, Thomas; Demoly, Pascal

    2016-01-01

    Allergy and hypersensitivity intervention management procedures, such as desensitization and/or tolerance induction and immunotherapy, have not been pondered up to now in the content of International Classification of Diseases (ICD) context because the focus has been on prioritizing the condition implementations. Tremendous efforts have been devoted to implementing allergic and hypersensitivity conditions in the forthcoming ICD-11. However, we consider that it is crucial now to have nomenclature and classification universally accepted for these procedures to be able to provide scientifically consistent proposals into the new ICD-11 platform for the best practice parameters of our specialty. With the aim of promoting a harmonized comprehension and aligning it with the ICD-11 revision, we have reviewed the definitions and concepts currently used for desensitization and/or tolerance induction and immunotherapy. We strongly believe that this review is a key instrument to support the allergy specialty identity into the ICD-11 framework and serves as a platform to perform positive quality improvement in clinical practice. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. All rights reserved.

  4. Photodynamic therapy of advanced malignant tumors

    NASA Astrophysics Data System (ADS)

    Wang, Lian-xing; Dai, Lu-pin; Lu, Wen-qin

    1993-03-01

    Forty patients with advanced tumors were treated by photodynamic therapy (PDT) from May 1991 to August 1991 in our hospital with age ranges from 30 to 81 years old. The pathological diagnosis shows that 13 had tumors in the colon, 3 in the stomach, 2 in the oesophageal, 2 in the palatum, 1 in the cervix, and 19 others with malignant cancers of the skin. The histology was as follows: squamous cell in 20, adenocarcinoma in 19, melanocarcinoma in 1. By TNM classification there were no cases of T1, 5 cases of T2, and 35 cases of T2 - T3. All patients were stage IV. The overall effective rate was 85%, our experience is that the PDT is suitable for the patients with advanced tumor, especially those whose tumor recurrences are hard to treat after conventional treatment (surgery, radiotherapy, chemotherapy). The PDT appears to be a new and promising possibility to treat advanced tumors and to improve the patients' survival rates.

  5. Clinician's Primer to ICD-10-CM Coding for Cleft Lip/Palate Care.

    PubMed

    Allori, Alexander C; Cragan, Janet D; Della Porta, Gina C; Mulliken, John B; Meara, John G; Bruun, Richard; Shusterman, Stephen; Cassell, Cynthia H; Raynor, Eileen; Santiago, Pedro; Marcus, Jeffrey R

    2017-01-01

    On October 1, 2015, the United States required use of the Clinical Modification of the International Classification of Diseases, 10th Revision (ICD-10-CM) for diagnostic coding. This primer was written to assist the cleft care community with understanding and use of ICD-10-CM for diagnostic coding related to cleft lip and/or palate (CL/P).

  6. Clinical benefit of antiangiogenic therapy in advanced and metastatic chondrosarcoma.

    PubMed

    Jones, Robin L; Katz, Daniela; Loggers, Elizabeth T; Davidson, Darin; Rodler, Eve T; Pollack, Seth M

    2017-08-29

    Chondrosarcoma is the most common bone sarcoma in adults. Conventional chondrosarcoma, the commonest histological subtype, is largely resistant to anthracycline-based chemotherapy. There have been anecdotal reports of durable clinical benefit with antiangiogenic agents in this disease. A retrospective search of patients treated at three sarcoma referral centers was performed to identify patients with advanced chondrosarcoma treated with antiangiogenic agents. The aim of this study was to evaluate the efficacy and safety of antiangiogenic agents in advanced chondrosarcoma. Ten patients were identified; seven with conventional, one each with clear cell, extraskeletal mesenchymal chondrosarcoma and extraskeletal myxoid chondrosarcoma. The median progression-free survival for patients with conventional and clear cell sarcoma was 22.6 months. Median overall survival has not been met. Antiangiogenic therapy was well tolerated in this series of patients. Our retrospective data suggest that antiangiogenic therapy can provide prolonged clinical benefit in advanced chondrosarcoma patients. Further prospective trials are required to precisely define the role of this class of agent in advanced chondrosarcoma.

  7. Implantable Cardioverter-Defibrillator Therapy in Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy: Predictors of Appropriate Therapy, Outcomes, and Complications.

    PubMed

    Orgeron, Gabriela M; James, Cynthia A; Te Riele, Anneline; Tichnell, Crystal; Murray, Brittney; Bhonsale, Aditya; Kamel, Ihab R; Zimmerman, Stephan L; Judge, Daniel P; Crosson, Jane; Tandri, Harikrishna; Calkins, Hugh

    2017-06-06

    Arrhythmogenic right ventricular dysplasia/cardiomyopathy is characterized by ventricular arrhythmias and sudden cardiac death. Once the diagnosis is established, risk stratification to determine whether implantable cardioverter-defibrillator (ICD) placement is warranted is critical. The cohort included 312 patients (163 men, age at presentation 33.6±13.9 years) with definite arrhythmogenic right ventricular dysplasia/cardiomyopathy who received an ICD. Over 8.8±7.33 years, 186 participants (60%) had appropriate ICD therapy and 58 (19%) had an intervention for ventricular fibrillation/flutter. Ventricular tachycardia at presentation (hazard ratio [HR]: 1.86; 95% confidence interval [CI], 1.38-2.49; P <0.001), inducibility on electrophysiology study (HR: 3.14; 95% CI, 1.95-5.05; P <0.001), male sex (HR: 1.62; 95% CI, 1.20-2.19; P =0.001), inverted T waves in ≥3 precordial leads (HR: 1.66; 95% CI, 1.09-2.52; P =0.018), and premature ventricular contraction count ≥1000/24 hours (HR: 2.30; 95% CI, 1.32-4.00; P =0.003) were predictors of any appropriate ICD therapy. Inducibility at electrophysiology study (HR: 2.28; 95% CI, 1.10-4.70; P =0.025) remained as the only predictor after multivariable analysis. The predictors for ventricular fibrillation/flutter were premature ventricular contraction ≥1000/24 hours (HR: 4.39; 95% CI, 1.32-14.61; P =0.016), syncope (HR: 1.85; 95% CI, 1.10-3.11; P =0.021), aged ≤30 years at presentation (HR: 1.76; 95% CI, 1.04-3.00; P <0.036), and male sex (HR: 1.73; 95% CI, 1.01-2.97; P =0.046). Younger age at presentation (HR: 3.14; 95% CI, 1.32-7.48; P =0.010) and high premature ventricular contraction burden (HR: 4.43; 95% CI, 1.35-14.57; P <0.014) remained as independent predictors of ventricular fibrillation/flutter. Complications occurred in 66 participants (21%), and 64 (21%) had inappropriate ICD interventions. Overall mortality was low at 2%, and 4% underwent heart transplantation. These findings represent an important

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

    PubMed

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

    2010-06-01

    The Secura ICD and Consulta CRT-D are the first defibrillators to have automatic right atrial (RA), right ventricular (RV), and left ventricular (LV) capture management (CM). Complete CM was evaluated in an implantable cardioverter defibrillator (ICD) population. Two prospective clinical studies were conducted in 28 centres in Europe and Israel. Automatic CM data were compared with manual threshold measurements, the CM applicability was determined, and adjustments to pacing outputs were analysed. In total, 160 patients [age 64.6 +/- 10.4 years, 77% male, 80 ICD and 80 cardiac resynchronization therapy defibrillator (CRT-D)] were included. The differences between automatic and manual measurements were 2.5 V) due to raised RA threshold in seven (4.4%), high RV threshold in nine (5.6%), and high LV threshold in three patients (3.8%). All high threshold detections and all automatic modulations of pacing output were adjudicated appropriate. Complete CM adjusts pacing output appropriately, permitting a reduction in office visits while it may maximize device longevity. The study was registered at ClinicalTrials.gov identifiers: NCT00526227 and NCT00526162.

  9. Comparison of ICD-9-based, retrospective, and prospective assessments of perioperative complications: assessment of accuracy in reporting.

    PubMed

    Campbell, Peter G; Malone, Jennifer; Yadla, Sanjay; Chitale, Rohan; Nasser, Rani; Maltenfort, Mitchell G; Vaccaro, Alex; Ratliff, John K

    2011-01-01

    large studies of ICD-9-based complication and hospital-acquired condition (HAC) chart reviews have not been validated through a comparison with prospective assessments of perioperative adverse event occurrence. Retrospective chart review, while generally assumed to underreport complication occurrence, has not been subjected to prospective study. It is unclear whether ICD-9-based population studies are more accurate than retrospective reviews or are perhaps equally susceptible to bias. To determine the validity of an ICD-9-based assessment of perioperative complications, the authors compared a prospective independent evaluation of such complications with ICD-9-based HAC data in a cohort of patients who underwent spine surgery. For further comparison, a separate retrospective review of the same cohort of patients was completed as well. a prospective assessment of complications in spine surgery over a 6-month period (May to December 2008) was completed using an independent auditor and a validated definition of perioperative complications. The auditor maintained a prospective database, which included complications occurring in the initial 30 days after surgery. All medical adverse events were included in the assessment. All patients undergoing spine surgery during the study period were eligible for inclusion; the only exclusionary criterion used was the availability of the auditor for patient assessment. From the overall patient database, 100 patients were randomly extracted for further review; in these patients ICD-9-based HAC data were obtained from coder data. Separately, a retrospective assessment of complication incidence was completed using chart and electronic medical record review. The same definition of perioperative adverse events and the inclusion of medical adverse events were applied in the prospective, ICD-9-based, and retrospective assessments. ninety-two patients had adequate records for the ICD-9 assessment, whereas 98 patients had adequate chart

  10. Advances in radiotherapy techniques and delivery for non-small cell lung cancer: benefits of intensity-modulated radiation therapy, proton therapy, and stereotactic body radiation therapy

    PubMed Central

    Diwanji, Tejan P.; Mohindra, Pranshu; Vyfhuis, Melissa; Snider, James W.; Kalavagunta, Chaitanya; Mossahebi, Sina; Yu, Jen; Feigenberg, Steven

    2017-01-01

    The 21st century has seen several paradigm shifts in the treatment of non-small cell lung cancer (NSCLC) in early-stage inoperable disease, definitive locally advanced disease, and the postoperative setting. A key driver in improvement of local disease control has been the significant evolution of radiation therapy techniques in the last three decades, allowing for delivery of definitive radiation doses while limiting exposure of normal tissues. For patients with locally-advanced NSCLC, the advent of volumetric imaging techniques has allowed a shift from 2-dimensional approaches to 3-dimensional conformal radiation therapy (3DCRT). The next generation of 3DCRT, intensity-modulated radiation therapy and volumetric-modulated arc therapy (VMAT), have enabled even more conformal radiation delivery. Clinical evidence has shown that this can improve the quality of life for patients undergoing definitive management of lung cancer. In the early-stage setting, conventional fractionation led to poor outcomes. Evaluation of altered dose fractionation with the previously noted technology advances led to advent of stereotactic body radiation therapy (SBRT). This technique has dramatically improved local control and expanded treatment options for inoperable, early-stage patients. The recent development of proton therapy has opened new avenues for improving conformity and the therapeutic ratio. Evolution of newer proton therapy techniques, such as pencil-beam scanning (PBS), could improve tolerability and possibly allow reexamination of dose escalation. These new progresses, along with significant advances in systemic therapies, have improved survival for lung cancer patients across the spectrum of non-metastatic disease. They have also brought to light new challenges and avenues for further research and improvement. PMID:28529896

  11. Less is more? Assessing the validity of the ICD-11 model of PTSD across multiple trauma samples

    PubMed Central

    Hansen, Maj; Hyland, Philip; Armour, Cherie; Shevlin, Mark; Elklit, Ask

    2015-01-01

    Background In the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the symptom profile of posttraumatic stress disorder (PTSD) was expanded to include 20 symptoms. An alternative model of PTSD is outlined in the proposed 11th edition of the International Classification of Diseases (ICD-11) that includes just six symptoms. Objectives and method The objectives of the current study are: 1) to independently investigate the fit of the ICD-11 model of PTSD, and three DSM-5-based models of PTSD, across seven different trauma samples (N=3,746) using confirmatory factor analysis; 2) to assess the concurrent validity of the ICD-11 model of PTSD; and 3) to determine if there are significant differences in diagnostic rates between the ICD-11 guidelines and the DSM-5 criteria. Results The ICD-11 model of PTSD was found to provide excellent model fit in six of the seven trauma samples, and tests of factorial invariance showed that the model performs equally well for males and females. DSM-5 models provided poor fit of the data. Concurrent validity was established as the ICD-11 PTSD factors were all moderately to strongly correlated with scores of depression, anxiety, dissociation, and aggression. Levels of association were similar for ICD-11 and DSM-5 suggesting that explanatory power is not affected due to the limited number of items included in the ICD-11 model. Diagnostic rates were significantly lower according to ICD-11 guidelines compared to the DSM-5 criteria. Conclusions The proposed factor structure of the ICD-11 model of PTSD appears valid across multiple trauma types, possesses good concurrent validity, and is more stringent in terms of diagnosis compared to the DSM-5 criteria. PMID:26450830

  12. Less is more? Assessing the validity of the ICD-11 model of PTSD across multiple trauma samples.

    PubMed

    Hansen, Maj; Hyland, Philip; Armour, Cherie; Shevlin, Mark; Elklit, Ask

    2015-01-01

    In the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the symptom profile of posttraumatic stress disorder (PTSD) was expanded to include 20 symptoms. An alternative model of PTSD is outlined in the proposed 11th edition of the International Classification of Diseases (ICD-11) that includes just six symptoms. The objectives of the current study are: 1) to independently investigate the fit of the ICD-11 model of PTSD, and three DSM-5-based models of PTSD, across seven different trauma samples (N=3,746) using confirmatory factor analysis; 2) to assess the concurrent validity of the ICD-11 model of PTSD; and 3) to determine if there are significant differences in diagnostic rates between the ICD-11 guidelines and the DSM-5 criteria. The ICD-11 model of PTSD was found to provide excellent model fit in six of the seven trauma samples, and tests of factorial invariance showed that the model performs equally well for males and females. DSM-5 models provided poor fit of the data. Concurrent validity was established as the ICD-11 PTSD factors were all moderately to strongly correlated with scores of depression, anxiety, dissociation, and aggression. Levels of association were similar for ICD-11 and DSM-5 suggesting that explanatory power is not affected due to the limited number of items included in the ICD-11 model. Diagnostic rates were significantly lower according to ICD-11 guidelines compared to the DSM-5 criteria. The proposed factor structure of the ICD-11 model of PTSD appears valid across multiple trauma types, possesses good concurrent validity, and is more stringent in terms of diagnosis compared to the DSM-5 criteria.

  13. Pediatric complex chronic conditions classification system version 2: updated for ICD-10 and complex medical technology dependence and transplantation

    PubMed Central

    2014-01-01

    Background The pediatric complex chronic conditions (CCC) classification system, developed in 2000, requires revision to accommodate the International Classification of Disease 10th Revision (ICD-10). To update the CCC classification system, we incorporated ICD-9 diagnostic codes that had been either omitted or incorrectly specified in the original system, and then translated between ICD-9 and ICD-10 using General Equivalence Mappings (GEMs). We further reviewed all codes in the ICD-9 and ICD-10 systems to include both diagnostic and procedural codes indicative of technology dependence or organ transplantation. We applied the provisional CCC version 2 (v2) system to death certificate information and 2 databases of health utilization, reviewed the resulting CCC classifications, and corrected any misclassifications. Finally, we evaluated performance of the CCC v2 system by assessing: 1) the stability of the system between ICD-9 and ICD-10 codes using data which included both ICD-9 codes and ICD-10 codes; 2) the year-to-year stability before and after ICD-10 implementation; and 3) the proportions of patients classified as having a CCC in both the v1 and v2 systems. Results The CCC v2 classification system consists of diagnostic and procedural codes that incorporate a new neonatal CCC category as well as domains of complexity arising from technology dependence or organ transplantation. CCC v2 demonstrated close comparability between ICD-9 and ICD-10 and did not detect significant discontinuity in temporal trends of death in the United States. Compared to the original system, CCC v2 resulted in a 1.0% absolute (10% relative) increase in the number of patients identified as having a CCC in national hospitalization dataset, and a 0.4% absolute (24% relative) increase in a national emergency department dataset. Conclusions The updated CCC v2 system is comprehensive and multidimensional, and provides a necessary update to accommodate widespread implementation of ICD-10

  14. Three Diagnostic Systems for Autism: DSM-III, DSM-III-R, and ICD-10.

    ERIC Educational Resources Information Center

    Volkmar, Fred R.; And Others

    1992-01-01

    This paper compared clinicians' diagnosis and DSM-III (Diagnostic and Statistical Manual), DSM-III-R (Revised), and ICD-10 (International Classification of Diseases) diagnoses of 52 individuals with autism and 62 nonautistic, developmentally disordered individuals. The DSM-III-R system overdiagnosed the presence of autism, and ICD-10 closely…

  15. Targeted genetic and viral therapy for advanced head and neck cancers.

    PubMed

    Huang, Pin-I; Chang, Ju-Fang; Kirn, David H; Liu, Ta-Chiang

    2009-06-01

    Head and neck cancers usually present with advanced disease and novel therapies are urgently needed. Genetic therapy aims at restoring malfunctioned tumor suppressor gene(s) or introducing proapoptotic genes. Oncolytic virotherapeutics induce multiple cycles of cancer-specific virus replication, followed by oncolysis, virus spreading and infection of adjacent cancer cells. Oncolytic viruses can also be armed to express therapeutic transgene(s). Recent advances in preclinical and clinical studies are revealing the potential of both therapeutic classes for advanced head and neck cancers, including the approval of two products (Gendicine and H101) by a governmental agency. This review summarizes the available clinical data to date and discusses the challenges and future directions.

  16. Intellectual developmental disorders: towards a new name, definition and framework for “mental retardation/intellectual disability” in ICD-11

    PubMed Central

    CARULLA, LUIS SALVADOR; REED, GEOFFREY M.; VAEZ-AZIZI, LEILA M.; COOPER, SALLY-ANN; LEAL, RAFAEL MARTINEZ; BERTELLI, MARCO; ADNAMS, COLLEEN; COORAY, SHERVA; DEB, SHOUMITRO; DIRANI, LEYLA AKOURY; GIRIMAJI, SATISH CHANDRA; KATZ, GREGORIO; KWOK, HENRY; LUCKASSON, RUTH; SIMEONSSON, RUNE; WALSH, CAROLYN; MUNIR, KEMIR; SAXENA, SHEKHAR

    2011-01-01

    Although “intellectual disability” has widely replaced the term “mental retardation”, the debate as to whether this entity should be conceptualized as a health condition or as a disability has intensified as the revision of the World Health Organization (WHO)’s International Classification of Diseases (ICD) advances. Defining intellectual disability as a health condition is central to retaining it in ICD, with significant implications for health policy and access to health services. This paper presents the consensus reached to date by the WHO ICD Working Group on the Classification of Intellectual Disabilities. Literature reviews were conducted and a mixed qualitative approach was followed in a series of meetings to produce consensus-based recommendations combining prior expert knowledge and available evidence. The Working Group proposes replacing mental retardation with intellectual developmental disorders, defined as “a group of developmental conditions characterized by significant impairment of cognitive functions, which are associated with limitations of learning, adaptive behaviour and skills”. The Working Group further advises that intellectual developmental disorders be incorporated in the larger grouping (parent category) of neurodevelopmental disorders, that current subcategories based on clinical severity (i.e., mild, moderate, severe, profound) be continued, and that problem behaviours be removed from the core classification structure of intellectual developmental disorders and instead described as associated features. PMID:21991267

  17. Deriving ICD-11 personality disorder domains from dsm-5 traits: initial attempt to harmonize two diagnostic systems.

    PubMed

    Bach, B; Sellbom, M; Kongerslev, M; Simonsen, E; Krueger, R F; Mulder, R

    2017-07-01

    The personality disorder domains proposed for the ICD-11 comprise Negative Affectivity, Detachment, Dissociality, Disinhibition, and Anankastia, which are reasonably concordant with the higher-order trait domains in the Alternative DSM-5 Model for Personality Disorders. We examined (i) whether designated DSM-5 trait facets can be used to describe the proposed ICD-11 trait domains, and (ii) how these ICD-11 trait features are hierarchically organized. A mixed Danish derivation sample (N = 1541) of 615 psychiatric out-patients and 925 community participants along with a US replication sample (N = 637) completed the Personality Inventory for DSM-5 (PID-5). Sixteen PID-5 traits were designated to cover features of the ICD-11 trait domains. Exploratory structural equation modeling (ESEM) analyzes showed that the designated traits were meaningfully organized in the proposed ICD-11 five-domain structure as well as other recognizable higher-order models of personality and psychopathology. Model fits revealed that the five proposed ICD-11 personality disorder domains were satisfactorily resembled, and replicated in the independent US sample. The proposed ICD-11 personality disorder domains can be accurately described using designated traits from the DSM-5 personality trait system. A scoring algorithm for the ICD-11 personality disorder domains is provided in appendix. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Wideband Arrhythmia-Insensitive-Rapid (AIR) Pulse Sequence for Cardiac T1 mapping without Image Artifacts induced by ICD

    PubMed Central

    Hong, KyungPyo; Jeong, Eun-Kee; Wall, T. Scott; Drakos, Stavros G.; Kim, Daniel

    2015-01-01

    Purpose To develop and evaluate a wideband arrhythmia-insensitive-rapid (AIR) pulse sequence for cardiac T1 mapping without image artifacts induced by implantable-cardioverter-defibrillator (ICD). Methods We developed a wideband AIR pulse sequence by incorporating a saturation pulse with wide frequency bandwidth (8.9 kHz), in order to achieve uniform T1 weighting in the heart with ICD. We tested the performance of original and “wideband” AIR cardiac T1 mapping pulse sequences in phantom and human experiments at 1.5T. Results In 5 phantoms representing native myocardium and blood and post-contrast blood/tissue T1 values, compared with the control T1 values measured with an inversion-recovery pulse sequence without ICD, T1 values measured with original AIR with ICD were considerably lower (absolute percent error >29%), whereas T1 values measured with wideband AIR with ICD were similar (absolute percent error <5%). Similarly, in 11 human subjects, compared with the control T1 values measured with original AIR without ICD, T1 measured with original AIR with ICD was significantly lower (absolute percent error >10.1%), whereas T1 measured with wideband AIR with ICD was similar (absolute percent error <2.0%). Conclusion This study demonstrates the feasibility of a wideband pulse sequence for cardiac T1 mapping without significant image artifacts induced by ICD. PMID:25975192

  19. EDITORIAL Complexity of advanced radiation therapy necessitates multidisciplinary inquiry into dose reconstruction and risk assessment Complexity of advanced radiation therapy necessitates multidisciplinary inquiry into dose reconstruction and risk assessment

    NASA Astrophysics Data System (ADS)

    Newhauser, Wayne

    2010-07-01

    technologically most complex beam delivery approach and is used in only a few centers worldwide. Coutrakon et al (2010) reported on an investigation of dosimetric errors associated with the delivery of scanned proton beams. Titt et al (2010) report on a novel method to adjust the size of scanned proton beams. This study is important because our inability to produce very small beam spot sizes has been an obstacle to realizing the full clinical potential of this technique. Yepes et al (2010) report on the speedup and accuracy of a fast proton dose algorithm that uses an array of graphics processing units; this technique represents a nascent low-cost alternative to the traditional approach of high-performance computing using central processing units. Radiation exposures from kilovoltage computed tomography (CT) procedures have increased dramatically, with the fraction of collective effective dose from CT exposures rising from 3% in the early 1980s to 49% in 2006 (NCRP 2009). Proton CT is an emerging technology that may enable reductions in both proton range uncertainties and the imaging dose to the patient relative to comparable kilovoltage CT techniques. Erdelyi (2010) reports on uncertainties in electron densities estimated using proton CT. Finally, Cheung et al (2010) report on the suitability of advanced composite fiducial markers for localization of the prostate in proton therapy. Their analysis is particularly important because approximately 60% of the proton treatment capacity in the United States is used for patients with prostate cancer. The symposium was the fourth of a series entitled 'Symposia on Computational Cancer Research'. The symposia have alternately been hosted by The University of Texas M D Anderson Cancer Center, Rice University, and Northern Illinois University. The fifth joint symposium will be held in Houston, on 5-7 April 2011, and will focus on survivorship issues after childhood cancers (www.regonline.com/5thjointsymposium). On behalf of the symposium

  20. Cardiac gene therapy: Recent advances and future directions.

    PubMed

    Mason, Daniel; Chen, Yu-Zhe; Krishnan, Harini Venkata; Sant, Shilpa

    2015-10-10

    Gene therapy has the potential to serve as an adaptable platform technology for treating various diseases. Cardiovascular disease is a major cause of mortality in the developed world and genetic modification is steadily becoming a more plausible method to repair and regenerate heart tissue. Recently, new gene targets to treat cardiovascular disease have been identified and developed into therapies that have shown promise in animal models. Some of these therapies have advanced to clinical testing. Despite these recent successes, several barriers must be overcome for gene therapy to become a widely used treatment of cardiovascular diseases. In this review, we evaluate specific genetic targets that can be exploited to treat cardiovascular diseases, list the important delivery barriers for the gene carriers, assess the most promising methods of delivering the genetic information, and discuss the current status of clinical trials involving gene therapies targeted to the heart. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. Development of advanced therapies in Italy: Management models and sustainability in six Italian cell factories.

    PubMed

    Gaipa, Giuseppe; Introna, Martino; Golay, Josee; Nolli, Maria Luisa; Vallanti, Giuliana; Parati, Eugenio; Giordano, Rosaria; Romagnoli, Luca; Melazzini, Mario; Biondi, Andrea; Biagi, Ettore

    2016-04-01

    On November 10, 2014, the representatives of all six certified Good Manufacturing Practices (GMP) cell factories operating in the Lombardy Region of Italy convened a 1-day workshop in Milan titled "Management Models for the Development And Sustainability of Cell Factories: Public-Private Partnership?" The speakers and panelists addressed not only the many scientific, technological and cultural challenges faced by Lombardy Cell Factories, but also the potential impact of advanced therapy medicinal products (ATMPs) on public health and the role played by translational research in this process. Future perspectives for research and development (R&D) and manufacturing processes in the field of regenerative medicine were discussed as well. This report summarizes the most important issues raised by the workshop participants with particular emphasis on strengths and limitations of the R&D and manufacturing processes for innovative therapeutics in Lombardy and what can be improved in this context while maintaining GMP standards. The participants highlighted several strategies to translate patient-specific advanced therapeutics into scaled manufacturing products for clinical application. These included (i) the development of a synergistic interaction between public and private institutions, (ii) better integration with Italian regulatory agencies and (iii) the creation of a network among Lombardy cell factories and other Italian and European institutions. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  2. CROI 2016: Advances in Antiretroviral Therapy.

    PubMed

    Taylor, Barbara S; Olender, Susan A; Tieu, Hong-Van; Wilkin, Timothy J

    2016-01-01

    The 2016 Conference on Retroviruses and Opportunistic Infections highlighted exciting advances in antiretroviral therapy, including important data on investigational antiretroviral drugs and clinical trials. Clinical trials demonstrated benefits from a long-acting injectable coformulation given as maintenance therapy, examined intravenous and subcutaneous administration of a monoclonal antibody directed at the CD4 binding site of HIV-1, and provided novel data on tenofovir alafenamide. Several studies focused on the role of HIV drug resistance, including the significance of minority variants, transmitted drug resistance, use of resistance testing, and drug class-related resistance. Novel data on the HIV care continuum in low- and middle-income settings concentrated on differentiated HIV care delivery models and outcomes. Data on progress toward reaching World Health Organization 90-90-90 targets as well as outcomes related to expedited initiation of HIV treatment and adherence strategies were presented. Results from a trial in Malawi showed reduced rates of mother-to-child transmission among HIV-infected women who initiated antiretroviral therapy prior to pregnancy, and several studies highlighted the effect of antiretroviral therapy in pediatric populations. A special session was dedicated to the findings of studies of Ebola virus disease and treatment during the outbreak in West Africa.

  3. Uncommon combinations of ICD10-PCS or ICD-9-CM operative procedure codes account for most inpatient surgery at half of Texas hospitals.

    PubMed

    O'Neill, Liam; Dexter, Franklin; Park, Sae-Hwan; Epstein, Richard H

    2017-09-01

    Recently, there has been interest in activity-based cost accounting for inpatient surgical procedures to facilitate "value based" analyses. Research 10-20years ago, performed using data from 3 large teaching hospitals, found that activity-based cost accounting was practical and useful for modeling surgeons and subspecialties, but inaccurate for individual procedures. We hypothesized that these older results would apply to hundreds of hospitals, currently evaluable using administrative databases. Observational study. State of Texas hospital discharge abstract data for 1st quarter of 2016, 4th quarter of 2015, 1st quarter of 2015, and 4th quarter of 2014. Discharged from an acute care hospital in Texas with at least 1 major therapeutic ("operative") procedure. Counts of discharges for each procedure or combination of procedures, classified by ICD-10-PCS or ICD-9-CM. At the average hospital, most surgical discharges were for procedures performed at most once a month at the hospital (54%, 95% confidence interval [CI] 51% to 55%). At the average hospital, approximately 90% of procedures were performed at most once a month at the hospital (93%, CI 93% to 94%). The percentages were insensitive to the quarter of the year. The percentages were 3% to 6% greater with ICD-10-PCS than for the superseded ICD 9 CM. There are many different procedure codes, and many different combinations of codes, relative to the number of different hospital discharges. Since most procedures at most hospitals are performed no more than once a month, activity-based cost accounting with a sample size sufficient to be useful is impractical for the vast majority of procedures, in contrast to analysis by surgeon and/or subspecialty. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. Vitamin D as Supplemental Therapy for Pneumocystis Pneumonia.

    PubMed

    Lei, Guang-Sheng; Zhang, Chen; Zimmerman, Michelle K; Lee, Chao-Hung

    2015-12-14

    The combination of all-trans retinoic acid (ATRA) and primaquine (PMQ) has been shown to be effective for therapy of Pneumocystis pneumonia (PCP). Since a high concentration of ATRA has significant adverse effects, the possibility that vitamin D can be used to replace ATRA for PCP therapy was investigated. C57BL/6 mice were immunosuppressed by depleting CD4(+) cells and infected with Pneumocystis murina 1 week after initiation of immunosuppression. Three weeks after infection, the mice were treated orally for 3 weeks with vitamin D3 (VitD3) alone, PMQ alone, a combination of VitD3 and PMQ (VitD3-PMQ), or a combination of trimethoprim and sulfamethoxazole (TMP-SMX). Results showed that VitD3 (300 IU/kg/day) had a synergistic effect with PMQ (5 mg/kg/day) for therapy of PCP. Flow cytometric studies showed that this VitD3-PMQ combination recovered the CD11b(low) CD11c(high) alveolar macrophage population in mice with PCP as effectively as TMP-SMX. The VitD3-PMQ combination also reduced the massive infiltration of inflammatory cells into the lungs and the severity of lung damage. VitD3 was also shown to reduce the dose of TMP-SMX required for effective treatment of PCP. Taken together, results of this study suggest that a VitD3-PMQ combination can be used as an alternative therapy for PCP. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  5. The discriminatory cost of ICD-10-CM transition between clinical specialties: metrics, case study, and mitigating tools

    PubMed Central

    Boyd, Andrew D; Li, Jianrong ‘John’; Burton, Mike D; Jonen, Michael; Gardeux, Vincent; Achour, Ikbel; Luo, Roger Q; Zenku, Ilir; Bahroos, Neil; Brown, Stephen B; Vanden Hoek, Terry; Lussier, Yves A

    2013-01-01

    Objective Applying the science of networks to quantify the discriminatory impact of the ICD-9-CM to ICD-10-CM transition between clinical specialties. Materials and Methods Datasets were the Center for Medicaid and Medicare Services ICD-9-CM to ICD-10-CM mapping files, general equivalence mappings, and statewide Medicaid emergency department billing. Diagnoses were represented as nodes and their mappings as directional relationships. The complex network was synthesized as an aggregate of simpler motifs and tabulation per clinical specialty. Results We identified five mapping motif categories: identity, class-to-subclass, subclass-to-class, convoluted, and no mapping. Convoluted mappings indicate that multiple ICD-9-CM and ICD-10-CM codes share complex, entangled, and non-reciprocal mappings. The proportions of convoluted diagnoses mappings (36% overall) range from 5% (hematology) to 60% (obstetrics and injuries). In a case study of 24 008 patient visits in 217 emergency departments, 27% of the costs are associated with convoluted diagnoses, with ‘abdominal pain’ and ‘gastroenteritis’ accounting for approximately 3.5%. Discussion Previous qualitative studies report that administrators and clinicians are likely to be challenged in understanding and managing their practice because of the ICD-10-CM transition. We substantiate the complexity of this transition with a thorough quantitative summary per clinical specialty, a case study, and the tools to apply this methodology easily to any clinical practice in the form of a web portal and analytic tables. Conclusions Post-transition, successful management of frequent diseases with convoluted mapping network patterns is critical. The http://lussierlab.org/transition-to-ICD10CM web portal provides insight in linking onerous diseases to the ICD-10 transition. PMID:23645552

  6. Accuracy of the new ICD-9-CM code for "drip-and-ship" thrombolytic treatment in patients with ischemic stroke.

    PubMed

    Tonarelli, Silvina B; Tibbs, Michael; Vazquez, Gabriela; Lakshminarayan, Kamakshi; Rodriguez, Gustavo J; Qureshi, Adnan I

    2012-02-01

    A new International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis code, V45.88, was approved by the Centers for Medicare and Medicaid Services (CMS) on October 1, 2008. This code identifies patients in whom intravenous (IV) recombinant tissue plasminogen activator (rt-PA) is initiated in one hospital's emergency department, followed by transfer within 24 hours to a comprehensive stroke center, a paradigm commonly referred to as "drip-and-ship." This study assessed the use and accuracy of the new V45.88 code for identifying ischemic stroke patients who meet the criteria for drip-and-ship at 2 advanced certified primary stroke centers. Consecutive patients over a 12-month period were identified by primary ICD-9-CM diagnosis codes related to ischemic stroke. The accuracy of V45.88 code utilization using administrative data provided by Health Information Management Services was assessed through a comparison with data collected in prospective stroke registries maintained at each hospital by a trained abstractor. Out of a total of 428 patients discharged from both hospitals with a diagnosis of ischemic stroke, 37 patients were given ICD-9-CM code V45.88. The internally validated data from the prospective stroke database demonstrated that a total of 40 patients met the criteria for drip-and-ship. A concurrent comparison found that 92% (sensitivity) of the patients treated with drip-and-ship were coded with V45.88. None of the non-drip-and-ship stroke cases received the V45.88 code (100% specificity). The new ICD-9-CM code for drip-and-ship appears to have high specificity and sensitivity, allowing effective data collection by the CMS. Copyright © 2012 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  7. A natural language based search engine for ICD10 diagnosis encoding.

    PubMed

    Baud, Robert

    2004-01-01

    We have developed a multiple step process for implementing an ICD10 search engine. The complexity of the task has been shown and we recommend collecting adequate expertise before starting any implementation. Underestimation of the expert time and inadequate data resources are probable reasons for failure. We also claim that when all conditions are met in term of resource and availability of the expertise, the benefits of a responsive ICD10 search engine will be present and the investment will be successful.

  8. Underestimated prevalence of heart failure in hospital inpatients: a comparison of ICD codes and discharge letter information.

    PubMed

    Kaspar, Mathias; Fette, Georg; Güder, Gülmisal; Seidlmayer, Lea; Ertl, Maximilian; Dietrich, Georg; Greger, Helmut; Puppe, Frank; Störk, Stefan

    2018-04-17

    Heart failure is the predominant cause of hospitalization and amongst the leading causes of death in Germany. However, accurate estimates of prevalence and incidence are lacking. Reported figures originating from different information sources are compromised by factors like economic reasons or documentation quality. We implemented a clinical data warehouse that integrates various information sources (structured parameters, plain text, data extracted by natural language processing) and enables reliable approximations to the real number of heart failure patients. Performance of ICD-based diagnosis in detecting heart failure was compared across the years 2000-2015 with (a) advanced definitions based on algorithms that integrate various sources of the hospital information system, and (b) a physician-based reference standard. Applying these methods for detecting heart failure in inpatients revealed that relying on ICD codes resulted in a marked underestimation of the true prevalence of heart failure, ranging from 44% in the validation dataset to 55% (single year) and 31% (all years) in the overall analysis. Percentages changed over the years, indicating secular changes in coding practice and efficiency. Performance was markedly improved using search and permutation algorithms from the initial expert-specified query (F1 score of 81%) to the computer-optimized query (F1 score of 86%) or, alternatively, optimizing precision or sensitivity depending on the search objective. Estimating prevalence of heart failure using ICD codes as the sole data source yielded unreliable results. Diagnostic accuracy was markedly improved using dedicated search algorithms. Our approach may be transferred to other hospital information systems.

  9. Validating the Use of ICD-9 Code Mapping to Generate Injury Severity Scores

    PubMed Central

    Fleischman, Ross J.; Mann, N. Clay; Dai, Mengtao; Holmes, James F.; Wang, N. Ewen; Haukoos, Jason; Hsia, Renee Y.; Rea, Thomas; Newgard, Craig D.

    2017-01-01

    The Injury Severity Score (ISS) is a measure of injury severity widely used for research and quality assurance in trauma. Calculation of ISS requires chart abstraction, so it is often unavailable for patients cared for in nontrauma centers. Whether ISS can be accurately calculated from International Classification of Diseases, Ninth Revision (ICD-9) codes remains unclear. Our objective was to compare ISS derived from ICD-9 codes with those coded by trauma registrars. This was a retrospective study of patients entered into 9 U.S. trauma registries from January 2006 through December 2008. Two computer programs, ICDPIC and ICDMAP, were used to derive ISS from the ICD-9 codes in the registries. We compared derived ISS with ISS hand-coded by trained coders. There were 24,804 cases with a mortality rate of 3.9%. The median ISS derived by both ICDPIC (ISS-ICDPIC) and ICDMAP (ISS-ICDMAP) was 8 (interquartile range [IQR] = 4–13). The median ISS in the registry (ISS-registry) was 9 (IQR = 4–14). The median difference between either of the derived scores and ISS-registry was zero. However, the mean ISS derived by ICD-9 code mapping was lower than the hand-coded ISS in the registries (1.7 lower for ICDPIC, 95% CI [1.7, 1.8], Bland–Altman limits of agreement = −10.5 to 13.9; 1.8 lower for ICDMAP, 95% CI [1.7, 1.9], limits of agreement = −9.6 to 13.3). ICD-9-derived ISS slightly underestimated ISS compared with hand-coded scores. The 2 methods showed moderate to substantial agreement. Although hand-coded scores should be used when possible, ICD-9-derived scores may be useful in quality assurance and research when hand-coded scores are unavailable. PMID:28033134

  10. Obsessive compulsive and related disorders: comparing DSM-5 and ICD-11.

    PubMed

    Marras, Anna; Fineberg, Naomi; Pallanti, Stefano

    2016-08-01

    Obsessive-compulsive disorder (OCD) has been recognized as mainly characterized by compulsivity rather than anxiety and, therefore, was removed from the anxiety disorders chapter and given its own in both the American Psychiatric Association (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and the Beta Draft Version of the 11th revision of the World Health Organization (WHO) International Classification of Diseases (ICD-11). This revised clustering is based on increasing evidence of common affected neurocircuits between disorders, differently from previous classification systems based on interrater agreement. In this article, we focus on the classification of obsessive-compulsive and related disorders (OCRDs), examining the differences in approach adopted by these 2 nosological systems, with particular attention to the proposed changes in the forthcoming ICD-11. At this stage, notable differences in the ICD classification are emerging from the previous revision, apparently converging toward a reformulation of OCRDs that is closer to the DSM-5.

  11. Nitric Oxide Donor-Based Cancer Therapy: Advances and Prospects.

    PubMed

    Huang, Zhangjian; Fu, Junjie; Zhang, Yihua

    2017-09-28

    The increasing understanding of the role of nitric oxide (NO) in cancer biology has generated significant progress in the use of NO donor-based therapy to fight cancer. These advances strongly suggest the potential adoption of NO donor-based therapy in clinical practice, and this has been supported by several clinical studies in the past decade. In this review, we first highlight several types of important NO donors, including recently developed NO donors bearing a dinitroazetidine skeleton, represented by RRx-001, with potential utility in cancer therapy. Special emphasis is then given to the combination of NO donor(s) with other therapies to achieve synergy and to the hybridization of NO donor(s) with an anticancer drug/agent/fragment to enhance the activity or specificity or to reduce toxicity. In addition, we briefly describe inducible NO synthase gene therapy and nanotechnology, which have recently entered the field of NO donor therapy.

  12. How well do the DSM-5 alcohol use disorder designations map to the ICD-10 disorders?

    PubMed

    Hoffmann, Norman G; Kopak, Albert M

    2015-04-01

    The Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and the International Statistical Classification of Diseases and Related Health Problems, 10th edition (ICD-10), both establish diagnostic criteria for alcohol use disorders. The dimensional severity perspective provided by the DSM-5 may overlap in important ways but also may diverge from the categorical harmful use versus dependence designations presented by the ICD-10. It is especially important to consider the convergence of these 2 diagnostic approaches as the DSM is widely used by clinicians, but the U.S. Centers for Medicare and Medicaid Services has recently required that providers bill for services using the ICD-10 designations. Data from 6,871 male and 801 female admissions to a state prison system were used to compare the DSM-5 severity index for alcohol use disorder to the ICD-10 clinical and research formulations for harmful use and dependence. The DSM-5 and the ICD-10 were highly convergent for the most severe alcohol use disorders and also for those who did not receive a diagnosis. Most DSM-5 moderate alcohol use disorder cases were classified as dependence cases under both the clinical and research ICD criteria. In contrast, there was much more variation in the DSM mild cases. These were divided into categories of harmful use or misuse, depending on whether the clinical or research ICD criteria were applied. Results were similar among male and female inmates. The DSM-5 and ICD-10 exhibit a high level of agreement for cases that would not receive a diagnosis as well as the most severe cases. However, there are important distinctions to be made between the 2 approaches for mild and moderate DSM disorders in addition to harmful use/misuse cases in the ICD. The cases influenced by these discrepancies are most likely to be affected by recently implemented service provider billing practices. Copyright © 2015 by the Research Society on Alcoholism.

  13. Effectiveness of prophylactic implantation of cardioverter-defibrillators without cardiac resynchronization therapy in patients with ischaemic or non-ischaemic heart disease: a systematic review and meta-analysis

    PubMed Central

    Theuns, Dominic A.M.J.; Smith, Tim; Hunink, Myriam G.M.; Bardy, Gust H.; Jordaens, Luc

    2010-01-01

    Aims Much controversy exists concerning the efficacy of primary prophylactic implantable cardioverter-defibrillators (ICDs) in patients with low ejection fraction due to coronary artery disease (CAD) or dilated cardiomyopathy (DCM). This is also related to the bias created by function improving interventions added to ICD therapy, e.g. resynchronization therapy. The aim was to investigate the efficacy of ICD-only therapy in primary prevention in patients with CAD or DCM. Methods and results Public domain databases, MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials, were searched from 1980 to 2009 for randomized clinical trials of ICD vs. conventional therapy. Two investigators independently abstracted the data. Pooled estimates were calculated using both fixed-effects and random-effects models. Eight trials were included in the final analysis (5343 patients). Implantable cardioverter-defibrillators significantly reduced the arrhythmic mortality [relative risk (RR): 0.40; 95% confidence interval (CI): 0.27–0.67] and all-cause mortality (RR: 0.73; 95% CI: 0.64–0.82). Regardless of aetiology of heart disease, ICD benefit was similar for CAD (RR: 0.67; 95% CI: 0.51–0.88) vs. DCM (RR: 0.74; 95% CI: 0.59–0.93). Conclusions The results of this meta-analysis provide strong evidence for the beneficial effect of ICD-only therapy on the survival of patients with ischaemic or non-ischaemic heart disease, with a left ventricular ejection fraction ≤35%, if they are 40 days from myocardial infarction and ≥3 months from a coronary revascularization procedure. PMID:20974768

  14. CADDIS Volume 5. Causal Databases: Interactive Conceptual Diagrams (ICDs)

    EPA Pesticide Factsheets

    In Interactive Conceptual Diagram (ICD) section of CADDIS allows users to create conceptual model diagrams, search a literature-based evidence database, and then attach that evidence to their diagrams.

  15. Subcutaneous ICD screening with the Boston Scientific ZOOM programmer versus a 12-lead ECG machine.

    PubMed

    Chang, Shu C; Patton, Kristen K; Robinson, Melissa R; Poole, Jeanne E; Prutkin, Jordan M

    2018-02-24

    The subcutaneous implantable cardioverter-defibrillator (S-ICD) requires preimplant screening to ensure appropriate sensing and reduce risk of inappropriate shocks. Screening can be performed using either an ICD programmer or a 12-lead electrocardiogram (ECG) machine. It is unclear whether differences in signal filtering and digital sampling change the screening success rate. Subjects were recruited if they had a transvenous single-lead ICD without pacing requirements or were candidates for a new ICD. Screening was performed using both a Boston Scientific ZOOM programmer (Marlborough, MA, USA) and General Electric MAC 5000 ECG machine (Fairfield, CT, USA). A pass was defined as having at least one lead that fit within the screening template in both supine and sitting positions. A total of 69 subjects were included and 27 sets of ECG leads had differing screening results between the two machines (7%). Of these sets, 22 (81%) passed using the ECG machine but failed using the programmer and five (19%) passed using the ECG machine but failed using the programmer (P < 0.001). Four subjects (6%) passed screening using the ECG machine but failed using the programmer. No subject passed screening with the programmer but failed with the ECG machine. There can be occasional disagreement in S-ICD patient screening between an ICD programmer and ECG machine, all of whom passed with the ECG machine but failed using the programmer. On a per lead basis, the ECG machine passes more subjects. It is unknown what the inappropriate shock rate would be if an S-ICD was implanted. Clinical judgment should be used in borderline cases. © 2018 Wiley Periodicals, Inc.

  16. Combination Therapy Shows Promise for Treating Advanced Breast Cancer

    Cancer.gov

    Adding the drug everolimus (Afinitor®) to exemestane helped postmenopausal women whose advanced breast cancer had stopped responding to hormonal therapy live about 4 months longer without the disease progressing than women who received exemestane alone.

  17. Gemcitabine and capecitabine as third- or later-line therapy for refractory advanced colorectal cancer: a retrospective study.

    PubMed

    Salgado, Mercedes; Reboredo, Margarita; Mendez, Juan Carlos; Quintero, Guillermo; Pellón, María Luz; Romero, Carlos; Jorge, Mónica; Montes, Ana Fernández; Valladares-Ayerbes, Manuel; Ramos, Manuel; Varela, Silvia; Alonso, Miguel Ángel

    2013-09-01

    To evaluate gemcitabine plus capecitabine as third-line or later-line therapy in patients with refractory advanced colorectal cancer (CRC) who maintain a good performance status (PS). We retrospectively evaluated patients who had failed at least two lines of therapy or had contraindication to standard therapy and received gemcitabine (1,000 mg/m(2), d1 biweekly) plus capecitabine (1,700 mg/m(2)/day, d1-7 every two weeks) in a compassionate use program. Thirty-nine patients were enrolled. The majority (85%) had ECOG PS 1. Gemcitabine plus capecitabine was administered as third- and fourth-line in 49% and 23% of patients, respectively; and as fifth-line or later-line in 28%. A clinical benefit of 21% was found. The median progression-free survival and overall survival were 3.0 and 7.3 months, respectively. Toxicity was mild to moderate, with no reported grade 4 toxicities. Gemcitabine plus capecitabine was safe and well-tolerated. While the efficacy of this regimen was modest in terms of response, the survival data were acceptable and consistent with previous publications on this setting.

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

    PubMed

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

    2016-01-01

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

  19. 42 CFR Appendix A to Part 81 - Glossary of ICD-9 Codes and Their Cancer Descriptions 1

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Glossary of ICD-9 Codes and Their Cancer.... 81, App. A Appendix A to Part 81—Glossary of ICD-9 Codes and Their Cancer Descriptions 1 ICD-9 code Cancer description 140 Malignant neoplasm of lip. 141 Malignant neoplasm of tongue. 142 Malignant...

  20. Advanced heart failure due to cancer therapy.

    PubMed

    Shah, Sachin; Nohria, Anju

    2015-01-01

    Certain chemotherapeutic agents and mediastinal irradiation can be cardiotoxic and place cancer survivors at risk for developing advanced heart failure (HF). Anthracyclines are the prototypical agents associated with left ventricular (LV) dysfunction. Newer agents including trastuzumab and certain tyrosine kinase inhibitors such as sunitinib can also cause cardiomyopathy. Cancer survivors with advanced HF refractory to standard medical management should be considered for advanced therapies, including mechanical circulatory support (MCS) and transplantation. While overall outcomes after MCS and transplantation are similar in cancer survivors compared to other etiologies of HF, patients with radiation-induced restrictive cardiomyopathy have a significantly worse prognosis after transplantation. The increased need for right ventricular (RV) support after MCS in cancer survivors necessitates a careful evaluation for pre-operative RV dysfunction. Special consideration must also be given to the risk for recurrent malignancy, neurocognitive dysfunction, and increased psychological needs in this patient population.

  1. Wearable cardioverter defibrillator: a life vest till the life boat (ICD) arrives.

    PubMed

    Francis, Johnson; Reek, Sven

    2014-01-01

    It is well established that implantable cardioverter defibrillator (ICD) is a life saving device ensuring protection against life threatening ventricular arrhythmias. But there are certain situations like a recent myocardial infarction where the standard guidelines do not recommend the implantation of an ICD while the patient can still be at a risk of demise due to a life threatening ventricular arrhythmia. There could also be a temporary indication for protection while explanting an infected ICD system. The wearable cardioverter defibrillator (WCD) is a device which comes to the rescue in such situations. In this brief review, we discuss the historical aspects of the development of a WCD, technical aspects as well as the clinical trial data and real world scenario of its use. Copyright © 2013 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  2. The Utility and Challenges of Using ICD Codes in Child Maltreatment Research: A Review of Existing Literature

    ERIC Educational Resources Information Center

    Scott, Debbie; Tonmyr, Lil; Fraser, Jenny; Walker, Sue; McKenzie, Kirsten

    2009-01-01

    Objective: The objectives of this article are to explore the extent to which the International Statistical Classification of Diseases and Related Health Problems (ICD) has been used in child abuse research, to describe how the ICD system has been applied, and to assess factors affecting the reliability of ICD coded data in child abuse research.…

  3. Recent advances in 3D printing of biomaterials.

    PubMed

    Chia, Helena N; Wu, Benjamin M

    2015-01-01

    3D Printing promises to produce complex biomedical devices according to computer design using patient-specific anatomical data. Since its initial use as pre-surgical visualization models and tooling molds, 3D Printing has slowly evolved to create one-of-a-kind devices, implants, scaffolds for tissue engineering, diagnostic platforms, and drug delivery systems. Fueled by the recent explosion in public interest and access to affordable printers, there is renewed interest to combine stem cells with custom 3D scaffolds for personalized regenerative medicine. Before 3D Printing can be used routinely for the regeneration of complex tissues (e.g. bone, cartilage, muscles, vessels, nerves in the craniomaxillofacial complex), and complex organs with intricate 3D microarchitecture (e.g. liver, lymphoid organs), several technological limitations must be addressed. In this review, the major materials and technology advances within the last five years for each of the common 3D Printing technologies (Three Dimensional Printing, Fused Deposition Modeling, Selective Laser Sintering, Stereolithography, and 3D Plotting/Direct-Write/Bioprinting) are described. Examples are highlighted to illustrate progress of each technology in tissue engineering, and key limitations are identified to motivate future research and advance this fascinating field of advanced manufacturing.

  4. Electrical Storm: Incidence, Prognosis and Therapy.

    PubMed

    Sagone, Antonio

    2015-12-01

    The term "electrical storm" indicates a life-threatening clinical condition characterized by the recurrence of hemodynamically unstable ventricular tachycardia and/or ventricular fibrillation, in particular in patients with ICD implanted for primary or secondary prevention. Although there isn't a shared definition of electrical storm, nowadays the most accepted definition refers to three or more separate arrhythmia episodes leading to ICD therapies including antitachycardia pacing or shock occurring over a single 24 hours' time period. Clinical presentation can be dramatic and triggering mechanism are not clear at all yet, but electrical storm is associated with high mortality rates and low patients quality of life, both in the acute phase and in the long term. The first line therapy is based on antiarrhythmic drugs to suppress electrical storm, but in refractory patients, interventions such as catheter ablation or in some cases surgical cardiac sympathetic denervation might be helpful. Anyhow, earlier interventional management can lead to better outcomes than persisting with antiarrhythmic pharmacologic therapy and, when available, an early interventional approach should be preferred.

  5. Application and comparison of the FADES, MADIT, and SHFM-D risk models for risk stratification of prophylactic implantable cardioverter-defibrillator treatment

    PubMed Central

    van der Heijden, Aafke C.; van Rees, Johannes B.; Levy, Wayne C.; van der Bom, Johanna G.; Cannegieter, Suzanne C.; de Bie, Mihàly K.; van Erven, Lieselot; Schalij, Martin J.; Borleffs, C. Jan  Willem

    2017-01-01

    Aims Implantable cardioverter-defibrillator (ICD) treatment is beneficial in selected patients. However, it remains difficult to accurately predict which patients benefit most from ICD implantation. For this purpose, different risk models have been developed. The aim was to validate and compare the FADES, MADIT, and SHFM-D models. Methods and results All patients receiving a prophylactic ICD at the Leiden University Medical Center were evaluated. Individual model performance was evaluated by C-statistics. Model performances were compared using net reclassification improvement (NRI) and integrated differentiation improvement (IDI). The primary endpoint was non-benefit of ICD treatment, defined as mortality without prior ventricular arrhythmias requiring ICD intervention. A total of 1969 patients were included (age 63 ± 11 years; 79% male). During a median follow-up of 4.5 ± 3.9 years, 318 (16%) patients died without prior ICD intervention. All three risk models were predictive for event-free mortality (all: P < 0.001). The C-statistics were 0.66, 0.69, and 0.75, respectively, for FADES, MADIT, and SHFM-D (all: P < 0.001). Application of the SHFM-D resulted in an improved IDI of 4% and NRI of 26% compared with MADIT; IDI improved 11% with the use of SHFM-D instead of FADES (all: P < 0.001), but NRI remained unchanged (P = 0.71). Patients in the highest-risk category of the MADIT and SHFM-D models had 1.7 times higher risk to experience ICD non-benefit than receive appropriate ICD interventions [MADIT: mean difference (MD) 20% (95% CI: 7–33%), P = 0.001; SHFM-D: MD 16% (95% CI: 5–27%), P = 0.005]. Patients in the highest-risk category of FADES were as likely to experience ICD intervention as ICD non-benefit [MD 3% (95% CI: –8 to 14%), P = 0.60]. Conclusion The predictive and discriminatory value of SHFM-D to predict non-benefit of ICD treatment is superior to FADES and MADIT in patients receiving prophylactic ICD treatment. PMID:28130376

  6. A review of current evidence regarding the ICD-11 proposals for diagnosing PTSD and complex PTSD.

    PubMed

    Brewin, Chris R; Cloitre, Marylène; Hyland, Philip; Shevlin, Mark; Maercker, Andreas; Bryant, Richard A; Humayun, Asma; Jones, Lynne M; Kagee, Ashraf; Rousseau, Cécile; Somasundaram, Daya; Suzuki, Yuriko; Wessely, Simon; van Ommeren, Mark; Reed, Geoffrey M

    2017-12-01

    The World Health Organization's proposals for posttraumatic stress disorder (PTSD) in the 11th edition of the International Classification of Diseases, scheduled for release in 2018, involve a very brief set of symptoms and a distinction between two sibling disorders, PTSD and Complex PTSD. This review of studies conducted to test the validity and implications of the diagnostic proposals generally supports the proposed 3-factor structure of PTSD symptoms, the 6-factor structure of Complex PTSD symptoms, and the distinction between PTSD and Complex PTSD. Estimates derived from DSM-based items suggest the likely prevalence of ICD-11 PTSD in adults is lower than ICD-10 PTSD and lower than DSM-IV or DSM-5 PTSD, but this may change with the development of items that directly measure the ICD-11 re-experiencing requirement. Preliminary evidence suggests the prevalence of ICD-11 PTSD in community samples of children and adolescents is similar to DSM-IV and DSM-5. ICD-11 PTSD detects some individuals with significant impairment who would not receive a diagnosis under DSM-IV or DSM-5. ICD-11 CPTSD identifies a distinct group who have more often experienced multiple and sustained traumas and have greater functional impairment than those with PTSD. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Tunnel Propagation Following Defibrillation with ICD Shocks: Hidden Postshock Activations in the Left Ventricular Wall Underlie Isoelectric Window

    PubMed Central

    Constantino, Jason; Long, Yun; Ashihara, Takashi; Trayanova, Natalia A.

    2010-01-01

    Background Following near-defibrillation threshold (DFT) shocks from an ICD, the first postshock activation that leads to defibrillation failure arises focally after an isolelectric window (IW). The mechanisms underlying the IW remain incompletely understood. Objective The goal of this study was to provide mechanistic insight into the origins of postshock activations and IW following ICD shocks, and to link shock outcome to the preshock state of the ventricles. We hypothesized that the non-uniform ICD field results in the formation of an intramural excitable area (tunnel) only in the LV free wall, through which both pre-existing and new shock-induced wavefronts propagate during the IW. Methods Simulations were conducted using a realistic 3-D model of defibrillation in the rabbit ventricles. Biphasic ICD shocks of varying strengths were delivered to 27 different fibrillatory states. Results Following near-DFT shocks, regardless of preshock state, the main postshock excitable area was always located within LV free wall, creating an intramural tunnel. Either preexisting fibrillatory or shock-induced wavefronts propagated during the IW (duration of up to 74ms) in this tunnel and emerged as breakthroughs on LV epicardium. Preshock activity within the LV played a significant role in shock outcome: large number of preshock filaments resulted in an IW associated with tunnel propagation of preexisting rather than shock-induced wavefronts. Furthermore, shocks were more likely to succeed if LV excitable area was smaller. Conclusions The LV intramural excitable area is the primary reason for near-DFT failure. Any intervention that decreases the extent of this area will improve the likelihood of defibrillation success. PMID:20348028

  8. Dominant Suppression of β1 Integrin by Ectopic CD98-ICD Inhibits Hepatocellular Carcinoma Progression

    PubMed Central

    Wu, Bo; Zhou, Yang; Wang, Yu; Yang, Xiang-Min; Liu, Zhen-Yu; Li, Jiang-Hua; Feng, Fei; Chen, Zhi-Nan; Jiang, Jian-Li

    2016-01-01

    Hepatocellular carcinoma (HCC) is currently the third most common cause of cancer-related death in the Asia-Pacific region. Our previous work showed that knockdown of CD98 significantly inhibits malignant HCC cell phenotypes in vitro and in vivo. The level of CD98 in the membrane is tightly regulated to mediate complex processes associated with cell–cell communication and intracellular signaling. In addition, the intracellular domain of CD98 (CD98-ICD) seems to be of vital importance for recycling CD98 to the membrane after it is endocytosed. The intracellular and transmembrane domains of CD98 associate with β-integrins (primarily β1 but also β3), and this association is essential for CD98 mediation of integrin-like signaling and complements dominant suppression of β1-integrin. We speculated that isolated CD98-ICD would similarly suppress β1-integrin activation and inhibit the malignant behaviors of cancer cells. In particular, the exact role of CD98-ICD has not been studied independently in HCC. In this study, we found that ectopic expression of CD98-ICD inhibited the malignant phenotypes of HCC cells, and the mechanism possibly involves β1-integrin suppression. Moreover, the expression levels of CD98, β1-integrin-A (the activated form of β1-integrin) and Ki-67 were significantly increased in HCC tissues relative to those of normal liver tissues. Therefore, our preliminary study indicates that ectopic CD98-ICD has an inhibitory role in the malignant development of HCC, and shows that CD98-ICD acts as a dominant negative mutant of CD98 that attenuates β1-integrin activation. CD98-ICD may emerge as a promising candidate for antitumor treatment. PMID:27834933

  9. Strategic Mobility 21 Initial Capabilities Document (ICD)

    DTIC Science & Technology

    2006-07-28

    MANDATORY ARCHITECTURE FRAMWORK DOCUMENT .......................................A-1 APPENDIX B: REFERENCES...Document July 27, 2006 JPPSP ICD Version 1.0 A-1 APPENDIX A: MANDATORY ARCHITECTURE FRAMWORK DOCUMENT Legend next page. Initial Capabilities...SM21 will combine several end-to-end Force Projection Process enablers. Some of the enablers described below are at the conceptual stage while others

  10. Scar Characterization to Predict Life-Threatening Arrhythmic Events and Sudden Cardiac Death in Patients With Cardiac Resynchronization Therapy: The GAUDI-CRT Study.

    PubMed

    Acosta, Juan; Fernández-Armenta, Juan; Borràs, Roger; Anguera, Ignasi; Bisbal, Felipe; Martí-Almor, Julio; Tolosana, Jose M; Penela, Diego; Andreu, David; Soto-Iglesias, David; Evertz, Reinder; Matiello, María; Alonso, Concepción; Villuendas, Roger; de Caralt, Teresa M; Perea, Rosario J; Ortiz, Jose T; Bosch, Xavier; Serra, Luis; Planes, Xavier; Greiser, Andreas; Ekinci, Okan; Lasalvia, Luis; Mont, Lluis; Berruezo, Antonio

    2018-04-01

    The aim of this study was to analyze whether scar characterization could improve the risk stratification for life-threatening ventricular arrhythmias and sudden cardiac death (SCD). Among patients with a cardiac resynchronization therapy (CRT) indication, appropriate defibrillator (CRT-D) therapy rates are low. Primary prevention patients with a class I indication for CRT were prospectively enrolled and assigned to CRT-D or CRT pacemaker according to physician's criteria. Pre-procedure contrast-enhanced cardiac magnetic resonance was obtained and analyzed to identify scar presence or absence, quantify the amount of core and border zone (BZ), and depict BZ distribution. The presence, mass, and characteristics of BZ channels in the scar were recorded. The primary endpoint was appropriate defibrillator therapy or SCD. 217 patients (39.6% ischemic) were included. During a median follow-up of 35.5 months (12 to 62 months), the primary endpoint occurred in 25 patients (11.5%) and did not occur in patients without myocardial scar. Among patients with scar (n = 125, 57.6%), those with implantable cardioverter-defibrillator (ICD) therapies or SCD exhibited greater scar mass (38.7 ± 34.2 g vs. 17.9 ± 17.2 g; p < 0.001), scar heterogeneity (BZ mass/scar mass ratio) (49.5 ± 13.0 vs. 40.1 ± 21.7; p = 0.044), and BZ channel mass (3.6 ± 3.0 g vs. 1.8 ± 3.4 g; p = 0.018). BZ mass (hazard ratio: 1.06 [95% confidence interval: 1.04 to 1.08]; p < 0.001) and BZ channel mass (hazard ratio: 1.21 [95% confidence interval: 1.10 to 1.32]; p < 0.001) were the strongest predictors of the primary endpoint. An algorithm based on scar mass and the absence of BZ channels identified 148 patients (68.2%) without ICD therapy/SCD during follow-up with a 100% negative predictive value. The presence, extension, heterogeneity, and qualitative distribution of BZ tissue of myocardial scar independently predict appropriate ICD therapies and SCD in CRT patients. Copyright © 2018 American

  11. Gender Disparities Across the Spectrum of Advanced Cardiac Therapies: Real or Imagined?

    PubMed

    Bogaev, Roberta C

    2016-11-01

    Cardiovascular disease has been responsible for more deaths in women than in men each year since 1985. This review discusses federal laws that have influenced the inclusion of women in research and reporting sex-specific differences, then addresses gender differences and gender disparities in four areas of clinical cardiovascular medicine: coronary heart disease, valvular heart disease, electrophysiology, and heart failure. The prevalence of disease in women is highlighted, the clinical characteristics of women at the time of referral for advanced therapies are reviewed, and the clinical outcomes of women are discussed. With the emergence of new technology such as smaller devices and less invasive procedures, more women are being referred for advanced therapies. However, a gap in awareness and diagnosis remains, contributing to later referrals for women. Women who do undergo advanced therapies often have more comorbidities and worse outcomes than men. A call is made to increase awareness, educate healthcare providers, and report more sex-specific data to resolve these gender disparities.

  12. Myasthenia gravis: recent advances in immunopathology and therapy.

    PubMed

    Lee, John-Ih; Jander, Sebastian

    2017-03-01

    Myasthenia gravis is the most frequent acquired disorder of neuromuscular transmission. In the majority of cases, pathogenic antibodies against components of the postsynaptic muscle endplate membrane can be detected. In recent years there have been significant advances in the pathophysiological understanding and therapy of the disease. Areas covered: PubMed searches were conducted for the term 'myasthenia gravis' cross-referenced with the terms 'immunology', 'subgroups', 'antibody', 'ocular', 'thymoma', 'treatment' and 'thymectomy'. Additionally, we summarized the current state of immunopathology and therapy. Expert commentary: Immunological research defined new target antigens at the postsynaptic neuromuscular junction which along with clinical features allow a refined definition of disease subgroups. Overall the prognosis of myasthenia gravis with best possible symptomatic, immunosuppressive and supportive treatment is good but new immunomodulatory treatment options are developed for patients who do not respond well to the first line therapy. For most patients individually adapted long-term drug therapy is needed.

  13. Advanced Gene Therapy for Treatment of Cardiomyopathy and Respiratory Insufficiency in Duchenne Muscular Dystrophy

    DTIC Science & Technology

    2014-09-01

    TITLE: Advanced Gene Therapy for Treatment of Cardiomyopathy and Respiratory Insufficiency in Duchenne Muscular Dystrophy PRINCIPAL...Advanced Gene Therapy for Treatment of Cardiomyopathy and Respiratory Insufficiency in Duchenne Muscular Dystrophy 5a. CONTRACT NUMBER 5b. GRANT...effective recombinant AAV vector serotype 9 delivery system for the treatment of cardiorespiratory dysfunction in Duchenne Muscular Dystrophy . 2

  14. Follow-up of the first patients with a totally subcutaneous ICD in Germany from implantation till battery depletion.

    PubMed

    Bettin, Markus; Rath, Benjamin; Ellermann, Christian; Leitz, Patrick; Reinke, Florian; Köbe, Julia; Eckardt, Lars; Frommeyer, Gerrit

    2018-06-12

    The subcutaneous ICD is a promising treatment option in patients at risk for sudden cardiac death. Approved in 2009, the first S-ICD ® in Germany was implanted in June 2010. Although large prospective registry studies have shown safety and efficacy of the system, there is a lack of long-term data with regard to battery longevity of the S-ICD ® . Therefore, we report follow-up of our first initial S-ICD ® cases from implantation till battery depletion. All S-ICD ® patients with device replacement for battery depletion in our large single-center S-ICD ® registry were included in this study. Baseline characteristics, appropriate and inappropriate shocks, and complications were documented in a median follow-up of 75.9 ± 6.8 months. Twenty-eight patients with S-ICD ® systems were included in this study. Of these patients, 21 were male and 7 were female, with an overall mean age of 41.9 ± 12.6 years. Primary prevention of sudden cardiac death was the indication in 19 patients (67.9%). Ventricular tachycardia was adequately terminated in two patients (7.1%). In 7 patients, non-sustained ventricular arrhythmias were not treated. A total of three inappropriate shocks occurred in three patients (10.7%). Mean time from implantation till battery depletion was 65.8 ± 8.1 months. Only one patient presented premature elective replacement criteria because of rapid battery depletion. No lead-related complication occurred during follow-up and no complications were seen regarding device replacement. In one patient (3.6%), the system was explanted without replacement due to patient's preference. The estimated battery longevity of S-ICD ® of about 5 years was reached in all but one patient. Compared to larger S-ICD ® registry studies, frequency of inappropriate shocks was relatively high in the initial S-ICD ® cases. Both technological improvement as well as programming and operators' experience have led to a reduction of complications. Replacement of the S-ICD

  15. Insulin therapy for type 2 diabetes - are we there yet? The d-Nav® story.

    PubMed

    Hodish, I

    2018-01-01

    Insulin replacement therapy is mostly used by patients with type 2 diabetes who become insulin deficient and have failed other therapeutic options. They comprise about a quarter of those with diabetes, endures the majority of the complications and consumes the majority of the resources. Adequate insulin replacement therapy can prevent complications and reduce expenses, as long as therapy goals are achieved and maintained. Sadly, these therapy goals are seldom achieved and outcomes have not improved for decades despite advances in pharmacotherapy and technology. There is a growing recognition that the low success rate of insulin therapy results from intra-individual and inter-individual variations in insulin requirements. Total insulin requirements per day vary considerably between patients and constantly change without achieving a steady state. Thus, the key element in effective insulin therapy is unremitting and frequent dosage adjustments that can overcome those dynamics. In practice, insulin adjustments are done sporadically during outpatient clinic. Due to time constraints, providers are not able to deliver appropriate insulin dosage optimization. The d-Nav® Insulin Guidance Service has been developed to provide appropriate insulinization in insulin users without increasing the burden on healthcare systems. It relies on dedicated clinicians and a spectrum of technological solutions. Patients are provided with a handheld device called d-Nav® which advises them what dose of insulin to administer during each injection and automatically adjust insulin dosage when needed. The d-Nav care specialists periodically follow-up with users through telephone calls and in-person consultations to bestow user confidence, correct usage errors, triage, and identify uncharacteristic clinical courses. The following review provide details about the service and its clinical outcomes.

  16. [Economic perspectives of the research on advanced therapies].

    PubMed

    Pamo Larrauri, Jose María

    2014-11-03

    Since a new advanced therapy medicinal product is discovered until finally allowed its sale in the domestic market, it has to overcome a series of stages. Biomedical research is the first phase, currently its situation is encouraging to the increase in the number of clinical trials in Spain and in the rest of the world, despite the economic situation and the various difficulties that have faced the pharmaceutical laboratories. The next phase consists in obtaining the authorization of marketing of the European Medicines Agency. After authorization, will attempt to set a fair and moderate price for inclusion in the list of health provision of Social Security. A price for a drug that provides added value to health and society, a price that is generated profits for the pharmaceutical companies that hope to make up for the years of work and investment. Commitment to advanced therapy must be clear and forceful, to fund ongoing research projects and encouraging their creation with economic aid. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  17. Validation of ICD-9-CM coding algorithm for improved identification of hypoglycemia visits.

    PubMed

    Ginde, Adit A; Blanc, Phillip G; Lieberman, Rebecca M; Camargo, Carlos A

    2008-04-01

    Accurate identification of hypoglycemia cases by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes will help to describe epidemiology, monitor trends, and propose interventions for this important complication in patients with diabetes. Prior hypoglycemia studies utilized incomplete search strategies and may be methodologically flawed. We sought to validate a new ICD-9-CM coding algorithm for accurate identification of hypoglycemia visits. This was a multicenter, retrospective cohort study using a structured medical record review at three academic emergency departments from July 1, 2005 to June 30, 2006. We prospectively derived a coding algorithm to identify hypoglycemia visits using ICD-9-CM codes (250.3, 250.8, 251.0, 251.1, 251.2, 270.3, 775.0, 775.6, and 962.3). We confirmed hypoglycemia cases by chart review identified by candidate ICD-9-CM codes during the study period. The case definition for hypoglycemia was documented blood glucose 3.9 mmol/l or emergency physician charted diagnosis of hypoglycemia. We evaluated individual components and calculated the positive predictive value. We reviewed 636 charts identified by the candidate ICD-9-CM codes and confirmed 436 (64%) cases of hypoglycemia by chart review. Diabetes with other specified manifestations (250.8), often excluded in prior hypoglycemia analyses, identified 83% of hypoglycemia visits, and unspecified hypoglycemia (251.2) identified 13% of hypoglycemia visits. The absence of any predetermined co-diagnosis codes improved the positive predictive value of code 250.8 from 62% to 92%, while excluding only 10 (2%) true hypoglycemia visits. Although prior analyses included only the first-listed ICD-9 code, more than one-quarter of identified hypoglycemia visits were outside this primary diagnosis field. Overall, the proposed algorithm had 89% positive predictive value (95% confidence interval, 86-92) for detecting hypoglycemia visits. The proposed algorithm

  18. Effect of radiation therapy on permanent pacemaker and implantable cardioverter-defibrillator function.

    PubMed

    Makkar, Akash; Prisciandaro, Joann; Agarwal, Sunil; Lusk, Morgan; Horwood, Laura; Moran, Jean; Fox, Colleen; Hayman, James A; Ghanbari, Hamid; Roberts, Brett; Belardi, Diego; Latchamsetty, Rakesh; Crawford, Thomas; Good, Eric; Jongnarangsin, Krit; Bogun, Frank; Chugh, Aman; Oral, Hakan; Morady, Fred; Pelosi, Frank

    2012-12-01

    Radiation therapy's (RT's) effects on cardiac implantable electronic devices (CIEDs) such as implantable cardioverter-defibrillators (ICDs) and pacemakers (PMs) are not well established, leading to device removal or relocation in preparation for RT. To determine the effect of scattered RT on CIED performance. We analyzed 69 patients--50 (72%) with PMs and 19 (28%) with ICDs--receiving RT at the University of Michigan. Collected data included device model, anatomic location, and treatment beam energies, treatment type, and estimated dose to the device. Patients were treated with either high-energy (16-MV) and/or low-energy (6 MV) photon beams with or without electron beams (6-16 MeV). The devices were interrogated with pre- and post-RT and/or weekly with either in-treatment or home interrogation, depending on the patient's dependence on the device and the estimated or measured delivered dose. Outcomes analyzed were inappropriate ICD therapies, device malfunctions, or device-related clinical events. The PMs were exposed to 84.4 ± 99.7 cGy of radiation, and the ICDs were exposed to 92.1 ± 72.6 cGy of radiation. Two patients with ICDs experienced a partial reset of the ICD with the loss of historic diagnostic data after receiving 123 and 4 cGy, respectively. No device malfunction or premature battery depletion was observed at 6-month follow-up from RT completion. CIED malfunction due to indirect RT exposure is uncommon. Regular in-treatment or home interrogation should be done to detect and treat these events and to ensure that diagnostic data are preserved. Copyright © 2012 Elsevier Inc. All rights reserved.

  19. Perinatal and infant mortality in urban slums under I.C.D.S. scheme.

    PubMed

    Thora, S; Awadhiya, S; Chansoriya, M; Kaul, K K

    1986-08-01

    Perinatal and infant mortality during the year 1985 was analyzed through a prospective study conducted in 12 Anganwadis (total population of 13,054) located in slum areas of India's Jabalpur city. Overall, the infant mortality rate was 128.7/1000 live births and the perinatal mortality rate was 88.5/1000 live births. 58.5% of deaths occurred in the neonatal period. Causes of neonatal deaths included prematurity, respiratory distress syndrome, birth asphyxia, septicemia, and neonatal tetanus. Postneonatal deaths were largely attributable to dehydration from diarrhea, bronchopneumonia, malnutrition, and infectious diseases. All mortality rates were significantly higher in Muslims than among Hindus. Muslims accounted for 28% of the study population, but contributed 63% of stillbirths and 55% of total infant deaths. This phenomenon appears attributable to the large family size among Muslims coupled with inadequate maternal-child health care. The national neonatal and postneonatal mortality rates are 88/1000 and 52/1000, respectively. The fact that the neonatal mortality rate in the study area was slightly lower than the national average may reflect the impact of ICDS services.

  20. A comparison of DSM-III-R and ICD-10 personality disorder criteria in an out-patient population.

    PubMed

    Sara, G; Raven, P; Mann, A

    1996-01-01

    This study reports the results of a comparison of DSM-III-R and ICD-10 personality disorder criteria by application of both sets of criteria to the same group of patients. Despite the clinical relevance of these disorders and the need for reliable diagnostic criteria, such a comparison has not previously been reported. DSM-III-R and ICD-10 have converged in their classification of personality disorders, but some important differences between the two systems remain. Personality disorder diagnoses from both systems were obtained in 52 out-patients, using the Standardized Assessment of Personality (SAP), a brief, informant-based interview which yields diagnoses in both DSM-III-R and ICD-10. For individual personality disorder diagnoses, agreement between systems was limited. Thirty-four subjects received a personality disorder diagnosis that had an equivalent form in both systems, but only 10 subjects (29%) received the same primary diagnosis in each system. There was a difference in rate of diagnosis, with ICD-10 making significantly more personality disorder diagnoses. The lower diagnostic threshold of the ICD-10 contributed most of this effect. Further modifications in ICD-10 Diagnostic Criteria for Research (DCR) and DSM-IV to the personality disorder category have been considered. The omission in DSM-IV of three categories unique to that system and the raising of the threshold in ICD-10 DCR, do seem to have been helpful in promoting convergence.

  1. Analysis of implantable defibrillator longevity under clinical circumstances: implications for device selection.

    PubMed

    Knops, Paul; Theuns, Dominic A M J; Res, Jan C J; Jordaens, Luc

    2009-10-01

    Information about implantable cardioverter-defibrillator (ICD) longevity is mostly calculated from measurements under ideal laboratory conditions. However, little information about longevity under clinical circumstances is available. This survey gives an overview on ICD service times and generator replacements in a cohort of consecutive ICD patients. Indications for replacement were classified as a normal end-of-service (EOS), premature EOS, system malfunction, infection and device advisory, or recall actions. From the premature and normal EOS group, longevity from single-chamber (SC), dual-chamber (DC), and cardiac resynchronization therapy defibrillator (CRT-D), rate-responsive (RR) settings, high output (HO) stimulation, and indication for ICD therapy was compared. Differences between brands were compared as well. In a total of 854 patients, 203 ICD replacements (165 patients) were recorded. Premature and normal EOS replacements consisted of 32 SC, 98 DC and 24 CRT-D systems. Longevity was significantly longer in SC systems compared to DC and CRT-D systems (54 +/- 19 vs. 40 +/- 17 and 42 +/- 15 months; P = 0.008). Longevity between non-RR (n = 143) and RR (n = 11) settings was not significantly different (43 +/- 18 vs. 45 +/- 13 months) as it also was not for HO versus non-HO stimulation (43 +/- 19 vs. 46 +/- 17 months). Longevity of ICDs was not significantly different between primary and secondary prevention (42 +/- 19 vs. 44 +/- 18 months). The average longevity on account of a device-based EOS message was 43 +/- 18 months. Average longevity for Biotronik (BIO, n = 72) was 33 +/- 10 months, for ELA Medical (ELA, n = 12) 44 +/- 17 months, for Guidant (GDT, n = 36) 49 +/- 12 months, for Medtronic (MDT, n = 29) 62 +/- 22 months, and for St. Jude Medical (SJM, n = 5) 31 +/- 9 months (P < 0.001). SC ICD generators had a longer service time compared to DC and CRT-D systems. No influence of indication for ICD therapy and HO stimulation on generator longevity was

  2. Stem-Cell Therapy Advances in China.

    PubMed

    Hu, Lei; Zhao, Bin; Wang, Songlin

    2018-02-01

    Stem-cell therapy is a promising method for treating patients with a wide range of diseases and injuries. Increasing government funding of scientific research has promoted rapid developments in stem-cell research in China, as evidenced by the substantial increase in the number and quality of publications in the past 5 years. Multiple high-quality studies have been performed in China that concern cell reprogramming, stem-cell homeostasis, gene modifications, and immunomodulation. The number of translation studies, including basic and preclinical investigations, has also increased. Around 100 stem-cell banks have been established in China, 10 stem-cell drugs are currently in the approval process, and >400 stem cell-based clinical trials are currently registered in China. With continued state funding, advanced biotechnical support, and the development of regulatory standards for the clinical application of stem cells, further innovations are expected that will lead to a boom in stem-cell therapies. This review highlights recent achievements in stem-cell research in China and discusses future prospects.

  3. Proposals for Paraphilic Disorders in the International Classification of Diseases and Related Health Problems, Eleventh Revision (ICD-11).

    PubMed

    Krueger, Richard B; Reed, Geoffrey M; First, Michael B; Marais, Adele; Kismodi, Eszter; Briken, Peer

    2017-07-01

    The World Health Organization is currently developing the 11th revision of the International Classifications of Diseases and Related Health Problems (ICD-11), with approval of the ICD-11 by the World Health Assembly anticipated in 2018. The Working Group on the Classification of Sexual Disorders and Sexual Health (WGSDSH) was created and charged with reviewing and making recommendations for categories related to sexuality that are contained in the chapter of Mental and Behavioural Disorders in ICD-10 (World Health Organization 1992a). Among these categories was the ICD-10 grouping F65, Disorders of sexual preference, which describes conditions now widely referred to as Paraphilic Disorders. This article reviews the evidence base, rationale, and recommendations for the proposed revisions in this area for ICD-11 and compares them with DSM-5. The WGSDSH recommended that the grouping, Disorders of sexual preference, be renamed to Paraphilic Disorders and be limited to disorders that involve sexual arousal patterns that focus on non-consenting others or are associated with substantial distress or direct risk of injury or death. Consistent with this framework, the WGSDSH also recommended that the ICD-10 categories of Fetishism, Fetishistic Transvestism, and Sadomasochism be removed from the classification and new categories of Coercive Sexual Sadism Disorder, Frotteuristic Disorder, Other Paraphilic Disorder Involving Non-Consenting Individuals, and Other Paraphilic Disorder Involving Solitary Behaviour or Consenting Individuals be added. The WGSDSH's proposals for Paraphilic Disorders in ICD-11 are based on the WHO's role as a global public health agency and the ICD's function as a public health reporting tool.

  4. WE-G-BRB-02: The Role of Program Project Grants in Study of 3D Conformal Therapy, Dose Escalation and Motion Management

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

    Fraass, B.

    2015-06-15

    Over the past 20 years the NIH has funded individual grants, program projects grants, and clinical trials which have been instrumental in advancing patient care. The ways that each grant mechanism lends itself to the different phases of translating research into clinical practice will be described. Major technological innovations, such as IMRT and proton therapy, have been advanced with R01-type and P01-type funding and will be discussed. Similarly, the role of program project grants in identifying and addressing key hypotheses on the potential of 3D conformal therapy, normal tissue-guided dose escalation and motion management will be described. An overview willmore » be provided regarding how these technological innovations have been applied to multi-institutional NIH-sponsored trials. Finally, the panel will discuss regarding which research questions should be funded by the NIH to inspire the next advances in radiation therapy. Learning Objectives: Understand the different funding mechanisms of the NIH Learn about research advances that have led to innovation in delivery Review achievements due to NIH-funded program project grants in radiotherapy over the past 20 years Understand example advances achieved with multi-institutional clinical trials NIH.« less

  5. Adaptation through Collaboration: Developing Novel Platforms to Advance the Delivery of Advanced Therapies to Patients

    PubMed Central

    Papadaki, Magdalini

    2017-01-01

    For the nascent field of advanced therapies, collaboration will be a game-changer, turning scientific progress that was once unimaginable into transformative medical practice. Despite promise for lifelong management and even cure of disease, skepticism remains about the feasibility of their delivery to patients, fueling investment risks. With the potential for long-term effectiveness in need of frequent reassessment, current approaches to predict real-life drug performance bear little relevance, necessitating novel and iterative schemes to monitoring the benefit–risk profiles throughout the life span of advanced therapies. This work explains that reinventing an adoption route for Advanced Therapy Medicinal Products is as much about the scientific and clinical components, as it is about the organizational structures, requiring an unprecedented level of interactions between stakeholders not traditionally connected; from developers and regulators, to payers, patients, and funders. By reflecting on the successes and lessons learned from the growing space of global precompetitive consortia and public–private partnerships, as well as a number of emerging accelerated development pathways, this work aims to inform the foundations for a future roadmap that can smooth the path to approval, reimbursement, and access, while delivering value to all stakeholders. Echoing the growing demands to bring these transformative products to patients, it provides critical insights to enhance our capacity in three fundamental domains: deploying the operational flexibilities offered by the growing space of collaborations, utilizing emerging flexible and accelerated pathways to tackle challenges in quantifying long-term effectiveness, and building the necessary digital and clinical infrastructure for knowledge development. PMID:28611985

  6. Stereotactic body radiation therapy planning with duodenal sparing using volumetric-modulated arc therapy vs intensity-modulated radiation therapy in locally advanced pancreatic cancer: A dosimetric analysis

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

    Kumar, Rachit; Wild, Aaron T.; Ziegler, Mark A.

    2013-10-01

    Stereotactic body radiation therapy (SBRT) achieves excellent local control for locally advanced pancreatic cancer (LAPC), but may increase late duodenal toxicity. Volumetric-modulated arc therapy (VMAT) delivers intensity-modulated radiation therapy (IMRT) with a rotating gantry rather than multiple fixed beams. This study dosimetrically evaluates the feasibility of implementing duodenal constraints for SBRT using VMAT vs IMRT. Non–duodenal sparing (NS) and duodenal-sparing (DS) VMAT and IMRT plans delivering 25 Gy in 1 fraction were generated for 15 patients with LAPC. DS plans were constrained to duodenal D{sub max} of<30 Gy at any point. VMAT used 1 360° coplanar arc with 4° spacingmore » between control points, whereas IMRT used 9 coplanar beams with fixed gantry positions at 40° angles. Dosimetric parameters for target volumes and organs at risk were compared for DS planning vs NS planning and VMAT vs IMRT using paired-sample Wilcoxon signed rank tests. Both DS VMAT and DS IMRT achieved significantly reduced duodenal D{sub mean}, D{sub max}, D{sub 1cc}, D{sub 4%}, and V{sub 20} {sub Gy} compared with NS plans (all p≤0.002). DS constraints compromised target coverage for IMRT as demonstrated by reduced V{sub 95%} (p = 0.01) and D{sub mean} (p = 0.02), but not for VMAT. DS constraints resulted in increased dose to right kidney, spinal cord, stomach, and liver for VMAT. Direct comparison of DS VMAT and DS IMRT revealed that VMAT was superior in sparing the left kidney (p<0.001) and the spinal cord (p<0.001), whereas IMRT was superior in sparing the stomach (p = 0.05) and the liver (p = 0.003). DS VMAT required 21% fewer monitor units (p<0.001) and delivered treatment 2.4 minutes faster (p<0.001) than DS IMRT. Implementing DS constraints during SBRT planning for LAPC can significantly reduce duodenal point or volumetric dose parameters for both VMAT and IMRT. The primary consequence of implementing DS constraints for VMAT is increased dose to other

  7. Advances in adult acute lymphoblastic leukemia therapy.

    PubMed

    Aldoss, Ibrahim; Stein, Anthony S

    2018-05-01

    Progress in adult acute lymphoblastic leukemia (ALL) treatment has been met with challenge until recently. A steady improvement in outcomes is being witnessed among adults with ALL, and it will be enhanced further with early referral of newly diagnosed ALL patients to specialized centers, enrolling more ALL adults in clinical trials, adopting pediatric-inspired ALL regimens in younger adults, tailoring treatments according to minimal residual disease response and disease genetics, incorporating novel therapies and tyrosine kinase inhibitors in frontline regimens, early referral to transplant when indicated, expanding the donor pool, and developing more effective salvage therapies for relapsed/refractory ALL. In this review, we will discuss the most significant advances in treating adult ALL observed in the last five years that have the potential to enhance adult ALL treatment and outcome.

  8. Mind-Body Therapies: Evidence and Implications in Advanced Oncology Practice

    PubMed Central

    Mayden,, Kelley D.

    2012-01-01

    The idea that thoughts and emotions influence health outcomes is an ancient concept that was initially abandoned by Western medicine researchers. Today, researchers are showing a renewed interest in the interactions of the mind and body and the role these interactions play in disease formation and recovery. Complementary and alternative interventions, such as mind-body therapies, are increasingly being used by cancer survivors for disease prevention, immune system enhancement, and symptom control. Traditional training has not been structured to provide advanced practitioners with an in-depth knowledge of the clinical applications of mind-body therapies. The aim of this article is to acquaint the reader with common mind-body modalities (meditation/mindfulness-based stress reduction, relaxation therapy, cognitive-behavioral therapy, hypnosis, biofeedback, music therapy, art therapy, support groups, and aromatherapy) and to examine important evidence in support of or against their clinical application. PMID:25031967

  9. Creating conditions for the success of the French industrial advanced therapy sector.

    PubMed

    Lirsac, Pierre Noel; Blin, Olivier; Magalon, Jérémy; Angot, Pierre; de Barbeyrac, Estelle; Bilbault, Pascal; Bourg, Elisabeth; Damour, Odile; Faure, Patrick; Ferry, Nicolas; Garbil, Bénédicte; Larghero, Jérôme; Nguon, Marina; Pattou, François; Thumelin, Stéphane; Yates, Frank

    2015-01-01

    Although the European Union merely followed the initiatives of the United States and Japan by introducing special regimes for orphan medicinal products, it has introduced a special status for a new category of biological medicinal products, advanced therapy medicinal products (ATMPs), adopting specific associated regulations. European Regulation (which constitutes the highest legal instrument in the hierarchy of European law texts) [EC] No. 1394/2007, published in 2007, uses this term to define somatic cell therapy medicinal products, tissue-engineered products, and gene therapy medicinal products, possibly combined with medical devices. The stated objective was two-fold: both to promote their industrialization and market access, while guaranteeing a high level of health protection for patients. Since publication of the regulation, few marketing authorizations have been granted in Europe, and these have not been accompanied by commercial success. However, certain recent studies show that this is a growing sector and that France remains the leading European nation in terms of clinical trials. This round table brought together a panel of representatives of French public and private protagonists from the advanced therapy sector. The discussions focused on the conditions to ensure the success of translational research and, more generally, the French advanced therapy sector. These enabled a number of obstacles to be identified, which once lifted, by means of recommendations, would facilitate the development and success of this sector. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  10. Visualization of hepatic arteries with 3D ultrasound during intra-arterial therapies

    NASA Astrophysics Data System (ADS)

    Gérard, Maxime; Tang, An; Badoual, Anaïs.; Michaud, François; Bigot, Alexandre; Soulez, Gilles; Kadoury, Samuel

    2016-03-01

    Liver cancer represents the second most common cause of cancer-related mortality worldwide. The prognosis is poor with an overall mortality of 95%. Moreover, most hepatic tumors are unresectable due to their advanced stage at discovery or poor underlying liver function. Tumor embolization by intra-arterial approaches is the current standard of care for advanced cases of hepatocellular carcinoma. These therapies rely on the fact that the blood supply of primary hepatic tumors is predominantly arterial. Feedback on blood flow velocities in the hepatic arteries is crucial to ensure maximal treatment efficacy on the targeted masses. Based on these velocities, the intra-arterial injection rate is modulated for optimal infusion of the chemotherapeutic drugs into the tumorous tissue. While Doppler ultrasound is a well-documented technique for the assessment of blood flow, 3D visualization of vascular anatomy with ultrasound remains challenging. In this paper we present an image-guidance pipeline that enables the localization of the hepatic arterial branches within a 3D ultrasound image of the liver. A diagnostic Magnetic resonance angiography (MRA) is first processed to automatically segment the hepatic arteries. A non-rigid registration method is then applied on the portal phase of the MRA volume with a 3D ultrasound to enable the visualization of the 3D mesh of the hepatic arteries in the Doppler images. To evaluate the performance of the proposed workflow, we present initial results from porcine models and patient images.

  11. Development of DSM-V and ICD-11: tendencies and potential of new classifications in psychiatry at the current state of knowledge.

    PubMed

    Möller, Hans-Jürgen

    2009-10-01

    A reason for the necessity to revise ICD-10 and DSM-IV is the increase of knowledge in the past 20 years, especially neurobiological knowledge. But is this increase of knowledge, for example in the field of neurogenetics, of such magnitude that a revision of the psychiatric classification is necessary and promises to be fruitful? The current plans for DSM-V or ICD-11, respectively, focus on different improvements. In this context also the introduction of a purely syndromatic/dimensional approach without including etiopathogenetic hypotheses, is discussed. A switch to such a dimensional approach, which was discussed among others in the DSM-V task force Deconstructing Psychosis, would be the most radical development. It could avoid many theoretical pre-assumptions about causal hypotheses, which are still associated with ICD-10 and DSM-IV. This would indeed increase the validity of psychiatric classification, but it would also reduce the information as compared to traditional diagnostic categories with all the current implications concerning etiopathogenesis, therapy and prognosis. Such a dimensional approach would also mean that the syndromes would have to be assessed in a standardized way for each person seeking help from the psychiatric service system or for each person undergoing psychiatric research. This would have to be a multi-dimensional assessment covering all syndromes existing within different psychiatric disorders. Based on the different aspects that must be considered in this context, a careful revision seems more advisable than a radical change of classification.

  12. The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial: concept and design of a randomized, controlled trial of intra-operative defibrillation testing during de novo defibrillator implantation.

    PubMed

    Bänsch, Dietmar; Bonnemeier, Hendrik; Brandt, Johan; Bode, Frank; Svendsen, Jesper Hastrup; Felk, Angelika; Hauser, Tino; Wegscheider, Karl

    2015-01-01

    Although defibrillation (DF) testing is still considered a standard procedure during implantable cardioverter-defibrillator (ICD) insertion and has been an essential element of all trials that demonstrated the survival benefit of ICD therapy, there are no large randomized clinical trials demonstrating that DF testing improves clinical outcome and if the outcome would remain the same by omitting DF testing. Between February 2011 and July 2013, we randomly assigned 1077 patients to ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres. After inducing a fast ventricular tachycardia (VT) with a heart rate ≥240 b.p.m. or ventricular fibrillation (VF) with a low-energy T-wave shock, DF was attempted with an initial 15 J shock. If the shock reversed the VT or VF, DF testing was considered successful and terminated. If unsuccessful, two effective 24 J shocks were administered. If DF was unsuccessful, the system was reconfigured and another DF testing was performed. An ICD shock energy of 40 J had to be programmed in all patients for treatment of spontaneous VT/VF episodes. The primary endpoint was the average efficacy of the first ICD shock for all true VT/VF episodes in each patient during follow-up. The secondary endpoints included the frequency of system revisions, total fluoroscopy, implantation time, procedural serious adverse events, and all-cause, cardiac, and arrhythmic mortality during follow-up. Home Monitoring was used in all patients to continuously monitor the system integrity, device programming and performance. The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial is one of two large prospective randomized trials assessing the effect of DF testing omission during ICD implantation. NCT01282918. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email

  13. Psychological adaptation to ICDs and the influence of anxiety sensitivity.

    PubMed

    Lemon, Jim; Edelman, Sarah

    2007-03-01

    Forty-nine patients scheduled for implantable cardioverter defibrillator (ICD) implantation completed self-report psychological questionnaires prior to surgery and at 2, 4 and 6 months after surgery. The most common psychological problem identified was anxiety, with clinically significant cases based on the Depression Anxiety and Stress Scale (DASS) ranging between 26% and 34%. Clinically significant depression ranged between 8% and 20%. Anxiety sensitivity was associated with high levels of anxiety, depression and stress at baseline, but not at follow-up assessments. It is possible that within this population anxiety sensitivity is associated with distress during high-threat situations, but the relationship diminishes once the threat has passed. In addition, the reassurance provided by the ICD may reduce negative perceptions of symptoms, promoting psychological adaptation.

  14. CIM explorer--intelligent tool for exploring the ICD Romanian version.

    PubMed

    Filip, F; Haras, C

    2000-01-01

    The CIM Explorer software provides us with an intelligent interface for exploring the Romanian version of the International Classification of Diseases (in Romanian Clasificarea Internationala a Maladiilor-CIM). The ICD was transposed from its initial appearance as a printed document into a database. The classification can be accessed in two modes: "Navigation" and "Code" and queried in the "Key words" mode. In the last mode CIM Explorer program searches for the right content of the ICD records starting from naturally written expressions which it "understands". As a results it returns all the records containing the key words regardless their grammatical form. This program implements the specificity of the Romanian language where the words are made up from a root and a flexional termination.

  15. Current advances in targeted therapies for metastatic gastric cancer: improving patient care.

    PubMed

    Aguiar, Pedro Nazareth; Muniz, Thiago Pimentel; Miranda, Raelson Rodrigues; Tadokoro, Hakaru; Forones, Nora Manoukian; Monteiro, Ines-de-Paula; Castelo-Branco, Pedro; Janjigian, Yelena Y; De Mello, Ramon Andrade

    2016-03-01

    In this article, we review the literature on the current advances in targeted therapies for metastatic gastric cancer aimed at improving patient care. We conclude that the key to guiding targeted therapy is individual biomarkers, which are not completely elucidated. HER2 overexpression is the only predictive biomarker currently in use. Furthermore, it is necessary to understand that gastric tumors are heterogeneous; therefore, is impossible to evaluate a novel biological compound without evaluating personal biomarkers. The selection of patients who are able to receive each treatment is paramount for improving advanced gastric cancer survival and reducing unnecessary costs.

  16. Advancing Translational Research Through the NHLBI Gene Therapy Resource Program (GTRP)

    PubMed Central

    Benson, Janet; Cornetta, Kenneth; Diggins, Margaret; Johnston, Julie C.; Sepelak, Susan; Wang, Gensheng; Wilson, James M.; Wright, J. Fraser; Skarlatos, Sonia I.

    2013-01-01

    Abstract Translational research is a lengthy, complex, and necessary endeavor in order to bring basic science discoveries to clinical fruition. The NIH offers several programs to support translational research including an important resource established specifically for gene therapy researchers—the National Heart, Lung, and Blood Institute (NHLBI) Gene Therapy Resource Program (GTRP). This paper reviews the core components of the GTRP and describes how the GTRP provides researchers with resources that are critical to advancing investigational gene therapy products into clinical testing. PMID:23692378

  17. WE-AB-BRA-07: Quantitative Evaluation of 2D-2D and 2D-3D Image Guided Radiation Therapy for Clinical Trial Credentialing, NRG Oncology/RTOG

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

    Giaddui, T; Yu, J; Xiao, Y

    Purpose: 2D-2D kV image guided radiation therapy (IGRT) credentialing evaluation for clinical trial qualification was historically qualitative through submitting screen captures of the fusion process. However, as quantitative DICOM 2D-2D and 2D-3D image registration tools are implemented in clinical practice for better precision, especially in centers that treat patients with protons, better IGRT credentialing techniques are needed. The aim of this work is to establish methodologies for quantitatively reviewing IGRT submissions based on DICOM 2D-2D and 2D-3D image registration and to test the methodologies in reviewing 2D-2D and 2D-3D IGRT submissions for RTOG/NRG Oncology clinical trials qualifications. Methods: DICOM 2D-2Dmore » and 2D-3D automated and manual image registration have been tested using the Harmony tool in MIM software. 2D kV orthogonal portal images are fused with the reference digital reconstructed radiographs (DRR) in the 2D-2D registration while the 2D portal images are fused with DICOM planning CT image in the 2D-3D registration. The Harmony tool allows alignment of the two images used in the registration process and also calculates the required shifts. Shifts calculated using MIM are compared with those submitted by institutions for IGRT credentialing. Reported shifts are considered to be acceptable if differences are less than 3mm. Results: Several tests have been performed on the 2D-2D and 2D-3D registration. The results indicated good agreement between submitted and calculated shifts. A workflow for reviewing these IGRT submissions has been developed and will eventually be used to review IGRT submissions. Conclusion: The IROC Philadelphia RTQA center has developed and tested a new workflow for reviewing DICOM 2D-2D and 2D-3D IGRT credentialing submissions made by different cancer clinical centers, especially proton centers. NRG Center for Innovation in Radiation Oncology (CIRO) and IROC RTQA center continue their collaborative efforts to

  18. Impact of a hybrid decision support system to improve the adherence to implantable cardioverter defibrillator therapy guidelines for primary prevention of sudden cardiac death.

    PubMed

    Vecchio, Nicolás; Belardi, Diego; Benzadón, Mariano; Seoane, Leonardo; Daquarti, Gustavo; Scazzuso, Fernando

    2018-06-01

    Despite the well-documented benefit of implantable cardioverter defibrillator (ICD) in patients with severe left ventricular dysfunction, there is a large number of patients who had not been offered this therapy. The aim of this study is to evaluate the utility of a hybrid decision support system (hCDSS) to improve the adherence to indicate ICD therapy in our institution. We conducted a retrospective, observational and single-center study. An hCDSS focused on patients with severe deterioration of the left ventricular function was implemented, creating a mandatory field containing the value of left ejection fraction and three options to choose: >35%, ≤ 35% or unknown. When the option ≤ 35% is checked, an email is automatically sent to the electrophysiology section where the staff can contact the treating physician to discuss the indication of ICD therapy. We measured the number of ICDs implanted before the alert (month 1-21), immediate post and late post alert (month 22-27 and 28-48 months respectively) RESULTS: The rate of ICD implantation increased from 1.76% per month in the pre-intervention period to 4.48% after the intervention (p < 0.001). This increase in the rate of ICD implantation remained stable between the immediate and late post-intervention period (4.6 vs. 4.4; p = .8) CONCLUSION: The implementation of a hybrid decision support system was associated with improved adherence to clinical guidelines for prevention of sudden cardiac death, as evidenced by a rapid and sustained increase in the number of ICD implants in patients with severe left ventricular dysfunction. Copyright © 2018 Elsevier B.V. All rights reserved.

  19. Recent advances in drug therapy for epilepsy.

    PubMed Central

    Bruni, J.

    1979-01-01

    Recent advances in drug therapy for epilepsy have contributed to the reduction in the proportion of persons whose epilepsy is uncontrolled. New knowledge of the pharmacokinetics of phenytoin has led to a better understanding of the drug's bioavailability and uses. Carbamazepine has recently been introduced for the treatment of generalized tonic-clonic and partial seizures. Clonazepam has been found of particular benefit in the treatment of absence and myoclonic seizures. Valproic acid is a promising antiepileptic drug with broad-spectrum activity, and is particularly useful in the treatment of absence and myoclonic seizures, although further clinical experience is required before it can supplant ethosuximide as the preferred drug for the treatment of absence seizures. Monitoring of the plasma concentration of antiepileptic drugs has added greatly to the achievement of optimal drug therapy and the prevention of toxic effects. PMID:371777

  20. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer.

    PubMed

    Goetz, Matthew P; Toi, Masakazu; Campone, Mario; Sohn, Joohyuk; Paluch-Shimon, Shani; Huober, Jens; Park, In Hae; Trédan, Olivier; Chen, Shin-Cheh; Manso, Luis; Freedman, Orit C; Garnica Jaliffe, Georgina; Forrester, Tammy; Frenzel, Martin; Barriga, Susana; Smith, Ian C; Bourayou, Nawel; Di Leo, Angelo

    2017-11-10

    Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy. Methods MONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole, daily. The primary objective was investigator-assessed progression-free survival. Secondary objectives included response evaluation and safety. A planned interim analysis occurred after 189 events. Results Median progression-free survival was significantly prolonged in the abemaciclib arm (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P = .000021; median: not reached in the abemaciclib arm, 14.7 months in the placebo arm). In patients with measurable disease, the objective response rate was 59% in the abemaciclib arm and 44% in the placebo arm ( P = .004). In the abemaciclib arm, diarrhea was the most frequent adverse effect (81.3%) but was mainly grade 1 (44.6%). Comparing abemaciclib and placebo, the most frequent grade 3 or 4 adverse events were neutropenia (21.1% v 1.2%), diarrhea (9.5% v 1.2%), and leukopenia (7.6% v 0.6%). Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer.

  1. Perspectives of newly diagnosed advanced cancer patients receiving dignity therapy during cancer treatment.

    PubMed

    Dose, Ann Marie; Rhudy, Lori M

    2018-01-01

    Dignity therapy is a psychosocial intervention that has been used primarily at the end of life to improve quality of life and other patient outcomes, but many individuals are unable to complete it due to health decline and death. The purpose of this study was to identify what individuals with advanced pancreatic or lung cancer with limited life expectancy, undergoing active cancer treatment describe during the dignity therapy intervention as important to them when not immediately facing end of life. Twenty patients undergoing chemotherapy for advanced cancer participated in a dignity therapy intervention study. Initial interviews were analyzed using descriptive content analysis. Family provided the overall context and background for emerging themes of defining events, accomplishments, and God's plan, which led to lessons learned, and resulted in messages of hope. Interviews were often autobiographical in nature and contained much reminiscence, consistent with dignity therapy's intent. Few participants spoke about their cancer diagnoses during the interview. This study adds unique insight into the use of dignity therapy for those still receiving active cancer treatment, different from work by others in which it was offered only at end of life. As part of supportive care, clinicians need to validate the importance of family to those with advanced cancer and to provide opportunities for patients to share what they have learned throughout life and to impart messages of hope to those closest to them.

  2. Targeted nanosystems: Advances in targeted dendrimers for cancer therapy.

    PubMed

    Yang, Hu

    2016-02-01

    Dendrimers possess discrete highly compact nanostructures constituted of successive branched layers. Soon after the inception of dendrimers, recognition of their tunable structures and biologically favorable properties provoked a great enthusiasm in delving deeply into the utility of dendrimers for biomedical and pharmaceutical applications. One of the most important nanotechnology applications is the development of nanomedicines for targeted cancer therapies. Tremendous success in targeted therapies has been achieved with the use of dendrimer-based nanomedicines. This article provides a concise review on latest advances in the utility of dendrimers in immunotherapies and hormone therapies. Much basic and clinical research has been done since the invention of dendrimers, which are highly branched nano-sized molecules with the ability to act as carriers in nanomedicine. In this concise review article, the authors highlighted the current use of dendrimers in immunotherapies and hormone therapies in the fight against cancers. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Advances in Induced Pluripotent Stem Cells, Genomics, Biomarkers, and Antiplatelet Therapy

    PubMed Central

    Barbato, Emanuele; Lara-Pezzi, Enrique; Stolen, Craig; Taylor, Angela; Barton, Paul J.; Bartunek, Jozef; Iaizzo, Paul; Judge, Daniel P.; Kirshenbaum, Lorrie; Blaxall, Burns C.; Terzic, Andre; Hall, Jennifer L.

    2014-01-01

    The Journal provides the clinician and scientist with the latest advances in discovery research, emerging technologies, pre-clinical research design and testing, and clinical trials. We highlight advances in areas of induced pluripotent stem cells, genomics, biomarkers, multi-modality imaging and antiplatelet biology and therapy. The top publications are critically discussed and presented along with anatomical reviews and FDA insight to provide context. PMID:24659088

  4. Nanoparticles for cancer gene therapy: Recent advances, challenges, and strategies.

    PubMed

    Wang, Kui; Kievit, Forrest M; Zhang, Miqin

    2016-12-01

    Compared to conventional treatments, gene therapy offers a variety of advantages for cancer treatment including high potency and specificity, low off-target toxicity, and delivery of multiple genes that concurrently target cancer tumorigenesis, recurrence, and drug resistance. In the past decades, gene therapy has undergone remarkable progress, and is now poised to become a first line therapy for cancer. Among various gene delivery systems, nanoparticles have attracted much attention because of their desirable characteristics including low toxicity profiles, well-controlled and high gene delivery efficiency, and multi-functionalities. This review provides an overview on gene therapeutics and gene delivery technologies, and highlight recent advances, challenges and insights into the design and the utility of nanoparticles in gene therapy for cancer treatment. Copyright © 2016. Published by Elsevier Ltd.

  5. Clinical trials update from the Heart Failure Society of America: EMOTE, HERB-CHF, BEST genetic sub-study and RHYTHM-ICD.

    PubMed

    Lalukota, Krishna; Cleland, John G F; Ingle, Lee; Clark, Andrew L; Coletta, Alison P

    2004-12-01

    This article summarises key presentations relevant to the pathophysiology, prevention or treatment of heart failure, from the Heart Failure Society of America annual meeting held in Toronto, Canada. Data from the EnoxiMone in intravenous inOTropE-dependent subjects (EMOTE) study suggest that the oral PDE-3 inhibitor enoximone may be effective for weaning severe heart failure patients from intravenous inotropic therapy. Hawthorn Extract Randomised Blinded Trial in CHF (HERB-CHF) failed to show a benefit of hawthorn extract added to conventional heart failure therapy. A genetic sub-group analysis of the Blocker Evaluation of Survival Trial (BEST) study showed that bucindolol reduced mortality and hospitalisations in patients who were homozygous for the Arg389 variant of the beta(1) adrenoceptor. In the Resynchronisation Hemodynamic Treatment for Heart Failure Management (RHYTHM-ICD) study, patients randomised to cardiac resynchronisation therapy (CRT) showed an improvement in symptoms and functional capacity compared to the control group.

  6. Leisure-time activities of patients with ICDs: findings of a survey with respect to sports activity, high altitude stays, and driving patterns.

    PubMed

    Kobza, Richard; Duru, Firat; Erne, Paul

    2008-07-01

    Physicians who are caring for patients with implantable cardioverter-defibrillators (ICDs) are regularly confronted with questions concerning daily activities. This study evaluates the habits of ICD patients with respect to sports activities, stays at high-altitude, and driving patterns. A survey was performed in 387 patients with ICDs who were followed at two hospitals in Switzerland. The special-designed questionnaire addressed lifestyle practices concerning sports activity, high-altitude visits, and driving motor vehicles. Fifty-nine percent of ICD patients participated in some kind of sports activity; an ICD shock was experienced in 14% of these patients. Fifty-six percent of the patients reported a stay at high altitudes at least 2,000 m above the sea level; 11% of them stayed regularly above 2,500 m; 4% of these patients experienced an ICD shock during high altitude stay. Seventy-nine percent of the patients drove a motor vehicle; 2% of them experienced an ICD shock during driving, but none of them reported loss of consciousness or a traffic accident. It is accepted that ICD patients disqualify for competitive sports. However, the patients may be encouraged to continue leisure-time physical activities at low-to-moderate intensity. Staying at high altitudes and driving motor vehicles are very rarely associated with ICD shocks. Therefore, these activities that are likely to contribute to a better quality of life should not be discouraged in most ICD recipients in the absence of other medical reasons.

  7. Right versus left parasternal electrode position in the entirely subcutaneous ICD.

    PubMed

    Bettin, Markus; Dechering, Dirk; Frommeyer, Gerrit; Larbig, Robert; Löher, Andreas; Reinke, Florian; Köbe, Julia; Eckardt, Lars

    2018-05-01

    The subcutaneous implantable cardioverter defibrillator (S-ICD ® ) has been established as an alternative to conventional transvenous ICD for the prevention of sudden cardiac death. Initial studies have shown safety and efficacy of the system with a left parasternal (LP) electrode. However, several case studies reported a right parasternal (RP) position. The purpose of this study was to analyze shock efficacy and safety of an RP electrode position. Between June 2010 and May 2016, 120 S-ICD ® were implanted at our institution. On the basis of the heart location on preoperative chest radiography (CXR), the investigators decided on an RP (n = 52) or LP electrode position (n = 68). All perioperative induced VF episodes, and spontaneous appropriate and inappropriate episodes during follow-up were analyzed. Patients with an RP electrode did not differ in terms of age, sex, or ejection fraction. A statistically significant difference in underlying cardiac disease was observed between the RP and LP electrode group, with more patients with channelopathies in the RP electrode group and more patients with non-ischemic cardiomyopathy in the LP electrode group. During a mean follow-up of 24.3 ± 19.5 months, 27 appropriate (19 in the LP group and 8 in the RP group) and 28 inappropriate (18 LP and 10 RP) ICD shocks occurred (p value = NS). In the present study, an RP electrode position was chosen on the basis of chest radiographic characteristics and was efficient in terms of sensing and shock efficacy. Thus, a right-sided electrode implant might be an alternative if a left-sided electrode implant is inadequate. It might also be favorable for young patients with narrow heart silhouettes in the midsagittal position.

  8. Comparison of ICD-10 and DC: 0-3R Diagnoses in Infants, Toddlers and Preschoolers

    ERIC Educational Resources Information Center

    Equit, Monika; Paulus, Frank; Fuhrmann, Pia; Niemczyk, Justine; von Gontard, Alexander

    2011-01-01

    The purpose of this study was to analyze and compare diagnoses of patients from a special outpatient department for infants, toddlers and preschoolers. Specifically, overlap, age and gender differences according to the two classification systems DC: 0-3R and ICD-10 were examined. 299 consecutive children aged 0-5;11 years received both ICD-10 and…

  9. Live Virtual Constructive (LVC): Interface Control Document (ICD) for the LVC Gateway. [Flight Test 3

    NASA Technical Reports Server (NTRS)

    Jovic, Srba

    2015-01-01

    This Interface Control Document (ICD) documents and tracks the necessary information required for the Live Virtual and Constructive (LVC) systems components as well as protocols for communicating with them in order to achieve all research objectives captured by the experiment requirements. The purpose of this ICD is to clearly communicate all inputs and outputs from the subsystem components.

  10. Comparison of ICD code-based diagnosis of obesity with measured obesity in children and the implications for health care cost estimates.

    PubMed

    Kuhle, Stefan; Kirk, Sara F L; Ohinmaa, Arto; Veugelers, Paul J

    2011-12-21

    Administrative health databases are a valuable research tool to assess health care utilization at the population level. However, their use in obesity research limited due to the lack of data on body weight. A potential workaround is to use the ICD code of obesity to identify obese individuals. The objective of the current study was to investigate the sensitivity and specificity of an ICD code-based diagnosis of obesity from administrative health data relative to the gold standard measured BMI. Linkage of a population-based survey with anthropometric measures in elementary school children in 2003 with longitudinal administrative health data (physician visits and hospital discharges 1992-2006) from the Canadian province of Nova Scotia. Measured obesity was defined based on the CDC cut-offs applied to the measured BMI. An ICD code-based diagnosis obesity was defined as one or more ICD-9 (278) or ICD-10 code (E66-E68) of obesity from a physician visit or a hospital stay. Sensitivity and specificity were calculated and health care cost estimates based on measured obesity and ICD-based obesity were compared. The sensitivity of an ICD code-based obesity diagnosis was 7.4% using ICD codes between 2002 and 2004. Those correctly identified had a higher BMI and had higher health care utilization and costs. An ICD diagnosis of obesity in Canadian administrative health data grossly underestimates the true prevalence of childhood obesity and overestimates the health care cost differential between obese and non-obese children.

  11. Integrative and complementary therapies for patients with advanced cancer.

    PubMed

    Marchand, Lucille

    2014-07-01

    In integrative medicine, well-being is emphasized, and in palliative care, quality of life (QOL) is a similar concept or goal. Both can occur despite advanced cancer. Integrative medicine serves to combine the best of alternative, complementary and conventional therapies to optimize well-being and QOL, whether or not a person is at the end of their life. When integrative medicine is combined with palliative care modalities, the toolbox to provide symptom control and well-being or QOL is increased or broadened. Palliative care and integrative medicine are best provided early in the trajectory of illness such as cancer, and increase in amount as the illness progresses toward end of life. In cancer care, symptoms of the cancer, as well as symptoms produced by cancer therapies, are addressed with conventional and integrative therapies. Goals of care change as the disease progresses, and a patient's unique situation creates a different balance of integrative and conventional therapies. Integrative therapies such as music, aromatherapy, and massage might appeal to more patients than more specific, less common integrative therapies that might be more expensive, or seem more unusual such as Ayurvedic medicine and energy modalities. Each person may be drawn to different integrative modalities depending on factors such as cultural traditions, beliefs, lifestyle, internet information, advice from family and friends, books, etc. This review focuses on how integrative and complementary modalities can be included in comprehensive palliative care for patients with advanced malignancies. Nutrition and movement, often neglected in conventional treatment strategies, will also be included in the larger context of integrative and palliative modalities. Both conventional and integrative modalities in palliative care help patients live with empowerment, hope, and well-being no matter how long their lives last. A comprehensive review of all integrative and complementary therapies is

  12. START: an advanced radiation therapy information system.

    PubMed

    Cocco, A; Valentini, V; Balducci, M; Mantello, G

    1996-01-01

    START is an advanced radiation therapy information system (RTIS) which connects direct information technology present in the devices with indirect information technology for clinical, administrative, information management integrated with the hospital information system (HIS). The following objectives are pursued: to support decision making in treatment planning and functional and information integration with the rest of the hospital; to enhance organizational efficiency of a Radiation Therapy Department; to facilitate the statistical evaluation of clinical data and managerial performance assessment; to ensure the safety and confidentiality of used data. For its development a working method based on the involvement of all operators of the Radiation Therapy Department, was applied. Its introduction in the work activity was gradual, trying to reuse and integrate the existing information applications. The START information flow identifies four major phases: admission, visit of admission, planning, therapy. The system main functionalities available to the radiotherapist are: clinical history/medical report linking function; folder function; planning function; tracking function; electronic mail and banner function; statistical function; management function. Functions available to the radiotherapy technician are: the room daily list function; management function: to the nurse the following functions are available: patient directing function; management function. START is a departmental client (pc-windows)-server (unix) developed on an integrated database of all information of interest (clinical, organizational and administrative) coherent with the standard and with a modular architecture which can evolve with additional functionalities in subsequent times. For a more thorough evaluation of its impact on the daily activity of a radiation therapy facility, a prolonged clinical validation is in progress.

  13. [Treatment manual for psychotherapy of acute and posttraumatic stress disorders after multiple ICD shocks].

    PubMed

    Jordan, J; Titscher, G; Kirsch, H

    2011-09-01

    In view of the inceasing number of implanted defibrillators in all industrial nations, the number of people who have suffered so-called multiple shocks (electrical storm, ES) also increases. Common complaints are severe and continuously recurrent massive anxiety, panic attacks, fear of death, helplessness and hopelessness, depression, nervosity and irritability as well as reclusive and uncontrollable avoidance behaviour, intrusions, nightmares, flashbacks, sleeplessness and the inability to show feelings and limitation of future perspectives. Because people with an ICD are often physically (very) ill and after multiple ICD shocks are additionally very insecure, it would seem logical if the inpatient treatment would be carried out in an institution which has close connections and is also spatially close to a cardiology department. The basis of the diagnostics is the clinical anamnesis and a systematic exploration of the trauma situation and the resulting complaints. As an additional diagnostic element psychological test procedures should be implemented to determine the core symptomatic (anxiety, depression, trauma symptoms). Psychological test procedures should be included in the diagnostics so that at the end of treatment it is obvious even to the patient which alterations have occurred. The core element of inpatient treatment is daily intensive psychotherapy and includes deep psychologically well-founded psychotherapy and behavioral therapeutic-oriented anxiety therapy as well as cognitive restructuring and elements of eye movement desensitization and reprocessing (EMDR). A follow-up examination within 4 months of the multiple shocks episode is recommended because symptoms of posttraumatic stress disorder often occur after a long latent time period.

  14. DSM-IV, DSM-5, and ICD-11: Identifying children with posttraumatic stress disorder after disasters.

    PubMed

    Danzi, BreAnne A; La Greca, Annette M

    2016-12-01

    Different criteria for diagnosing posttraumatic stress disorder (PTSD) have been recommended by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and the proposed 11th edition of the International Classification of Diseases (ICD-11). Although children are vulnerable to PTSD following disasters, little is known about whether these revised criteria are appropriate for preadolescents, as diagnostic revisions have been based primarily on adult research. This study investigated rates of PTSD using DSM-IV, DSM-5, and ICD-11 diagnostic criteria, and their associations with symptom severity, impairment, and PTSD risk factors. Children (7-11 years) exposed to Hurricanes Ike (n = 327) or Charley (n = 383) completed measures 8-9 months postdisaster. Using diagnostic algorithms for DSM-IV, DSM-5, and ICD-11, rates of 'probable' PTSD were calculated. Across samples, rates of PTSD were similar. However, there was low agreement across the diagnostic systems, with about a third overlap in identified cases. Children identified only by ICD-11 had higher 'core' symptom severity but lower impairment than children identified only by DSM-IV or DSM-5. ICD-11 was associated with more established risk factors for PTSD than was DSM-5. Findings revealed differences in PTSD diagnosis across major diagnostic systems for preadolescent children, with no clear advantage to any one system. Further research on developmentally sensitive PTSD criteria for preadolescent children is needed. © 2016 Association for Child and Adolescent Mental Health.

  15. Concordances and discrepancies between ICD-10 and DSM-IV criteria for anxiety disorders in childhood and adolescence

    PubMed Central

    2012-01-01

    Background Mental disorders are classified by two major nosological systems, the ICD-10 and the DSM-IV-TR, consisting of different diagnostic criteria. The present study investigated the diagnostic concordance between the two systems for anxiety disorders in childhood and adolescence, in particular for separation anxiety disorder (SAD), specific phobia, social phobia, and generalized anxiety disorder (GAD). Methods A structured clinical interview, the Kinder-DIPS, was administered to 210 children and 258 parents. The percentage of agreement, kappa, and Yule’s Y coefficients were calculated for all diagnoses. Specific criteria causing discrepancies between the two classification systems were identified. Results DSM-IV-TR consistently classified more children than ICD-10 with an anxiety disorder, with a higher concordance between DSM-IV-TR and the ICD-10 child section (F9) than with the adult section (F4) of the ICD-10. This result was found for all four investigated anxiety disorders. The results revealed low to high levels of concordance and poor to good agreement between the classification systems, depending on the anxiety disorder. Conclusions The two classification systems identify different children with an anxiety disorder. However, it remains an open question, whether the research results can be generalized to clinical practice since DSM-IV-TR is mainly used in research while ICD-10 is widely established in clinical practice in Europe. Therefore, the population investigated by the DSM (research population) is not identical with the population examined using the ICD (clinical population). PMID:23267678

  16. A new humanized in vivo model of KIT D816V+ advanced systemic mastocytosis monitored using a secreted luciferase

    PubMed Central

    Bibi, Siham; Zhang, Yanyan; Hugonin, Caroline; Mangean, Mallorie Depond; He, Liang; Wedeh, Ghaith; Launay, Jean-Marie; Van Rijn, Sjoerd; Würdinger, Thomas; Louache, Fawzia; Arock, Michel

    2016-01-01

    Systemic mastocytosis are rare neoplasms characterized by accumulation of mast cells in at least one internal organ. The majority of systemic mastocytosis patients carry KIT D816V mutation, which activates constitutively the KIT receptor. Patient with advanced forms of systemic mastocytosis, such as aggressive systemic mastocytosis or mast cell leukemia, are poorly treated to date. Unfortunately, the lack of in vivo models reflecting KIT D816V+ advanced disease hampers pathophysiological studies and preclinical development of new therapies for such patients. Here, we describe a new in vivo model of KIT D816V+ advanced systemic mastocytosis developed by transplantation of the human ROSAKIT D816V-Gluc mast cell line in NOD-SCID IL-2R g−/− mice, using Gaussia princeps luciferase as a reporter. Intravenous injection of ROSAKIT D816V-Gluc cells led, in 4 weeks, to engraftment in all injected primary recipient mice. Engrafted cells were found at high levels in bone marrow, and at lower levels in spleen, liver and peripheral blood. Disease progression was easily monitored by repeated quantification of Gaussia princeps luciferase activity in peripheral blood. This quantification evidenced a linear relationship between the number of cells injected and the neoplastic mast cell burden in mice. Interestingly, the secondary transplantation of ROSAKIT D816V-Gluc cells increased their engraftment capability. To conclude, this new in vivo model mimics at the best the features of human KIT D816V+ advanced systemic mastocytosis. In addition, it is a unique and convenient tool to study the kinetics of the disease and the potential in vivo activity of new drugs targeting neoplastic mast cells. PMID:27783996

  17. A new humanized in vivo model of KIT D816V+ advanced systemic mastocytosis monitored using a secreted luciferase.

    PubMed

    Bibi, Siham; Zhang, Yanyan; Hugonin, Caroline; Mangean, Mallorie Depond; He, Liang; Wedeh, Ghaith; Launay, Jean-Marie; Van Rijn, Sjoerd; Würdinger, Thomas; Louache, Fawzia; Arock, Michel

    2016-12-13

    Systemic mastocytosis are rare neoplasms characterized by accumulation of mast cells in at least one internal organ. The majority of systemic mastocytosis patients carry KIT D816V mutation, which activates constitutively the KIT receptor. Patient with advanced forms of systemic mastocytosis, such as aggressive systemic mastocytosis or mast cell leukemia, are poorly treated to date. Unfortunately, the lack of in vivo models reflecting KIT D816V+ advanced disease hampers pathophysiological studies and preclinical development of new therapies for such patients. Here, we describe a new in vivo model of KIT D816V+ advanced systemic mastocytosis developed by transplantation of the human ROSAKIT D816V-Gluc mast cell line in NOD-SCID IL-2R γ-/- mice, using Gaussia princeps luciferase as a reporter. Intravenous injection of ROSAKIT D816V-Gluc cells led, in 4 weeks, to engraftment in all injected primary recipient mice. Engrafted cells were found at high levels in bone marrow, and at lower levels in spleen, liver and peripheral blood. Disease progression was easily monitored by repeated quantification of Gaussia princeps luciferase activity in peripheral blood. This quantification evidenced a linear relationship between the number of cells injected and the neoplastic mast cell burden in mice. Interestingly, the secondary transplantation of ROSAKIT D816V-Gluc cells increased their engraftment capability. To conclude, this new in vivo model mimics at the best the features of human KIT D816V+ advanced systemic mastocytosis. In addition, it is a unique and convenient tool to study the kinetics of the disease and the potential in vivo activity of new drugs targeting neoplastic mast cells.

  18. Overexpression of the NADP+-specific isocitrate dehydrogenase gene (icdA) in citric acid-producing Aspergillus niger WU-2223L.

    PubMed

    Kobayashi, Keiichi; Hattori, Takasumi; Hayashi, Rie; Kirimura, Kohtaro

    2014-01-01

    In the tricarboxylic acid (TCA) cycle, NADP(+)-specific isocitrate dehydrogenase (NADP(+)-ICDH) catalyzes oxidative decarboxylation of isocitric acid to form α-ketoglutaric acid with NADP(+) as a cofactor. We constructed an NADP(+)-ICDH gene (icdA)-overexpressing strain (OPI-1) using Aspergillus niger WU-2223L as a host and examined the effects of increase in NADP(+)-ICDH activity on citric acid production. Under citric acid-producing conditions with glucose as the carbon source, the amounts of citric acid produced and glucose consumed by OPI-1 for the 12-d cultivation period decreased by 18.7 and 10.5%, respectively, compared with those by WU-2223L. These results indicate that the amount of citric acid produced by A. niger can be altered with the NADP(+)-ICDH activity. Therefore, NADP(+)-ICDH is an important regulator of citric acid production in the TCA cycle of A. niger. Thus, we propose that the icdA gene is a potentially valuable tool for modulating citric acid production by metabolic engineering.

  19. Systematic review of validated case definitions for diabetes in ICD-9-coded and ICD-10-coded data in adult populations.

    PubMed

    Khokhar, Bushra; Jette, Nathalie; Metcalfe, Amy; Cunningham, Ceara Tess; Quan, Hude; Kaplan, Gilaad G; Butalia, Sonia; Rabi, Doreen

    2016-08-05

    With steady increases in 'big data' and data analytics over the past two decades, administrative health databases have become more accessible and are now used regularly for diabetes surveillance. The objective of this study is to systematically review validated International Classification of Diseases (ICD)-based case definitions for diabetes in the adult population. Electronic databases, MEDLINE and Embase, were searched for validation studies where an administrative case definition (using ICD codes) for diabetes in adults was validated against a reference and statistical measures of the performance reported. The search yielded 2895 abstracts, and of the 193 potentially relevant studies, 16 met criteria. Diabetes definition for adults varied by data source, including physician claims (sensitivity ranged from 26.9% to 97%, specificity ranged from 94.3% to 99.4%, positive predictive value (PPV) ranged from 71.4% to 96.2%, negative predictive value (NPV) ranged from 95% to 99.6% and κ ranged from 0.8 to 0.9), hospital discharge data (sensitivity ranged from 59.1% to 92.6%, specificity ranged from 95.5% to 99%, PPV ranged from 62.5% to 96%, NPV ranged from 90.8% to 99% and κ ranged from 0.6 to 0.9) and a combination of both (sensitivity ranged from 57% to 95.6%, specificity ranged from 88% to 98.5%, PPV ranged from 54% to 80%, NPV ranged from 98% to 99.6% and κ ranged from 0.7 to 0.8). Overall, administrative health databases are useful for undertaking diabetes surveillance, but an awareness of the variation in performance being affected by case definition is essential. The performance characteristics of these case definitions depend on the variations in the definition of primary diagnosis in ICD-coded discharge data and/or the methodology adopted by the healthcare facility to extract information from patient records. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  20. Accuracy of ICD-10 Coding System for Identifying Comorbidities and Infectious Conditions Using Data from a Thai University Hospital Administrative Database.

    PubMed

    Rattanaumpawan, Pinyo; Wongkamhla, Thanyarak; Thamlikitkul, Visanu

    2016-04-01

    To determine the accuracy of International Statistical Classification of Disease and Related Health Problems, 10th Revision (ICD-10) coding system in identifying comorbidities and infectious conditions using data from a Thai university hospital administrative database. A retrospective cross-sectional study was conducted among patients hospitalized in six general medicine wards at Siriraj Hospital. ICD-10 code data was identified and retrieved directly from the hospital administrative database. Patient comorbidities were captured using the ICD-10 coding algorithm for the Charlson comorbidity index. Infectious conditions were captured using the groups of ICD-10 diagnostic codes that were carefully prepared by two independent infectious disease specialists. Accuracy of ICD-10 codes combined with microbiological dataf or diagnosis of urinary tract infection (UTI) and bloodstream infection (BSI) was evaluated. Clinical data gathered from chart review was considered the gold standard in this study. Between February 1 and May 31, 2013, a chart review of 546 hospitalization records was conducted. The mean age of hospitalized patients was 62.8 ± 17.8 years and 65.9% of patients were female. Median length of stay [range] was 10.0 [1.0-353.0] days and hospital mortality was 21.8%. Conditions with ICD-10 codes that had good sensitivity (90% or higher) were diabetes mellitus and HIV infection. Conditions with ICD-10 codes that had good specificity (90% or higher) were cerebrovascular disease, chronic lung disease, diabetes mellitus, cancer HIV infection, and all infectious conditions. By combining ICD-10 codes with microbiological results, sensitivity increased from 49.5 to 66%for UTI and from 78.3 to 92.8%for BS. The ICD-10 coding algorithm is reliable only in some selected conditions, including underlying diabetes mellitus and HIV infection. Combining microbiological results with ICD-10 codes increased sensitivity of ICD-10 codes for identifying BSI. Future research is

  1. Conventional and right-sided screening for subcutaneous ICD in a population with congenital heart disease at high risk of sudden cardiac death.

    PubMed

    Alonso, Pau; Osca, Joaquín; Rueda, Joaquín; Cano, Oscar; Pimenta, Pedro; Andres, Ana; Sancho, María José; Martinez, Luis

    2017-11-01

    Information regarding suitability for subcutaneous defibrillator (sICD) implantation in tetralogy of Fallot (ToF) and systemic right ventricle is scarce and needs to be further explored. The main objective of our study was to determine the proportion of patients with ToF and systemic right ventricle eligible for sICD with both, standard and right-sided screening methods. Secondary objectives were: (i) to study sICD eligibility specifically in patients at high risk of sudden cardiac death, (ii) to identify independent predictors for sICD eligibility, and (iii) to compare the proportion of eligible patients in a nonselected ICD population. We recruited 102 patients with ToF, 33 with systemic right ventricle, and 40 consecutive nonselected patients. Conventional electrocardiographic screening was performed as usual. Right-sided alternative screening was studied by positioning the left-arm and right-arm electrodes 1 cm right lateral of the xiphoid midline. The Boston Scientific ECG screening tool was utilized. In high-risk patients with ToF, eligibility was higher with right-sided screening in comparison with standard screening (61% vs. 44%; p = .018). Eligibility in high-risk right ventricle population was identical with both screening methods (77%, p = ns). The only independent predictor for sICD eligibility was QRS duration. In high-risk patients with ToF, right-sided implantation of the sICD could be an alternative to a conventional ICD. In patients with a systemic right ventricle, implantation of a sICD is an alternative to a conventional sICD. © 2017 Wiley Periodicals, Inc.

  2. Nanophotosensitizers toward advanced photodynamic therapy of Cancer.

    PubMed

    Lim, Chang-Keun; Heo, Jeongyun; Shin, Seunghoon; Jeong, Keunsoo; Seo, Young Hun; Jang, Woo-Dong; Park, Chong Rae; Park, Soo Young; Kim, Sehoon; Kwon, Ick Chan

    2013-07-01

    Photodynamic therapy (PDT) is a non-invasive treatment modality for selective destruction of cancer and other diseases and involves the colocalization of light, oxygen, and a photosensitizer (PS) to achieve photocytotoxicity. Although this therapeutic method has considerably improved the quality of life and life expectancy of cancer patients, further advances in selectivity and therapeutic efficacy are required to overcome numerous side effects related to classical PDT. The application of nanoscale photosensitizers (NPSs) comprising molecular PSs and nanocarriers with or without other biological/photophysical functions is a promising approach for improving PDT. In this review, we focus on four nanomedical approaches for advanced PDT: (1) nanocarriers for targeted delivery of PS, (2) introduction of active targeting moieties for disease-specific PDT, (3) stimulus-responsive NPSs for selective PDT, and (4) photophysical improvements in NPS for enhanced PDT efficacy. ► Conservation of normal tissues demands non-invasive therapeutic methods. ► PDT is a light-activated, non-invasive modality for selective destruction of cancers.► Success of PDT requires further advances to overcome the limitations of classical PDT. ►Nanophotosensitizers help improve target selectivity and therapeutic efficacy of PDT. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  3. Anti-angiogenic Therapy in Patients with Advanced Gastric and Gastroesophageal Junction Cancer: A Systematic Review

    PubMed Central

    Chen, Li-Tzong; Oh, Do-Youn; Ryu, Min-Hee; Yeh, Kun-Huei; Yeo, Winnie; Carlesi, Roberto; Cheng, Rebecca; Kim, Jongseok; Orlando, Mauro; Kang, Yoon-Koo

    2017-01-01

    Despite advancements in therapy for advanced gastric and gastroesophageal junction cancers, their prognosis remains dismal. Tumor angiogenesis plays a key role in cancer growth and metastasis, and recent studies indicate that pharmacologic blockade of angiogenesis is a promising approach to therapy. In this systematic review, we summarize current literature on the clinical benefit of anti-angiogenic agents in advanced gastric cancer. We conducted a systematic search of PubMed and conference proceedings including the American Society of Clinical Oncology, the European Society for Medical Oncology, and the European Cancer Congress. Included studies aimed to prospectively evaluate the efficacy and safety of anti-angiogenic agents in advanced gastric or gastroesophageal junction cancer. Each trial investigated at least one of the following endpoints: overall survival, progression-free survival/time to progression, and/or objective response rate. Our search yielded 139 publications. Forty-two met the predefined inclusion criteria. Included studies reported outcomes with apatinib, axitinib, bevacizumab, orantinib, pazopanib, ramucirumab, regorafenib, sorafenib, sunitinib, telatinib, and vandetanib. Second-line therapy with ramucirumab and third-line therapy with apatinib are the only anti-angiogenic agents so far shown to significantly improve survival of patients with advanced gastric cancer. Overall, agents that specifically target the vascular endothelial growth factor ligand or receptor have better safety profile compared to multi-target tyrosine kinase inhibitors. PMID:28052652

  4. Anti-angiogenic Therapy in Patients with Advanced Gastric and Gastroesophageal Junction Cancer: A Systematic Review.

    PubMed

    Chen, Li-Tzong; Oh, Do-Youn; Ryu, Min-Hee; Yeh, Kun-Huei; Yeo, Winnie; Carlesi, Roberto; Cheng, Rebecca; Kim, Jongseok; Orlando, Mauro; Kang, Yoon-Koo

    2017-10-01

    Despite advancements in therapy for advanced gastric and gastroesophageal junction cancers, their prognosis remains dismal. Tumor angiogenesis plays a key role in cancer growth and metastasis, and recent studies indicate that pharmacologic blockade of angiogenesis is a promising approach to therapy. In this systematic review, we summarize current literature on the clinical benefit of anti-angiogenic agents in advanced gastric cancer. We conducted a systematic search of PubMed and conference proceedings including the American Society of Clinical Oncology, the European Society for Medical Oncology, and the European Cancer Congress. Included studies aimed to prospectively evaluate the efficacy and safety of anti-angiogenic agents in advanced gastric or gastroesophageal junction cancer. Each trial investigated at least one of the following endpoints: overall survival, progression-free survival/time to progression, and/or objective response rate. Our search yielded 139 publications. Forty-two met the predefined inclusion criteria. Included studies reported outcomes with apatinib, axitinib, bevacizumab, orantinib, pazopanib, ramucirumab, regorafenib, sorafenib, sunitinib, telatinib, and vandetanib. Second-line therapy with ramucirumab and third-line therapy with apatinib are the only anti-angiogenic agents so far shown to significantly improve survival of patients with advanced gastric cancer. Overall, agents that specifically target the vascular endothelial growth factor ligand or receptor have better safety profile compared to multi-target tyrosine kinase inhibitors.

  5. Dysphagia after sequential chemoradiation therapy for advanced head and neck cancer.

    PubMed

    Goguen, Laura A; Posner, Marshall R; Norris, Charles M; Tishler, Roy B; Wirth, Lori J; Annino, Donald J; Gagne, Adele; Sullivan, Christopher A; Sammartino, Daniel E; Haddad, Robert I

    2006-06-01

    Assess impact of sequential chemoradiation therapy (SCRT) for advanced head and neck cancer (HNCA) on swallowing, nutrition, and quality of life. Prospective cohort study of 59 patients undergoing SCRT for advanced head and neck cancer. Follow-up median was 47.5 months. Regional Cancer Center. Median time to gastrostomy tube removal was 21 weeks. Eighteen of 23 patients who underwent modified barium swallow demonstrated aspiration; none developed pneumonia. Six of 7 with pharyngoesophageal stricture underwent successful dilatation. Functional Assessment of Cancer Therapy-Head and Neck Scale questionnaires at median 6 months after treatment revealed "somewhat" satisfaction with swallowing. At the time of analysis, 97% have the gastronomy tube removed and take soft/regular diet. Early after treatment dysphagia adversely affected weight, modified barium swallow results, and quality of life. Diligent swallow therapy, and dilation as needed, allowed nearly all patients to have their gastronomy tubes removed and return to a soft/regular diet. Dysphagia is significant after SCRT but generally slowly recovers 6 to 12 months after SCRT. C-4.

  6. Interaction between shock coils increased the incidence of inappropriate therapies and lead failure in implantable cardioverter defibrillator.

    PubMed

    El Garhy, Mohammad; Ohlow, Marc-Alexander; Lauer, Bernward

    Shock coil interaction in patients with multiple implantable cardioverter defibrillator (ICD) leads is occasionally observed. We aimed to evaluate the incidence of shock coil interaction and its clinical relevance. All ICD patients (646 patients) who came to follow up control in our ICD ambulance between January 1, 2011, and December 31, 2011 in the department of cardiology in Bad Berka hospital were retrospectively evaluated in this study. All baseline demographic, clinical, and procedural characteristics and postoperative chest x ray in postero-anterior and lateral view as well as clinical and ICD follow up data were evaluated. Among 646 patients 42 had multiple ICD leads (6.5%) of whom 36 patients (5.5% of total cohort patients and 85.7% of patients with multiple ICD leads) had shock coil interaction and presented the study group (Group I). The control group (Group II) consisted of 610 patients without coil-coil interaction including patients with single shock lead (604 patients) or patients with multiple leads but without interaction between shock coils (6 patients). Inappropriate anti-tachycardia therapies and RV lead revisions were more frequent in patients with interaction between shock coils (Group I vs Group II: 27.7% and 5.7%; p = 0.049 and 30.6% vs 6.4; p = 0.0001, respectively). Interaction between shock coils may be one of possible causes of lead failure and resulted in inappropriate therapies and subsequent lead revision. Copyright © 2018 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.

  7. TH-F-202-03: Advances in MRI for Radiation Therapy

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

    Cai, J.

    MRI has excellent soft tissue contrast and can provide both anatomical and physiological information. It is becoming increasingly important in radiation therapy for treatment planning, image-guided radiation therapy, and treatment assessment. It is critically important at this time point to educate and update our medical physicists about MRI to prepare for the upcoming surge of MRI applications in radiation therapy. This session will review important basics of MR physics, pulse sequence designs, and current radiotherapy application, as well as showcase exciting new developments in MRI that can be potentially useful in radiation therapy. Learning Objectives: To learn basics of MRmore » physics and understand the differences between various pulse sequences To review current applications of MRI in radiation therapy.To discuss recent MRI advances for future MRI guided radiation therapy Partly supported by NIH (1R21CA165384).; W. Miller, Research supported in part by Siemens Healthcare; G. Li, My clinical research is in part supported by NIH U54CA137788. I have a collaborative research project with Philips Healthcare.; J. Cai, jing cai.« less

  8. Comparing the dimensional structure and diagnostic algorithms between DSM-5 and ICD-11 PTSD in children and adolescents.

    PubMed

    Sachser, Cedric; Berliner, Lucy; Holt, Tonje; Jensen, Tine; Jungbluth, Nathaniel; Risch, Elizabeth; Rosner, Rita; Goldbeck, Lutz

    2018-02-01

    In contrast to the DSM-5, which expanded the posttraumatic stress disorder (PTSD) symptom profile to 20 symptoms, a workgroup of the upcoming ICD-11 suggested a reduced symptom profile with six symptoms for PTSD. Therefore, the objective of the study was to investigate the dimensional structure of DSM-5 and ICD-11 PTSD in a clinical sample of trauma-exposed children and adolescents and to compare the diagnostic rates of PTSD between diagnostic systems. The study sample consisted of 475 self-reports and 424 caregiver-reports on the child and adolescent trauma screen (CATS), which were collected at pediatric mental health clinics in the US, Norway and Germany. The factor structure of the PTSD construct as defined in the DSM-5 and in alternative models of both DSM-5 and ICD-11 was investigated using confirmatory factor analyses (CFA). To evaluate differences in PTSD prevalence, McNemar's tests for correlated proportions were used. CFA results demonstrated excellent model fit for the proposed ICD-11 model of PTSD. For the DSM-5 models we found the best fit for the hybrid model. Diagnostic rates were significantly lower according to ICD-11 (self-report: 23.4%; caregiver-report: 16.5%) compared with the DSM-5 (self-report: 37.8%; caregiver-report: 31.8%). Agreement was low between diagnostic systems. Study findings provide support for an alternative latent dimensionality of DSM-5 PTSD in children and adolescents. The conceptualization of ICD-11 PTSD shows an excellent fit. Inconsistent PTSD constructs and significantly diverging diagnostic rates between DSM-5 and the ICD-11 will result in major challenges for researchers and clinicians in the field of psychotraumatology.

  9. Gender-Related Differences in Outcomes of Patients with Cardiac Resynchronization Therapy.

    PubMed

    Nevzorov, Roman; Porter, Avital; Mostov, Shanie; Kazum, Shirit; Eisen, Alon; Goldenberg, Gustavo; Iakobishvili, Zaza; Kusniec, Jairo; Golovchiner, Gregory; Strasberg, Boris; Haim, Moti

    2018-05-01

    Gender-related differences (GRD) exist in the outcome of patients with cardiac resynchronization therapy (CRT). To assess GRD in patients who underwent CRT. A retrospective cohort of 178 patients who were implanted with a CRT in a tertiary center 2005-2009 was analyzed. Primary outcome was 1 year mortality. Secondary endpoints were readmission and complication rates. No statistically significant difference was found in 1 year mortality rates (14.6% males vs. 11.8% females, P = 0.7) or in readmission rate (50.7% vs. 41.2%, P = 0.3). The complication rate was only numerically higher in women (14.7% vs. 5.6%, P = 0.09). Men more often had CRT-defibrillator (CRT-D) implants (63.2% vs. 35.3%, P = 0.003) and had a higher rate of ischemic cardiomyopathy (79.2% vs. 38.2%, P < 0.001). There was a trend to higher incidence of ventricular fibrillation/ventricular tachycardia in men before CRT implantation (29.9% vs. 14.7%, P = 0.07%). A higher proportion of men upgraded from implantable cardioverter defibrillator (ICD) to CRT-D, 20.8% vs. 8.8%, P = 0.047. On multivariate model, chronic renal failure was an independent predictor of 1 year mortality (hazard ratio [HR] 3.6; 95% confidence interval [95%CI] 1.4-9.5), CRT-D had a protective effect compared to CRT-pacemaker (HR 0.3, 95%CI 0.12-0.81). No GRD was found in 1 year mortality or readmission rates in patients treated with CRT. There was a trend toward a higher complication rate in females. Men were implanted more often with CRT-D and more frequently underwent upgrading of ICD to CRT-D.

  10. [Advanced therapy: from European regulatory framework to national regulatory framework].

    PubMed

    Lucas-Samuel, S

    2013-05-01

    The European regulation n(o) 1394/2007/CE published on the 13th of November 2007 defined and harmonized the European regulatory framework for advanced therapy medicinal products. It creates a specialized committee located at the European Medicine Agency, in charge of the assessment of these medicinal products. The consequences of this regulation are introduced in the French regulation by the law n(o) 2011-302 published on the 22nd of March 2011. It detailed notably the possibility for public establishments (except health establishments) and nonprofit organisms to create pharmaceutical establishments. This law defined also a specific category of advanced therapy medicinal products, which fall under the "hospital exemption" framework. The rules regarding the authorizations of the establishments able to prepare these types of medicinal products and the authorization of the products are defined by the n(o) 2012-1236 decree published on the 6th of November 2012. Copyright © 2013. Published by Elsevier SAS.

  11. Epigenetics Advancing Personalized Nanomedicine in Cancer Therapy

    PubMed Central

    Liu, Shujun

    2012-01-01

    Personalized medicine aims to deliver the right drug to a right patient at the right time. It offers unique opportunities to integrate new technologies and concepts to disease prognosis, diagnosis and therapeutics. While selective personalized therapies are conceptually impressive, the majority of cancer therapies have dismal outcome. Such therapeutic failure could result from no response, drug resistance, disease relapse or severe side effect from improper drug delivery. Nanomedicine, the application of nanotechnology in medicine, has a potential to advance the identification of diagnostic and prognostic biomarkers and the delivery of right drug to disease sites. Epigenetic aberrations dynamically contribute to cancer pathogenesis. Given the individualized traits of epigenetic biomarkers, epigenetic considerations would significantly refine personalized nanomedicine. This review aims to dissect the interface of personalized medicine with nanomedicine and epigenetics. I will outline the progress and highlight challenges and areas that can be further explored perfecting the personalized health care. PMID:22921595

  12. Adapting a Clinical Data Repository to ICD-10-CM through the use of a Terminology Repository

    PubMed Central

    Cimino, James J.; Remennick, Lyubov

    2014-01-01

    Clinical data repositories frequently contain patient diagnoses coded with the International Classification of Diseases, Ninth Revision (ICD-9-CM). These repositories now need to accommodate data coded with the Tenth Revision (ICD-10-CM). Database users wish to retrieve relevant data regardless of the system by which they are coded. We demonstrate how a terminology repository (the Research Entities Dictionary or RED) serves as an ontology relating terms of both ICD versions to each other to support seamless version-independent retrieval from the Biomedical Translational Research Information System (BTRIS) at the National Institutes of Health. We make use of the Center for Medicare and Medicaid Services’ General Equivalence Mappings (GEMs) to reduce the modeling effort required to determine whether ICD-10-CM terms should be added to the RED as new concepts or as synonyms of existing concepts. A divide-and-conquer approach is used to develop integration heuristics that offer a satisfactory interim solution and facilitate additional refinement of the integration as time and resources allow. PMID:25954344

  13. Modeling Signaling Networks to Advance New Cancer Therapies.

    PubMed

    Saez-Rodriguez, Julio; MacNamara, Aidan; Cook, Simon

    2015-01-01

    Cell signaling pathways control cells' responses to their environment through an intricate network of proteins and small molecules partitioned by intracellular structures, such as the cytoskeleton and nucleus. Our understanding of these pathways has been revised recently with the advent of more advanced experimental techniques; no longer are signaling pathways viewed as linear cascades of information flowing from membrane-bound receptors to the nucleus. Instead, such pathways must be understood in the context of networks, and studying such networks requires an integration of computational and experimental approaches. This understanding is becoming more important in designing novel therapies for diseases such as cancer. Using the MAPK (mitogen-activated protein kinase) and PI3K (class I phosphoinositide-3' kinase) pathways as case studies of cellular signaling, we give an overview of these pathways and their functions. We then describe, using a number of case studies, how computational modeling has aided in understanding these pathways' deregulation in cancer, and how such understanding can be used to optimally tailor current therapies or help design new therapies against cancer.

  14. Interferon-Free Therapy in Elderly Patients With Advanced Liver Disease.

    PubMed

    Lens, Sabela; Fernández, Inmaculada; Rodríguez-Tajes, Sergio; Hontangas, Vanessa; Vergara, Mercedes; Forné, Montserrat; Calleja, Jose Luis; Diago, Moisés; Llaneras, Jordi; Llerena, Susana; Torras, Xavier; Sacristán, Begoña; Roget, Merce; Fernández-Rodríguez, Conrado Manuel; Navascués, Mari Carmen; Fuentes, Javier; Sánchez-Ruano, Juan-José; Simón, Miguel-Ángel; Sáez-Royuela, Federico; Baliellas, Carmen; Morillas, Rosa; Forns, Xavier

    2017-09-01

    Interferon-free therapies have an improved safety and efficacy profile. However, data in elderly patients, who have frequently advanced liver disease, associated comorbidities, and use concomitant medications are scarce. The im of this study was to assess the effectiveness and tolerability of all-oral regimens in elderly patients in real-life clinical practice. Retrospective analysis of hepatitis C virus (HCV) patients aged ≥65 years receiving interferon-free regimens within the Spanish National Registry (Hepa-C). Data of 1,252 patients were recorded. Of these, 955 (76%) were aged 65-74 years, 211 (17%) were aged 75-79 years, and 86 (7%) were aged ≥80 years at the start of antiviral therapy. HCV genotype-1b was predominant (88%) and 48% were previous non-responders. A significant proportion of patients had cirrhosis (922; 74%), of whom 11% presented decompensated liver disease. The most used regimens were SOF/LDV (33%), 3D (28%), and SOF/SMV (26%). Ribavirin was added in 49% of patients. Overall, the sustained virological response (SVR12) rate was 94% without differences among the three age categories. Albumin ≤3.5 g/dl was the only independent negative predictor of response (0.25 (0.15-0.41); P<0.01). Regarding tolerability, the rate of severe adverse events increased with age category (8.8, 13, and 14%; P=0.04). In addition, the main predictors of mortality (2.3%) were age ≥75 years (2.59 (1.16-5.83); P =0.02) and albumin ≤3.5 (17 (6.3-47); P <0.01). SVR rates with interferon-free regimens in elderly patients are high and comparable to the general population. Baseline low albumin levels (≤3.5 g/dl) was the only predictor of treatment failure. Importantly, the rate of severe adverse events and death increased with age. Elderly patients (≥75 years) or those with advanced liver disease (albumin ≤3.5) presented higher mortality. Thus a careful selection of patients for antiviral treatment is recommended.

  15. Amplification and overexpression of topoisomerase IIalpha predict response to anthracycline-based therapy in locally advanced breast cancer.

    PubMed

    Coon, John S; Marcus, Elizabeth; Gupta-Burt, Shalina; Seelig, Steven; Jacobson, Kris; Chen, Shande; Renta, Vivian; Fronda, Geraldo; Preisler, Harvey D

    2002-04-01

    The putative association between erbB-2 overexpression and favorable response to anthracyline-based therapy in breast cancer is controversial, and the mechanism unclear. We sought to determine whether coamplification and overexpression of the topoisomerase IIalpha gene, near erbB-2 on chromosome 17, and a known anthracycline target, may underlie the association. Thirty-five patients who had locally advanced breast cancer (LABC) and who had received neoadjuvant, anthracycline-based therapy were studied. Copy number of topoisomerase IIalpha and erbB-2 was determined by fluorescence in situ hybridization, and expression by immunohistochemistry. Of 8 patients with erbB-2 amplification, 5 had a complete response (CR) or minimal residual disease (MRD), 3 had a partial response (PR), and none had stable (StD) or progressive disease (PD) at the time of mastectomy, versus 3 CR or MRD, 16 PR, and 8 StD or PD for patients without amplification (P = 0.008). In contrast, erbB-2 overexpression was not significantly associated with response (P = 0.114). Of 6 patients with topoisomerase IIalpha amplification, 4 had CR or MRD, 2 PR, and none StD or PD, versus 4 CR or MRD, 17 PR, and 8 StD or PD for patients without amplification (P = 0.034). All of the tumors with topoisomerase IIalpha amplification also had erbB-2 amplification, but not vice versa. Overexpression of topoisomerase IIalpha (9 patients) was also associated with favorable response (P = 0.021). Coamplification of erbB-2 and topoisomerase IIalpha is significantly associated with favorable local response to anthracycline-based therapy in LABC. The expression data favor a plausible mechanism based on topoisomerase IIalpha biology.

  16. Implantable intravascular defibrillator: defibrillation thresholds of an intravascular cardioverter-defibrillator compared with those of a conventional ICD in humans.

    PubMed

    Neuzil, Petr; Reddy, Vivek Y; Merkely, Bela; Geller, Laszlo; Molnar, Levente; Bednarek, Jacek; Bartus, Krzysztof; Richey, Mark; Bsee, T J Ransbury; Sanders, William E

    2014-02-01

    A percutaneous intravascular cardioverter-defibrillator (PICD) has been developed with a right ventricular (RV) single-coil lead and titanium electrodes in the superior vena cava (SVC)-brachiocephalic vein (BCV) region and the inferior vena cava (IVC). To compare defibrillation thresholds (DFTs) of the PICD with those of a conventional ICD in humans. Ten patients with ischemic cardiomyopathy and ejection fraction ≤35% were randomized to initial testing with either PICD or conventional ICD. A standard dual-coil lead was positioned in the RV apex. If randomized to PICD, the device was placed into the vasculature such that 1 titanium electrode was positioned in the SVC-BCV region and the second in the IVC. For PICD DFTs, the RV coil of the conventional ICD lead was connected to the PICD mandrel [shock vector: RV (+) to SVC-BCV (-) + IVC (-)]. When testing the conventional ICD, a subcutaneous pocket was formed in the left pectoralis region and the ICD was connected to the lead system and positioned in the pocket [shock vector: RV (+) to SVC (-) + active can (-)]. Each device was removed before testing with the other. A step-down binary search protocol determined the DFT, with the initial shock being 9 J. The mean PICD DFT was 7.6 ± 3.3 J, and the conventional ICD system demonstrated a mean DFT of 9.5 ± 4.7 J (N = 10; paired t test, P = .28). The intravascular defibrillator has DFTs similar to those of commercially available ICDs. Published by Heart Rhythm Society on behalf of Heart Rhythm Society.

  17. International variation in the definition of 'main condition' in ICD-coded health data.

    PubMed

    Quan, H; Moskal, L; Forster, A J; Brien, S; Walker, R; Romano, P S; Sundararajan, V; Burnand, B; Henriksson, G; Steinum, O; Droesler, S; Pincus, H A; Ghali, W A

    2014-10-01

    Hospital-based medical records are abstracted to create International Classification of Disease (ICD) coded discharge health data in many countries. The 'main condition' is not defined in a consistent manner internationally. Some countries employ a 'reason for admission' rule as the basis for the main condition, while other countries employ a 'resource use' rule. A few countries have recently transitioned from one of these approaches to the other. The definition of 'main condition' in such ICD data matters when it is used to define a disease cohort to assign diagnosis-related groups and to perform risk adjustment. We propose a method of harmonizing the international definition to enable researchers and international organizations using ICD-coded health data to aggregate or compare hospital care and outcomes across countries in a consistent manner. Inter-observer reliability of alternative harmonization approaches should be evaluated before finalizing the definition and adopting it worldwide. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  18. The impact of changes in LVEF and renal function on the prognosis of ICD patients after elective device replacement.

    PubMed

    Vandenberk, Bert; Robyns, Tomas; Garweg, Christophe; Floré, Vincent; Foulon, Stefaan; Voros, Gabor; Ector, Joris; Willems, Rik

    2017-10-01

    A proportion of patients with an implantable cardioverter-defibrillator (ICD) in prevention of sudden cardiac death will only receive their first appropriate ICD therapy (AT) after device replacement. Clinical reassessment at the time of replacement could be helpful to guide the decision to replace or not in the future. All patients with an ICD for primary or secondary prevention in ischemic (ICM) or nonischemic cardiomyopathy were included in a single-center retrospective registry. The association of changes in left ventricular ejection fraction (LVEF; cut-off at 35%), worsening renal function (decrease in estimated glomerular filtration rate > 15 mL/min), and worsening New York Heart Association class at elective device replacement with mortality and AT was analyzed using adjusted Cox regression analysis. A total of 238 (33%) out of 727 patients received elective device replacement (86.1% male, 74.4% ICM, 42.9% primary prevention). During this replacement 20.2% received a device upgrade. The mean time to replacement was 6.4 ± 2.0 years and mean follow-up after replacement was 3.4 ± 3.0 years. Of patients who did not receive AT before replacement 23.1% received their first AT after replacement. Worsening renal function (hazard ratio [HR] 2.79, 95% confidence interval [CI] 1.50-5.18) and a consistently LVEF ≤35% compared to a consistently LVEF >35% (HR 2.15, 95% CI 1.10-4.19) at the time of replacement were independent predictors of mortality. Independent predictors of first AT after replacement could not be identified. Although reassessment of LVEF and renal function at replacement can be helpful in predicting total mortality, the clinical utility to guide reimplantation seemed limited. Our experience indicates that approximately 25% of patients received their first AT only after replacement. © 2017 Wiley Periodicals, Inc.

  19. Gender, Racial, and Health Insurance Differences in the Trend of Implantable Cardioverter-Defibrillator (ICD) Utilization: A United States Experience Over the Last Decade.

    PubMed

    Patel, Nileshkumar J; Edla, Sushruth; Deshmukh, Abhishek; Nalluri, Nikhil; Patel, Nilay; Agnihotri, Kanishk; Patel, Achint; Savani, Chirag; Patel, Nish; Bhimani, Ronak; Thakkar, Badal; Arora, Shilpkumar; Asti, Deepak; Badheka, Apurva O; Parikh, Valay; Mitrani, Raul D; Noseworthy, Peter; Paydak, Hakan; Viles-Gonzalez, Juan; Friedman, Paul A; Kowalski, Marcin

    2016-02-01

    Prior studies have highlighted disparities in cardiac lifesaving procedure utilization, particularly among women and in minorities. Although there has been a significant increase in implantable cardioverter-defibrillator (ICD) insertion, socioeconomic disparities still exist in the trend of ICD utilization. With the use of the Nationwide Inpatient Sample from 2003 through 2011, we identified subjects with ICD insertion (procedure code 37.94) and cardiac resynchronization defibrillator (procedure code 00.50, 00.51) as codified by the International Classification of Diseases, Ninth Revision, Clinical Modification. Overall, 1 020 076 ICDs were implanted in the United States from 2003 to 2011. We observed an initial increase in ICD utilization by 51%, from 95 062 in 2003 to 143 262 in 2006, followed by a more recent decline. The majority of ICDs were implanted in men age ≥65 years. Implantation of ICDs was 2.5× more common in men than in women (402 per million vs 163 per million). Approximately 95% of the ICDs were implanted in insured patients, and 5% were used in the uninsured population. There has been a significant increase in ICD implantation in blacks, from 162 per million in 2003 to 291 per million in 2011. We found a significant difference in the volume of ICD implants between the insured and the uninsured patient populations. Racial disparities have narrowed significantly in comparison with those noted in earlier studies and are now more reflective of the population demographics at large. On the other hand, significant gender disparities continue to exist. © 2016 Wiley Periodicals, Inc.

  20. Implantable defibrillators configured for hybrid therapy of persistent and permanent atrial fibrillation: initial clinical experience with a novel lead system.

    PubMed

    Rao, Hygriv B; Saksena, Sanjeev

    2005-08-01

    Hybrid therapy strategies have combined antiarrhythmic drugs (AAD) with pacemakers, atrio-ventricular defibrillators (AV ICD) or atrial ablation individually. The feasibility combining AAD with dual site RA pacing (DAP) in an AV ICD has not been examined. We used an AV ICD with a novel lead configuration permitting DAP, antitachycardia pacing (ATP) or atrial shocks (ADF) in patients (pts) with refractory persistent or permanent AF. Hybrid therapy included linear RA ablation and/or focal ablation. Continuous DAP and automatic ATP with patient or physician activated ADF. 24 pts, mean age 66 +/- 10 yrs, with cardiac disease (22 pts), underwent insertion of an AVICD with dual RA leads. 20 patients had concomitant ablative procedures (RA only = 19, RA + LA = 1) and all pts continued previously ineffective AAD. During a follow-up of 2-36 months (mean 17 +/- 8 mos), rhythm control was restored in all pts & maintained long-term in 19 (83%) pts. 8 pts used AF termination therapies successfully. Device datalogs showed no episodes of AF in 6 pts, asymptomatic brief arrhythmias in 4 pts, infrequent paroxysmal AF in 9 pts & persistent AF recurred in 5 pts. AV ICD detection algorithms reliably detected AF or AT in the DAP mode in all pts. Intermittent brief P wave double counting occurred during AT in selected pts. No pt received inappropriate ADF therapy. 1. DAP can be safely incorporated in an AVICD devices for use in an hybrid therapy strategy for AF pts. 2. These devices can be effective for both AF prevention & termination. 3. Long term rhythm control can be achieved and documented by device datalogs in persistent and permanent AF.

  1. Recent Advances in Monoclonal Antibody Therapies for Multiple Sclerosis.

    PubMed

    Wootla, Bharath; Watzlawik, Jens O; Stavropoulos, Nikolaos; Wittenberg, Nathan J; Dasari, Harika; Abdelrahim, Murtada A; Henley, John R; Oh, Sang-Hyun; Warrington, Arthur E; Rodriguez, Moses

    2016-06-01

    Multiple sclerosis (MS) is the most common chronic inflammatory, demyelinating disease of the CNS and results in neurological disability. Existing immunomodulatory and immunosuppressive approaches lower the number of relapses but do not cure or reverse existing deficits nor improve long-term disability in MS patients. Monogenic antibodies were described as treatment options for MS, however the immunogenicity of mouse antibodies hampered the efficacy of potential therapeutics in humans. Availability of improved antibody production technologies resulted in a paradigm shift in MS treatment strategies. In this review, an overview of immunotherapies for MS that use conventional monoclonal antibodies reactive to immune system and their properties and mechanisms of action will be discussed, including recent advances in MS therapeutics and highlight natural autoantibodies (NAbs) that directly target CNS cells. Recent challenges for MS therapy are the identification of relevant molecular and cellular targets, time frame of treatment, and antibody toxicity profiles to identify safe treatment options for MS patients. The application of monoclonal antibody therapies with better biological efficacy associated with minimum side effects possesses huge clinical potential. Advances in monoclonal antibody technologies that directly target cells of nervous system may promote the CNS regeneration field from bench to bedside.

  2. ICDE Librarians' Roundtable (Hong Kong, October 11-12, 1999).

    ERIC Educational Resources Information Center

    Wai-man, Wong; Schafer, Steve; Watson, Elizabeth F.; Tai-loon, Fong

    The International Council for Open and Distance Education (ICDE) Librarians' Roundtable is the first of its kind for librarians of international distance and open education institutions to exchange their views on how to cope with the development of their institutions in the use of new technology, and in the provision of library services to…

  3. Chronic lymphocytic leukemia skin infiltration mimicking an ICD pocket infection: a case report.

    PubMed

    Snorek, M; Bulava, A; Vonke, I

    2017-03-24

    We are presenting a case report on an unreported and unusual cutaneous manifestation of chronic lymphocytic leukemia in a patient with an implantable cardioverter-defibrillator (ICD). A 65-year-old man with a history of chronic lymphocytic leukemia (CLL), previously treated with chlorambucil, was referred in October 2013 for extraction of a single chamber ICD due to a suspected device-related infection in the pulse generator area (left-hand side of Fig. 1). The ICD system (Current VR, St. Jude Medical, USA) had been implanted in November 2009. The patient complained of painless erythema with pruritus in the pocket area. Inflammatory blood parameters were C-reactive protein 17.3 mg/L and leucocytes 29.0 × 10 9 /L. Due to the atypical appearance of the pocket area we did not extract the device. Instead, we created an exploratory excision in the skin induration, which had been present for approximately 6 weeks, and conducted a microbiological and histological examination. All cultivation examinations were negative. However, we did histologically show skin infiltration by CD-5 positive low-grade B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma (B-CLL/SLL). Re-initiation of chemotherapy was not necessary and the skin induration completely disappeared within 2 months (right-hand side of Fig. 1). Complete removal of an ICD system carries considerable risk. In patients with a history of hematological disease, it is crucial to exclude cutaneous manifestations of the disease prior to device removal.

  4. Audits for advanced treatment dosimetry

    NASA Astrophysics Data System (ADS)

    Ibbott, G. S.; Thwaites, D. I.

    2015-01-01

    Radiation therapy has advanced rapidly over the last few decades, progressing from 3D conformal treatment to image-guided intensity modulated therapy of several different flavors, both 3D and 4D and to adaptive radiotherapy. The use of intensity modulation has increased the complexity of quality assurance and essentially eliminated the physicist's ability to judge the validity of a treatment plan, even approximately, on the basis of appearance and experience. Instead, complex QA devices and procedures are required at the institutional level. Similarly, the assessment of treatment quality through remote and on-site audits also requires greater sophistication. The introduction of 3D and 4D dosimetry into external audit systems must follow, to enable quality assurance systems to perform meaningful and thorough audits.

  5. Immunologic advances in monoclonal antibody therapy: implications for oncology nursing.

    PubMed

    Karius, D; Marriott, M A

    1997-04-01

    To provide an overview of monoclonal antibody (MoAb) formation, therapeutic and diagnostic uses of MoAbs, and the implications for oncology nurses. Books and Journal articles (including research studies). Clinical trials have demonstrated the diagnostic and therapeutic potential of MoAb therapy. Advances in hybridoma technology and gene-splicing techniques have led to the formation of chimeric MoAbs, which exhibit decreased immunogenicity in the recipient. Clinical limitations with MoAb therapy include cross-reactivity with normal tissues, heterogeneity of antigen expression, presence of circulating antigen, antigenic modulation, tumor size and vascularity, and the anti-antibody response. MoAbs currently are used for diagnostic purposes and in phase I, II, and III clinical trials for cancer treatment. As research progresses, MoAbs are likely to be incorporated into the mainstream of cancer therapy as have other biologic response modifiers. Current uses of MoAb therapy in clinical trials involve nurses in many roles, including clinical nurse specialist, staff nurse, and research nurse. As more oncology nurses encounter MoAb therapy in practice, they will have to have an increased understanding of basic immunologic principles and the expertise to manage the unique toxicities associated with MoAb therapy.

  6. International variation in the definition of ‘main condition’ in ICD-coded health data

    PubMed Central

    Quan, H.; Moskal, L.; Forster, A.J.; Brien, S.; Walker, R.; Romano, P.S.; Sundararajan, V.; Burnand, B.; Henriksson, G.; Steinum, O.; Droesler, S.; Pincus, H.A.; Ghali, W.A.

    2014-01-01

    Hospital-based medical records are abstracted to create International Classification of Disease (ICD) coded discharge health data in many countries. The ‘main condition’ is not defined in a consistent manner internationally. Some countries employ a ‘reason for admission’ rule as the basis for the main condition, while other countries employ a ‘resource use’ rule. A few countries have recently transitioned from one of these approaches to the other. The definition of ‘main condition’ in such ICD data matters when it is used to define a disease cohort to assign diagnosis-related groups and to perform risk adjustment. We propose a method of harmonizing the international definition to enable researchers and international organizations using ICD-coded health data to aggregate or compare hospital care and outcomes across countries in a consistent manner. Inter-observer reliability of alternative harmonization approaches should be evaluated before finalizing the definition and adopting it worldwide. PMID:24990594

  7. Complex PTSD as Proposed for ICD-11: Validation of a New Disorder in Children and Adolescents and Their Response to Trauma-Focused Cognitive Behavioral Therapy

    ERIC Educational Resources Information Center

    Sachser, Cedric; Keller, Ferdinand; Goldbeck, Lutz

    2017-01-01

    Background: To evaluate whether the symptoms of children and adolescents with clinically significant posttraumatic stress symptoms (PTSS) form classes consistent with the diagnostic criteria of complex PTSD (CPTSD) as proposed for the ICD-11, and to relate the emerging classes with treatment outcome of Trauma-Focused Cognitive Behavioral Therapy…

  8. Constructing a classification of hypersensitivity/allergic diseases for ICD-11 by crowdsourcing the allergist community.

    PubMed

    Tanno, L K; Calderon, M A; Goldberg, B J; Gayraud, J; Bircher, A J; Casale, T; Li, J; Sanchez-Borges, M; Rosenwasser, L J; Pawankar, R; Papadopoulos, N G; Demoly, P

    2015-06-01

    The global allergy community strongly believes that the 11th revision of the International Classification of Diseases (ICD-11) offers a unique opportunity to improve the classification and coding of hypersensitivity/allergic diseases via inclusion of a specific chapter dedicated to this disease area to facilitate epidemiological studies, as well as to evaluate the true size of the allergy epidemic. In this context, an international collaboration has decided to revise the classification of hypersensitivity/allergic diseases and to validate it for ICD-11 by crowdsourcing the allergist community. After careful comparison between ICD-10 and 11 beta phase linearization codes, we identified gaps and trade-offs allowing us to construct a classification proposal, which was sent to the European Academy of Allergy and Clinical Immunology (EAACI) sections, interest groups, executive committee as well as the World Allergy Organization (WAO), and American Academy of Allergy Asthma and Immunology (AAAAI) leaderships. The crowdsourcing process produced comments from 50 of 171 members contacted by e-mail. The classification proposal has also been discussed at face-to-face meetings with experts of EAACI sections and interest groups and presented in a number of business meetings during the 2014 EAACI annual congress in Copenhagen. As a result, a high-level complex structure of classification for hypersensitivity/allergic diseases has been constructed. The model proposed has been presented to the WHO groups in charge of the ICD revision. The international collaboration of allergy experts appreciates bilateral discussion and aims to get endorsement of their proposals for the final ICD-11. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Inclusion of Gaming Disorder in ICD has more advantages than disadvantages.

    PubMed

    Király, Orsolya; Demetrovics, Zsolt

    2017-09-01

    This paper is a response to a recent debate paper in which Aarseth et al. argue that the inclusion of a formal diagnosis and categories for problematic video gaming or Gaming Disorder (GD) in the World Health Organization's 11th Revision of the International Classification of Diseases (ICD-11) is premature and therefore the proposal should be removed. The present authors systematically address all the six main arguments presented by Aarseth et al. and argue that, even though some of the concerns presented in the debate paper are legitimate, the inclusion of GD in ICD-11 has more advantages than disadvantages. Furthermore, the present authors also argue that the two GD subtypes ("GD, predominantly online" and "GD, predominantly offline") are unnecessary and rather problematic; the main category for GD would be perfectly sufficient.

  10. Advances toward LSD1 inhibitors for cancer therapy.

    PubMed

    Fu, Xiaoli; Zhang, Peng; Yu, Bin

    2017-07-01

    LSD1 has become an important biologically validated epigenetic target for cancer therapy since its identification in 2004. LSD1 mediates many cellular signaling pathways and is involved in the initiation and development of cancers. Aberrant overexpression of LSD1 has been observed in different types of cancers, and inactivation by small molecules suppresses cancer cell differentiation, proliferation, invasion and migration. To date, a large number of LSD1 inhibitors have been reported, RG6016, GSK-2879552, INCB059872, IMG-7289 and CC-90011 are currently undergoing clinical assessment for the treatment of acute myeloid leukemia, small-cell lung cancer, etc. In this review, we briefly highlight recent advances of LSD1 inhibitors mainly covering the literatures from 2015 to 2017 and tentatively propose our perspectives on the design of new LSD1 inhibitors for cancer therapy.

  11. [A Case of Locally Advanced Thoracic Esophageal Cancer with Larynx Preservation and Curative Resection via Combined Modality Therapy].

    PubMed

    Iwama, Mitsuru; Kimura, Yutaka; Shiraishi, Osamu; Kato, Hiroaki; Hiraki, Yoko; Tanaka, Yumiko; Yasuda, Atsushi; Shinkai, Masayuki; Imano, Motohiro; Imamoto, Haruhiko; Yasuda, Takushi

    2017-11-01

    Prognosis of locally advanced esophageal cancer is poor. The greatest prognostic factor of locally advanced esophageal cancer is a local control. We experienced a case of T4 locally advanced thoracic esophageal cancer who was successfully resected without any combined resection after multimodality therapy. A male in 75-year-old. was diagnosed with type 3 locally advanced upper thoracic esophageal cancer whose metastatic right recurrent laryngeal lymph node invaded into the trachea. Definitive chemoradiation therapy(CRT)was performed, leading to a significant shrinkage of the main tumor, but T4 lesion remained. Next, adding DCF therapy(docetaxel, CDDP and 5-FU), a relief of T4 was finally obtained. Then, salvage surgery with subtotalesophagectomy and retrosternalesophagealreconstruction with gastric tube was performed, resulting in R0 resection without any combined resection. The postoperative course was uneventful, and the patient has been alive without recurrence for 1 year after surgery. In locally advanced cancer, focusing on T4 downstaging, it is significantly important in terms of safety, curativity and organ preservation to perform surgery after a sure sign of T4 relief by multimodality therapy.

  12. Concurrent apatinib and local radiation therapy for advanced gastric cancer: A case report and review of the literature.

    PubMed

    Zhang, Ming; Deng, Weiye; Cao, Xiaoci; Shi, Xiaoming; Zhao, Huanfen; Duan, Zheping; Lv, Bonan; Liu, Bin

    2017-03-01

    Apatinib is a novel anti-angiogenic agent targeting vascular endothelial growth factor receptor-2, which is effective in patients with chemotherapy-refractory gastric cancer. There are no reports of concurrent apatinib with local radiation therapy in elderly patients with advanced gastric cancer. PATIENT CONCERNS AND DIAGNOSES:: we present the first published report of a 70-year-old male patient with advanced gastric cancer who received concurrent apatinib and local radiation therapy after failure of oxaliplatin and S-1 chemotherapy. The patient received concurrent apatinib and local radiation therapy and was followed up 7 months after therapy without disease progress, 14 months later indicated extensive metastasis and this patient died of pulmonary infection. Elderly patients with advanced gastric cancer may benefit from concurrent apatinib with local radiation therapy when chemotherapy is not tolerated or successful. Further studies are needed to investigate the clinical outcomes and toxicities associated with concurrent apatinib and radiation therapy in gastric cancer.

  13. Technological Advancements and Error Rates in Radiation Therapy Delivery

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

    Margalit, Danielle N., E-mail: dmargalit@partners.org; Harvard Cancer Consortium and Brigham and Women's Hospital/Dana Farber Cancer Institute, Boston, MA; Chen, Yu-Hui

    2011-11-15

    Purpose: Technological advances in radiation therapy (RT) delivery have the potential to reduce errors via increased automation and built-in quality assurance (QA) safeguards, yet may also introduce new types of errors. Intensity-modulated RT (IMRT) is an increasingly used technology that is more technically complex than three-dimensional (3D)-conformal RT and conventional RT. We determined the rate of reported errors in RT delivery among IMRT and 3D/conventional RT treatments and characterized the errors associated with the respective techniques to improve existing QA processes. Methods and Materials: All errors in external beam RT delivery were prospectively recorded via a nonpunitive error-reporting system atmore » Brigham and Women's Hospital/Dana Farber Cancer Institute. Errors are defined as any unplanned deviation from the intended RT treatment and are reviewed during monthly departmental quality improvement meetings. We analyzed all reported errors since the routine use of IMRT in our department, from January 2004 to July 2009. Fisher's exact test was used to determine the association between treatment technique (IMRT vs. 3D/conventional) and specific error types. Effect estimates were computed using logistic regression. Results: There were 155 errors in RT delivery among 241,546 fractions (0.06%), and none were clinically significant. IMRT was commonly associated with errors in machine parameters (nine of 19 errors) and data entry and interpretation (six of 19 errors). IMRT was associated with a lower rate of reported errors compared with 3D/conventional RT (0.03% vs. 0.07%, p = 0.001) and specifically fewer accessory errors (odds ratio, 0.11; 95% confidence interval, 0.01-0.78) and setup errors (odds ratio, 0.24; 95% confidence interval, 0.08-0.79). Conclusions: The rate of errors in RT delivery is low. The types of errors differ significantly between IMRT and 3D/conventional RT, suggesting that QA processes must be uniquely adapted for each technique

  14. Advance in Photosensitizers and Light Delivery for Photodynamic Therapy

    PubMed Central

    Yoon, Il; Li, Jia Zhu

    2013-01-01

    The brief history of photodynamic therapy (PDT) research has been focused on photosensitizers (PSs) and light delivery was introduced recently. The appropriate PSs were developed from the first generation PS Photofrin (QLT) to the second (chlorins or bacteriochlorins derivatives) and third (conjugated PSs on carrier) generations PSs to overcome undesired disadvantages, and to increase selective tumor accumulation and excellent targeting. For the synthesis of new chlorin PSs chlorophyll a is isolated from natural plants or algae, and converted to methyl pheophorbide a (MPa) as an important starting material for further synthesis. MPa has various active functional groups easily modified for the preparation of different kinds of PSs, such as methyl pyropheophorbide a, purpurin-18, purpurinimide, and chlorin e6 derivatives. Combination therapy, such as chemotherapy and photothermal therapy with PDT, is shortly described here. Advanced light delivery system is shown to establish successful clinical applications of PDT. Phtodynamic efficiency of the PSs with light delivery was investigated in vitro and/or in vivo. PMID:23423543

  15. Advances in targeting strategies for nanoparticles in cancer imaging and therapy.

    PubMed

    Yhee, Ji Young; Lee, Sangmin; Kim, Kwangmeyung

    2014-11-21

    In the last decade, nanoparticles have offered great advances in diagnostic imaging and targeted drug delivery. In particular, nanoparticles have provided remarkable progress in cancer imaging and therapy based on materials science and biochemical engineering technology. Researchers constantly attempted to develop the nanoparticles which can deliver drugs more specifically to cancer cells, and these efforts brought the advances in the targeting strategy of nanoparticles. This minireview will discuss the progress in targeting strategies for nanoparticles focused on the recent innovative work for nanomedicine.

  16. Defibrillator implantations for primary prevention in the United States: Inappropriate care or inadequate documentation: Insights from the National Cardiovascular Data ICD Registry.

    PubMed

    Kaiser, Daniel W; Tsai, Vivian; Heidenreich, Paul A; Goldstein, Mary K; Wang, Yongfei; Curtis, Jeptha; Turakhia, Mintu P

    2015-10-01

    Prior studies have reported that more than 20% of implantable cardioverter-defibrillator (ICD) implantations in the United States do not adhere to trial-based criteria. We sought to investigate the patient characteristics associated with not meeting the inclusion criteria of the clinical trials that have demonstrated the efficacy of primary prevention ICDs. Using data from the National Cardiovascular Data Registry's ICD Registry, we identified patients who received ICDs for primary prevention from January 2006 to December 2008. We determined whether patients met the inclusion criteria of at least 1 of the 4 ICD primary prevention trials: Multicenter Automatic Defibrillator Implantation Trial (MADIT), MADIT-II, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Multicenter Unsustained Tachycardia Trial (MUSTT). Among 150,264 patients, 86% met criteria for an ICD implantation based on trial data. The proportion of patients who did not meet trial-based criteria increased as age decreased. In multivariate analysis, the significant predictors for not meeting trial criteria included prior cardiac transplantation (odds ratio [OR] 2.1), pediatric electrophysiology operator (OR 2.0), and high-grade atrioventricular conduction disease (OR 1.4). Among National Cardiovascular Data Registry registrants receiving first-time ICDs for primary prevention, the majority met trial-based criteria. Multivariate analyses suggested that many patients who did not meet the trial-based criteria may have had clinical circumstances that warranted ICD implantation. These findings caution against the use of trial-based indications to determine site quality metrics that could penalize sites that care for younger patients. The planned incorporation of appropriate use criteria into the ICD registry may better characterize patient- and site-level quality and performance. Published by Elsevier Inc.

  17. The DRG shift: a new twist for ICD-10 preparation.

    PubMed

    Long, Peri L

    2012-06-01

    Analysis of your specific business is a key component of ICD-10 implementation. An understanding of your organization's current reimbursement trends will go a long way to assessing and preparing for the impact of ICD-10 in your environment. If you cannot be prepared for each detailed scenario, remember that much of the analysis and resolution requires familiar coding, DRG analysis, and claims processing best practices. Now, they simply have the new twist of researching new codes and some new concepts. The news of a delay in the implementation compliance date, along with the release of grouper Version 29, should encourage your educational and business analysis efforts. This is a great opportunity to maintain open communication with the Centers for Medicare & Medicaid Services, Department of Health and Human Services, and Centers for Disease Control. This is also a key time to report any unusual or discrepant findings in order to provide input to the final rule.

  18. Targeted therapy in advanced gastric carcinoma: the future is beginning.

    PubMed

    Schinzari, G; Cassano, A; Orlandi, A; Basso, M; Barone, C

    2014-01-01

    Gastric cancer represents one of the most common cancer worldwide. Unfortunately, the majority of patients present in advanced stage and outcome still remains poor with high mortality rate despite decreasing incidence and new diagnostic and therapeutic strategies. Although utility of classical chemotherapy agents has been widely explored, advances have been slow and the efficacy of these agents has reached a plateau of median overall survival not higher than 12 months. Therefore, researchers focused their attention on better understanding molecular biology of carcinogenesis and deeper knowledge of the cancer cell phenotype, as well on development of rationally designed drugs that would target specific molecular aberrancies in signal transduction pathways. These targets include cell surface receptors, circulating growth and angiogenic factors and other molecules involved in downstream intracellular signaling pathways, including receptor tyrosine kinases. However, therapeutic advances in gastric cancer are not so encouraging when compared to other solid organ malignancies such as breast and colorectal cancer. This article reviews the role of targeted agents in gastric cancer as single-agent therapy or in combination regimens, including their rational and emerging mechanism of action, current and emerging data. We focused our attention mainly on published phase III studies, therefore cornerstone clinical trials with trastuzumab and bevacizumab have been largely discussed. Phase III studies presented in important international meetings are also reviewed as well phase II published studies and promising new therapies investigated in preclinical or phase I studies. Today, in first-line treatment only trastuzumab has shown significantly increased survival in combination with chemotherapy, whereas ramucirumab as single agent resulted effective in progressing patients, but - despite several disappointing results - these are the proof of principle that targeting the proper

  19. Development of the Music Therapy Assessment Tool for Advanced Huntington's Disease: A Pilot Validation Study.

    PubMed

    O'Kelly, Julian; Bodak, Rebeka

    2016-01-01

    Case studies of people with Huntington's disease (HD) report that music therapy provides a range of benefits that may improve quality of life; however, no robust music therapy assessment tools exist for this population. Develop and conduct preliminary psychometric testing of a music therapy assessment tool for patients with advanced HD. First, we established content and face validity of the Music Therapy Assessment Tool for Advanced HD (MATA-HD) through focus groups and field testing. Second, we examined psychometric properties of the resulting MATA-HD in terms of its construct validity, internal consistency, and inter-rater and intra-rater reliability over 10 group music therapy sessions with 19 patients. The resulting MATA-HD included a total of 15 items across six subscales (Arousal/Attention, Physical Presentation, Communication, Musical, Cognition, and Psychological/Behavioral). We found good construct validity (r ≥ 0.7) for Mood, Communication Level, Communication Effectiveness, Choice, Social Behavior, Arousal, and Attention items. Cronbach's α of 0.825 indicated good internal consistency across 11 items with a common focus of engagement in therapy. The inter-rater reliability (IRR) Intra-Class Coefficient (ICC) scores averaged 0.65, and a mean intra-rater ICC reliability of 0.68 was obtained. Further training and retesting provided a mean of IRR ICC of 0.7. Preliminary data indicate that the MATA-HD is a promising tool for measuring patient responses to music therapy interventions across psychological, physical, social, and communication domains of functioning in patients with advanced HD. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  20. Association between Serum Uric Acid Level and Ventricular Tachyarrhythmia in Heart Failure Patients with Implantable Cardioverter-Defibrillator.

    PubMed

    Nodera, Minoru; Suzuki, Hitoshi; Matsumoto, Yoshiyuki; Kamioka, Masashi; Kaneshiro, Takashi; Yoshihisa, Akiomi; Ohira, Tetsuya; Takeishi, Yasuchika

    2018-05-25

    The uric acid (UA) level is related to cardiac events and mortality, but little is known about the clinical significance of serum UA with regard to the ventricular tachyarrhythmia (VT) risk in patients with heart failure. The present study enrolled 56 patients with ischemic and nonischemic cardiomyopathy (37 males, mean age 64.7 ± 11.1 years) who received prophylactic implantable cardioverter-defibrillator (ICD) implantation. Based on a median serum UA value, study subjects were divided into two groups: serum UA < 6.1 mg/dL (group L, n = 29) and ≥6.1 mg/dL (group H, n = 27). Echo- and electrocardiograms (QRS duration and QTc intervals) were examined in each group. During the follow-up period (30 ± 8 months), 22 (39%) patients had appropriate ICD therapies for sustained VT. There was no significant difference in the electro- and echocardiographic data between both groups. However, appropriate ICD therapies were significantly higher in group H than in group L (p  =  0.02). In multivariate analysis, UA was an independent predictor of appropriate ICD therapies (hazard ratio 1.826, 95% confidence interval 1.248-2.671, p = 0.002). Serum UA levels might be a predictor of VT, providing new aspects regarding the decision to adapt ICD implantation in patients with heart failure. © 2018 S. Karger AG, Basel.

  1. T-wave loop area from a pre-implant 12-lead ECG is associated with appropriate ICD shocks

    PubMed Central

    Hnatkova, Katerina; Friede, Tim; Malik, Marek; Zabel, Markus

    2017-01-01

    Aims In implantable cardioverter-defibrillator (ICD) patients, predictors of ICD shocks and mortality are needed to improve patient selection. Electrocardiographic (ECG) markers are simple to obtain and have been demonstrated to predict mortality. We aimed to assess the association of T-wave loop area and circularity with ICD shocks. Methods The study investigated patients with ICDs implanted between 1998 and 2010 for whom digital 12-lead ECGs (Schiller CS200 ECG-Network) of sufficient quality were obtained within 1 month prior to the implantation. T-wave loop area and circularity were calculated. Follow-up data of appropriate shocks were obtained during ICD clinic visits that included reviews of device stored electrograms. Results A total of 605 patients (82% males) were included; 68% had ischemic cardiomyopathy and 72% were treated for primary prevention. Over 3.8±1.4 years of follow-up, 114 patients (19%) experienced appropriate shock(s). Those with smaller T-wave loop area received fewer shocks (TLA, hazard ratio, HR, per increase of 1 technical unit, 0.71; [95% confidence interval, 0.53–0.94]; P = 0.02) and those with larger T-wave loop circularity (TLC) representing rounder T wave loop received more shocks (HR per 1% TLC increase 2.96; [0.85–10.36]; P = 0.09). When the quartile containing the largest TLA and TLC values, respectively, were compared to the remaining cases, TLA remained significantly associated with fewer and TLC with more frequent shocks also after multivariate adjustment for clinical variables (HR, 0.59 [0.35–0.99], P = 0.044; and 1.64 [1.08–2.49], P = 0.021, respectively). Conclusions The size and shape of the T-wave loop calculated from pre-implantation 12-lead ECGs are associated with appropriate ICD shocks. PMID:28291831

  2. DSM-5 AND ICD-11 DEFINITIONS OF POSTTRAUMATIC STRESS DISORDER: INVESTIGATING “NARROW” AND “BROAD” APPROACHES

    PubMed Central

    Stein, Dan J.; McLaughlin, Katie A.; Koenen, Karestan C.; Atwoli, Lukoye; Friedman, Matthew J.; Hill, Eric D.; Maercker, Andreas; Petukhova, Maria; Shahly, Victoria; van Ommeren, Mark; Alonso, Jordi; Borges, Guilherme; de Girolamo, Giovanni; de Jonge, Peter; Demyttenaere, Koen; Florescu, Silvia; Karam, Elie G.; Kawakami, Norito; Matschinger, Herbert; Okoliyski, Michail; Posada-Villa, Jose; Scott, Kate M.; Viana, Maria Carmen; Kessler, Ronald C.

    2014-01-01

    Background The development of the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) and ICD-11 has led to reconsideration of diagnostic criteria for posttraumatic stress disorder (PTSD). The World Mental Health (WMH) Surveys allow investigation of the implications of the changing criteria compared to DSM-IV and ICD-10. Methods WMH Surveys in 13 countries asked respondents to enumerate all their lifetime traumatic events (TEs) and randomly selected one TE per respondent for PTSD assessment. DSMIV and ICD-10 PTSD were assessed for the 23,936 respondents who reported lifetime TEs in these surveys with the fully structured Composite International Diagnostic Interview (CIDI). DSM-5 and proposed ICD-11 criteria were approximated. Associations of the different criteria sets with indicators of clinical severity (distress-impairment, suicidality, comorbid fear-distress disorders, PTSD symptom duration) were examined to investigate the implications of using the different systems. Results A total of 5.6% of respondents met criteria for “broadly defined” PTSD (i.e., full criteria in at least one diagnostic system), with prevalence ranging from 3.0% with DSM-5 to 4.4% with ICD-10. Only one-third of broadly defined cases met criteria in all four systems and another one third in only one system (narrowly defined cases). Between-system differences in indicators of clinical severity suggest that ICD-10 criteria are least strict and DSM-IV criteria most strict. The more striking result, though, is that significantly elevated indicators of clinical significance were found even for narrowly defined cases for each of the four diagnostic systems. Conclusions These results argue for a broad definition of PTSD defined by any one of the different systems to capture all clinically significant cases of PTSD in future studies. PMID:24894802

  3. Depathologising gender diversity in childhood in the process of ICD revision and reform.

    PubMed

    Suess Schwend, Amets; Winter, Sam; Chiam, Zhan; Smiley, Adam; Cabral Grinspan, Mauro

    2018-01-24

    From 2007 on, the World Health Organisation (WHO) has been revising its diagnostic manual, the International Statistical Classification of Diseases and Related Health Problems (ICD), with approval of ICD-11 due in 2018. The ICD revision has prompted debates on diagnostic classifications related to gender diversity and gender development processes, and specifically on the 'Gender incongruence of childhood' (GIC) code. These debates have taken place at a time an emergent trans depathologisation movement is becoming increasingly international, and regional and international human rights bodies are recognising gender identity as a source of discrimination. With reference to the history of diagnostic classification of gender diversity in childhood, this paper conducts a literature review of academic, activist and institutional documents related to the current discussion on the merits of retaining or abandoning the GIC code. Within this broader discussion, the paper reviews in more detail recent publications arguing for the abandonment of this diagnostic code drawing upon clinical, bioethical and human rights perspectives. The review indicates that gender diverse children engaged in exploring their gender identity and expression do not benefit from diagnosis. Instead they benefit from support from their families, their schools and from society more broadly.

  4. Inclusion of Gaming Disorder in ICD has more advantages than disadvantages

    PubMed Central

    Király, Orsolya; Demetrovics, Zsolt

    2017-01-01

    This paper is a response to a recent debate paper in which Aarseth et al. argue that the inclusion of a formal diagnosis and categories for problematic video gaming or Gaming Disorder (GD) in the World Health Organization’s 11th Revision of the International Classification of Diseases (ICD-11) is premature and therefore the proposal should be removed. The present authors systematically address all the six main arguments presented by Aarseth et al. and argue that, even though some of the concerns presented in the debate paper are legitimate, the inclusion of GD in ICD-11 has more advantages than disadvantages. Furthermore, the present authors also argue that the two GD subtypes (“GD, predominantly online” and “GD, predominantly offline”) are unnecessary and rather problematic; the main category for GD would be perfectly sufficient. PMID:28816495

  5. ICD Social Codes: An Underutilized Resource for Tracking Social Needs.

    PubMed

    Torres, Jacqueline M; Lawlor, John; Colvin, Jeffrey D; Sills, Marion R; Bettenhausen, Jessica L; Davidson, Amber; Cutler, Gretchen J; Hall, Matt; Gottlieb, Laura M

    2017-09-01

    Social determinants of health (SDH) data collected in health care settings could have important applications for clinical decision-making, population health strategies, and the design of performance-based incentives and penalties. One source for cataloging SDH data is the International Statistical Classification of Diseases and Related Health Problems (ICD). To explore how SDH are captured with ICD Ninth revision SDH V codes in a national inpatient discharge database. Data come from the 2013 Healthcare Cost and Utilization Project (HCUP) National Inpatient Sample, a national stratified sample of discharges from 4363 hospitals from 44 US states. We estimate the rate of ICD-9 SDH V code utilization overall and by patient demographics and payer categories. We additionally estimate the rate of SDH V code utilization for: (a) the 5 most common reasons for hospitalization; and (b) the 5 conditions with the highest rates of SDH V code utilization. Fewer than 2% of overall discharges in the National Inpatient Sample were assigned an SDH V code. There were statistically significant differences in the rate of overall SDH V code utilization by age categories, race/ethnicity, sex, and payer (all P<0.001). Nevertheless, SDH V codes were assigned to <7% of discharges in any demographic or payer subgroup. SDH V code utilization was highest for major diagnostic categories related to mental health and alcohol/substance use-related discharges. SDH V codes are infrequently utilized in inpatient settings for discharges other than those related to mental health and alcohol/substance use. Utilization incentives will likely need to be developed to realize the potential benefits of cataloging SDH information.

  6. Novel Androgen Deprivation Therapy (ADT) in the Treatment of Advanced Prostate Cancer.

    PubMed

    Aragon-Ching, Jeanny B; Dahut, William L

    2010-07-01

    Androgen deprivation therapy has been the mainstay of treatment for advanced and metastatic prostate cancer. The use of novel agents targeting the androgen receptor and its signaling pathways offers a promising approach that is both safe and effective. We describe the rationale behind the use of these compounds in clinical development and the existing challenges as to how best to incorporate these new and emerging therapies in the changing treatment paradigm of metastatic prostate cancer.

  7. How does an implantable cardioverter defibrillator (ICD) affect the lives of patients and their families?

    PubMed

    Eckert, Marion; Jones, Tina

    2002-06-01

    This study aimed to identify the lived experience of patients with implantable cardioverter defibrillators (ICD) and their families. The methodology used was interpretative phenomenology. Unstructured interviews were conducted with three family members and three ICD recipients. Using a methodological approach outlined by van Manen, the participants transcribed texts were analysed looking for similar concepts and ideas that developed into themes that explicated the meaning of this phenomena. The themes that emerged were: dependence, which encompassed their perceptions about the life-saving device; the memory of their first defibrillation experience; lifestyle changes, which incorporated modification techniques; lack of control, which highlighted feelings such as fear, anxiety and powerlessness; mind game, which illustrated psychological challenges; and the issue of security, demonstrating how 'being there' and not 'being there' impacted on their everyday lives. The long-term outcomes of living with an ICD are important considerations for all health-care providers. This research highlights the everyday activities of recipients, the lifestyle changes they have made, the emotional significance of the device and the psychological coping strategies that the participants have adopted. The findings of this research will allow health-care professionals to be better prepared to provide education and support for ICD recipients and their families in regards to issues related to insertion of the device during the postinsertion recovery period and for long-term management after hospital discharge.

  8. Recent Advances in Monoclonal Antibody Therapies for Multiple Sclerosis

    PubMed Central

    Stavropoulos, Nikolaos; Wittenberg, Nathan J.; Dasari, Harika; Abdelrahim, Murtada A.; Henley, John R.; Oh, Sang-Hyun; Warrington, Arthur E.; Rodriguez, Moses

    2016-01-01

    Introduction Multiple sclerosis (MS) is the most common chronic inflammatory, demyelinating disease of the CNS and results in neurological disability. Existing immunomodulatory and immunosuppressive approaches lower the number of relapses but do not cure or reverse existing deficits nor improve long-term disability in MS patients. Areas Covered Monogenic antibodies were described as treatment options for MS, however the immunogenicity of mouse antibodies hampered the efficacy of potential therapeutics in humans. Availability of improved antibody production technologies resulted in a paradigm shift in MS treatment strategies. In this review, an overview of immunotherapies for MS that use conventional monoclonal antibodies reactive to immune system and their properties and mechanisms of action will be discussed, including recent advances in MS therapeutics and highlight natural autoantibodies (NAbs) that directly target CNS cells. Expert Opinion Recent challenges for MS therapy are the identification of relevant molecular and cellular targets, time frame of treatment, and antibody toxicity profiles to identify safe treatment options for MS patients. The application of monoclonal antibody therapies with better biological efficacy associated with minimum side effects possesses huge clinical potential. Advances in monoclonal antibody technologies that directly target cells of nervous system may promote the CNS regeneration field from bench to bedside. PMID:26914737

  9. Stroke: advances in medical therapy and acute stroke intervention.

    PubMed

    Barrett, Kevin M; Lal, Brajesh K; Meschia, James F

    2015-10-01

    Evidence-based therapeutic options for stroke continue to emerge based on results from well-designed clinical studies. Ischemic stroke far exceeds hemorrhagic stroke in terms of prevalence and incidence, both in the USA and worldwide. The public health effect of reducing death and disability related to ischemic stroke justifies the resources that have been invested in identifying safe and effective treatments. The emergence of novel oral anticoagulants for ischemic stroke prevention in atrial fibrillation has introduced complexity to clinical decision making for patients with this common cardiac arrhythmia. Some accepted ischemic stroke preventative strategies, such as carotid revascularization for asymptomatic carotid stenosis, require reassessment, given advances in risk factor management, antithrombotic therapy, and surgical techniques. Intra-arterial therapy, particularly with stent retrievers after intravenous tissue plasminogen activator, has recently been demonstrated to improve functional outcomes and will require investment in system-based care models to ensure that effective treatments are received by patients in a timely fashion. The purpose of this review is to describe recent advances in medical and surgical approaches to ischemic stroke prevention and acute treatment. Results from recently published clinical trials will be highlighted along with ongoing clinical trials addressing key questions in ischemic stroke management and prevention where equipoise remains.

  10. Advancements in anti-inflammatory therapy for dry eye syndrome.

    PubMed

    McCabe, Erin; Narayanan, Srihari

    2009-10-01

    The goal of this literature review is to discuss recent discoveries in the pathophysiology of dry eye and the subsequent evolution of diagnostic and management techniques. The mechanisms of various anti-inflammatory treatments are reviewed, and the efficacy of common pharmacologic agents is assessed. Anti-inflammatory therapy is evaluated in terms of its primary indications, target population, and utility within a clinical setting. The Medline PubMed database and the World Wide Web were searched for current information regarding dry eye prevalence, pathogenesis, diagnosis, and management. After an analysis of the literature, major concepts were integrated to generate an updated portrayal of the status of dry eye syndrome. Inflammation appears to play a key role in perpetuating and sustaining dry eye. Discoveries of inflammatory markers found within the corneal and conjunctival epithelium of dry eye patients have triggered recent advancements in therapy. Pharmacologic anti-inflammatory therapy for dry eye includes 2 major categories: corticosteroids and immunomodulatory agents. Fatty acid and androgen supplementation and oral antibiotics have also shown promise in dry eye therapy because of their anti-inflammatory effects. Anti-inflammatory pharmacologic agents have shown great success in patients with moderate to severe dry eye when compared with alternative treatment modalities. A deeper understanding of the link between inflammation and dry eye validates the utilization of anti-inflammatory therapy in everyday optometric practice.

  11. DSM-5 and ICD-11 as competing models of PTSD in preadolescent children exposed to a natural disaster: assessing validity and co-occurring symptomatology.

    PubMed

    La Greca, Annette M; Danzi, BreAnne A; Chan, Sherilynn F

    2017-01-01

    Background : Major revisions have been made to the DSM and ICD models of post-traumatic stress disorder (PTSD). However, it is not known whether these models fit children's post-trauma responses, even though children are a vulnerable population following disasters. Objective : Using data from Hurricane Ike, we examined how well trauma-exposed children's symptoms fit the DSM-IV, DSM-5 and ICD-11 models, and whether the models varied by gender. We also evaluated whether elevated symptoms of depression and anxiety characterized children meeting PTSD criteria based on DSM-5 and ICD-11. Method : Eight-months post-disaster, children ( N  = 327, 7-11 years) affected by Hurricane Ike completed measures of PTSD, anxiety and depression. Algorithms approximated a PTSD diagnosis based on DSM-5 and ICD-11 models. Results : Using confirmatory factor analysis, ICD-11 had the best-fitting model, followed by DSM-IV and DSM-5. The ICD-11 model also demonstrated strong measurement invariance across gender. Analyses revealed poor overlap between DSM-5 and ICD-11, although children meeting either set of criteria reported severe PTSD symptoms. Further, children who met PTSD criteria for DSM-5, but not for ICD-11, reported significantly higher levels of depression and general anxiety than children not meeting DSM-5 criteria. Conclusions : Findings support the parsimonious ICD-11 model of PTSD for trauma-exposed children, although adequate fit also was obtained for DSM-5. Use of only one model of PTSD, be it DSM-5 or ICD-11, will likely miss children with significant post-traumatic stress. DSM-5 may identify children with high levels of comorbid symptomatology, which may require additional clinical intervention.

  12. Phase 1 Study of Erlotinib Plus Radiation Therapy in Patients With Advanced Cutaneous Squamous Cell Carcinoma

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

    Heath, C. Hope; Deep, Nicholas L.; Nabell, Lisle

    Purpose: To assess the toxicity profile of erlotinib therapy combined with postoperative adjuvant radiation therapy in patients with advanced cutaneous squamous cell carcinoma. Methods and Materials: This was a single-arm, prospective, phase 1 open-label study of erlotinib with radiation therapy to treat 15 patients with advanced cutaneous head-and-neck squamous cell carcinoma. Toxicity data were summarized, and survival was analyzed with the Kaplan-Meier method. Results: The majority of patients were male (87%) and presented with T4 disease (93%). The most common toxicity attributed to erlotinib was a grade 2-3 dermatologic reaction occurring in 100% of the patients, followed by mucositis (87%).more » Diarrhea occurred in 20% of the patients. The 2-year recurrence rate was 26.7%, and mean time to cancer recurrence was 10.5 months. Two-year overall survival was 65%, and disease-free survival was 60%. Conclusions: Erlotinib and radiation therapy had an acceptable toxicity profile in patients with advanced cutaneous squamous cell carcinoma. The disease-free survival in this cohort was comparable to that in historical controls.« less

  13. Severe myositis of the hip flexors after pre-operative chemoradiation therapy for locally advanced rectal cancer: case report.

    PubMed

    Florczynski, Matthew M; Sanatani, Michael S; Mai, Lauren; Fisher, Barbara; Moulin, Dwight E; Cao, Jeffrey; Louie, Alexander V; Pope, Janet E; Leung, Eric

    2016-03-22

    The use of neoadjuvant radiation therapy and chemotherapy in the treatment of locally advanced rectal adenocarcinoma has been shown to reduce disease recurrence when combined with surgery and adjuvant chemotherapy. We report a case of a patient who developed a debilitating bilateral myopathy of the hip flexors after successful treatment for rectal cancer. To the best of our knowledge, this is the first such complication from radiation therapy reported in a patient with colorectal cancer. The disproportionate severity of our patient's myopathy relative to the dose of radiation used also makes this case unique among reports of neuromuscular complications from radiation therapy. The patient is a 65-year-old male with node negative, high-grade adenocarcinoma of the rectum penetrating through the distal rectal wall. He underwent neoadjuvant concurrent pelvic radiation therapy and capecitabine-based chemotherapy, followed by abdominoperineal resection and post-operative FOLFOX chemotherapy. Five months post-completion of pelvic radiotherapy and 2 months after the completion of adjuvant chemotherapy, he presented with bilateral weakness of the iliopsoas muscles and severe pain radiating to the groin. The patient improved with 40 mg/d of prednisone, which was gradually tapered to 2 mg/d over 6 months, with substantial recovery of muscle strength and elimination of pain. The timing, presentation and response of our patient's symptoms to corticosteroids are most consistent with a radiation recall reaction. Radiation recall is a phenomenon whereby previously irradiated tissue becomes vulnerable to toxicity by subsequent systemic therapy and is rarely associated with myopathies. Radiation recall should be considered a potential complication of neoadjuvant radiation therapy for rectal cancer, and for ongoing research into the optimization of treatment for these patients. Severe myopathies caused by radiation recall may be fully reversible with corticosteroid treatment.

  14. Anti-PD-1/PD-L1 antibody therapy for pretreated advanced nonsmall-cell lung cancer

    PubMed Central

    Zhou, Guo-Wu; Xiong, Ye; Chen, Si; Xia, Fan; Li, Qiang; Hu, Jia

    2016-01-01

    Abstract Background: Anti-PD-1/PD-L1 antibody therapy is a promising clinical treatment for nonsmall-cell lung cancer (NSCLC). However, whether anti-PD-1/PD-L1 antibody therapy can provide added benefits for heavily pretreated patients with advanced NSCLC and whether the efficacy of anti-PD-1/PD-L1 antibody therapy relates to the tumor PD-L1 expression level remain controversial. Thus, this meta-analysis evaluated the efficacy and safety of anti-PD-1/PD-L1 antibody therapy for pretreated patients with advanced NSCLC. Methods: Randomized clinical trials were retrieved by searching the PubMed, EMBASE, ASCO meeting abstract, clinicaltrial.gov, and Cochrane library databases. The pooled hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS), and odds ratios for the overall response rate and adverse events (AEs) were calculated by STATA software. Results: Three randomized clinical trials involving 1141 pretreated patients with advanced NSCLC were included. These trials all compared the efficacy and safety of anti-PD-1/PD-L1 antibodies (nivolumab and MPDL3280A) with docetaxel. The results suggested that, for all patients, anti-PD-1/PD-L1 therapy could acquire a greater overall response (odds ratio = 1.50, 95% CI: 1.08–2.07, P = 0.015, P for heterogeneity [Ph] = 0.620) and longer OS (HR = 0.71, 95% CI: 0.61–0.81, P < 0.001, Ph = 0.361) than docetaxel, but not PFS (HR = 0.83, 95% CI: 0.65–1.06, P = 0.134; Ph = 0.031). Subgroup analyses according to the tumor PD-L1 expression level showed that anti-PD-1/PD-L1 therapy could significantly improve both OS and PFS in patients with high expressions of PD-L1, but not in those with low expressions. Generally, the rates of grade 3 or 4 AEs of anti-PD-1/PD-L1 therapy were significantly lower than that of docetaxel. However, the risks of pneumonitis and hypothyroidism were significantly higher. Conclusion: Anti-PD-1/PD-L1 antibody therapy may significantly improve

  15. Impact of the diagnostic changes to post-traumatic stress disorder for DSM-5 and the proposed changes to ICD-11.

    PubMed

    O'Donnell, Meaghan L; Alkemade, Nathan; Nickerson, Angela; Creamer, Mark; McFarlane, Alexander C; Silove, Derrick; Bryant, Richard A; Forbes, David

    2014-09-01

    There have been changes to the criteria for diagnosing post-traumatic stress disorder (PTSD) in DSM-5 and changes are proposed for ICD-11. To investigate the impact of the changes to diagnostic criteria for PTSD in DSM-5 and the proposed changes in ICD-11 using a large multisite trauma-exposed sample and structured clinical interviews. Randomly selected injury patients admitted to four hospitals were assessed 72 months post trauma (n = 510). Structured clinical interviews for PTSD and major depressive episode, as well as self-report measures of disability and quality of life were administered. Current prevalence of PTSD under DSM-5 scoring was not significantly different from DSM-IV (6.7% v. 5.9%, z = 0.53, P = 0.59). However, the ICD-11 prevalence was significantly lower than ICD-10 (3.3% v. 9.0%, z = -3.8, P<0.001). The PTSD current prevalence was significantly higher for DSM-5 than ICD-11 (6.7% v. 3.3%, z = 2.5, P = 0.01). Using ICD-11 tended to show lower rates of comorbidity with depression and a slightly lower association with disability. The diagnostic systems performed in different ways in terms of current prevalence rates and levels of comorbidity with depression, but on other broad key indicators they were relatively similar. There was overlap between those with PTSD diagnosed by ICD-11 and DSM-5 but a substantial portion met one but not the other set of criteria. This represents a challenge for research because the phenotype that is studied may be markedly different according to the diagnostic system used. Royal College of Psychiatrists.

  16. Recent Advances in Hydrogel-Based Drug Delivery for Melanoma Cancer Therapy: A Mini Review

    PubMed Central

    Elupula, Ravinder

    2017-01-01

    The purpose of this study is to describe some of the latest advances in using hydrogels for cancer melanoma therapy. Hydrogel formulations of polymeric material from natural or synthetic sources combined with therapeutic agents have gained great attention in the recent years for treating various maladies. These formulations can be categorized according to the strategies that induce cancer cell death in melanoma. First of all, we should note that these formulations can only play a supporting role that releases bioactive agents against cancer cells rather than the main role. This strategy involves delivering the drug via transdermal pathways, resulting in the death of cancerous cells. Another strategy utilizes magnetic gel composites to combat melanoma via hyperthermia therapy. This review discusses both transdermal and hyperthermia therapies and the recent advances that have occurred in the field. PMID:28852576

  17. Novel Androgen Deprivation Therapy (ADT) in the Treatment of Advanced Prostate Cancer

    PubMed Central

    Aragon-Ching, Jeanny B.; Dahut, William L.

    2011-01-01

    Androgen deprivation therapy has been the mainstay of treatment for advanced and metastatic prostate cancer. The use of novel agents targeting the androgen receptor and its signaling pathways offers a promising approach that is both safe and effective. We describe the rationale behind the use of these compounds in clinical development and the existing challenges as to how best to incorporate these new and emerging therapies in the changing treatment paradigm of metastatic prostate cancer. PMID:21922023

  18. Oxygen therapy in advanced COPD: in whom does it work?

    PubMed

    Make, Barry; Krachman, Samuel; Panos, Ralph J; Doherty, Dennis E; Stoller, James K

    2010-06-01

    Supplemental oxygen therapy is commonly used in patients with advanced chronic obstructive pulmonary disease (COPD) and severe hypoxemia at rest. Use of oxygen in these patients is justified by studies showing a mortality benefit. However, the use of oxygen in other patients with advanced COPD has not clearly been established. Long-term studies assessing not only mortality but also other outcomes that are important to patients and physicians such as dyspnea, health status, and exercise capacity are lacking. This article reviews the available studies of the use of supplemental oxygen in patients with less severe hypoxemia at rest during the day, hypoxemia occurring only at night, and hypoxemia occurring only with exercise. With the knowledge that studies in patients with advanced COPD and less severe hypoxemia are limited, recommendations are provided on oxygen use in these groups of patients.

  19. Advances in Systemic Therapy for Metastatic or Advanced Gastric Cancer.

    PubMed

    Shitara, Kohei; Ohtsu, Atsushi

    2016-10-01

    In recent years, various new agents have been investigated for the treatment of advanced gastric cancer (AGC). The anti-HER2 antibody trastuzumab has been shown to prolong the overall survival of patients with HER2-positive AGC and has become a standard treatment. However, lapatinib, or ado-trastuzumab emtansine (T-DM1), did not show survival benefit in AGC, although it has shown remarkable efficacy for HER2-positive breast cancer. The efficacy of the anti-vascular endothelial growth factor receptor monoclonal antibody ramucirumab for pretreated gastric cancer is a milestone for antiangiogenic therapy for AGC. Early clinical trials of TAS-118, TAS-102, and STAT3 inhibitors; IMAB362 (anti-Claudin 18.2); and immune checkpoint inhibitors are all encouraging. These findings warrant further evaluation in larger clinical trials. Copyright © 2016 by the National Comprehensive Cancer Network.

  20. Radiation Hardness of dSiPM Sensors in a Proton Therapy Radiation Environment

    NASA Astrophysics Data System (ADS)

    Diblen, Faruk; Buitenhuis, Tom; Solf, Torsten; Rodrigues, Pedro; van der Graaf, Emiel; van Goethem, Marc-Jan; Brandenburg, Sytze; Dendooven, Peter

    2017-07-01

    In vivo verification of dose delivery in proton therapy by means of positron emission tomography (PET) or prompt gamma imaging is mostly based on fast scintillation detectors. The digital silicon photomultiplier (dSiPM) allows excellent scintillation detector timing properties and is thus being considered for such verification methods. We present here the results of the first investigation of radiation damage to dSiPM sensors in a proton therapy radiation environment. Radiation hardness experiments were performed at the AGOR cyclotron facility at the KVI-Center for Advanced Radiation Technology, University of Groningen. A 150-MeV proton beam was fully stopped in a water target. In the first experiment, bare dSiPM sensors were placed at 25 cm from the Bragg peak, perpendicular to the beam direction, a geometry typical for an in situ implementation of a PET or prompt gamma imaging device. In the second experiment, dSiPM-based PET detectors containing lutetium yttrium orthosilicate scintillator crystal arrays were placed at 2 and 4 m from the Bragg peak, perpendicular to the beam direction; resembling an in-room PET implementation. Furthermore, the experimental setup was simulated with a Geant4-based Monte Carlo code in order to determine the angular and energy distributions of the neutrons and to determine the 1-MeV equivalent neutron fluences delivered to the dSiPM sensors. A noticeable increase in dark count rate (DCR) after an irradiation with about 108 1-MeV equivalent neutrons/cm2 agrees with observations by others for analog SiPMs, indicating that the radiation damage occurs in the single photon avalanche diodes and not in the electronics integrated on the sensor chip. It was found that in the in situ location, the DCR becomes too large for successful operation after the equivalent of a few weeks of use in a proton therapy treatment room (about 5 × 1013 protons). For PET detectors in an in-room setup, detector performance was unchanged even after an

  1. Increased confidence to engage in physical exertion: older ICD recipients' experiences of participating in an exercise training programme.

    PubMed

    Morken, Ingvild Margreta; Norekvål, Tone M; Isaksen, Kjetil; Munk, Peter S; Karlsen, Bjørg; Larsen, Alf I

    2013-06-01

    Research suggests that exercise training (ET) programmes may improve both physical and psychosocial functioning in implantable cardioverter defibrillator (ICD) recipients. Most of this research has been conducted by means of quantitative methods. However, knowledge of older ICD recipients' experiences of participating in such programmes is sparse. There is thus a need for more detailed qualitative data from the perspective of older patients. To describe older ICD recipients' experiences of participating in an ET programme. A qualitative design with semistructured interviews involving 12 older ICD recipients who had participated in a 3-month ET programme. Mini-disc recordings of the interviews were transcribed verbatim and analysed using content analysis. The analysis revealed two major themes: (1) 'increased confidence to engage in physical exertion'; and (2) 'increased satisfaction with life'. The first theme is illustrated by three subthemes: 'perceived support from physiotherapists', 'perceiving the heart rate monitor as a motivation to exercise', and 'perceiving peers as motivators for enjoyment and making the effort to exercise'. The second theme was illustrated by the following subthemes: 'perceived psychosocial benefits', 'perceived physical benefits', and 'exercise as a new health habit'. The findings indicate that exercising in a cardiac rehabilitation centre together with peers and supervised by skilled healthcare professionals may increase motivation to exert oneself, leading to emotional and physical benefits as well as a more social and active lifestyle for older ICD recipients.

  2. ERCC1 protein as a guide for individualized therapy of late-stage advanced non-small cell lung cancer.

    PubMed

    Gao, Zhiqiang; Han, Baohui; Shen, Jie; Gu, Aiqin; Qi, Dajiang; Huang, Jinsu; Shi, Chunlei; Xiong, Liwen; Zhao, Yizhuo; Jiang, Liyan; Wang, Huimin; Chen, Yurong

    2011-09-01

    Excision repair cross-complementation group 1 (ERCC1) protein has been associated with cisplatin resistance. The objective of this study was to investigate the correlation between ERCC1 protein levels and the therapeutic effect of individualized therapy in advanced non-small cell lung cancer (NSCLC). A total of 190 advanced NSCLC patients were included in this study. Patients were randomized into either the individualized therapy group or the standard therapy group at a ratio of 2:1. Patients in the standard therapy group were treated with either gemcitabine plus cisplatin or vinorelbine plus cisplatin. The expression of ERCC1 protein in lung cancer tissues of patients from the individualized therapy group was detected with immunohistochemistry. Patients with low ERCC1 levels received either gemcitabine plus cisplatin or vinorelbine plus cisplatin, and patients with high levels received gemcitabine plus vinorelbine. The main outcome assessments were response rate (RR), overall survival (OS) and time to progression (TTP). Follow-up data were recorded until September 30, 2010. RR, 1-year survival rate and TTP were not statistically significant. The median survival time was 10.10 months in the standard therapy group (95% CI 8.48-11.92) and 13.59 months in the individualized therapy group (95% CI 11.86-14.74). The difference in median survival time was significantly different between these groups (P=0.036). The median survival time was longer in the individualized group compared to the standard therapy group. ERCC1 protein expression in advanced NSCLC patients, however, was not significantly correlated with RR, OS and TTP in the individualized therapy group. Therefore, this study suggests that ERCC1 protein levels should be assessed in combination with additional biomarkers to determine an optimal index for individualized therapy in advanced NSCLC patients.

  3. [Coding in general practice-Will the ICD-11 be a step forward?

    PubMed

    Kühlein, Thomas; Virtanen, Martti; Claus, Christoph; Popert, Uwe; van Boven, Kees

    2018-07-01

    Primary care physicians in Germany don't benefit from coding diagnoses-they are coding for the needs of others. For coding, they mostly are using either the thesaurus of the German Institute of Medical Documentation and Information (DIMDI) or self-made cheat-sheets. Coding quality is low but seems to be sufficient for the main use case of the resulting data, which is the morbidity adjusted risk compensation scheme that distributes financial resources between the many German health insurance companies.Neither the International Classification of Diseases and Health Related Problems (ICD-10) nor the German thesaurus as an interface terminology are adequate for coding in primary care. The ICD-11 itself will not recognizably be a step forward from the perspective of primary care. At least the browser database format will be advantageous. An implementation into the 182 different electronic health records (EHR) on the German market would probably standardize the coding process and make code finding easier. This method of coding would still be more cumbersome than the current coding with self-made cheat-sheets.The first steps towards a useful official cheat-sheet for primary care have been taken, awaiting implementation and evaluation. The International Classification of Primary Care (ICPC-2) already provides an adequate classification standard for primary care that can also be used in combination with ICD-10. A new version of ICPC (ICPC-3) is under development. As the ICPC-2 has already been integrated into the foundation layer of ICD-11 it might easily become the future standard for coding in primary care. Improving communication between the different EHR would make taking over codes from other healthcare providers possible. Another opportunity to improve the coding quality might be creating use cases for the resulting data for the primary care physicians themselves.

  4. DSM-5 and ICD-11 as competing models of PTSD in preadolescent children exposed to a natural disaster: assessing validity and co-occurring symptomatology

    PubMed Central

    La Greca, Annette M.; Danzi, BreAnne A.; Chan, Sherilynn F.

    2017-01-01

    ABSTRACT Background: Major revisions have been made to the DSM and ICD models of post-traumatic stress disorder (PTSD). However, it is not known whether these models fit children’s post-trauma responses, even though children are a vulnerable population following disasters. Objective: Using data from Hurricane Ike, we examined how well trauma-exposed children’s symptoms fit the DSM-IV, DSM-5 and ICD-11 models, and whether the models varied by gender. We also evaluated whether elevated symptoms of depression and anxiety characterized children meeting PTSD criteria based on DSM-5 and ICD-11. Method: Eight-months post-disaster, children (N = 327, 7–11 years) affected by Hurricane Ike completed measures of PTSD, anxiety and depression. Algorithms approximated a PTSD diagnosis based on DSM-5 and ICD-11 models. Results: Using confirmatory factor analysis, ICD-11 had the best-fitting model, followed by DSM-IV and DSM-5. The ICD-11 model also demonstrated strong measurement invariance across gender. Analyses revealed poor overlap between DSM-5 and ICD-11, although children meeting either set of criteria reported severe PTSD symptoms. Further, children who met PTSD criteria for DSM-5, but not for ICD-11, reported significantly higher levels of depression and general anxiety than children not meeting DSM-5 criteria. Conclusions: Findings support the parsimonious ICD-11 model of PTSD for trauma-exposed children, although adequate fit also was obtained for DSM-5. Use of only one model of PTSD, be it DSM-5 or ICD-11, will likely miss children with significant post-traumatic stress. DSM-5 may identify children with high levels of comorbid symptomatology, which may require additional clinical intervention. PMID:28451076

  5. Risk stratification for implantable cardioverter defibrillator therapy: the role of the wearable cardioverter-defibrillator.

    PubMed

    Klein, Helmut U; Goldenberg, Ilan; Moss, Arthur J

    2013-08-01

    The benefit of implantable cardioverter-defibrillator (ICD) therapy depends upon appropriate evaluation of a persisting risk of sudden death and estimation of the patient's overall survival. Assessment of a stable and unchangeable arrhythmogenic substrate is often difficult. Structural abnormality and ventricular dysfunction, the two major risk parameters, may recover, and heart failure symptoms can improve so that ICD therapy may not be indicated. Risk stratification can take time while the patient continues to be at high risk of arrhythmic death, and patients may need temporary bridging by a defibrillator in cases of interrupted ICD therapy. The wearable cardioverter-defibrillator (WCD) combines a long-term electrocardiogram (ECG)-monitoring system with an external automatic defibrillator. The LIfeVest® (ZOLL, Pittsburgh, PA, USA) is composed of a garment, containing two defibrillation patch electrodes on the back, and an elastic belt with a front-defibrillation patch electrode and four non-adhesive ECG electrodes, connected to a monitoring and defibrillation unit. The WCD is a safe and effective tool to terminate ventricular tachycardia/ventricular fibrillation events, unless a conscious patient withholds shock delivery. It may be used in patients in the early phase after acute myocardial infarction with poor left ventricular function, after acute coronary revascularization procedures (percutaneous coronary intervention or coronary artery bypass grafting) and reduced left ventricular ejection fraction (≤35%), in patients with acute heart failure in non-ischaemic cardiomyopathy of uncertain aetiology and prognosis. The WCD may be helpful in subjects with syncope of assumed tachyarrhythmia origin or in patients with inherited arrhythmia syndromes. The WCD may replace ICD implantation in patients waiting for heart transplantation or who need a ventricular-assist device. This review describes the technical details and characteristics of the WCD, discusses its

  6. Advances in targeted therapy for acute myeloid leukaemia.

    PubMed

    Kayser, Sabine; Levis, Mark J

    2018-02-01

    In the past few years, research in the underlying pathogenic mechanisms of acute myeloid leukaemia (AML) has led to remarkable advances in our understanding of the disease. Cytogenetic and molecular aberrations are the most important factors in determining response to chemotherapy as well as long-term outcome, but beyond prognostication are potential therapeutic targets. Our increased understanding of the pathogenesis of AML, facilitated by next-generation sequencing, has spurred the development of new compounds in the treatment of AML, particularly the creation of small molecules that target the disease on a molecular level. Various new agents, such as tyrosine kinase inhibitors, immune checkpoint inhibitors, monoclonal or bispecific T-cell engager antibodies, metabolic and pro-apoptotic agents are currently investigated within clinical trials. The highest response rates are often achieved when new molecularly targeted therapies are combined with standard chemotherapy. Presented here is an overview of novel therapies currently being evaluated in AML. © 2017 John Wiley & Sons Ltd.

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

    PubMed

    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

    2015-08-01

    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. 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. 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. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

  8. From Novice to Expert: Problem Solving in ICD-10-PCS Procedural Coding

    PubMed Central

    Rousse, Justin Thomas

    2013-01-01

    The benefits of converting to ICD-10-CM/PCS have been well documented in recent years. One of the greatest challenges in the conversion, however, is how to train the workforce in the code sets. The International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS) has been described as a language requiring higher-level reasoning skills because of the system's increased granularity. Training and problem-solving strategies required for correct procedural coding are unclear. The objective of this article is to propose that the acquisition of rule-based logic will need to be augmented with self-evaluative and critical thinking. Awareness of how this process works is helpful for established coders as well as for a new generation of coders who will master the complexities of the system. PMID:23861674

  9. Recent Advances in Cancer Therapy Based on Dual Mode Gold Nanoparticles

    PubMed Central

    Spyratou, Ellas; Makropoulou, Mersini; Sihver, Lembit

    2017-01-01

    Many tumor-targeted strategies have been used worldwide to limit the side effects and improve the effectiveness of therapies, such as chemotherapy, radiotherapy (RT), etc. Biophotonic therapy modalities comprise very promising alternative techniques for cancer treatment with minimal invasiveness and side-effects. These modalities use light e.g., laser irradiation in an extracorporeal or intravenous mode to activate photosensitizer agents with selectivity in the target tissue. Photothermal therapy (PTT) is a minimally invasive technique for cancer treatment which uses laser-activated photoabsorbers to convert photon energy into heat sufficient to induce cells destruction via apoptosis, necroptosis and/or necrosis. During the last decade, PTT has attracted an increased interest since the therapy can be combined with customized functionalized nanoparticles (NPs). Recent advances in nanotechnology have given rise to generation of various types of NPs, like gold NPs (AuNPs), designed to act both as radiosensitizers and photothermal sensitizing agents due to their unique optical and electrical properties i.e., functioning in dual mode. Functionalized AuNPS can be employed in combination with non-ionizing and ionizing radiation to significantly improve the efficacy of cancer treatment while at the same time sparing normal tissues. Here, we first provide an overview of the use of NPs for cancer therapy. Then we review many recent advances on the use of gold NPs in PTT, RT and PTT/RT based on different types of AuNPs, irradiation conditions and protocols. We refer to the interaction mechanisms of AuNPs with cancer cells via the effects of non-ionizing and ionizing radiations and we provide recent existing experimental data as a baseline for the design of optimized protocols in PTT, RT and PTT/RT combined treatment. PMID:29257070

  10. Advancement of 31P Magnetic Resonance Spectroscopy Using GRAPPA Reconstruction on a 3D Volume

    NASA Astrophysics Data System (ADS)

    Clevenger, Tony

    The overall objective of this research is to improve currently available metabolic imaging techniques for clinical use in monitoring and predicting treatment response to radiation therapy in liver cancer. Liver metabolism correlates with inflammatory and neoplastic liver diseases, which alter the intracellular concentration of phosphorus- 31 (31P) metabolites [1]. It is assumed that such metabolic changes occur prior to physical changes of the tissue. Therefore, information on regional changes of 31P metabolites in the liver, obtained by Magnetic Resonance Spectroscopic Imaging (MRSI) [1,2], can help in diagnosis and follow-up of various liver diseases. Specifically, there appears to be an immediate need of this technology for both the assessment of tumor response in patients with Hepatocellular Carcinoma (HCC) treated with Stereotactic Body Radiation Therapy (SBRT) [3--5], as well as assessment of radiation toxicity, which can result in worsening liver dysfunction [6]. Pilot data from our lab has shown that 31P MRSI has the potential to identify treatment response five months sooner than conventional methods [7], and to assess the biological response of liver tissue to radiation 24 hours post radiation therapy [8]. While this data is very promising, commonly occurring drawbacks for 31P MRSI are patient discomfort due to long scan times and prone positioning within the scanner, as well as reduced data quality due to patient motion and respiration. To further advance the full potential of 31P MRSI as a clinical diagnostic tool in the management of liver cancer, this PhD research project had the following aims: I) Reduce the long acquisition time of 3D 31P MRS by formulating and imple- menting an appropriate GRAPPA undersampling scheme and reconstruction on a clinical MRI scanner II) Testing and quantitative validation of GRAPPA reconstruction on 3D 31P MRSI on developmental phantoms and healthy volunteers At completion, this work should considerably advance 31P MRSI

  11. The Role of Conventional and Right-Sided ECG Screening for Subcutaneous ICD in a Tetralogy of Fallot Population.

    PubMed

    Alonso, Pau; Osca, Joaquín; Cano, Oscar; Pimenta, Pedro; Andrés, Ana; Yagüe, Jaime; Millet, José; Rueda, Joaquín; Sancho-Tello, María José

    2017-02-01

    Information regarding suitability for subcutaneous implantable cardioverter-defibrillator (S-ICD) implant in tetralogy of Fallot (ToF) population is scarce and needs to be further explored. (1) to determine the proportion of patients with ToF eligible for S-ICD, (2) to identify the optimal sensing vector in ToF patients, (3) to test specifically the eligibility for S-ICD with right-sided screening, and (4) to compare with the proportion of eligible patients in a nonselected ICD population. We recruited 60 consecutive patients with ToF and 40 consecutive nonselected patients. Conventional electrocardiographic screening was performed as usual. Right-sided alternative screening was studied by positioning the left arm and right arm electrodes 1 cm right lateral to the xiphoid midline. The Boston Scientific electrocardiogram (ECG) screening tool was utilized. We found a higher proportion of patients with right-sided positive screening in comparison with standard screening (77 ± 0.4% vs. 67 ± 0.4%; P < 0.0001) and a trend to higher number of appropriate leads in right-sided screening (1.3 ± 1 vs. 1.1 ± 1 ms; P = 0.07). Patients who failed the screening had a longer QRS duration and longer QT interval. Standard and right-sided screening showed a higher percent of positive patients in the control group compared to ToF patients (P < 0.001). Right-sided screening was associated with a significant 10% increase in S-ICD eligibility in ToF patients. When comparing with an acquired cardiomyopathies group, ToF showed a lower eligibility for S-ICD. The most appropriate ECG vector was the alternate vector in contrast to what is observed in the general population. © 2017 Wiley Periodicals, Inc.

  12. Advancing the field of 3D biomaterial printing.

    PubMed

    Jakus, Adam E; Rutz, Alexandra L; Shah, Ramille N

    2016-01-11

    3D biomaterial printing has emerged as a potentially revolutionary technology, promising to transform both research and medical therapeutics. Although there has been recent progress in the field, on-demand fabrication of functional and transplantable tissues and organs is still a distant reality. To advance to this point, there are two major technical challenges that must be overcome. The first is expanding upon the limited variety of available 3D printable biomaterials (biomaterial inks), which currently do not adequately represent the physical, chemical, and biological complexity and diversity of tissues and organs within the human body. Newly developed biomaterial inks and the resulting 3D printed constructs must meet numerous interdependent requirements, including those that lead to optimal printing, structural, and biological outcomes. The second challenge is developing and implementing comprehensive biomaterial ink and printed structure characterization combined with in vitro and in vivo tissue- and organ-specific evaluation. This perspective outlines considerations for addressing these technical hurdles that, once overcome, will facilitate rapid advancement of 3D biomaterial printing as an indispensable tool for both investigating complex tissue and organ morphogenesis and for developing functional devices for a variety of diagnostic and regenerative medicine applications.

  13. Correlation analysis between 2D and quasi-3D gamma evaluations for both intensity-modulated radiation therapy and volumetric modulated arc therapy

    PubMed Central

    Kim, Jung-in; Choi, Chang Heon; Wu, Hong-Gyun; Kim, Jin Ho; Kim, Kyubo; Park, Jong Min

    2017-01-01

    The aim of this work was to investigate correlations between 2D and quasi-3D gamma passing rates. A total of 20 patients (10 prostate cases and 10 head and neck cases, H&N) were retrospectively selected. For each patient, both intensity-modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT) plans were generated. For each plan, 2D gamma evaluation with radiochromic films and quasi-3D gamma evaluation with fluence measurements were performed with both 2%/2 mm and 3%/3 mm criteria. Gamma passing rates were grouped together according to delivery techniques and treatment sites. Statistical analyses were performed to examine the correlation between 2D and quasi-3D gamma evaluations. Statistically significant difference was observed between delivery techniques only in the quasi-3D gamma passing rates with 2%/2 mm. Statistically significant differences were observed between treatment sites in the 2D gamma passing rates (differences of less than 8%). No statistically significant correlations were observed between 2D and quasi-3D gamma passing rates except the VMAT group and the group including both IMRT and VMAT with 3%/3 mm (r = 0.564 with p = 0.012 for theVMAT group and r = 0.372 with p = 0.020 for the group including both IMRT and VMAT), however, those were not strong. No strong correlations were observed between 2D and quasi-3D gamma evaluations. PMID:27690300

  14. Protein biomarkers identify patients unlikely to benefit from primary prevention implantable cardioverter defibrillators: findings from the Prospective Observational Study of Implantable Cardioverter Defibrillators (PROSE-ICD).

    PubMed

    Cheng, Alan; Zhang, Yiyi; Blasco-Colmenares, Elena; Dalal, Darshan; Butcher, Barbara; Norgard, Sanaz; Eldadah, Zayd; Ellenbogen, Kenneth A; Dickfeld, Timm; Spragg, David D; Marine, Joseph E; Guallar, Eliseo; Tomaselli, Gordon F

    2014-12-01

    Primary prevention implantable cardioverter defibrillators (ICDs) reduce all-cause mortality, but the benefits are heterogeneous. Current risk stratification based on left ventricular ejection fraction has limited discrimination power. We hypothesize that biomarkers for inflammation, neurohumoral activation, and cardiac injury can predict appropriate shocks and all-cause mortality in patients with primary prevention ICDs. The Prospective Observational Study of Implantable Cardioverter Defibrillators (PROSe-ICD) enrolled 1189 patients with systolic heart failure who underwent ICD implantation for primary prevention of sudden cardiac death. The primary end point was an ICD shock for adjudicated ventricular tachyarrhythmia. The secondary end point was all-cause mortality. After a median follow-up of 4.0 years, 137 subjects experienced an appropriate ICD shock and 343 participants died (incidence rates of 3.2 and 5.8 per 100 person-years, respectively). In multivariable-adjusted models, higher interleukin-6 levels increased the risk of appropriate ICD shocks. In contrast, C-reactive protein, interleukin-6, tumor necrosis factor-α receptor II, pro-brain natriuretic peptide (pro-BNP), and cardiac troponin T showed significant linear trends for increased risk of all-cause mortality across quartiles. A score combining these 5 biomarkers identified patients who were much more likely to die than to receive an appropriate shock from the ICD. An increase in serum biomarkers of inflammation, neurohumoral activation, and myocardial injury increased the risk for death but poorly predicted the likelihood of an ICD shock. These findings highlight the potential importance of serum-based biomarkers in identifying patients who are unlikely to benefit from primary prevention ICDs. clinicaltrials.gov; Unique Identifier: NCT00733590. © 2014 American Heart Association, Inc.

  15. SlicerRT: radiation therapy research toolkit for 3D Slicer.

    PubMed

    Pinter, Csaba; Lasso, Andras; Wang, An; Jaffray, David; Fichtinger, Gabor

    2012-10-01

    Interest in adaptive radiation therapy research is constantly growing, but software tools available for researchers are mostly either expensive, closed proprietary applications, or free open-source packages with limited scope, extensibility, reliability, or user support. To address these limitations, we propose SlicerRT, a customizable, free, and open-source radiation therapy research toolkit. SlicerRT aspires to be an open-source toolkit for RT research, providing fast computations, convenient workflows for researchers, and a general image-guided therapy infrastructure to assist clinical translation of experimental therapeutic approaches. It is a medium into which RT researchers can integrate their methods and algorithms, and conduct comparative testing. SlicerRT was implemented as an extension for the widely used 3D Slicer medical image visualization and analysis application platform. SlicerRT provides functionality specifically designed for radiation therapy research, in addition to the powerful tools that 3D Slicer offers for visualization, registration, segmentation, and data management. The feature set of SlicerRT was defined through consensus discussions with a large pool of RT researchers, including both radiation oncologists and medical physicists. The development processes used were similar to those of 3D Slicer to ensure software quality. Standardized mechanisms of 3D Slicer were applied for documentation, distribution, and user support. The testing and validation environment was configured to automatically launch a regression test upon each software change and to perform comparison with ground truth results provided by other RT applications. Modules have been created for importing and loading DICOM-RT data, computing and displaying dose volume histograms, creating accumulated dose volumes, comparing dose volumes, and visualizing isodose lines and surfaces. The effectiveness of using 3D Slicer with the proposed SlicerRT extension for radiation therapy

  16. Phase I Trial of Adenovirus-Mediated IL-12 Gene Transduction in Patients with Recurrent Locally Advanced Prostate Cancer Following Therapy

    DTIC Science & Technology

    2005-10-01

    salvage seed implant, cryotherapy ) or who have a rising PSA while on hormone therapy for locally advanced prostate cancer are as follows: a. A...Gene Transduction in Patients with Recurrent Locally Advanced Prostate Cancer Following Therapy PRINCIPAL INVESTIGATOR: Simon J. Hall, MD...CONTRACT NUMBER Phase I Trial of Adenovirus-Mediated IL-12 Gene Transduction in Patients with Recurrent Locally Advanced Prostate Cancer Following

  17. Irreversible electroporation therapy in the management of locally advanced pancreatic adenocarcinoma.

    PubMed

    Martin, Robert C G; McFarland, Kelli; Ellis, Susan; Velanovich, Vic

    2012-09-01

    Locally advanced pancreatic cancer patients have limited options for disease control. Local ablation technologies based on thermal damage have been used but are associated with major complications in this region of the pancreas. Irreversible electroporation (IRE) is a nonthermal ablation technology that we have shown is safe near vital vascular and ductal structures. The aim of this study was to evaluate the safety and efficacy of IRE as a therapy in the treatment of locally advanced pancreatic cancer. We performed a prospective multi-institutional pilot evaluation of patients undergoing IRE for locally advanced pancreatic cancer from December 2009 to March 2011. These patients were evaluated for 90-day morbidity, mortality, and local disease control. Twenty-seven patients (13 women and 14 men) underwent IRE, with median age of 61 years (range 45 to 80 years). Eight patients underwent margin accentuation with IRE in combination with left-sided resection (n = 4) or pancreatic head resection (n = 4). Nineteen patients had in situ IRE. All patients underwent successful IRE, with intraoperative imaging confirming effective delivery of therapy. All 27 patients demonstrated nonclinically relevant elevation of their amylase and lipase, which peaked at 48 hours and returned to normal at 72 hour postprocedure. There has been one 90-day mortality. No patient has shown evidence of clinical pancreatitis or fistula formation. After all patients have completed 90-day follow-up, there has been 100% ablation success. IRE ablation of locally advanced pancreatic cancer tumors is a safe and feasible primary local treatment in unresectable, locally advanced disease. Confirming these early results must occur in a planned phase II investigational device exemption (IDE) study to be initiated in 2012. Copyright © 2012 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  18. Atmospheric, Magnetospheric and Plasmas in Space (AMPS) spacelab payload definition study. Volume 3: Interface control documents. Part 2: AMPS payload to spacelab ICD

    NASA Technical Reports Server (NTRS)

    1976-01-01

    The AMPS to Spacelab Interface Control Document which is to be used as a guide for format and information content in generating specific AMPS Mission ICDs is presented. This document is meant to supplement the Spacelab Payload Accommodations Handbook in that it only defines interfaces which are not discussed in the handbook to the level required for design purposes. The AMPS Top Level Requirements Tree, illustrates this ICD by a shaded area and its relationship to the other AMPS technical documents. Other interface documents shown are the Level II, AMPS to Space Shuttle Vehicle ICD and the Level III, AMPS to Instruments ICD.

  19. Assessment of community contribution to the ICDS scheme in district Agra: a case study.

    PubMed

    Nayar, D; Kapil, U; Nandan, D

    1999-01-01

    This study was conducted to assess community contribution to the Integrated Child Development Services (ICDS) program, which promotes mother and child health in the Agra district, Uttar Pradesh, India. Three rural ICDS projects in the district were selected, out of which a total of 74 Anganwadi centers (AWCs) were chosen for the study. The Anganwadi workers (AWWs) were interviewed through a semi-structured questionnaire to assess the community¿s contribution during the previous 6 months. Results revealed that about 68% of AWWs had been able to receive assistance in bringing the children to the AWC. 53.3% had received free accommodation for AWC, and 42.6% had obtained assistance in implementation of health activities. Only 4% and 12% of the AWWs reported community assistance in the preparation and distribution of nutritional supplements, respectively. There had been no contribution received in terms of raw food for supplementary nutrition and fuel for cooking. The study concludes that rural area free accommodation for the AWC and community assistance in bringing children to the AWC were the most common forms of community contribution to the ICDS program.

  20. Impulse Control Disorders and Related Complications of Parkinson’s Disease Therapy

    PubMed Central

    Lopez, Alexander M.; Weintraub, Daniel; Claassen, Daniel O.

    2017-01-01

    Impulsive and compulsive behaviors in Parkinson’s disease (PD) patients are most often attributed to dopamine agonist therapy; dysregulation of the mesocorticolimbic system accounts for this behavioral phenotype. The clinical presentation is commonly termed impulse control disorder (ICD): Behaviors include hypersexuality, compulsive eating, shopping, pathological gambling, and compulsive hobby participation. However, not all PD individuals taking dopamine agonists develop these behavioral changes. In this review, the authors focus on the similarities between the phenotypic presentation of ICDs with that of other reward-based behavioral disorders, including binge eating disorder, pathological gambling, and substance use disorders. With this comparison, we emphasize that the transition from an impulsive to compulsive behavior likely follows a ventral to dorsal striatal pattern, where an altered dopaminergic reward system underlies the emergence of these problematic behaviors. The authors discuss the neurobiological similarities between these latter disorders and ICDs, emphasizing similar pathophysiological processes and discussing treatment options that have potential for translation to PD patients. PMID:28511259

  1. Examining the impact of introducing ICD-MM on observed trends in maternal mortality rates in the UK 2003-13.

    PubMed

    Knight, Marian; Nair, Manisha; Brocklehurst, Peter; Kenyon, Sara; Neilson, James; Shakespeare, Judy; Tuffnell, Derek; Kurinczuk, Jennifer J

    2016-07-20

    The causes of maternal death are now classified internationally according to ICD-MM. One significant change with the introduction of ICD-MM in 2012 was the reclassification of maternal suicide from the indirect group to the direct group. This has led to concerns about the impact of this reclassification on calculated mortality rates. The aim of this analysis was to examine the trends in maternal deaths in the UK over the past 10 years, and to investigate the impact of reclassification using ICD-MM on the observed rates. Data about all maternal deaths between 2003-13 in the UK were included in this analysis. Data about maternal deaths occurring prior to 2009 were obtained from previously published reports. The deaths of women from 2009-13 during or after pregnancy were identified through the MBRRACE-UK Confidential Enquiry into Maternal Deaths. The underlying causes of maternal death were reclassified from a disease-based system to ICD-MM. Maternal mortality rates with 95 % confidence intervals were calculated using national data on the number of maternities as the denominator. Rate ratios with 95 % CI were calculated to compare the change in rates of maternal death as per ICD-MM relative to the old classification system. There was a decrease in the maternal death rate between 2003-05 and 2011-13 (rate ratio (RR) 0.65; 95 % CI 0.54-0.77 comparing 2003-5 with 2011-13; p = 0.005 for trend over time). The direct maternal death rate calculated using the old classification decreased with a RR of 0.47 (95 % CI 0.34-0.63) when comparing 2011-13 with 2003-05; p = 0.005 for trend over time. Reclassification using ICD-MM made little material difference to the observed trend in direct maternal death rates, RR = 0.51 (95 % CI 0.39-0.68) when comparing 2003-5 with 2011-13; p = 0.005 for trend over time. The impact of reclassifying maternal deaths according to ICD-MM in the UK was minimal. However, such reclassification raises awareness of maternal suicides

  2. Antiretroviral Therapy in Advanced HIV Disease: Which is the Best Regimen?

    PubMed

    Burgos, Joaquin; Ribera, Esteban; Falcó, Vicenç

    2018-01-01

    Advanced HIV disease, defined as a CD4 cell count below 200 cells/μl or the presence of an AIDS-defining illness, remains common among HIV-infected individuals who first present for medical care. In developed countries, nearly 30% of new HIV diagnoses occurred at advanced stages of the disease, and it is important because advanced HIV disease has been associated with worse clinical outcomes, including lower rates of virological response, higher morbidity, and higher mortality. However, there are scarce data regarding which is the best antiretroviral regimen in these patients. Nowadays, integrase inhibitor-based regimens are widely recommended as the best initial therapy for treatment-naïve HIV-infected patients by all international guidelines. However, these guidelines hardly mention the recommended regimens in individuals with advanced HIV disease. Otherwise, recent data indicating a higher risk of immune reconstitution inflammatory syndrome associated to the use of integrase inhibitors have raised concerns on the use of these drugs in patients with advanced HIV disease. The aim of this article is to review the available evidence from randomized clinical trials for the best treatment in patients with advanced HIV disease.

  3. Proposed declassification of disease categories related to sexual orientation in the International Statistical Classification of Diseases and Related Health Problems (ICD-11).

    PubMed

    Cochran, Susan D; Drescher, Jack; Kismödi, Eszter; Giami, Alain; García-Moreno, Claudia; Atalla, Elham; Marais, Adele; Vieira, Elisabeth Meloni; Reed, Geoffrey M

    2014-09-01

    The World Health Organization is developing the 11th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-11), planned for publication in 2017. The Working Group on the Classification of Sexual Disorders and Sexual Health was charged with reviewing and making recommendations on disease categories related to sexuality in the chapter on mental and behavioural disorders in the 10th revision (ICD-10), published in 1990. This chapter includes categories for diagnoses based primarily on sexual orientation even though ICD-10 states that sexual orientation alone is not a disorder. This article reviews the scientific evidence and clinical rationale for continuing to include these categories in the ICD. A review of the evidence published since 1990 found little scientific interest in these categories. In addition, the Working Group found no evidence that they are clinically useful: they neither contribute to health service delivery or treatment selection nor provide essential information for public health surveillance. Moreover, use of these categories may create unnecessary harm by delaying accurate diagnosis and treatment. The Working Group recommends that these categories be deleted entirely from ICD-11. Health concerns related to sexual orientation can be better addressed using other ICD categories.

  4. Proposed declassification of disease categories related to sexual orientation in the International Statistical Classification of Diseases and Related Health Problems (ICD-11)

    PubMed Central

    Drescher, Jack; Kismödi, Eszter; Giami, Alain; García-Moreno, Claudia; Atalla, Elham; Marais, Adele; Vieira, Elisabeth Meloni; Reed, Geoffrey M

    2014-01-01

    Abstract The World Health Organization is developing the 11th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-11), planned for publication in 2017. The Working Group on the Classification of Sexual Disorders and Sexual Health was charged with reviewing and making recommendations on disease categories related to sexuality in the chapter on mental and behavioural disorders in the 10th revision (ICD-10), published in 1990. This chapter includes categories for diagnoses based primarily on sexual orientation even though ICD-10 states that sexual orientation alone is not a disorder. This article reviews the scientific evidence and clinical rationale for continuing to include these categories in the ICD. A review of the evidence published since 1990 found little scientific interest in these categories. In addition, the Working Group found no evidence that they are clinically useful: they neither contribute to health service delivery or treatment selection nor provide essential information for public health surveillance. Moreover, use of these categories may create unnecessary harm by delaying accurate diagnosis and treatment. The Working Group recommends that these categories be deleted entirely from ICD-11. Health concerns related to sexual orientation can be better addressed using other ICD categories. PMID:25378758

  5. Overcoming barriers to population-based injury research: development and validation of an ICD10-to-AIS algorithm.

    PubMed

    Haas, Barbara; Xiong, Wei; Brennan-Barnes, Maureen; Gomez, David; Nathens, Avery B

    2012-02-01

    Hospital administrative databases are a useful source of population-level data on injured patients; however, these databases use the International Classification of Diseases (ICD) system, which does not provide a direct means of estimating injury severity. We created and validated a crosswalk to derive Abbreviated Injury Scale (AIS) scores from injury-related diagnostic codes in the tenth revision of the ICD (ICD-10). We assessed the validity of the crosswalk using data from the Ontario Trauma Registry Comprehensive Data Set (OTRCDS). The AIS and Injury Severity Scores (ISS) derived using the algorithm were compared with those assigned by expert abstractors. We evaluated the ability of the algorithm to identify patients with AIS scores of 3 or greater. We used κ and intraclass correlation coefficients (ICC) as measures of concordance. In total, 10 431 patients were identified in the OTRCDS. The algorithm accurately identified patients with at least 1 AIS score of 3 or greater (κ 0.65), as well as patients with a head AIS score of 3 or greater (κ 0.78). Mapped and abstracted ISS were similar; ICC across the entire cohort was 0.83 (95% confidence interval 0.81-0.84), indicating good agreement. When comparing mapped and abstracted ISS, the difference between scores was 10 or less in 87% of patients. Concordance between mapped and abstracted ISS was similar across strata of age, mechanism of injury and mortality. Our ICD-10-to-AIS algorithm produces reliable estimates of injury severity from data available in administrative databases. This algorithm can facilitate the use of administrative data for population-based injury research in jurisdictions using ICD-10.

  6. Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial.

    PubMed

    Hosseinipour, Mina C; Bisson, Gregory P; Miyahara, Sachiko; Sun, Xin; Moses, Agnes; Riviere, Cynthia; Kirui, Fredrick K; Badal-Faesen, Sharlaa; Lagat, David; Nyirenda, Mulinda; Naidoo, Kogieleum; Hakim, James; Mugyenyi, Peter; Henostroza, German; Leger, Paul D; Lama, Javier R; Mohapi, Lerato; Alave, Jorge; Mave, Vidya; Veloso, Valdilea G; Pillay, Sandy; Kumarasamy, Nagalingeswaran; Bao, Jing; Hogg, Evelyn; Jones, Lynne; Zolopa, Andrew; Kumwenda, Johnstone; Gupta, Amita

    2016-03-19

    Mortality within the first 6 months after initiating antiretroviral therapy is common in resource-limited settings and is often due to tuberculosis in patients with advanced HIV disease. Isoniazid preventive therapy is recommended in HIV-positive adults, but subclinical tuberculosis can be difficult to diagnose. We aimed to assess whether empirical tuberculosis treatment would reduce early mortality compared with isoniazid preventive therapy in high-burden settings. We did a multicountry open-label randomised clinical trial comparing empirical tuberculosis therapy with isoniazid preventive therapy in HIV-positive outpatients initiating antiretroviral therapy with CD4 cell counts of less than 50 cells per μL. Participants were recruited from 18 outpatient research clinics in ten countries (Malawi, South Africa, Haiti, Kenya, Zambia, India, Brazil, Zimbabwe, Peru, and Uganda). Individuals were screened for tuberculosis using a symptom screen, locally available diagnostics, and the GeneXpert MTB/RIF assay when available before inclusion. Study candidates with confirmed or suspected tuberculosis were excluded. Inclusion criteria were liver function tests 2·5 times the upper limit of normal or less, a creatinine clearance of at least 30 mL/min, and a Karnofsky score of at least 30. Participants were randomly assigned (1:1) to either the empirical group (antiretroviral therapy and empirical tuberculosis therapy) or the isoniazid preventive therapy group (antiretroviral therapy and isoniazid preventive therapy). The primary endpoint was survival (death or unknown status) at 24 weeks after randomisation assessed in the intention-to-treat population. Kaplan-Meier estimates of the primary endpoint across groups were compared by the z-test. All participants were included in the safety analysis of antiretroviral therapy and tuberculosis treatment. This trial is registered with ClinicalTrials.gov, number NCT01380080. Between Oct 31, 2011, and June 9, 2014, we enrolled 850

  7. HER Story: The Next Chapter in HER-2-Directed Therapy for Advanced Breast Cancer

    PubMed Central

    Joy, Anil A.; Rayson, Daniel; McLeod, Deanna; Brezden-Masley, Christine; Boileau, Jean-François; Gelmon, Karen A.

    2013-01-01

    Untreated human epidermal growth factor receptor-2 (HER-2)-positive advanced breast cancer (ABC) is an aggressive disease, associated with a poor prognosis and short overall survival. HER-2-directed therapy prolongs both time to disease progression and overall survival when combined with chemotherapy and has become the standard of care for those with HER-2-positive breast cancer in the early and advanced settings. Despite the remarkable therapeutic impact HER-2-directed therapy has had on disease outcomes, some patients with HER-2-positive disease will have primary resistant disease and others will respond initially but will eventually have progression, underscoring the need for other novel therapeutic options. This article reviews recent phase III trial data and discusses a practical approach to sequencing of HER-2-directed therapy in patients with HER-2-positive ABC. The significant cumulative survival gains seen in these trials are slowly reshaping the landscape of HER-2-positive ABC outcomes. PMID:24212500

  8. Advanced resin systems and 3D textile preforms for low cost composite structures

    NASA Technical Reports Server (NTRS)

    Shukla, J. G.; Bayha, T. D.

    1993-01-01

    Advanced resin systems and 3D textile preforms are being evaluated at Lockheed Aeronautical Systems Company (LASC) under NASA's Advanced Composites Technology (ACT) Program. This work is aimed towards the development of low-cost, damage-tolerant composite fuselage structures. Resin systems for resin transfer molding and powder epoxy towpreg materials are being evaluated for processability, performance and cost. Three developmental epoxy resin systems for resin transfer molding (RTM) and three resin systems for powder towpregging are being investigated. Various 3D textile preform architectures using advanced weaving and braiding processes are also being evaluated. Trials are being conducted with powdered towpreg, in 2D weaving and 3D braiding processes for their textile processability and their potential for fabrication in 'net shape' fuselage structures. The progress in advanced resin screening and textile preform development is reviewed here.

  9. Liposomal Drug Delivery System for Cancer Therapy: Advancement and Patents.

    PubMed

    Jha, Sheetal; Sharma, Pramod K; Malviya, Rishabha

    2016-01-01

    In this review article, authors reviewed about the liposomes which are amongst various drug delivering systems for the delivery of the therapeutic agents at the target site. Advances in liposomal drug delivery systems for the cancer therapy have enhanced the therapeutic levels of the anticancer moieties. Liposomes show promising action on the tumor by incorporating less amount of drug at the target site, with minimum toxic effect and maximum therapeutic effect and thereby enhancing the bioavailability. Liposome-based drug delivery systems provide the potential to elevate the effect of drug concentration in tumor cells. Manuscript briefly describes the role of liposomes in cancer therapy and various patents based on the same. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  10. Recent advances in intensity modulated radiotherapy and proton therapy for esophageal cancer.

    PubMed

    Xi, Mian; Lin, Steven H

    2017-07-01

    Radiotherapy is an important component of the standard of care for esophageal cancer. In the past decades, significant improvements in the planning and delivery of radiation techniques have led to better dose conformity to the target volume and improved normal tissue sparing. Areas covered: This review focuses on the advances in radiotherapy techniques and summarizes the availably dosimetric and clinical outcomes of intensity-modulated radiation therapy (IMRT), volumetric modulated arc therapy, proton therapy, and four-dimensional radiotherapy for esophageal cancer, and discusses the challenges and future development of proton therapy. Expert commentary: Although three-dimensional conformal radiotherapy is the standard radiotherapy technique in esophageal cancer, the retrospectively comparative studies strongly suggest that the dosimetric advantage of IMRT over three-dimensional conformal radiotherapy can translate into improved clinical outcomes, despite the lack of prospective randomized evidence. As a novel form of conventional IMRT technique, volumetric modulated arc therapy can produce equivalent or superior dosimetric quality with significantly higher treatment efficiency in esophageal cancer. Compared with photon therapy, proton therapy has the potential to achieve further clinical improvement due to their physical properties; however, prospective clinical data, long-term results, and cost-effectiveness are needed.

  11. Advanced computational tools for 3-D seismic analysis

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

    Barhen, J.; Glover, C.W.; Protopopescu, V.A.

    1996-06-01

    The global objective of this effort is to develop advanced computational tools for 3-D seismic analysis, and test the products using a model dataset developed under the joint aegis of the United States` Society of Exploration Geophysicists (SEG) and the European Association of Exploration Geophysicists (EAEG). The goal is to enhance the value to the oil industry of the SEG/EAEG modeling project, carried out with US Department of Energy (DOE) funding in FY` 93-95. The primary objective of the ORNL Center for Engineering Systems Advanced Research (CESAR) is to spearhead the computational innovations techniques that would enable a revolutionary advancemore » in 3-D seismic analysis. The CESAR effort is carried out in collaboration with world-class domain experts from leading universities, and in close coordination with other national laboratories and oil industry partners.« less

  12. Personalized pulmonary rehabilitation and occupational therapy based on cardiopulmonary exercise testing for patients with advanced chronic obstructive pulmonary disease

    PubMed Central

    Maekura, Ryoji; Hiraga, Toru; Miki, Keisuke; Kitada, Seigo; Miki, Mari; Yoshimura, Kenji; Yamamoto, Hiroshi; Kawabe, Toshiko; Mori, Masahide

    2015-01-01

    Take-home summary Personalized pulmonary rehabilitation including occupational therapy improves the prognosis of patients with advanced COPD. Purpose We previously reported that patients with chronic obstructive pulmonary disease (COPD) exhibit three exercise-induced life-threatening conditions: hypoxemia, sympathetic overactivity, and respiratory acidosis. We aimed to verify whether mortality in patients with advanced COPD could be reduced by a personalized pulmonary rehabilitation (PPR) program in hospital, which determines individual safe ranges and includes occupational therapy (PPR-OT), to prevent desaturation and sympathetic nerve activation during daily activities. Patients and methods The novel PPR-OT program was evaluated in a retrospective study of patients with COPD (Global Initiative for Chronic Obstructive Lung Disease [GOLD] Grade D) who underwent cardiopulmonary exercise testing (CPET) between April 1990 and December 1999. They received regular treatment without the proposed therapy (control group: n=61; male-to-female ratio [M:F] =57:4; mean age: 68.5±6.7 years) or with the proposed therapy (PPR-OT group: n=46; M:F =44:2; mean age: 68.7±7.1 years). A prospective observational study included patients with COPD receiving home oxygen therapy (HOT) between April 1995 and March 2007 to compare the survival rates of the control group (n=47; M:F ratio =34:13; mean age: 71.3±10.0 years) and the PPR-OT group (n=85; M:F =78:7; mean age: 70.7±6.1 years) who completed the proposed therapy. Survival after CPET or HOT was analyzed using Cox proportional-hazards regression and Kaplan–Meier analyses. Results In both studies, the program significantly improved all-cause mortality (retrospective study: risk ratio =0.389 [range: 0.172–0.800]; P=0.0094; log-rank test, P=0.0094; observational study: risk ratio =0.515 [range: 0.296–0.933]; P=0.0291; log-rank test, P=0.0232]. At 5 years and 7 years, all-cause mortality was extremely low in patients in the PPR

  13. 3D treatment planning systems.

    PubMed

    Saw, Cheng B; Li, Sicong

    2018-01-01

    Three-dimensional (3D) treatment planning systems have evolved and become crucial components of modern radiation therapy. The systems are computer-aided designing or planning softwares that speed up the treatment planning processes to arrive at the best dose plans for the patients undergoing radiation therapy. Furthermore, the systems provide new technology to solve problems that would not have been considered without the use of computers such as conformal radiation therapy (CRT), intensity-modulated radiation therapy (IMRT), and volumetric modulated arc therapy (VMAT). The 3D treatment planning systems vary amongst the vendors and also the dose delivery systems they are designed to support. As such these systems have different planning tools to generate the treatment plans and convert the treatment plans into executable instructions that can be implemented by the dose delivery systems. The rapid advancements in computer technology and accelerators have facilitated constant upgrades and the introduction of different and unique dose delivery systems than the traditional C-arm type medical linear accelerators. The focus of this special issue is to gather relevant 3D treatment planning systems for the radiation oncology community to keep abreast of technology advancement by assess the planning tools available as well as those unique "tricks or tips" used to support the different dose delivery systems. Copyright © 2018 American Association of Medical Dosimetrists. Published by Elsevier Inc. All rights reserved.

  14. Integrated Child Development Services (ICDS): harbinger of safe motherhood and child development.

    PubMed

    Lal, S

    1993-01-01

    Editorial comment was provided on the features that made the Integrated Child Development Services (ICDS) program in India unique and on whether or not the system could focus on younger age groups (e.g., 2-3 years of age). As part of a worldwide effort, India's ICDS program has been directed to human resource development. Over the past 17 years, the program has expanded to include almost 50% of the country's most vulnerable and deprived population. The focus on children aimed to improve their nutrition and health by reducing the incidence of morbidity, mortality, malnutrition, and school dropouts. The concern encompassed physical, social, and psychological development. The focus on mothers stressed enabling them to better care for the health and nutrition of their children. The program included prenatal care, safe delivery, and post natal concern for lactation, breast feeding, and physical growth monitoring in the early years. The program's unique features were its voluntary membership of community health workers, integrated services, and targeted coverage of economically weaker and deprived populations during critical child development periods. Indigenous Indian resources provided the primary financial support. Nation coverage was given for universal immunization, family welfare, child and maternal health, diarrheal disease control, vitamin A supplementation, and anemia screening and treatment. The multisectoral nature of the program has been realized at the village, sector, block, and district levels with linkages within Health, Education, and Social Welfare sectors, and with the Medical Colleges and Home Science Colleges. Feedback from operations research studies and other research activities was provided at the local program level, and interactions occurred between students in training programs and health care delivery systems. The program will be expanded to include the entire country. Health and nutrition education were considered the weakest part of ICDS

  15. Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial.

    PubMed

    Gasparini, Maurizio; Galimberti, Paola; Bragato, Renato; Ghio, Stefano; Raineri, Claudia; Landolina, Maurizio; Chieffo, Enrico; Lunati, Maurizio; Mulargia, Ederina; Proclemer, Alessandro; Facchin, Domenico; Rordorf, Roberto; Vicentini, Alessandro; Marcantoni, Lina; Zanon, Francesco; Klersy, Catherine

    2016-12-03

    Despite an intensive search for predictors of the response to cardiac resynchronization therapy (CRT), the QRS duration remains the simplest and most robust predictor of a positive response. QRS duration of ≥ 130 ms is considered to be a prerequisite for CRT; however, some studies have shown that CRT may also be effective in heart failure (HF) patients with a narrow QRS (<130 ms). Since CRT can now be performed by pacing the left ventricle from multiple vectors via a single quadripolar lead, it is possible that multipoint pacing (MPP) might be effective in HF patients with a narrow QRS. This article reports the design of the MPP Narrow QRS trial, a prospective, randomized, multicenter, controlled feasibility study to investigate the efficacy of MPP using two LV pacing vectors in patients with a narrow QRS complex (100-130 ms). Fifty patients with a standard ICD indication will be enrolled and randomized (1:1) to either an MPP group or a Standard ICD group. All patients will undergo a low-dose dobutamine stress echo test and only those with contractile reserve will be included in the study and randomized. The primary endpoint will be the percentage of patients in each group that have reverse remodeling at 12 months, defined as a reduction in left ventricular end-systolic volume (LVESV) of >15% from the baseline. This feasibility study will determine whether MPP improves reverse remodeling, as compared with standard ICD, in HF patients who have a narrow QRS complex (100-130 ms). ClinicalTrials.gov, NCT02402816 . Registered on 25 March 2015.

  16. A Comparison of the Quality of Life of Patients With an Entirely Subcutaneous Implantable Defibrillator System Versus a Transvenous System (from the EFFORTLESS S-ICD Quality of Life Substudy).

    PubMed

    Pedersen, Susanne S; Mastenbroek, Mirjam H; Carter, Nathan; Barr, Craig; Neuzil, Petr; Scholten, Marcoen; Lambiase, Pier D; Boersma, Lucas; Johansen, Jens B; Theuns, Dominic A M J

    2016-08-15

    The first clinical results from the Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness of the subcutaneous implantable cardioverter defibrillator (EFFORTLESS S-ICD) Registry on the entirely S-ICD system are promising, but the impact of the S-ICD system on patients' quality of life (QoL) is not known. We evaluated the QoL of patients with an S-ICD against an unrelated cohort with a transvenous (TV)-ICD system during 6 months of follow-up. Consecutively implanted patients with an S-ICD system were matched with patients with a TV-ICD system on a priori selected variables including baseline QoL. QoL was measured with the Short-Form Health Survey at baseline, 3, and 6 months after implant and compared using multivariable modeling with repeated measures. Patients with an S-ICD (n = 167) versus a TV-ICD system (n = 167) did not differ significantly on physical (p = 0.8157) and mental QoL scores (p = 0.9080) across baseline, 3, and 6 months after implantation in adjusted analyses. The evolution in physical (p = 0.0503) and mental scores (p = 0.3772) during follow-up was similar for both cohorts, as indicated by the nonsignificant interaction effect for ICD system by time. Both patients with an S-ICD system and a TV-ICD system experienced significant improvements in physical and mental QoL between time of implant and 3 months (both p's <0.0001) and between time of implant and 6 months (both p's <0.0001) but not between 3 and 6 months (both p's >0.05). In conclusion, these first results show that the QoL of patients with an S-ICD versus TV-ICD system is similar and that patients with either system experience improvements in QoL on the short term. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Simple score to predict risk of hepatocellular carcinoma in chronic hepatitis C patients with advanced fibrosis after pegylated interferon and ribavirin therapy.

    PubMed

    Hu, Ching-Chih; Weng, Cheng-Hao; Chang, Liang-Che; Lin, Chih-Lang; Chen, Yen-Ting; Hu, Ching-Fang; Hua, Man-Chin; Chen, Li-Wei; Chien, Rong-Nan

    2018-01-01

    Eradication of chronic hepatitis C virus (HCV) after interferon-based therapy and its association with the reduction of risk of hepatocellular carcinoma (HCC) in HCV-infected patients with advanced fibrosis is controversial. The study is aimed to develop a simple scoring model for HCC prediction among advanced fibrotic chronic hepatitis C (CHC) patients after pegylated interferon (pegIFN) and ribavirin (RBV) therapy. We enrolled 271 biopsy-proven CHC patients with advanced fibrosis between 2003 and 2016, and divided them into non-HCC (n=211) and HCC (n=60) groups. The median observation duration was 6.0 years (range: 0.9-12.6 years). The HCC prevalence after pegIFN and RBV therapy in CHC patients with sustained virologic response (SVR) and without SVR was 14.7% and 32.2%, respectively. Multivariate Cox regression showed age ≥59.5 years old at initiation of therapy (HR: 2.542, 95% CI: 1.390-4.650, P =0.002), pretreatment total bilirubin ≥1.1 mg/dL (HR: 2.630, 95% CI: 1.420-4.871, P =0.002), pretreatment platelet counts <146.5 × 10 3 /μL (HR: 2.751, 95% CI: 1.373-5.511, P =0.004), no achievement of SVR (HR: 2.331, 95% CI: 1.277-4.253, P =0.006), and no diabetes at treatment initiation (HR: 3.085, 95% CI: 1.283-7.418, P =0.012) were significant predictors of HCC development. The scoring model consisted of the five categorical predictors and had an optimal cutoff point of 2.5. The area under receiver operating characteristic (AUROC) of the scoring model was 0.774±0.035 ( P <0.001). The sensitivity and specificity of the cutoff value to detect HCC were 81.3% and 57.5%. The 5-year and 10-year cumulative incidence of HCC was 4.9% and 10.0% in patients with simple score ≤2; and 25.9% and 44.6% in patients with simple score ≥3 ( P <0.001). The simple clinical-guided score has high discriminatory power for HCC prediction in advanced fibrotic CHC patients after pegIFN and RBV therapy.

  18. Advancing Treatment of Pituitary Adenomas through Targeted Molecular Therapies: The Acromegaly and Cushing Disease Paradigms.

    PubMed

    Mooney, Michael A; Simon, Elias D; Little, Andrew S

    2016-01-01

    The current treatment of pituitary adenomas requires a balance of conservative management, surgical resection, and in select tumor types, molecular therapy. Acromegaly treatment is an evolving field where our understanding of molecular targets and drug therapies has improved treatment options for patients with excess growth hormone levels. We highlight the use of molecular therapies in this disease process and advances in this field, which may represent a paradigm shift for the future of pituitary adenoma treatment.

  19. Gender incongruence: a comparative study using ICD-10 and DSM-5 diagnostic criteria.

    PubMed

    Soll, Bianca M; Robles-García, Rebeca; Brandelli-Costa, Angelo; Mori, Daniel; Mueller, Andressa; Vaitses-Fontanari, Anna M; Cardoso-da-Silva, Dhiordan; Schwarz, Karine; Abel-Schneider, Maiko; Saadeh, Alexandre; Lobato, Maria-Inês-Rodrigues

    2018-01-01

    To compare the presence of criteria listed in the DSM-5 and ICD-10 diagnostic manuals in a Brazilian sample of transgender persons seeking health services specifically for physical transition. This multicenter cross-sectional study included a sample of 103 subjects who sought services for gender identity disorder in two main reference centers in Brazil. The method involved a structured interview encompassing the diagnostic criteria in the two manuals. The results revealed that despite theoretical disagreement about the criteria, the manuals overlap regarding diagnosis confirmation; the DSM-5 was more inclusive (97.1%) than the ICD-10 (93.2%) in this population. Although there is no consensus on diagnostic criteria on transgenderism in the diversity of social and cultural contexts, more comprehensive diagnostic criteria are evolving due to society's increasing inclusivity.

  20. The 1-month prevalence of generalized anxiety disorder according to DSM-IV, DSM-V, and ICD-10 among nondemented 75-year-olds in Gothenburg, Sweden.

    PubMed

    Nilsson, Johan; Östling, Svante; Waern, Margda; Karlsson, Björn; Sigström, Robert; Guo, Xinxin; Skoog, Ingmar

    2012-11-01

    To examine the 1-month prevalence of generalized anxiety disorder (GAD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), Diagnostic and Statistical Manual of Mental, Fifth Edition (DSM-V), and International Classification of Diseases, Tenth Revision (ICD-10), and the overlap between these criteria, in a population sample of 75-year-olds. We also aimed to examine comorbidity between GAD and other psychiatric diagnoses, such as depression. During 2005-2006, a comprehensive semistructured psychiatric interview was conducted by trained nurses in a representative population sample of 75-year-olds without dementia in Gothenburg, Sweden (N = 777; 299 men and 478 women). All psychiatric diagnoses were made according to DSM-IV. GAD was also diagnosed according to ICD-10 and DSM-V. The 1-month prevalence of GAD was 4.1% (N = 32) according to DSM-IV, 4.5% (N = 35) according to DSM-V, and 3.7% (N = 29) according to ICD-10. Only 46.9% of those with DSM-IV GAD fulfilled ICD-10 criteria, and only 51.7% and 44.8% of those with ICD-10 GAD fulfilled DSM-IV/V criteria. Instead, 84.4% and 74.3% of those with DSM-IV/V GAD and 89.7% of those with ICD-10 GAD had depression. Also other psychiatric diagnoses were common in those with ICD-10 and DSM-IV GAD. Only a small minority with GAD, irrespective of criteria, had no other comorbid psychiatric disorder. ICD-10 GAD was related to an increased mortality rate. While GAD was common in 75-year-olds, DSM-IV/V and ICD-10 captured different individuals. Current definitions of GAD may comprise two different expressions of the disease. There was greater congruence between GAD in either classification system and depression than between DSM-IV/V GAD and ICD-10 GAD, emphasizing the close link between these entities. 2012 American Association for Geriatric Psychiatry

  1. Validity of registration of ICD codes and prescriptions in a research database in Swedish primary care: a cross-sectional study in Skaraborg primary care database

    PubMed Central

    2010-01-01

    Background In recent years, several primary care databases recording information from computerized medical records have been established and used for quality assessment of medical care and research. However, to be useful for research purposes, the data generated routinely from every day practice require registration of high quality. In this study we aimed to investigate (i) the frequency and validity of ICD code and drug prescription registration in the new Skaraborg primary care database (SPCD) and (ii) to investigate the sources of variation in this registration. Methods SPCD contains anonymous electronic medical records (ProfDoc III) automatically retrieved from all 24 public health care centres (HCC) in Skaraborg, Sweden. The frequencies of ICD code registration for the selected diagnoses diabetes mellitus, hypertension and chronic cardiovascular disease and the relevant drug prescriptions in the time period between May 2002 and October 2003 were analysed. The validity of data registration in the SPCD was assessed in a random sample of 50 medical records from each HCC (n = 1200 records) using the medical record text as gold standard. The variance of ICD code registration was studied with multi-level logistic regression analysis and expressed as median odds ratio (MOR). Results For diabetes mellitus and hypertension ICD codes were registered in 80-90% of cases, while for congestive heart failure and ischemic heart disease ICD codes were registered more seldom (60-70%). Drug prescription registration was overall high (88%). A correlation between the frequency of ICD coded visits and the sensitivity of the ICD code registration was found for hypertension and congestive heart failure but not for diabetes or ischemic heart disease. The frequency of ICD code registration varied from 42 to 90% between HCCs, and the greatest variation was found at the physician level (MORPHYSICIAN = 4.2 and MORHCC = 2.3). Conclusions Since the frequency of ICD code registration varies

  2. Validity of registration of ICD codes and prescriptions in a research database in Swedish primary care: a cross-sectional study in Skaraborg primary care database.

    PubMed

    Hjerpe, Per; Merlo, Juan; Ohlsson, Henrik; Bengtsson Boström, Kristina; Lindblad, Ulf

    2010-04-23

    In recent years, several primary care databases recording information from computerized medical records have been established and used for quality assessment of medical care and research. However, to be useful for research purposes, the data generated routinely from every day practice require registration of high quality. In this study we aimed to investigate (i) the frequency and validity of ICD code and drug prescription registration in the new Skaraborg primary care database (SPCD) and (ii) to investigate the sources of variation in this registration. SPCD contains anonymous electronic medical records (ProfDoc III) automatically retrieved from all 24 public health care centres (HCC) in Skaraborg, Sweden. The frequencies of ICD code registration for the selected diagnoses diabetes mellitus, hypertension and chronic cardiovascular disease and the relevant drug prescriptions in the time period between May 2002 and October 2003 were analysed. The validity of data registration in the SPCD was assessed in a random sample of 50 medical records from each HCC (n = 1200 records) using the medical record text as gold standard. The variance of ICD code registration was studied with multi-level logistic regression analysis and expressed as median odds ratio (MOR). For diabetes mellitus and hypertension ICD codes were registered in 80-90% of cases, while for congestive heart failure and ischemic heart disease ICD codes were registered more seldom (60-70%). Drug prescription registration was overall high (88%). A correlation between the frequency of ICD coded visits and the sensitivity of the ICD code registration was found for hypertension and congestive heart failure but not for diabetes or ischemic heart disease.The frequency of ICD code registration varied from 42 to 90% between HCCs, and the greatest variation was found at the physician level (MORPHYSICIAN = 4.2 and MORHCC = 2.3). Since the frequency of ICD code registration varies between different diagnoses, each

  3. Advances in research on 2D and 3D graphene-based supercapacitors

    NASA Astrophysics Data System (ADS)

    Mensing, Johannes Ph.; Poochai, Chatwarin; Kerdpocha, Sadanan; Sriprachuabwong, Chakrit; Wisitsoraat, Anurat; Tuantranont, Adisorn

    2017-09-01

    Graphene-based materials in two-dimensional (2D) and three-dimensional (3D) configurations are promising as electrode materials for supercapacitors due to their large surface area, excellent electrical conductivity, high electrochemical activity and high stability. In this article recent advances in research on 2D and 3D graphene-based materials for supercapacitor electrodes are reviewed extensively in aspects of fabrication methods and electrochemical performances. From the survey, the performance of 2D and 3D graphene-based materials could be significantly enhanced by employing nanostructures of metal oxides, metals and polymers as well as doping graphene with hetero atoms such as nitrogen and boron. In addition, the charge storage performances were found to depend greatly on materials, preparation method and structural configuration. With similar material components, 3D graphene-based networks tended to exhibit superior supercapacitive performances. Therefore, future research should be focusing on further development of 3D graphene-based materials for supercapacitor applications. Invited talk at 5th Thailand International Nanotechnology Conference (Nano Thailand-2016), 27-29 November 2016, Nakhon Ratchasima, Thailand.

  4. Space Segment (SS) and the Navigation User Segment (US) Interface Control Document (ICD)

    DOT National Transportation Integrated Search

    1993-10-10

    This Interface Control Document (ICD) defines the requirements related to the interface between the Space Segment (SS) of the Global Positioning System (GPS) and the Navigation Users Segment of the GPS. 2880k, 154p.

  5. Influence of time between last myocardial infarction and prophylactic implantable defibrillator implant on device detections and therapies. “Routine Practice” data from the SEARCH MI registry

    PubMed Central

    2012-01-01

    Background A multicenter European Registry, SEARCH-MI, was instituted in the year 2002 in order to assess patients’ outcomes and ICD interventions in patients with a previous MI and depressed LV function, treated with an ICD according to MADIT II results. In this analysis, we evaluate the influence of the time elapsed between last myocardial infarction (MI) and prophylactic cardioverter defibrillator (ICD) implant on device activations. Methods 643 patients with left ventricular dysfunction (mean LVEF 26 ± 5%) and NYHA class I-III were prospectively followed for 1.8 ± 1.2 years in a multicenter registry. The population was divided into 3 groups according to the time between last MI and ICD implant: [1] from 40 days to less than 1.5 years; [2] from 1.5 to less than 7 years and [3] at least 7 years. Results The cumulative incidence of ventricular tachyarrhymias and appropriate device therapy (ATP or shock) were higher in patients implanted longer time from last MI (Gray’s Test p = 0.002 and p = 0.013 respectively). No significant differences were seen in all cause mortality (Gray’s Test p = 0.618) or sudden cardiac death across the MI stratification groups (Gray’s Test p = 0.663). Conclusions Patients implanted with an ICD longer after the MI have a higher chance of presenting ventricular tachyarrhythmias and appropriate ICD therapy, while no differences were seen in overall mortality. These observations may be important for improving patient targeting in sudden death prevention. PMID:22966862

  6. Validation and optimisation of an ICD-10-coded case definition for sepsis using administrative health data

    PubMed Central

    Jolley, Rachel J; Jetté, Nathalie; Sawka, Keri Jo; Diep, Lucy; Goliath, Jade; Roberts, Derek J; Yipp, Bryan G; Doig, Christopher J

    2015-01-01

    Objective Administrative health data are important for health services and outcomes research. We optimised and validated in intensive care unit (ICU) patients an International Classification of Disease (ICD)-coded case definition for sepsis, and compared this with an existing definition. We also assessed the definition's performance in non-ICU (ward) patients. Setting and participants All adults (aged ≥18 years) admitted to a multisystem ICU with general medicosurgical ICU care from one of three tertiary care centres in the Calgary region in Alberta, Canada, between 1 January 2009 and 31 December 2012 were included. Research design Patient medical records were randomly selected and linked to the discharge abstract database. In ICU patients, we validated the Canadian Institute for Health Information (CIHI) ICD-10-CA (Canadian Revision)-coded definition for sepsis and severe sepsis against a reference standard medical chart review, and optimised this algorithm through examination of other conditions apparent in sepsis. Measures Sensitivity (Sn), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) were calculated. Results Sepsis was present in 604 of 1001 ICU patients (60.4%). The CIHI ICD-10-CA-coded definition for sepsis had Sn (46.4%), Sp (98.7%), PPV (98.2%) and NPV (54.7%); and for severe sepsis had Sn (47.2%), Sp (97.5%), PPV (95.3%) and NPV (63.2%). The optimised ICD-coded algorithm for sepsis increased Sn by 25.5% and NPV by 11.9% with slightly lowered Sp (85.4%) and PPV (88.2%). For severe sepsis both Sn (65.1%) and NPV (70.1%) increased, while Sp (88.2%) and PPV (85.6%) decreased slightly. Conclusions This study demonstrates that sepsis is highly undercoded in administrative data, thus under-ascertaining the true incidence of sepsis. The optimised ICD-coded definition has a higher validity with higher Sn and should be preferentially considered if used for surveillance purposes. PMID:26700284

  7. Validation and optimisation of an ICD-10-coded case definition for sepsis using administrative health data.

    PubMed

    Jolley, Rachel J; Quan, Hude; Jetté, Nathalie; Sawka, Keri Jo; Diep, Lucy; Goliath, Jade; Roberts, Derek J; Yipp, Bryan G; Doig, Christopher J

    2015-12-23

    Administrative health data are important for health services and outcomes research. We optimised and validated in intensive care unit (ICU) patients an International Classification of Disease (ICD)-coded case definition for sepsis, and compared this with an existing definition. We also assessed the definition's performance in non-ICU (ward) patients. All adults (aged ≥ 18 years) admitted to a multisystem ICU with general medicosurgical ICU care from one of three tertiary care centres in the Calgary region in Alberta, Canada, between 1 January 2009 and 31 December 2012 were included. Patient medical records were randomly selected and linked to the discharge abstract database. In ICU patients, we validated the Canadian Institute for Health Information (CIHI) ICD-10-CA (Canadian Revision)-coded definition for sepsis and severe sepsis against a reference standard medical chart review, and optimised this algorithm through examination of other conditions apparent in sepsis. Sensitivity (Sn), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) were calculated. Sepsis was present in 604 of 1001 ICU patients (60.4%). The CIHI ICD-10-CA-coded definition for sepsis had Sn (46.4%), Sp (98.7%), PPV (98.2%) and NPV (54.7%); and for severe sepsis had Sn (47.2%), Sp (97.5%), PPV (95.3%) and NPV (63.2%). The optimised ICD-coded algorithm for sepsis increased Sn by 25.5% and NPV by 11.9% with slightly lowered Sp (85.4%) and PPV (88.2%). For severe sepsis both Sn (65.1%) and NPV (70.1%) increased, while Sp (88.2%) and PPV (85.6%) decreased slightly. This study demonstrates that sepsis is highly undercoded in administrative data, thus under-ascertaining the true incidence of sepsis. The optimised ICD-coded definition has a higher validity with higher Sn and should be preferentially considered if used for surveillance purposes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go

  8. A comparison of DSM-5 and ICD-11 PTSD prevalence, comorbidity and disability: an analysis of the Ukrainian Internally Displaced Person's Mental Health Survey.

    PubMed

    Shevlin, M; Hyland, P; Vallières, F; Bisson, J; Makhashvili, N; Javakhishvili, J; Shpiker, M; Roberts, B

    2018-02-01

    Recently, the American Psychiatric Association (DSM-5) and the World Health Organization (ICD-11) have both revised their formulation of post-traumatic stress disorder (PTSD). The primary aim of this study was to compare DSM-5 and ICD-11 PTSD prevalence and comorbidity rates, as well as the level of disability associated with each diagnosis. This study was based on a representative sample of adult Ukrainian internally displaced persons (IDPs: N = 2203). Post-traumatic stress disorder prevalence was assessed using the PTSD Checklist for DSM-5 and the International Trauma Questionnaire (ICD-11). Anxiety and depression were measured using the Generalized Anxiety Disorder Scale and the Patient Health Questionnaire-Depression. Disability was measured using the WHO Disability Assessment Schedule 2.0. The prevalence of DSM-5 PTSD (27.4%) was significantly higher than ICD-11 PTSD (21.0%), and PTSD rates for females were significantly higher using both criteria. ICD-11 PTSD was associated with significantly higher levels of disability and comorbidity. The ICD-11 diagnosis of PTSD appears to be particularly well suited to identifying those with clinically relevant levels of disability. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. [11C]Choline PET/CT in therapy response assessment of a neoadjuvant therapy in locally advanced and high risk prostate cancer before radical prostatectomy.

    PubMed

    Schwarzenböck, Sarah M; Knieling, Anna; Souvatzoglou, Michael; Kurth, Jens; Steiger, Katja; Eiber, Matthias; Esposito, Irene; Retz, Margitta; Kübler, Hubert; Gschwend, Jürgen E; Schwaiger, Markus; Krause, Bernd J; Thalgott, Mark

    2016-09-27

    Recent studies have shown promising results of neoadjuvant therapy in prostate cancer (PC). The aim of this study was to evaluate the potential of [11C]Choline PET/CT in therapy response monitoring after combined neoadjuvant docetaxel chemotherapy and complete androgen blockade in locally advanced and high risk PC patients. In [11C]Choline PET/CT there was a significant decrease of SUVmax and SUVmean (p = 0.004, each), prostate volume (p = 0.005) and PSA value (p = 0.003) after combined neoadjuvant therapy. MRI showed a significant prostate and tumor volume reduction (p = 0.003 and 0.005, respectively). Number of apoptotic cells was significantly higher in prostatectomy specimens of the therapy group compared to pretherapeutic biopsies and the control group (p = 0.02 and 0.003, respectively). 11 patients received two [11C]Choline PET/CT and MRI scans before and after combined neoadjuvant therapy followed by radical prostatectomy and pelvic lymph node dissection. [11C]Choline uptake, prostate and tumor volume, PSA value (before/after neoadjuvant therapy) and apoptosis (of pretherapeutic biopsy/posttherapeutic prostatectomy specimens of the therapy group and prostatectomy specimens of a matched control group without neoadjuvant therapy) were assessed and tested for differences and correlation using SPSS. The results showing a decrease in choline uptake after combined neoadjuvant therapy (paralleled by regressive and apoptotic changes in histopathology) confirm the potential of [11C]Choline PET/CT to monitor effects of neoadjuvant therapy in locally advanced and high risk PC patients. Further studies are recommended to evaluate its use during the course of neoadjuvant therapy for early response assessment.

  10. Home inotropic therapy in advanced heart failure: cost analysis and clinical outcomes.

    PubMed

    Harjai, K J; Mehra, M R; Ventura, H O; Lapeyre, Y M; Murgo, J P; Stapleton, D D; Smart, F W

    1997-11-05

    This study was conducted to assess cost savings and clinical outcomes associated with the use of home i.v. inotropic therapy in patients with advanced (New York Heart Association [NYHA] class IV) heart failure. Retrospective analysis. Tertiary care referral center. Twenty-four patients (13 men, 11 women; age, 61+/-12 years) with left ventricular ejection fraction <30% and heart failure refractory to oral agents required home i.v. inotropic therapy for at least 4 consecutive weeks between May 1994 and April 1996. Inotropic agents used included dobutamine (n=20; dose, 5.0+/-2.2 microg/kg/min) or milrinone (n=7; dose, 0.53+/-0.05 microg/kg/min). Cost of care and clinical outcomes (hospital admissions, length of hospital stay, NYHA functional class) were compared during the period of inotropic therapy (study period) and the immediate preceding period of equal duration (control period). In comparison to the control period, the study period (3.9+/-2.7 months) was associated with a 16% reduction in cost, amounting to a calculated savings of $5,700 per patient or $1,465 per patient per month. Concomitantly, a decrease in the number of hospital admissions from 2.7+/-2.6 to 1.3+/-1.3 (p=0.056) and length of hospital stay from 20.9+/-12.7 to 5.5+/-5.4 days (p=0.0004) was observed with improvement in NYHA functional class from 4.0+/-0.0 to 2.7+/-0.9 (p<0.0001). Eight patients (38%) died after 2.8+/-1.7 months of home i.v. inotropic therapy. Home i.v. inotropic therapy reduces hospital admissions, length of stay, and cost of care and improves functional class in patients with advanced (NYHA class IV) heart failure.

  11. Validity of International Classification of Diseases (ICD) coding for dengue infections in hospital discharge records in Malaysia.

    PubMed

    Woon, Yuan-Liang; Lee, Keng-Yee; Mohd Anuar, Siti Fatimah Zahra; Goh, Pik-Pin; Lim, Teck-Onn

    2018-04-20

    Hospitalization due to dengue illness is an important measure of dengue morbidity. However, limited studies are based on administrative database because the validity of the diagnosis codes is unknown. We validated the International Classification of Diseases, 10th revision (ICD) diagnosis coding for dengue infections in the Malaysian Ministry of Health's (MOH) hospital discharge database. This validation study involves retrospective review of available hospital discharge records and hand-search medical records for years 2010 and 2013. We randomly selected 3219 hospital discharge records coded with dengue and non-dengue infections as their discharge diagnoses from the national hospital discharge database. We then randomly sampled 216 and 144 records for patients with and without codes for dengue respectively, in keeping with their relative frequency in the MOH database, for chart review. The ICD codes for dengue were validated against lab-based diagnostic standard (NS1 or IgM). The ICD-10-CM codes for dengue had a sensitivity of 94%, modest specificity of 83%, positive predictive value of 87% and negative predictive value 92%. These results were stable between 2010 and 2013. However, its specificity decreased substantially when patients manifested with bleeding or low platelet count. The diagnostic performance of the ICD codes for dengue in the MOH's hospital discharge database is adequate for use in health services research on dengue.

  12. The continuing role of chemotherapy for advanced non-small cell lung cancer in the targeted therapy era.

    PubMed

    Lwin, Zarnie; Riess, Jonathan W; Gandara, David

    2013-10-01

    There have been remarkable advances in the targeted treatment of advanced non-small cell lung cancer (NSCLC) over the past several years. Survival outcomes are steadily improving as management paradigms shift in the diagnosis and treatment of advanced NSCLC. Customizing treatment based on histology and molecular typing has become a standard of care in this era of targeted therapy. While new chemotherapeutic agents have proven effective, the pivotal role of platinum-based chemotherapy doublets has been confirmed. Maintenance chemotherapy has become an option, but who to employ it in remains unclear in the real-world setting. Efforts to overcome resistance to targeted agents are ongoing utilizing combination regimens of chemotherapy plus targeted agents, but optimizing combination strategies needs further exploration. This review highlights recent developments in novel chemotherapeutics and in chemotherapy strategies over the past two years. Despite advances in molecular medicine, there remains an essential role for chemotherapy in advanced NSCLC, even in the recent targeted therapy era.

  13. Predictive Validity of ICD-11 PTSD as Measured by the Impact of Event Scale-Revised: A 15-Year Prospective Study of Political Prisoners.

    PubMed

    Hyland, Philip; Brewin, Chris R; Maercker, Andreas

    2017-04-01

    The 11 th edition of the International Classification of Diseases (ICD-11; World Health Organization, 2017) proposes a model of posttraumatic stress disorder (PTSD) that includes 6 symptoms. This study assessed the ability of a classification-independent measure of posttraumatic stress symptoms, the Impact of Event Scale-Revised (Weiss & Marmar, 1996), to capture the ICD-11 model of PTSD. The current study also provided the first assessment of the predictive validity of ICD-11 PTSD. Former East German political prisoners were assessed in 1994 (N = 144) and in 2008-2009 (N = 88) on numerous psychological variables using self-report measures. Of the participants, 48.2% and 36.8% met probable diagnosis for ICD-11 PTSD at the first and second assessments, respectively. Confirmatory factor analysis supported the factorial validity of the 3-factor ICD-11 model of PTSD, as represented by items selected from the Impact of Event Scale-Revised. Hierarchical multiple regression analysis demonstrated that, controlling for sex, the symptom clusters of ICD-11 PTSD (reexperiencing, avoidance, and sense of threat) significantly contributed to the explanation of depression (R 2 = .17), quality of life (R 2 = .21), internalized anger (R 2 = .10), externalized anger (R 2 = .12), hatred of perpetrators (R 2 = .15), dysfunctional disclosure (R 2 = .27), and social acknowledgment as a victim (R 2 = .12) across the 15-year study period. Current findings add support for the factorial and predictive validity of ICD-11 PTSD within a unique cohort of political prisoners. Copyright © 2017 International Society for Traumatic Stress Studies.

  14. Mesenchymal Stem Cells in Chronic Wounds: The Spectrum from Basic to Advanced Therapy

    PubMed Central

    Otero-Viñas, Marta; Falanga, Vincent

    2016-01-01

    Significance: Almost 7 million Americans have chronic cutaneous wounds and billions of dollars are spent on their treatment. The number of patients with nonhealing wounds keeps increasing worldwide due to an ever-aging population, increasing number of obese and diabetic patients, and cardiovascular disease. Recent Advances: Advanced treatments for difficult wounds are needed. Therapy with mesenchymal stem cells (MSCs) is attractive due to their differentiating potential, their immunomodulating properties, and their paracrine effects. Critical Issues: New technologies (including growth factors and skin substitutes) are now widely used for stimulating wound healing. However, in spite of these advances, the percentage of complete wound closure in most clinical situations is around 50–60%. Moreover, there is a high rate of wound recurrence. Future Directions: Recently, it has been demonstrated that MSCs speed up wound healing by decreasing inflammation, by promoting angiogenesis, and by decreasing scarring. However, there are some potential limitations to successful MSC therapy. These limitations include the need to improve cell delivery methods, cell viability, heterogeneity in MSC preparations, and suboptimal wound bed preparation. Further large, controlled clinical trials are needed to establish the safety of MSCs before widespread clinical application. PMID:27076993

  15. RNAi therapy targeting KRAS in combination with chemotherapy for locally advanced pancreatic cancer patients

    PubMed Central

    Golan, Talia; Khvalevsky, Elina Zorde; Hubert, Ayala; Gabai, Rachel Malka; Hen, Naama; Segal, Amiel; Domb, Abraham; Harari, Gil; David, Eliel Ben; Raskin, Stephen; Goldes, Yuri; Goldin, Eran; Eliakim, Rami; Lahav, Maor; Kopleman, Yael; Dancour, Alain; Shemi, Amotz; Galun, Eithan

    2015-01-01

    Purpose The miniature biodegradable implant siG12D-LODER™ was inserted into a tumor and released a siRNA drug against KRAS(G12D) along four months. This novel siRNA based drug was studied, in combination with chemotherapy, as targeted therapy for Locally Advanced Pancreatic Cancer (LAPC). Methods An open-label Phase 1/2a study in the first-line setting of patients with non-operable LAPC was initiated. In this study patients were assigned to receive a single dose of siG12D-LODERs, in three escalating dose cohorts (0.025mg, 0.75mg and 3.0mg). Gemcitabine was given on a weekly basis, following the siG12D-LODERTM insertion, until disease progression. The recommended dose was further examined with modified FOLFIRINOX. The follow up period was eight weeks and survival until death. Results Fifteen patients with LAPC were enrolled. Among the 15 treated patients, the most frequent adverse events observed were grade 1or 2 in severity (89%); five patients experienced serious adverse events (SAEs). In 12 patients analyzed by CT scans, none showed tumor progression, the majority (10/12) demonstrated stable disease and two showed partial response. Decrease in tumor marker CA19-9 was observed in 70% (7/10) of patients. Median overall survival was 15.12 months; 18 month survival was 38.5%. Conclusions The combination of siG12D-LODER™ and chemotherapy is well tolerated, safe and demonstrated a potential efficacy in patients with LAPC. NCT01188785 PMID:26009994

  16. NHLBI's program for VAD therapy for moderately advanced heart failure: the REVIVE-IT pilot trial.

    PubMed

    Baldwin, J Timothy; Mann, Douglas L

    2010-11-01

    Ventricular assist devices (VADs) are used to bridge heart failure patients to transplantation, to allow their own hearts to recover, or as permanent ("destination") therapy. To date, the use of VADs has been limited to late-stage heart failure patients because of the associated device risks. In 2008, a National Heart, Lung, and Blood Institute (NHLBI) working group met to evaluate the treatment of heart failure using VADs and to advise the institute on how therapy for heart failure may be best advanced by clinical trials involving the devices. Recognizing the improvements in VAD technology and in patient care and selection over the past decade, the working group recommended that a trial be performed to assess the use of chronic VAD therapy in patients who are less ill than those currently eligible for destination therapy. The hypothesis proposed for the trial is that VAD therapy may improve both survival and quality of life in moderately advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility. Based on the group's recommendations, NHLBI issued an RFP in 2009 for the REVIVE-IT Pilot Trail, which will serve to test the hypothesis and inform the pivotal trial. Published by Elsevier Inc.

  17. Recent advances in hyaluronic acid-decorated nanocarriers for targeted cancer therapy

    PubMed Central

    Wickens, Jennifer M.; Alsaab, Hashem O.; Kesharwani, Prashant; Bhise, Ketki; Amin, Mohd Cairul Iqbal Mohd; Tekade, Rakesh Kumar; Gupta, Umesh; Iyer, Arun K.

    2016-01-01

    The cluster-determinant 44 (CD44) receptor has a high affinity for hyaluronic acid (HA) binding and is a desirable receptor for active targeting based on its overexpression in cancer cells compared with normal body cells. The nanocarrier affinity can be increased by conjugating drug-loaded carriers with HA, allowing enhanced cancer cell uptake via the HA-CD44 receptor-mediated endocytosis pathway. In this review, we discuss recent advances in HA-based nanocarriers and micelles for cancer therapy. In vitro and in vivo experiments have repeatedly indicated HA-based nanocarriers to be a target-specific drug and gene delivery platform with great promise for future applications in clinical cancer therapy. PMID:28017836

  18. Recent advances in hyaluronic acid-decorated nanocarriers for targeted cancer therapy.

    PubMed

    Wickens, Jennifer M; Alsaab, Hashem O; Kesharwani, Prashant; Bhise, Ketki; Amin, Mohd Cairul Iqbal Mohd; Tekade, Rakesh Kumar; Gupta, Umesh; Iyer, Arun K

    2017-04-01

    The cluster-determinant 44 (CD44) receptor has a high affinity for hyaluronic acid (HA) binding and is a desirable receptor for active targeting based on its overexpression in cancer cells compared with normal body cells. The nanocarrier affinity can be increased by conjugating drug-loaded carriers with HA, allowing enhanced cancer cell uptake via the HA-CD44 receptor-mediated endocytosis pathway. In this review, we discuss recent advances in HA-based nanocarriers and micelles for cancer therapy. In vitro and in vivo experiments have repeatedly indicated HA-based nanocarriers to be a target-specific drug and gene delivery platform with great promise for future applications in clinical cancer therapy. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Overcoming barriers to population-based injury research: development and validation of an ICD-10–to–AIS algorithm

    PubMed Central

    Haas, Barbara; Xiong, Wei; Brennan-Barnes, Maureen; Gomez, David; Nathens, Avery B.

    2012-01-01

    Background Hospital administrative databases are a useful source of population-level data on injured patients; however, these databases use the International Classification of Diseases (ICD) system, which does not provide a direct means of estimating injury severity. We created and validated a crosswalk to derive Abbreviated Injury Scale (AIS) scores from injury-related diagnostic codes in the tenth revision of the ICD (ICD-10). Methods We assessed the validity of the crosswalk using data from the Ontario Trauma Registry Comprehensive Data Set (OTR-CDS). The AIS and Injury Severity Scores (ISS) derived using the algorithm were compared with those assigned by expert abstractors. We evaluated the ability of the algorithm to identify patients with AIS scores of 3 or greater. We used κ and intraclass correlation coefficients (ICC) as measures of concordance. Results In total, 10 431 patients were identified in the OTR-CDS. The algorithm accurately identified patients with at least 1 AIS score of 3 or greater (κ 0.65), as well as patients with a head AIS score of 3 or greater (κ 0.78). Mapped and abstracted ISS were similar; ICC across the entire cohort was 0.83 (95% confidence interval 0.81–0.84), indicating good agreement. When comparing mapped and abstracted ISS, the difference between scores was 10 or less in 87% of patients. Concordance between mapped and abstracted ISS was similar across strata of age, mechanism of injury and mortality. Conclusion Our ICD-10–to–AIS algorithm produces reliable estimates of injury severity from data available in administrative databases. This algorithm can facilitate the use of administrative data for population-based injury research in jurisdictions using ICD-10. PMID:22269308

  20. Projected impact of the ICD-10-CM/PCS conversion on longitudinal data and the Joint Commission Core Measures.

    PubMed

    Fenton, Susan H; Benigni, Mary Sue

    2014-01-01

    The transition from ICD-9-CM to ICD-10-CM/PCS is expected to result in longitudinal data discontinuities, as occurred with cause-of-death in 1999. The General Equivalence Maps (GEMs), while useful for suggesting potential maps do not provide guidance regarding the frequency of any matches. Longitudinal data comparisons can only be reliable if they use comparability ratios or factors which have been calculated using records coded in both classification systems. This study utilized 3,969 de-identified dually coded records to examine raw comparability ratios, as well as the comparability ratios between the Joint Commission Core Measures. The raw comparability factor results range from 16.216 for Nicotine dependence, unspecified, uncomplicated to 118.009 for Chronic obstructive pulmonary disease, unspecified. The Joint Commission Core Measure comparability factor results range from 27.15 for Acute Respiratory Failure to 130.16 for Acute Myocardial Infarction. These results indicate significant differences in comparability between ICD-9-CM and ICD-10-CM code assignment, including when the codes are used for external reporting such as the Joint Commission Core Measures. To prevent errors in decision-making and reporting, all stakeholders relying on longitudinal data for measure reporting and other purposes should investigate the impact of the conversion on their data.

  1. The ICD diagnoses of fetishism and sadomasochism.

    PubMed

    Reiersøl, Odd; Skeid, Svein

    2006-01-01

    In this article we discuss psychiatric diagnoses of sexual deviation as they appear in the International Classification of Diseases (ICD-10), the internationally accepted classification and diagnostic system of the World Health Organization (WHO). Namely, we discuss the background of three diagnostic categories: Fetishism (F65.0), Fetishistic Transvestism (F65.1), and Sadomasochism (F65.5). Pertinent background issues regarding the above categories are followed by a critique of the usefulness of diagnosing these phenomena today. Specifically, we argue that Fetishism, Fetishistic Transvestism, and Sadomasochism, also labeled Paraphilia or perversion, should not be considered illnesses. Finally, we present the efforts of an initiative known as ReviseF65, which was established in 1997, to abolish these diagnoses.

  2. Deep neural models for ICD-10 coding of death certificates and autopsy reports in free-text.

    PubMed

    Duarte, Francisco; Martins, Bruno; Pinto, Cátia Sousa; Silva, Mário J

    2018-04-01

    We address the assignment of ICD-10 codes for causes of death by analyzing free-text descriptions in death certificates, together with the associated autopsy reports and clinical bulletins, from the Portuguese Ministry of Health. We leverage a deep neural network that combines word embeddings, recurrent units, and neural attention, for the generation of intermediate representations of the textual contents. The neural network also explores the hierarchical nature of the input data, by building representations from the sequences of words within individual fields, which are then combined according to the sequences of fields that compose the inputs. Moreover, we explore innovative mechanisms for initializing the weights of the final nodes of the network, leveraging co-occurrences between classes together with the hierarchical structure of ICD-10. Experimental results attest to the contribution of the different neural network components. Our best model achieves accuracy scores over 89%, 81%, and 76%, respectively for ICD-10 chapters, blocks, and full-codes. Through examples, we also show that our method can produce interpretable results, useful for public health surveillance. Copyright © 2018 Elsevier Inc. All rights reserved.

  3. Trends in Prevalence of Advanced HIV Disease at Antiretroviral Therapy Enrollment - 10 Countries, 2004-2015.

    PubMed

    Auld, Andrew F; Shiraishi, Ray W; Oboho, Ikwo; Ross, Christine; Bateganya, Moses; Pelletier, Valerie; Dee, Jacob; Francois, Kesner; Duval, Nirva; Antoine, Mayer; Delcher, Chris; Desforges, Gracia; Griswold, Mark; Domercant, Jean Wysler; Joseph, Nadjy; Deyde, Varough; Desir, Yrvel; Van Onacker, Joelle Deas; Robin, Ermane; Chun, Helen; Zulu, Isaac; Pathmanathan, Ishani; Dokubo, E Kainne; Lloyd, Spencer; Pati, Rituparna; Kaplan, Jonathan; Raizes, Elliot; Spira, Thomas; Mitruka, Kiren; Couto, Aleny; Gudo, Eduardo Samo; Mbofana, Francisco; Briggs, Melissa; Alfredo, Charity; Xavier, Carla; Vergara, Alfredo; Hamunime, Ndapewa; Agolory, Simon; Mutandi, Gram; Shoopala, Naemi N; Sawadogo, Souleymane; Baughman, Andrew L; Bashorun, Adebobola; Dalhatu, Ibrahim; Swaminathan, Mahesh; Onotu, Dennis; Odafe, Solomon; Abiri, Oseni Omomo; Debem, Henry H; Tomlinson, Hank; Okello, Velephi; Preko, Peter; Ao, Trong; Ryan, Caroline; Bicego, George; Ehrenkranz, Peter; Kamiru, Harrison; Nuwagaba-Biribonwoha, Harriet; Kwesigabo, Gideon; Ramadhani, Angela A; Ng'wangu, Kahemele; Swai, Patrick; Mfaume, Mohamed; Gongo, Ramadhani; Carpenter, Deborah; Mastro, Timothy D; Hamilton, Carol; Denison, Julie; Wabwire-Mangen, Fred; Koole, Olivier; Torpey, Kwasi; Williams, Seymour G; Colebunders, Robert; Kalamya, Julius N; Namale, Alice; Adler, Michelle R; Mugisa, Bridget; Gupta, Sundeep; Tsui, Sharon; van Praag, Eric; Nguyen, Duc B; Lyss, Sheryl; Le, Yen; Abdul-Quader, Abu S; Do, Nhan T; Mulenga, Modest; Hachizovu, Sebastian; Mugurungi, Owen; Barr, Beth A Tippett; Gonese, Elizabeth; Mutasa-Apollo, Tsitsi; Balachandra, Shirish; Behel, Stephanie; Bingham, Trista; Mackellar, Duncan; Lowrance, David; Ellerbrock, Tedd V

    2017-06-02

    Monitoring prevalence of advanced human immunodeficiency virus (HIV) disease (i.e., CD4+ T-cell count <200 cells/μL) among persons starting antiretroviral therapy (ART) is important to understand ART program outcomes, inform HIV prevention strategy, and forecast need for adjunctive therapies.* , † , § To assess trends in prevalence of advanced disease at ART initiation in 10 high-burden countries during 2004-2015, records of 694,138 ART enrollees aged ≥15 years from 797 ART facilities were analyzed. Availability of national electronic medical record systems allowed up-to-date evaluation of trends in Haiti (2004-2015), Mozambique (2004-2014), and Namibia (2004-2012), where prevalence of advanced disease at ART initiation declined from 75% to 34% (p<0.001), 73% to 37% (p<0.001), and 80% to 41% (p<0.001), respectively. Significant declines in prevalence of advanced disease during 2004-2011 were observed in Nigeria, Swaziland, Uganda, Vietnam, and Zimbabwe. The encouraging declines in prevalence of advanced disease at ART enrollment are likely due to scale-up of testing and treatment services and ART-eligibility guidelines encouraging earlier ART initiation. However, in 2015, approximately a third of new ART patients still initiated ART with advanced HIV disease. To reduce prevalence of advanced disease at ART initiation, adoption of World Health Organization (WHO)-recommended "treat-all" guidelines and strategies to facilitate earlier HIV testing and treatment are needed to reduce HIV-related mortality and HIV incidence.

  4. Disability, employment and work performance among people with ICD-10 anxiety disorders.

    PubMed

    Waghorn, Geoff; Chant, David; White, Paul; Whiteford, Harvey

    2005-01-01

    To ascertain at a population level, patterns of disability, labour force participation, employment and work performance among people with ICD-10 anxiety disorders in comparison to people without disability or long-term health conditions. A secondary analysis was conducted of a probability sample of 42 664 individuals collected in an Australian Bureau of Statistics (ABS) national survey in 1998. Trained lay interviewers using ICD-10 computer-assisted interviews identified household residents with anxiety disorders. Anxiety disorders were associated with: reduced labour force participation, degraded employment trajectories and impaired work performance compared to people without disabilities or long-term health conditions. People with anxiety disorders may need more effective treatments and assistance with completing education and training, joining and rejoining the workforce, developing career pathways, remaining in the workforce and sustaining work performance. A whole-of-government approach appears needed to reduce the burden of disease and increase community labour resources. Implications for clinicians, vocational professionals and policy makers are discussed.

  5. Evaluating Open-Source Full-Text Search Engines for Matching ICD-10 Codes.

    PubMed

    Jurcău, Daniel-Alexandru; Stoicu-Tivadar, Vasile

    2016-01-01

    This research presents the results of evaluating multiple free, open-source engines on matching ICD-10 diagnostic codes via full-text searches. The study investigates what it takes to get an accurate match when searching for a specific diagnostic code. For each code the evaluation starts by extracting the words that make up its text and continues with building full-text search queries from the combinations of these words. The queries are then run against all the ICD-10 codes until a match indicates the code in question as a match with the highest relative score. This method identifies the minimum number of words that must be provided in order for the search engines choose the desired entry. The engines analyzed include a popular Java-based full-text search engine, a lightweight engine written in JavaScript which can even execute on the user's browser, and two popular open-source relational database management systems.

  6. Persisting malnutrition in Chandigarh: decadal underweight trends and impact of ICDS program.

    PubMed

    Thakur, Jarnail Singh; Prinja, Shankar; Bhatia, Satpal Singh

    2011-04-01

    Decline in malnutrition levels has been dismal since the 1990s. We ascertained decadal trend in childhood nutritional status between 1997 and 2007 in Chandigarh, India and assessed impact of Integrated Child Development Services (ICDS) on childhood undernutrition. A total of 803 under-five children, 547 children between 12-23 months age, and 218 women with an infant child were recruited for the study. Findings of present study were compared with another methodologically similar study (1997) from Chandigarh and Reproductive and Child Health Rapid Household Survey (1998) to draw decadal trends. Prevalence of underweight among under-five children remained almost stagnant in the last one decade from 51.6%; (1997) to 50.4%; (2007). There was insignificant difference (P=0.3) in prevalence of underweight among children registered under ICDS program (52.1%;) and those not registered (48.4%;) in 2007. Other health and service provision indicators had mixed results in the past decade. Health services utilization was poorest in urban slums.

  7. Gender trouble: The World Health Organization, the International Statistical Classification of Diseases and Related Health Problems (ICD)-11 and the trans kids.

    PubMed

    Winter, Sam

    2017-10-01

    The World Health Organization (WHO) is revising its diagnostic manual, the International Statistical Classification of Diseases and Related Health Problems (ICD). At the time of writing, and based on recommendations from its ICD Working Group on Sexual Disorders and Sexual Health, WHO is proposing a new ICD chapter titled Conditions Related to Sexual Health, and that the gender incongruence diagnoses (replacements for the gender identity disorder diagnoses used in ICD-10) should be placed in that chapter. WHO is proposing that there should be a Gender incongruence of childhood (GIC) diagnosis for children below the age of puberty. This last proposal has come under fire. Trans community groups, as well as many healthcare professionals and others working for transgender health and wellbeing, have criticised the proposal on the grounds that the pathologisation of gender diversity at such a young age is inappropriate, unnecessary, harmful and inconsistent with WHO's approach in regard to other aspects of development in childhood and youth. Counter proposals have been offered that do not pathologise gender diversity and instead make use of Z codes to frame and document any contacts that young gender diverse children may have with health services. The author draws on his involvement in the ICD revision process, both as a member of the aforementioned WHO Working Group and as one of its critics, to put the case against the GIC proposal, and to recommend an alternative approach for ICD in addressing the needs of gender diverse children.

  8. Glucose Addiction in Cancer Therapy: Advances and Drawbacks.

    PubMed

    Granja, Sara; Pinheiro, Céline; Reis, Rui Manuel; Martinho, Olga; Baltazar, Fátima

    2015-01-01

    While normal differentiated cells primarily use mitochondrial respiration to generate the required energy for cellular processes, most cancer cells rely on glycolysis, even in sufficient oxygen conditions. This phenomenon is known as the "Warburg effect" or aerobic glycolysis and the metabolic reprogramming of cancer cells towards this altered energy metabolism is currently recognized as one of the "hallmarks of cancer". Aerobic glycolysis underlies the rapid growth of tumor cells, with high rates of glucose consumption and lactic acid production, leading to cellular acidosis. Metabolic reprogramming renders cancer cells dependent on specific metabolic enzymes or pathways that could be exploited in cancer therapy. The development of treatments that target tumor glucose metabolism is receiving renewed attention, with several drugs targeting metabolic pathways currently in clinical trials. The search for suitable targets, however, is limited by the high plasticity of the metabolic network that can induce compensatory routes. Deregulated glucose metabolism is a prominent feature associated with resistance to classical chemotherapy or oncogene-targeted therapies, strengthening the clinical potential of combining these therapies with glycolysis inhibitors. The aim of this review is to compare the advances of different therapeutic strategies targeting the glucose "addiction" of tumor cells, highlighting their potential as effective weapons against cancer. We further discuss recent evidence for the involvement of glucose metabolism as a compensatory response to the use of drugs that target different signaling pathways, where the combination with glycolysis inhibitors could prove extraordinarily useful.

  9. 48 CFR 252.232-7005 - Reimbursement of subcontractor advance payments-DoD pilot mentor-protege program.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... subcontractor advance payments-DoD pilot mentor-protege program. 252.232-7005 Section 252.232-7005 Federal... subcontractor advance payments—DoD pilot mentor-protege program. As prescribed in 232.412-70(c), use the following clause: Reimbursement of Subcontractor Advance Payments—DoD Pilot Mentor-Protege Program (SEP 2001...

  10. New therapeutic directions for advanced pancreatic cancer: cell cycle inhibitors, stromal modifiers and conjugated therapies.

    PubMed

    Matera, Robert; Saif, Muhammad Wasif

    2017-09-01

    Pancreatic adenocarcinoma is a devastating malignancy with an extremely poor prognosis. These tumors progress rapidly and somewhat silently with few specific symptoms and are relatively resistant to chemotherapeutic agents. Many agents, including cell cycle inhibitors, are under development for the treatment of this cancer for which there are disappointingly few treatment options. Areas covered: Here we outline the existing approved treatments for advanced pancreatic disease and discuss a range of novel therapies currently under development including cell cycle inhibitors, stromal modifiers and conjugated therapies. We also describe the current state of the pancreatic cancer therapeutics market both past and future. Expert opinion: Despite the recent explosion of novel therapies with an array of unique targets, the core treatment of pancreatic cancer still with traditional cytotoxic agents with a few exceptions. However, as these novel treatments move through the pipeline, we are hopeful that there will soon be a number of effective options for patients with advanced pancreatic cancer.

  11. Cost-effectiveness of Paclitaxel + Ramucirumab Combination Therapy for Advanced Gastric Cancer Progressing After First-line Chemotherapy in Japan.

    PubMed

    Saito, Shota; Muneoka, Yusuke; Ishikawa, Takashi; Akazawa, Kouhei

    2017-12-01

    The combination of paclitaxel + ramucirumab is a standard second-line treatment in patients with advanced gastric cancer. This therapy has been associated with increased median overall survival and progression-free survival compared with those with paclitaxel monotherapy. We evaluated the cost-effectiveness of paclitaxel + ramucirumab combination therapy in patients with advanced gastric cancer, from the perspective of health care payers in Japan. We constructed a Markov model to compare, over a time horizon of 3 years, the costs and effectiveness of the combination of paclitaxel + ramucirumab and paclitaxel alone as second-line therapies for advanced gastric cancer in Japan. Health outcomes were measured in life-years (LYs) and quality-adjusted (QA) LYs gained. Costs were calculated using year-2016 Japanese yen (¥1 = US $17.79) according to the social insurance reimbursement schedule and drug tariff of the fee-for-service system in Japan. Model robustness was addressed through 1-way and probabilistic sensitivity analyses. The costs and QALYs were discounted at a rate of 2% per year. The willingness-to-pay threshold was set at the World Health Organization's criterion of ¥12 million, because no consensus exists regarding the threshold for acceptable cost per QALY ratios in Japan's health policy. Paclitaxel + ramucirumab combination therapy was estimated to provide an additional 0.09 QALYs (0.10 LYs) at a cost of ¥3,870,077, resulting in an incremental cost-effectiveness ratio of ¥43,010,248/QALY. The incremental cost-effectiveness ratio for the combination therapy was >¥12 million/QALY in all of the 1-way and probabilistic sensitivity analyses. Adding ramucirumab to a regimen of paclitaxel in the second-line treatment of advanced gastric cancer is expected to provide a minimal incremental benefit at a high incremental cost per QALY. Based on our findings, adjustments in the price of ramucirumab, as well as improves in other clinical parameters such as survival

  12. Does defibrillation testing influence outcomes after CRT-D implantation? A cause-of-death analysis from the DAI-PP study.

    PubMed

    Perrin, Tilman; Mechulan, Alexis; Boveda, Serge; Beganton, Frankie; Defaye, Pascal; Sadoul, Nicolas; Piot, Olivier; Klug, Didier; Gras, Daniel; Perier, Marie-Cécile; Algalarrondo, Vincent; Bordachar, Pierre; Babuty, Dominique; Fauchier, Laurent; Leclercq, Christophe; Marijon, Eloi; Deharo, Jean-Claude

    2016-10-15

    Little data address the usefulness of defibrillation testing in patients with prolonged QRS duration, known for more advanced myocardial disease. We aimed to compare baseline characteristics and outcomes between patients who underwent defibrillation testing (DT+) and those who did not (DT-), immediately after the implantation of a cardiac resynchronization therapy with defibrillator (CRT-D). Data from all patients with ischemic or non-ischemic cardiomyopathy implanted in primary prevention with a CRT-D in 12 French centers were considered for analysis (2002-2012). Out of the 1516 patients with DT information available, DT was performed in 958(63%) patients. Compared to DT- patients, DT+ patients presented no significant differences in terms of age (65.1±10.8 vs 64.7±10.3years, p=0.45), LVEF (25%[20.0-30.0] vs 25%[20.5-30.0], p=0.30), or etiologies of heart failure (ischemic: 49.6% vs 46.9%, p=0.32). By contrast, DT+ patients were less likely to present atrial fibrillation (25.3% vs 33.4%, p=0.001), renal insufficiency (eGFR<60ml/min in 45.3% vs 51.7%, p=0.04) and NYHA functional class≥III (68.9% vs 77.4%, p=0.0006). All of the three perioperative deaths occurred in the DT+ group and were related to DT itself. After a mean follow-up of 3.1±2.1years, the adjusted incidence of overall mortality was lower among DT+ patients (adjusted HR 0.6, 95%CI 0.4-0.7, p<0.0001). However, ICD-unresponsive sudden deaths remained very rare and no more frequently observed among DT- patients (p=0.41). In our cohort, the higher (up to 40%) mortality at midterm among DT- patients is mainly reflecting their more severe cardiac disease, rather than a higher rate of ICD-unresponsive sudden death. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  13. Comparison of ICD-10R, DSM-IV-TR and DSM-5 in an Adult Autism Spectrum Disorder Diagnostic Clinic

    ERIC Educational Resources Information Center

    Wilson, C. Ellie; Gillan, Nicola; Spain, Deborah; Robertson, Dene; Roberts, Gedeon; Murphy, Clodagh M.; Maltezos, Stefanos; Zinkstok, Janneke; Johnston, Katie; Dardani, Christina; Ohlsen, Chris; Deeley, P. Quinton; Craig, Michael; Mendez, Maria A.; Happé, Francesca; Murphy, Declan G. M.

    2013-01-01

    An Autism Spectrum Disorder (ASD) diagnosis is often used to access services. We investigated whether ASD diagnostic outcome varied when DSM-5 was used compared to ICD-10R and DSM-IV-TR in a clinical sample of 150 intellectually able adults. Of those diagnosed with an ASD using ICD-10R, 56% met DSM-5 ASD criteria. A further 19% met DSM-5 (draft)…

  14. FY2016 Advanced Batteries R&D Annual Progress Report

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

    None, None

    The Advanced Batteries research and development (R&D) subprogram within the DOE Vehicle Technologies Office (VTO) provides support and guidance for projects focusing on batteries for plug-in electric vehicles. Program targets focus on overcoming technical barriers to enable market success including: (1) significantly reducing battery cost, (2) increasing battery performance (power, energy, durability), (3) reducing battery weight & volume, and (4) increasing battery tolerance to abusive conditions such as short circuit, overcharge, and crush. This report describes the progress made on the research and development projects funded by the Battery subprogram in 2016. This section covers the Vehicle Technologies Office overview;more » the Battery subprogram R&D overview; Advanced Battery Development project summaries; and Battery Testing, Analysis, and Design project summaries. It also includes the cover and table of contents.« less

  15. Immunogenic cancer cell death selectively induced by near infrared photoimmunotherapy initiates host tumor immunity.

    PubMed

    Ogawa, Mikako; Tomita, Yusuke; Nakamura, Yuko; Lee, Min-Jung; Lee, Sunmin; Tomita, Saori; Nagaya, Tadanobu; Sato, Kazuhide; Yamauchi, Toyohiko; Iwai, Hidenao; Kumar, Abhishek; Haystead, Timothy; Shroff, Hari; Choyke, Peter L; Trepel, Jane B; Kobayashi, Hisataka

    2017-02-07

    Immunogenic cell death (ICD) is a form of cell death that activates an adaptive immune response against dead-cell-associated antigens. Cancer cells killed via ICD can elicit antitumor immunity. ICD is efficiently induced by near-infrared photo-immunotherapy (NIR-PIT) that selectively kills target-cells on which antibody-photoabsorber conjugates bind and are activated by NIR light exposure. Advanced live cell microscopies showed that NIR-PIT caused rapid and irreversible damage to the cell membrane function leading to swelling and bursting, releasing intracellular components due to the influx of water into the cell. The process also induces relocation of ICD bio markers including calreticulin, Hsp70 and Hsp90 to the cell surface and the rapid release of immunogenic signals including ATP and HMGB1 followed by maturation of immature dendritic cells. Thus, NIR-PIT is a therapy that kills tumor cells by ICD, eliciting a host immune response against tumor.

  16. Combination Therapy with Capecitabine and Cisplatin as Second-Line Chemotherapy for Advanced Biliary Tract Cancer.

    PubMed

    Jung, Jang Han; Lee, Hee Seung; Jo, Jung Hyun; Cho, In Rae; Chung, Moon Jae; Bang, Seungmin; Park, Seung Woo; Song, Si Young; Park, Jeong Youp

    2017-01-01

    Palliative chemotherapy is the main treatment for advanced biliary tract cancer (BTC). However, there is a lack of established second-line chemotherapy to treat disease progression after first-line chemotherapy. We examined combination therapy with capecitabine and cisplatin for advanced BTC as a second-line regimen. We analyzed the medical records of 40 patients diagnosed with BTC who received palliative second-line chemotherapy with capecitabine and cisplatin. The median overall survival from the start of second-line chemotherapy was 6.3 months. The median overall survival from diagnosis was 17.9 months. The median progression-free survival during second-line chemotherapy was 2.3 months. Nine (30%) patients experienced adverse events of grade ≥3. Eastern Cooperative Oncology Group performance score was an independent predictor of adverse events. Combination therapy with capecitabine and cisplatin may be an option for second-line chemotherapy in some of patients with advanced BTC. © 2017 S. Karger AG, Basel.

  17. Vitamin D Supplementation is a Promising Therapy for Pancreatic Ductal Adenocarcinoma in Conjunction with Current Chemoradiation Therapy.

    PubMed

    Mukai, Yosuke; Yamada, Daisaku; Eguchi, Hidetoshi; Iwagami, Yoshifumi; Asaoka, Tadafumi; Noda, Takehiro; Kawamoto, Koichi; Gotoh, Kunihito; Kobayashi, Shogo; Takeda, Yutaka; Tanemura, Masahiro; Mori, Masaki; Doki, Yuichiro

    2018-04-19

    The cancer-associated fibroblasts (CAFs) in pancreatic ductal adenocarcinoma (PDAC) are well known to play a dominant role in distant metastasis. Nevertheless, the effect on CAFs with current chemoradiation therapies remains uncertain. This study aimed to reveal the role of CAFs under current chemoradiation therapy (CRT) and investigate the factors regulating CAFs. α-SMA-positive cells in 86 resected PDAC specimens with/without preoperative CRT were evaluated by immunohistochemistry. Various factors, including the plasma levels of vitamin D, were investigated for association with the number of CAFs or distant metastasis-free survival (DMFS). Human pancreatic satellite cells (hPSCs) extracted from clinical specimens were used to validate the factors. All PDAC samples contained CAFs but the number varied widely. Multivariate analysis for DMFS indicated a larger number of CAFs was a significant risk factor. Univariate analysis for the number of CAFs identified two clinical factors: preoperative CRT and lower plasma levels of vitamin D. In subgroup analysis, the higher plasma level of vitamin D was a dominant factor for longer DMFS in PDAC patients after preoperative CRT. These results were validated by using extracted hPSCs. Irradiation activated stromal cells into CAFs facilitating malignant characteristics of PDAC and the change was inhibited by vitamin D supplementation in vitro. In conjunction with established current therapies, vitamin D supplementation may be an effective treatment for PDAC patients by inactivating CAFs.

  18. Simultaneous Integrated Boost–Intensity Modulated Radiation Therapy With Concomitant Capecitabine and Mitomycin C for Locally Advanced Anal Carcinoma: A Phase 1 Study

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

    Deenen, Maarten J.; Dewit, Luc; Boot, Henk

    2013-04-01

    Purpose: Newer radiation techniques, and the application of continuous 5-FU exposure during radiation therapy using oral capecitabine may improve the treatment of anal cancer. This phase 1, dose-finding study assessed the feasibility and efficacy of simultaneous integrated boost–intensity modulated radiation therapy (SIB-IMRT) with concomitant capecitabine and mitomycin C in locally advanced anal cancer, including pharmacokinetic and pharmacogenetic analyses. Methods and Materials: Patients with locally advanced anal carcinoma were treated with SIB-IMRT in 33 daily fractions of 1.8 Gy to the primary tumor and macroscopically involved lymph nodes and 33 fractions of 1.5 Gy electively to the bilateral iliac and inguinalmore » lymph node areas. Patients received a sequential radiation boost dose of 3 × 1.8 Gy on macroscopic residual tumor if this was still present in week 5 of treatment. Mitomycin C 10 mg/m{sup 2} (maximum 15 mg) was administered intravenously on day 1, and capecitabine was given orally in a dose-escalated fashion (500-825 mg/m{sup 2} b.i.d.) on irradiation days, until dose-limiting toxicity emerged in ≥2 of maximally 6 patients. An additional 8 patients were treated at the maximum tolerated dose (MTD). Results: A total of 18 patients were included. The MTD of capecitabine was determined to be 825 mg/m{sup 2} b.i.d. The predominant acute grade ≥3 toxicities included radiation dermatitis (50%), fatigue (22%), and pain (6%). Fifteen patients (83% [95%-CI: 66%-101%]) achieved a complete response, and 3 (17%) patients a partial response. With a median follow-up of 28 months, none of the complete responders, and 2 partial responders had relapsed. Conclusions: SIB-IMRT with concomitant single dose mitomycin C and capecitabine 825 mg/m{sup 2} b.i.d. on irradiation days resulted in an acceptable safety profile, and proved to be a tolerable and effective treatment regimen for locally advanced anal cancer.« less

  19. Alcohol Use Disorders in Argentinian Girls and Women 12 Months Before Delivery: Comparison of DSM-IV, DSM-5, and ICD-10 Diagnostic Criteria.

    PubMed

    López, Mariana B; Conde, Karina; Cremonte, Mariana

    The evidence of important problems related to prenatal alcohol exposure has faced researchers with the problem of understanding and screening alcohol use in this population. Although any alcohol use should be considered risky during pregnancy, identifying alcohol-drinking problems (ADPs) could be especially important because women with ADPs could not benefit from a simple advice of abstinence and because their offsprings are subjected to a higher risk of problems related with prenatal alcohol exposure. In this context, we aim to study the prevalence and characteristics of ADPs in pregnant women, evaluating the performance of different diagnostic systems in this population. The aims of the study were to describe the prevalence of ADPs obtained with the criteria of the Diagnostic and Statistical Manual of Mental Disorders in its fourth (DSM-IV) and fifth edition (DSM-5), and the International Classification of Diseases (ICD)-10, in Argentinean females aged 13 to 44 years, 12 months before delivery; to evaluate the level of agreement between these classification systems; and to analyze the performance of each diagnosis criterion in this population. Data were collected through personal interviews of a probability sample of puerperal women (N = 641) in the city of Santa Fe (Argentina), between October 2010 and February 2011. Diagnoses compatible with DSM-IV, DSM-5, and ICD-10 were obtained through the Composite International Diagnostic Interview. Agreement among diagnostic systems was measured through Cohen kappa. Diagnosis criteria performance were analyzed considering their prevalence and discriminating ability (D value). Total ADP prevalence was 6.4% for DSM-IV (4.2% abuse and 2.2% dependence), 8.1% for DSM-5 (6.4% mild, 0.8% moderate, and 0.9% severe alcohol use disorder), and 14.1% for the ICD-10 (11.9% harmful use and 2.2% dependence). DSM-5 modifications improved agreement between DSM and ICD. The least prevalent and worst discriminating ability diagnostic

  20. Importance of the atrial channel for ventricular arrhythmia therapy in the dual chamber implantable cardioverter defibrillator.

    PubMed

    Dijkman, B; Wellens, H J

    2000-12-01

    Performance of dual chamber implantable cardioverter defibrillator (ICD) systems has been judged based on functioning of the ventricular tachycardia:supraventricular tachycardia (VT:SVT) discrimination criteria and DDD pacing. The purpose of this study was to evaluate the use of dual chamber diagnostics to improve the electrical and antiarrhythmic therapy of ventricular arrhythmias. Information about atrial and ventricular rhythm in relation to ventricular arrhythmia occurrence and therapy was evaluated in 724 spontaneous arrhythmia episodes detected and treated by three types of dual chamber ICDs in 41 patients with structural heart disease. Device programming was based on clinically documented and induced ventricular arrhythmias. In ambulatory patients, sinus tachycardia preceded ventricular arrhythmias more often than in the hospital during exercise testing. The incidence of these VTs could be reduced by increasing the dose of a beta-blocking agent in only two patients. In five patients in whom sinus tachycardia developed after onset of hemodynamic stable VT, propranolol was more effective than Class III antiarrhythmics combined with another beta-blocking agent with regard to the incidence of VT and pace termination. In all but three cases, atrial arrhythmias were present for a longer time before the onset of ventricular arrhythmias. During atrial arrhythmias, fast ventricular rates before the onset of ventricular rate were observed more often than RR irregularities and short-long RR sequences. Dual chamber diagnostics allowed proper interpretation of detection and therapy outcome in patients with different types of ventricular arrhythmia. The advantages of the dual chamber ICD system go further than avoiding the shortcomings of the single chamber system. Information from the atrial chamber allows better device programming and individualization of drug therapy for ventricular arrhythmia.

  1. Needle segmentation using 3D Hough transform in 3D TRUS guided prostate transperineal therapy

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

    Qiu Wu; Imaging Research Laboratories, Robarts Research Institute, Western University, London, Ontario N6A 5K8; Yuchi Ming

    Purpose: Prostate adenocarcinoma is the most common noncutaneous malignancy in American men with over 200 000 new cases diagnosed each year. Prostate interventional therapy, such as cryotherapy and brachytherapy, is an effective treatment for prostate cancer. Its success relies on the correct needle implant position. This paper proposes a robust and efficient needle segmentation method, which acts as an aid to localize the needle in three-dimensional (3D) transrectal ultrasound (TRUS) guided prostate therapy. Methods: The procedure of locating the needle in a 3D TRUS image is a three-step process. First, the original 3D ultrasound image containing a needle is cropped;more » the cropped image is then converted to a binary format based on its histogram. Second, a 3D Hough transform based needle segmentation method is applied to the 3D binary image in order to locate the needle axis. The position of the needle endpoint is finally determined by an optimal threshold based analysis of the intensity probability distribution. The overall efficiency is improved through implementing a coarse-fine searching strategy. The proposed method was validated in tissue-mimicking agar phantoms, chicken breast phantoms, and 3D TRUS patient images from prostate brachytherapy and cryotherapy procedures by comparison to the manual segmentation. The robustness of the proposed approach was tested by means of varying parameters such as needle insertion angle, needle insertion length, binarization threshold level, and cropping size. Results: The validation results indicate that the proposed Hough transform based method is accurate and robust, with an achieved endpoint localization accuracy of 0.5 mm for agar phantom images, 0.7 mm for chicken breast phantom images, and 1 mm for in vivo patient cryotherapy and brachytherapy images. The mean execution time of needle segmentation algorithm was 2 s for a 3D TRUS image with size of 264 Multiplication-Sign 376 Multiplication-Sign 630 voxels

  2. Antiangiogenic therapy for patients with aggressive or refractory advanced non-small cell lung cancer in the second-line setting.

    PubMed

    Reck, Martin; Garassino, Marina Chiara; Imbimbo, Martina; Shepherd, Frances A; Socinski, Mark A; Shih, Jin-Yuan; Tsao, Anne; Lee, Pablo; Winfree, Katherine B; Sashegyi, Andreas; Cheng, Rebecca; Varea, Rocio; Levy, Benjamin; Garon, Edward

    2018-06-01

    A majority of patients with advanced or metastatic non-small cell lung cancer (NSCLC) will experience disease progression after first-line therapy. Patients who have advanced NSCLC that is especially aggressive, which is defined as disease that rapidly progresses on first-line treatment or disease that is refractory to first-line treatment, have a critical unmet medical need. These patients have a poor prognosis in the second-line setting. Several studies have recently shown that treatment with an antiangiogenic therapy may benefit these patients. This review summarizes the approved antiangiogenic therapies for the treatment of patients with advanced NSCLC in the second-line setting, specifically focusing on the outcomes from subgroups of patients with rapidly progressing or refractory disease. Several antiangiogenic agents, as monotherapy or in combination with other treatments, have been or are currently being studied in patients with advanced NSCLC. Antiangiogenics that are approved for use in patients with advanced NSCLC are limited to bevacizumab in combination with chemotherapy (nonsquamous NSCLC), ramucirumab in combination with docetaxel (all histologies), and nintedanib in combination with docetaxel (adenocarcinoma histology). This review focuses on the efficacy, safety, and quality of life outcomes in the subpopulation of patients with rapidly progressing or refractory NSCLC treated with approved antiangiogenic therapies in the second-line setting. We also discuss the impact of newly approved immunotherapy agents on the outcomes of patients with aggressive or refractory disease. Studies in progress and planned future research will determine if combination treatment with antiangiogenics and immunotherapies will benefit patients with aggressive, advanced NSCLC. Copyright © 2018. Published by Elsevier B.V.

  3. Dosimetric comparison between proton beam therapy and photon radiation therapy for locally advanced esophageal squamous cell carcinoma.

    PubMed

    Hirano, Yasuhiro; Onozawa, Masakatsu; Hojo, Hidehiro; Motegi, Atsushi; Zenda, Sadatomo; Hotta, Kenji; Moriya, Shunsuke; Tachibana, Hidenobu; Nakamura, Naoki; Kojima, Takashi; Akimoto, Tetsuo

    2018-02-09

    The purpose of this study was to perform a dosimetric comparison between proton beam therapy (PBT) and photon radiation therapy in patients with locally advanced esophageal squamous cell carcinoma (ESCC) who were treated with PBT in our institution. In addition, we evaluated the correlation between toxicities and dosimetric parameters, especially the doses to normal lung or heart tissue, to clarify the clinical advantage of PBT over photon radiation therapy. A total of 37 consecutive patients with Stage III thoracic ESCC who had received PBT with or without concurrent chemotherapy between October 2012 and December 2015 were evaluated in this study. The dose distributions of PBT were compared with those of dummy 3-dimensional conformal radiation therapy (3DCRT) and Intensity Modulated Radiation Therapy (IMRT), focusing especially on the doses to organs at risk, such as normal lung and heart tissue. Of the 37 patients, the data from 27 patients were analyzed. Among these 27 patients, four patients (15%) developed grade 2 pericardial effusion as a late toxicity. None of the patients developed grade 3 or worse acute or late pulmonary and cardiac toxicities. When the dosimetric parameters between PBT and planned 3DCRT were compared, all the PBT domestic variables for the lung dose except for lung V10 GyE and V15 GyE were significantly lower than those for the dummy 3DCRT plans, and the PBT domestic variables for the heart dose were also significantly lower than those for the dummy 3DCRT plans. When the PBT and IMRT plans were compared, all the PBT domestic variables for the doses to the lung and heart were significantly lower than those for the dummy IMRT plans. Regarding the correlation between the grades of toxicities and the dosimetric parameters, no significant correlation was seen between the occurrence of grade 2 pericardial effusion and the dose to the heart. When the dosimetric parameters of the dose distributions for the treatment of patients with locally

  4. Associations Between Vitamin D Intake and Progression to Incident Advanced Age-Related Macular Degeneration

    PubMed Central

    Merle, Bénédicte M. J.; Silver, Rachel E.; Rosner, Bernard; Seddon, Johanna M.

    2017-01-01

    Purpose There is growing evidence of the importance of nutrition in age-related macular degeneration (AMD), but no prospective studies have explored the impact of vitamin D. We evaluated the association between vitamin D intake and progression to advanced AMD. Methods Among 2146 participants (3965 eyes), 541 (777 eyes) progressed from early or intermediate AMD to advanced disease (mean follow-up: 9.4 years) based on ocular imaging. Nutrients were log transformed and calorie adjusted. Survival analysis was used to assess associations between incident advanced disease and vitamin D intake. Neovascular disease (NV) and geographic atrophy (GA) were evaluated separately. Combined effects of dietary vitamin D and calcium were assessed based on high or low consumption of each nutrient. Results There was a lower risk of progression to advanced AMD in the highest versus lowest quintile of dietary vitamin D intake after adjustment for demographic, behavioral, ocular, and nutritional factors (hazard ratio [HR]: 0.60; 95% confidence interval [CI]: 0.43–0.83; P trend = 0.0007). Similar results were observed for NV (HR: 0.59; 95% CI: 0.39–0.89; P trend = 0.005) but not GA (HR: 0.83; 95% CI: 0.53–1.30; P trend = 0.35). A protective effect was observed for advanced AMD among participants with high vitamin D and low calcium compared to the group with low levels for each nutrient (HR: 0.67; 95% CI: 0.50–0.88; P = 0.005). When supplement use was considered, the effect was in the protective direction but was not significant. Conclusions A diet rich in vitamin D may prevent or delay progression to advanced AMD, especially NV. Additional exploration is needed to elucidate the potential protective role of vitamin D and its contribution to reducing visual loss. PMID:28892825

  5. Associations Between Vitamin D Intake and Progression to Incident Advanced Age-Related Macular Degeneration.

    PubMed

    Merle, Bénédicte M J; Silver, Rachel E; Rosner, Bernard; Seddon, Johanna M

    2017-09-01

    There is growing evidence of the importance of nutrition in age-related macular degeneration (AMD), but no prospective studies have explored the impact of vitamin D. We evaluated the association between vitamin D intake and progression to advanced AMD. Among 2146 participants (3965 eyes), 541 (777 eyes) progressed from early or intermediate AMD to advanced disease (mean follow-up: 9.4 years) based on ocular imaging. Nutrients were log transformed and calorie adjusted. Survival analysis was used to assess associations between incident advanced disease and vitamin D intake. Neovascular disease (NV) and geographic atrophy (GA) were evaluated separately. Combined effects of dietary vitamin D and calcium were assessed based on high or low consumption of each nutrient. There was a lower risk of progression to advanced AMD in the highest versus lowest quintile of dietary vitamin D intake after adjustment for demographic, behavioral, ocular, and nutritional factors (hazard ratio [HR]: 0.60; 95% confidence interval [CI]: 0.43-0.83; P trend = 0.0007). Similar results were observed for NV (HR: 0.59; 95% CI: 0.39-0.89; P trend = 0.005) but not GA (HR: 0.83; 95% CI: 0.53-1.30; P trend = 0.35). A protective effect was observed for advanced AMD among participants with high vitamin D and low calcium compared to the group with low levels for each nutrient (HR: 0.67; 95% CI: 0.50-0.88; P = 0.005). When supplement use was considered, the effect was in the protective direction but was not significant. A diet rich in vitamin D may prevent or delay progression to advanced AMD, especially NV. Additional exploration is needed to elucidate the potential protective role of vitamin D and its contribution to reducing visual loss.

  6. Initiative for Molecular Profiling and Advanced Cancer Therapy and challenges in the implementation of precision medicine.

    PubMed

    Tsimberidou, Apostolia-Maria

    In the last decade, breakthroughs in technology have improved our understanding of genomic, transcriptional, proteomic, epigenetic aberrations and immune mechanisms in carcinogenesis. Genomics and model systems have enabled the validation of novel therapeutic strategies. Based on these developments, in 2007, we initiated the IMPACT (Initiative for Molecular Profiling and Advanced Cancer Therapy) study, the first personalized medicine program for patients with advanced cancer at The University of Texas MD Anderson Cancer Center. We demonstrated that in patients referred for Phase I clinical trials, the use of tumor molecular profiling and treatment with matched targeted therapy was associated with encouraging rates of response, progression-free survival and overall survival compared to non-matched therapy. We are currently conducting IMPACT2, a randomized study evaluating molecular profiling and targeted agents in patients with metastatic cancer. Optimization of innovative biomarker-driven clinical trials that include targeted therapy and/or immunotherapeutic approaches for carefully selected patients will accelerate the development of novel drugs and the implementation of precision medicine. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Single-agent Taxane Versus Taxane-containing Combination Chemotherapy as Salvage Therapy for Advanced Urothelial Carcinoma.

    PubMed

    Sonpavde, Guru; Pond, Gregory R; Choueiri, Toni K; Mullane, Stephanie; Niegisch, Guenter; Albers, Peter; Necchi, Andrea; Di Lorenzo, Giuseppe; Buonerba, Carlo; Rozzi, Antonio; Matsumoto, Kazumasa; Lee, Jae-Lyun; Kitamura, Hiroshi; Kume, Haruki; Bellmunt, Joaquim

    2016-04-01

    Single-agent taxanes are commonly used as salvage systemic therapy for patients with advanced urothelial carcinoma (UC). To study the impact of combination chemotherapy delivering a taxane plus other chemotherapeutic agents compared with single-agent taxane as salvage therapy. Individual patient-level data from phase 2 trials of salvage systemic therapy were used. Trials evaluating either single agents (paclitaxel or docetaxel) or combination chemotherapy (taxane plus one other chemotherapeutic agent or more) following prior platinum-based therapy were used. Information regarding the known major baseline prognostic factors was required: time from prior chemotherapy, hemoglobin, performance status, albumin, and liver metastasis status. Cox proportional hazards regression was used to evaluate the association of prognostic factors and combination versus single-agent chemotherapy with overall survival (OS). Data were available from eight trials including 370 patients; two trials (n=109) evaluated single-agent chemotherapy with docetaxel (n=72) and cremophor-free paclitaxel (n=37), and six trials (n=261) evaluated combination chemotherapy with gemcitabine-paclitaxel (two trials, with n=99 and n=24), paclitaxel-cyclophosphamide (n=32), paclitaxel-ifosfamide-nedaplatin (n=45), docetaxel-ifosfamide-cisplatin (n=26), and paclitaxel-epirubicin (n=35). On multivariable analysis after adjustment for baseline prognostic factors, combination chemotherapy was independently and significantly associated with improved OS (hazard ratio: 0.60; 95% confidence interval, 0.45-0.82; p=0.001). The retrospective design of this analysis and the trial-eligible population were inherent limitations. Patients enrolled in trials of combination chemotherapy exhibited improved OS compared with patients enrolled in trials of single-agent chemotherapy as salvage therapy for advanced UC. Prospective randomized trials are required to validate a potential role for rational and tolerable combination

  8. Recent Advances in Upconversion Nanoparticles-Based Multifunctional Nanocomposites for Combined Cancer Therapy.

    PubMed

    Tian, Gan; Zhang, Xiao; Gu, Zhanjun; Zhao, Yuliang

    2015-12-16

    Lanthanide-doped upconversion nanoparticles (UCNPs) have the ability to generate ultraviolet or visible emissions under continuous-wave near-infrared (NIR) excitation. Utilizing this special luminescence property, UCNPs are approved as a new generation of contrast agents in optical imaging with deep tissue-penetration ability and high signal-to-noise ratio. The integration of UCNPs with other functional moieties can endow them with highly enriched functionalities for imaging-guided cancer therapy, which makes composites based on UCNPs emerge as a new class of theranostic agents in biomedicine. Here, recent progress in combined cancer therapy using functional nanocomposites based on UCNPs is reviewed. Combined therapy referring to the co-delivery of two or more therapeutic agents or a combination of different treatments is becoming more popular in clinical treatment of cancer because it generates synergistic anti-cancer effects, reduces individual drug-related toxicity and suppresses multi-drug resistance through different mechanisms of action. Here, the recent advances of combined therapy contributed by UCNPs-based nanocomposites on two main branches are reviewed: i) photodynamic therapy and ii) chemotherapy, which are the two most widely adopted therapies of UCNPs-based composites. The future prospects and challenges in this emerging field will be also discussed. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  9. Data management procedures for Tiepoint Registration, pre and post processing, and ICD116

    NASA Technical Reports Server (NTRS)

    Nowakowski, B. S.

    1983-01-01

    The data management procedures for tiepoint registration, pre and post processing, and "ICD116' are described. With each procedure description, the pertinent execs are listed and purposes defined. An example run of each of the 32 execs is included with user inputs identified.

  10. Optimal Implantable Cardioverter Defibrillator Programming.

    PubMed

    Shah, Bindi K

    Optimal programming of implantable cardioverter defibrillators (ICDs) is essential to appropriately treat ventricular tachyarrhythmias and to avoid unnecessary and inappropriate shocks. There have been a series of large clinical trials evaluating tailored programming of ICDs. We reviewed the clinical trials evaluating ICD therapies and detection, and the consensus statement on ICD programming. In doing so, we found that prolonged ICD detection times, higher rate cutoffs, and antitachycardia pacing (ATP) programming decreases inappropriate and painful therapies in a primary prevention population. The use of supraventricular tachyarrhythmia discriminators can also decrease inappropriate shocks. Tailored ICD programming using the knowledge gained from recent ICD trials can decrease inappropriate and unnecessary ICD therapies and decrease mortality.

  11. Clinical features and response to systemic therapy in a historical cohort of advanced or unresectable mucosal melanoma.

    PubMed

    Shoushtari, Alexander N; Bluth, Mark J; Goldman, Debra A; Bitas, Christiana; Lefkowitz, Robert A; Postow, Michael A; Munhoz, Rodrigo R; Buchar, Gauri; Hester, Robert H; Romero, Jacqueline A; Fitzpatrick, Laura J; Weiser, Martin R; Panageas, Katherine S; Wolchok, Jedd D; Chapman, Paul B; Carvajal, Richard D

    2017-02-01

    There are very few data available regarding the pattern of first metastases in resected mucosal melanomas (MMs) as well as the response of advanced MM to cytotoxic therapy. A retrospective, single-institution cohort was assembled of all patients with advanced/unresectable MM between 1995 and 2012 who had received systemic therapy with available imaging (N=81). Responses to first-line and second-line systemic therapy were assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The relationship between response, overall survival, and clinical covariates was investigated using Cox proportional hazards regression. Primary sites included anorectal (N=31, 38%), vulvovaginal (N=28, 35%), head and neck (N=21, 26%), and gallbladder (N=1, 1%) mucosa. Seven percent of patients had their first relapse in the brain. Cytotoxic therapy represented 82 and 51% of first-line and second-line regimens. The best response achieved in the first-line setting was similar for single-agent [10%; 95% confidence interval (CI): 1-32%] and combination alkylator therapy (8%; 95% CI: 2-21%). Median overall survival from first-line treatment was 10.3 months (95% CI: 8.7-13.9 months). Patients with elevated lactic dehydrogenase [hazard ratio (HR): 1.87, 95% CI: 1.10-3.19, P=0.020] and Eastern Cooperative Oncology Group performance status 1-2 (HR: 1.69, 95% CI: 1.05-2.72, P=0.030) had a higher risk of death, whereas patients with 12-week objective responses had a lower risk of death (HR: 0.12, 95% CI: 0.04-0.41, P<0.001). Cytotoxic systemic therapy has modest activity in advanced/unresectable MM, belying its adjuvant benefit. Patients whose tumors have an objective response to therapy have a lower probability of death. Brain imaging should be considered in routine surveillance.

  12. Comparison of validity of mapping between drug indications and ICD-10. Direct and indirect terminology based approaches.

    PubMed

    Choi, Y; Jung, C; Chae, Y; Kang, M; Kim, J; Joung, K; Lim, J; Cho, S; Sung, S; Lee, E; Kim, S

    2014-01-01

    Mapping of drug indications to ICD-10 was undertaken in Korea by a public and a private institution for their own purposes. A different mapping approach was used by each institution, which presented a good opportunity to compare the validity of the two approaches. This study was undertaken to compare the validity of a direct mapping approach and an indirect terminology based mapping approach of drug indications against the gold standard drawn from the results of the two mapping processes. Three hundred and seventy-five cardiovascular reference drugs were selected from all listed cardiovascular drugs for the study. In the direct approach, two experienced nurse coders mapped the free text indications directly to ICD-10. In the indirect terminology based approach, the indications were extracted and coded in the Korean Standard Terminology of Medicine. These terminology coded indications were then manually mapped to ICD-10. The results of the two approaches were compared to the gold standard. A kappa statistic was calculated to see the compatibility of both mapping approaches. Recall, precision and F1 score of each mapping approach were calculated and analyzed using a paired t-test. The mean number of indications for the study drugs was 5.42. The mean number of ICD-10 codes that matched in direct approach was 46.32 and that of indirect terminology based approach was 56.94. The agreement of the mapping results between the two approaches were poor (kappa = 0.19). The indirect terminology based approach showed higher recall (86.78%) than direct approach (p < 0.001). However, there was no difference in precision and F1 score between the two approaches. Considering no differences in the F1 scores, both approaches may be used in practice for mapping drug indications to ICD-10. However, in terms of consistency, time and manpower, better results are expected from the indirect terminology based approach.

  13. Effects of Vitamin D Therapy on Quality of Life in Patients with Fibromyalgia.

    PubMed

    Dogru, Atalay; Balkarli, Ayse; Cobankara, Veli; Tunc, Sevket Ercan; Sahin, Mehmet

    2017-06-01

    The role of vitamin D in the etiopathogenesis of fibromyalgia and non-specific musculoskeletal pain is controversial. In our study, we aimed to investigate the effect of vitamin D therapy on quality of life in patients with fibromyalgia. Seventy patients diagnosed with fibromyalgia and 65 age- and sex-matched controls were included in the study. Patients were grouped as deficient (<20 ng/mL), inadequate (20-30 ng/mL), and sufficient (>30 ng/mL) according to the levels of vitamin D. Vitamin D replacement was performed for patients with deficiencies and inadequacies. Before and after vitamin D therapy, patients filled in the assessment tools, fibromyalgia impact questionnaire (FIQ), Arizona sexual experience scale (ASEX), Beck depression inventory (BDI), visual analog scale (VAS), and short form-36 (SF-36). Vitamin D deficiencies and inadequacies were observed in 60% of the patients (n=42). Among patients with low and normal levels of vitamin D, no statistically significant difference was observed in their values. In scales examined after vitamin D replacement therapy, statistically significant differences were observed in the FIQ, BDI, VAS, and SF-36 compared with pre-treatment. Vitamin D deficiency seems to be linked to the pathogenesis of fibromyalgia. Vitamin D supplementation may improve the quality of life in patients with fibromyalgia.

  14. [Academic cell therapy facilities are challenged by European regulation on advanced therapy medicinal products].

    PubMed

    Chabannon, Christian; Sabatier, Florence; Rial-Sebbag, Emmanuelle; Calmels, Boris; Veran, Julie; Magalon, Guy; Lemarie, Claude; Mahalatchimy, Aurélie

    2014-05-01

    Regulation (EC) n° 1394/2007 from the European Parliament and the Council describes a new category of health products termed « Advanced Therapy Medicinal Products » (ATMPs). ATMPs derive from cell engineering, tissue engineering or genetic manipulations, and can in some instances be combined with medical devices. ATMPs are distributed and administered to patients, after biotechnology or pharmaceutical companies have obtained a marketing authorization that is granted by the European Commission on the basis of the European Medicines Agency (EMA) assessment. Seven years after the publication of the regulation, few of these therapies have received a marketing authorization, and even fewer have met commercial success, suggesting that a number of medical and economic issues still need to be sorted out in order to achieve sustainability in this field. The coexistence of three sets of rules for three categories of health products that are biologically and medically related - ATMPs, ATMPs produced under the hospital exemption rule, and cell therapy products (CTPs) (a specific legal category in France) that have long been used in hematopoietic cell transplantation - constitutes a complex regulatory framework. This situation raises significant issues for historical as well as emerging operators in this moving field that are discussed thereafter. © 2014 médecine/sciences – Inserm.

  15. Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators.

    PubMed

    Zabel, Markus; Müller-Riemenschneider, Falk; Geller, J Christoph; Brachmann, Johannes; Kühlkamp, Volker; Dissmann, Rüdiger; Reinhold, Thomas; Roll, Stephanie; Lüthje, Lars; Bode, Frank; Eckardt, Lars; Willich, Stefan N

    2014-10-01

    Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial. Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD (Lumax VR-T or Lumax DR-T; Biotronik SE & Co KG, Berlin, Germany). Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed, and 416 patients have been enrolled. Subjects are followed-up for a minimum of 12months and a maximum of 24months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups. Secondary end points include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality, and additional health economic end points. The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM. Copyright © 2014 Mosby, Inc. All rights reserved.

  16. Advances in Cell and Gene-based Therapies for Cystic Fibrosis Lung Disease

    PubMed Central

    Oakland, Mayumi; Sinn, Patrick L; McCray Jr, Paul B

    2012-01-01

    Cystic fibrosis (CF) is a disease characterized by airway infection, inflammation, remodeling, and obstruction that gradually destroy the lungs. Direct delivery of the cystic fibrosis transmembrane conductance regulator (CFTR) gene to airway epithelia may offer advantages, as the tissue is accessible for topical delivery of vectors. Yet, physical and host immune barriers in the lung present challenges for successful gene transfer to the respiratory tract. Advances in gene transfer approaches, tissue engineering, and novel animal models are generating excitement within the CF research field. This review discusses current challenges and advancements in viral and nonviral vectors, cell-based therapies, and CF animal models. PMID:22371844

  17. Nanoscience and Nanotechnology: From Energy Applications to Advanced Medical Therapies

    ScienceCinema

    Tijana Rajh

    2017-12-09

    Dr. Rajh will present a general talk on nanotechnology – an overview of why nanotechnology is important and how it is useful in various fields. The specific focus will be on Solar energy conversion, environmental applications and advanced medical therapies. She has broad expertise in synthesis and characterization of nanomaterials that are used in nanotechnology including novel hybrid systems connecting semiconductors to biological molecules like DNA and antibodies. This technology could lead to new gene therapy procedures, cancer treatments and other medical applications. She will also discuss technologies made possible by organizing small semiconductor particles called quantum dots, materials that exhibit a rich variety of phenomena that are size and shape dependent. Development of these new materials that harnesses the unique properties of materials at the 1-100 nanometer scale resulted in the new field of nanotechnology that currently affects many applications in technological and medical fields.

  18. Mental health professionals' natural taxonomies of mental disorders: implications for the clinical utility of the ICD-11 and the DSM-5.

    PubMed

    Reed, Geoffrey M; Roberts, Michael C; Keeley, Jared; Hooppell, Catherine; Matsumoto, Chihiro; Sharan, Pratap; Robles, Rebeca; Carvalho, Hudson; Wu, Chunyan; Gureje, Oye; Leal-Leturia, Itzear; Flanagan, Elizabeth H; Correia, João Mendonça; Maruta, Toshimasa; Ayuso-Mateos, José Luís; de Jesus Mari, Jair; Xiao, Zeping; Evans, Spencer C; Saxena, Shekhar; Medina-Mora, María Elena

    2013-12-01

    To examine the conceptualizations held by psychiatrists and psychologists around the world of the relationships among mental disorders in order to inform decisions about the structure of the classification of mental and behavioral disorders in World Health Organization's International Classification of Diseases and Related Health Problems 11th Revision (ICD-11). 517 mental health professionals in 8 countries sorted 60 cards containing the names of mental disorders into groups of similar disorders, and then formed a hierarchical structure by aggregating and disaggregating these groupings. Distance matrices were created from the sorting data and used in cluster and correlation analyses. Clinicians' taxonomies were rational, interpretable, and extremely stable across countries, diagnostic system used, and profession. Clinicians' consensus classification structure was different from ICD-10 and the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV), but in many respects consistent with ICD-11 proposals. The clinical utility of the ICD-11 may be improved by making its structure more compatible with the common conceptual organization of mental disorders observed across diverse global clinicians. © 2013 Wiley Periodicals, Inc.

  19. NHLBI’s Program for VAD Therapy for Moderately Advanced Heart Failure: The REVIVE-IT Pilot Trial

    PubMed Central

    Baldwin, J. Timothy; Mann, Douglas L.

    2010-01-01

    Background VADs are used to bridge heart failure patients to transplantation, to allow their own hearts to recover, or as permanent (“destination”) therapy. To date, the use of VADs has been limited to late-stage heart failure patients because of the associated device risks. In 2008, an NHLBI working group met to evaluate the treatment of heart failure using VADs and to advise the institute on how therapy for heart failure may be best advanced by clinical trials involving the devices. Discussion and Recommendations Recognizing the improvements in VAD technology and in patient care and selection over the past decade, the working group recommended that a trial be performed to assess the use of chronic VAD therapy in patients who are less ill than those currently eligible for destination therapy. The hypothesis proposed for the trial is that VAD therapy may improve both survival and quality of life in moderately advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility. Based on the group’s recommendations, NHLBI issued an RFP in 2009 for the REVIVE-IT Pilot Trail which will serve to test the hypothesis and inform the pivotal trial. PMID:21055648

  20. Comparison of several inflow control devices for flight simulation of fan tone noise using a JT15D-1 engine

    NASA Technical Reports Server (NTRS)

    Mcardle, J. G.; Jones, W. L.; Heidelberg, L. J.; Homyak, L.

    1980-01-01

    To enable accurate simulation of in-flight fan tone noise during ground static tests, four devices intended to reduce inflow disturbances and turbulence were tested with a JT15D-1 turbofan engine. These inflow control devices (ICD's) consisted of honeycomb/screen structures mounted over the engine inlet. The ICD's ranged from 1.6 to 4 fan diameters in size, and differed in shape and fabrication method. All the ICD's significantly reduced the BPF tone in the far-field directivity patterns, but the smallest ICD's apparently introduced propagating modes which could be recognized by additional lobes in the speeds; at supersonic fan tip speed the smallest ICD's had some measurable loss, but the largest had no loss. Data from a typical transducer show that the unsteady inflow distortion modes (turbulence) were eliminated or significantly reduced when either of the ICD's was installed. However, some steady inflow distortion modes remained.

  1. Opportunities for Regenerative Rehabilitation and Advanced Technologies in Physical Therapy: Perspective From Academia.

    PubMed

    Norland, Ryan; Muchnick, Matthew; Harmon, Zachary; Chin, Tiffany; Kakar, Rumit Singh

    2016-04-01

    As rehabilitation specialists, physical therapists must continue to stay current with advances in technologies to provide appropriate rehabilitation protocols, improve patient outcomes, and be the preferred clinician of choice. To accomplish this vision, the physical therapy profession must begin to develop a culture of lifelong learning at the early stages of education and clinical training in order to embrace cutting-edge advancements such as stem cell therapies, tissue engineering, and robotics, to name a few. The purposes of this article are: (1) to provide a current perspective on faculty and graduate student awareness of regenerative rehabilitation concepts and (2) to advocate for increased integration of these emerging technologies within the doctor of physical therapy (DPT) curriculum. An online survey was designed to gauge awareness of principles in regenerative rehabilitation and to determine whether the topic was included and assessed in doctoral curricula. The survey yielded 1,006 responses from 82 DPT programs nationwide and indicated a disconnect in familiarity with the term "regenerative rehabilitation" and awareness of the inclusion of this material in the curriculum. To resolve this disconnect, the framework of the curriculum can be used to integrate new material via guest lecturers, interdisciplinary partnerships, and research opportunities. Successfully mentoring a generation of clinicians and rehabilitation scientists who incorporate new medical knowledge and technology into their own clinical and research practice depends greatly on sharing the responsibility among graduate students, professors, the American Physical Therapy Association (APTA), and DPT programs. Creating an interdisciplinary culture and integrating regenerative medicine and rehabilitation concepts into the curriculum will cultivate individuals who will be advocates for interprofessional behaviors and will ensure that the profession meets the goals stated in APTA Vision 2020.

  2. Impact of Prior Platinum-Based Therapy on Patients Receiving Salvage Systemic Treatment for Advanced Urothelial Carcinoma.

    PubMed

    Sonpavde, G; Pond, G R; Di Lorenzo, G; Buonerba, C; Rozzi, A; Lanzetta, G; Necchi, A; Giannatempo, P; Raggi, D; Matsumoto, K; Choueiri, T K; Mullane, S; Niegisch, G; Albers, P; Lee, J L; Kitamura, H; Kume, H; Bellmunt, J

    2016-12-01

    Trials of salvage therapy for advanced urothelial carcinoma have required prior platinum-based therapy. This practice requires scrutiny because non-platinum-based first-line therapy may be offered to cisplatin-ineligible patients. Data of patients receiving salvage systemic chemotherapy were collected. Data on prior first-line platinum exposure were required in addition to treatment-free interval, hemoglobin, Eastern Cooperative Oncology Group performance status, albumin, and liver metastasis status. Cox proportional hazard regression was used to evaluate their association with overall survival (OS) after accounting for salvage single-agent or combination chemotherapy. Data were obtained from 455 patients previously exposed to platinum-based therapy and 37 not exposed to platinum. In the group exposed to prior platinum therapy, salvage therapy consisted of a single-agent taxane (n = 184) or a taxane-containing combination chemotherapy (n = 271). In the group not exposed to prior platinum therapy, salvage therapy consisted of taxane or vinflunine (n = 20), 5-fluorouracil (n = 1), taxane-containing combination chemotherapy (n = 12), carboplatin-based combinations (n = 2), and cisplatin-based combinations (n = 2). The median OS for the prior platinum therapy group was 7.8 months (95% confidence interval, 7.0, 8.1), and for the group that had not received prior platinum therapy was 9.0 months (95% confidence interval, 6.0, 11.0; P = .50). In the multivariable analysis, prior platinum therapy versus no prior platinum exposure did not confer an independent impact on OS (hazard ratio, 1.10; 95% confidence interval, 0.75, 1.64; P = .62). Prior platinum- versus non-platinum-based chemotherapy did not have a prognostic impact on OS after accounting for major prognostic factors in patients receiving salvage systemic chemotherapy for advanced urothelial carcinoma. Lack of prior platinum therapy should not disqualify patients from inclusion onto trials of salvage

  3. Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States.

    PubMed

    Ivaskiene, Tatjana; Mauricas, Mykolas; Ivaska, Justinas

    2017-01-01

    Regulation (EC) 1394/2007 of the European Parliament and the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 allowed the use of non - authorized advanced therapy medicinal products under the certain circumstances. This socalled hospital exemption rule needs to be applied in the each Member State of the European Union individually and for this purpose Member States should provide national procedures and control measures. The aim of this article is to clear up the criteria for hospital exemption listed in Regulation (EC) 1394/2007 and to contrast the difference in implementing hospital exemption rule into national legal regimes on examples of the United Kingdom, Lithuania and Poland.

  4. Nine-year prostate cancer survival differences between aggressive versus conservative therapy in men with advanced and metastatic prostate cancer.

    PubMed

    Dall'Era, Marc A; Lo, Mary J; Chen, Jaclyn; Cress, Rosemary; Hamilton, Ann S

    2018-05-01

    To the authors' knowledge, the survival benefit of local therapy in the setting of advanced prostate cancer remains unknown. The authors investigated whether prostate-directed treatment with either surgery or radiotherapy versus conservative treatment in the setting of locally advanced or metastatic disease was associated with improved survival within a cohort of men from the Centers for Disease Control and Prevention's (CDC) Breast and Prostate Cancer Data Quality and Patterns of Care Study (CDC POC-BP). Men diagnosed with locally advanced (cT3-T4 or N+ and M0) or metastatic prostate cancer were identified. The authors compared survival by treatment type, categorized as conservative (androgen deprivation therapy only) versus aggressive (radical prostatectomy or any type of radiotherapy). Nine-year overall survival and prostate cancer-specific survival were estimated using the Kaplan-Meier method. The Cox proportional hazards model was used to determine factors independently associated with 9-year prostate cancer-specific survival. For men with advanced, nonmetastatic prostate cancer, conservative treatment alone was associated with a 4 times higher likelihood of prostate cancer mortality compared with men treated with surgery (hazard ratio, 4.18; 95% confidence interval, 1.44-12.14). In contrast, no difference was found between conservative versus aggressive treatment after adjusting for covariates for men with metastatic disease. The 9-year prostate cancer-specific survival rate was 27% for those receiving aggressive treatment versus 24% for men undergoing conservative treatment. The authors did not observe a survival advantage with local therapy in addition to standard androgen deprivation therapy for men with metastatic prostate cancer. However, the results of the current study did affirm advantages in the setting of locally advanced disease. Aggressive local therapy in the setting of metastatic disease needs to be studied carefully before clinical adoption

  5. Impact of Intensity-Modulated Radiation Therapy Technique for Locally Advanced Non-Small-Cell Lung Cancer: A Secondary Analysis of the NRG Oncology RTOG 0617 Randomized Clinical Trial.

    PubMed

    Chun, Stephen G; Hu, Chen; Choy, Hak; Komaki, Ritsuko U; Timmerman, Robert D; Schild, Steven E; Bogart, Jeffrey A; Dobelbower, Michael C; Bosch, Walter; Galvin, James M; Kavadi, Vivek S; Narayan, Samir; Iyengar, Puneeth; Robinson, Clifford G; Wynn, Raymond B; Raben, Adam; Augspurger, Mark E; MacRae, Robert M; Paulus, Rebecca; Bradley, Jeffrey D

    2017-01-01

    Purpose Although intensity-modulated radiation therapy (IMRT) is increasingly used to treat locally advanced non-small-cell lung cancer (NSCLC), IMRT and three-dimensional conformal external beam radiation therapy (3D-CRT) have not been compared prospectively. This study compares 3D-CRT and IMRT outcomes for locally advanced NSCLC in a large prospective clinical trial. Patients and Methods A secondary analysis was performed to compare IMRT with 3D-CRT in NRG Oncology clinical trial RTOG 0617, in which patients received concurrent chemotherapy of carboplatin and paclitaxel with or without cetuximab, and 60- versus 74-Gy radiation doses. Comparisons included 2-year overall survival (OS), progression-free survival, local failure, distant metastasis, and selected Common Terminology Criteria for Adverse Events (version 3) ≥ grade 3 toxicities. Results The median follow-up was 21.3 months. Of 482 patients, 53% were treated with 3D-CRT and 47% with IMRT. The IMRT group had larger planning treatment volumes (median, 427 v 486 mL; P = .005); a larger planning treatment volume/volume of lung ratio (median, 0.13 v 0.15; P = .013); and more stage IIIB disease (30.3% v 38.6%, P = .056). Two-year OS, progression-free survival, local failure, and distant metastasis-free survival were not different between IMRT and 3D-CRT. IMRT was associated with less ≥ grade 3 pneumonitis (7.9% v 3.5%, P = .039) and a reduced risk in adjusted analyses (odds ratio, 0.41; 95% CI, 0.171 to 0.986; P = .046). IMRT also produced lower heart doses ( P < .05), and the volume of heart receiving 40 Gy (V40) was significantly associated with OS on adjusted analysis ( P < .05). The lung V5 was not associated with any ≥ grade 3 toxicity, whereas the lung V20 was associated with increased ≥ grade 3 pneumonitis risk on multivariable analysis ( P = .026). Conclusion IMRT was associated with lower rates of severe pneumonitis and cardiac doses in NRG Oncology clinical trial RTOG 0617, which supports

  6. Optimization and simplification of the Allergic and Hypersensitivity conditions classification for the ICD-11.

    PubMed

    Tanno, L K; Calderon, M A; Demoly, P

    2016-05-01

    Since 2013, an international collaboration of Allergy Academies, including first the World Allergy Organization (WAO), the American Academy of Allergy Asthma and Immunology (AAAAI), and the European Academy of Allergy and Clinical Immunology (EAACI), and then the American College of Allergy, Asthma and Immunology (ACAAI), the Latin American Society of Allergy, Asthma and Immunology (SLAAI), and the Asia Pacific Association of Allergy, Asthma and Clinical Immunology (APAAACI), has spent tremendous efforts to have a better and updated classification of allergic and hypersensitivity conditions in the forthcoming International Classification of Diseases (ICD)-11 version by providing evidences and promoting actions for the need for changes. The latest action was the implementation of a classification proposal of hypersensitivity/allergic diseases built by crowdsourcing the Allergy Academy leaderships. Following bilateral discussions with the representatives of the ICD-11 revision, a face-to-face meeting was held at the United Nations Office in Geneva and a simplification process of the hypersensitivity/allergic disorders classification was carried out to better fit the ICD structure. We are here presenting the end result of what we consider to be a model of good collaboration between the World Health Organization and a specialty. We strongly believe that the outcomes of all past and future actions will impact positively the recognition of the allergy specialty as well as the quality improvement of healthcare system for allergic and hypersensitivity conditions worldwide. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Budgetary Impact of Medicinal Therapies for Rare Diseases in Bulgaria.

    PubMed

    Iskrov, Georgi G; Jakovljevic, Mihajlo Michael; Stefanov, Rumen S

    2018-03-01

    Rare diseases have been continually outlined as one of the causes for the National Health Insurance Fund's (NHIF) deficit spending in Bulgaria. To estimate the budgetary impact of rare disease medicinal therapies from NHIF perspective for 2014 and 2016. Budgetary impact of rare diseases is calculated as a percentage of NHIF total pharmaceutical spending. Total expenditure per ICD-10 code, mean annual number of patients reimbursed and mean annual cost per patient are analysed. Budgetary impact of rare diseases reached a plateau of about 9% of NHIF total pharmaceutical spending for 2014-2016. Mean number of patients reimbursed and mean annual cost per patient increased by median rates of 4.27% and 2.54%, respectively. Glycogen storage disease, neuropathic heredofamilial amyloidosis and C1 esterase inhibitor deficiency stood out, as they had the second, fourth and fifth most expensive medicinal treatment cost. While accounting for only 92 patients in 2016, these three conditions contributed for 22.89% of NHIF total expenditure on rare disease medicinal therapies. For comparison, coagulation defects, with the biggest total cost per indication, had a similar budgetary impact - 24.88%, but for 277 patients reimbursed. Our study does not support the concerns about uncontrolled growth of expenditures for rare disease medicinal therapies. Nevertheless, there is a need for enhanced post-marketing surveillance and performance-based payment of these treatments. Development, collection and analysis of local real-world data have been increasingly applied as a tool to advance these health policy goals.

  8. SU-F-T-123: The Simulated Effect of the Breath-Hold Reproducibility Treating Locally-Advanced Lung Cancer with Pencil Beam Scanned Proton Therapy

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

    Dueck, J; Department of Oncology, Rigshospitalet, Copenhagen; Niels Bohr Institute, University of Copenhagen, Copenhagen

    Purpose: The breath-hold (BH) technique has been suggested to mitigate motion and reduce target coverage degradation due to motion effects. The aim of this study was to investigate the effect of inter-BH residual motion on the dose distribution for pencil beam scanned (PBS) proton therapy of locally-advanced lung cancer patients. Methods: A dataset of visually-guided BH CT scans was acquired (10 scans per patient) taken from five lung cancer patients: three intra-fractionally repeated CT scans on treatment days 2,16 and 31, in addition to the day 0 planning CT scan. Three field intensity-modulated proton therapy (IMPT) plans were constructed onmore » the planning CT scan. Dose delivery on fraction 2, 16 and 31 were simulated on the three consecutive CT scans, assuming BH duration of 20s and soft tissue match. The dose was accumulated in the planning CT using deformable image registration, and scaled to simulate the full treatment of 66Gy(RBE) in 33 fractions. Results: The mean dose to the lungs and heart, and maximum dose to the spinal cord and esophagus were within 1% of the planned dose. The CTV V95% decreased and the inhomogeneity (D5%–D95%) increased on average 4.1% (0.4–12.2%) and 5.8% (2.2–13.4%), respectively, over the five patient cases. Conclusion: The results showed that the BH technique seems to spare the OARs in spite of inter-BH residual motion. However, small degradation of target coverage occurred for all patients, with 3/5 patients having a decrease in V95% ≤1%. For the remaining two patients, where V95% decreased up to 12%, the cause could be related to treatment related anatomical changes and, as in photon therapy, plan adaptation may be necessary to ensure target coverage. This study showed that BH could be a potential treatment option to reliably mitigate motion for the treatment of locally-advanced lung cancer using PBS proton therapy.« less

  9. Potential role for mammalian target of rapamycin inhibitors as first-line therapy in hormone receptor–positive advanced breast cancer

    PubMed Central

    Beck, J Thaddeus

    2015-01-01

    Despite advances in cytotoxic chemotherapy and targeted therapies, 5-year survival rates remain low for patients with advanced breast cancer at diagnosis. This highlights the limited effectiveness of current treatment options. An improved understanding of cellular functions associated with the development and progression of breast cancer has resulted in the creation of a number of novel targeted molecular therapies. However, more work is needed to improve outcomes, particularly in the first-line recurrent or metastatic hormone receptor–positive breast cancer setting. The phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (mTOR) pathway is a major intracellular signaling pathway that is often upregulated in breast cancer, and overactivation of this pathway has been associated with primary or developed resistance to endocrine treatment. Clinical data from the Phase III Breast Cancer Trials of Oral Everolimus-2 (BOLERO-2) study of the mTOR inhibitor everolimus combined with exemestane in hormone receptor–positive advanced breast cancer were very promising, highlighting the potential role of mTOR inhibitors in combination with endocrine therapies as a first-line treatment option for these patients. It is hoped that the use of mTOR inhibitors combined with current standard-of-care endocrine therapies, such as aromatase inhibitors, in the first-line advanced breast cancer setting may result in greater antitumor effects and also delay or reverse treatment resistance. PMID:26675495

  10. WE-H-209-01: Advances in Ultrasound Therapy

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

    Hynynen, K.

    Focused ultrasound has been shown to be the only method that allows noninvasive thermal coagulation of tissues and recently this potential has been explored for image-guided drug delivery. In this presentation, the advances in ultrasound phased array technology for energy delivery, exposure monitoring and control will be discussed. Experimental results from novel multi-frequency transmit/receive arrays will be presented. In addition, the feasibility of fully electronically focused and steered high power arrays with many thousands of transducer elements will be discussed. Finally, some of the recent clinical and preclinical results for the treatment of brain disease will be reviewed. Learning Objectives:more » Introduce FUS therapy principles and modern techniques Discuss use of FUS for drug delivery Cover the technology required to deliver FUS and monitor therapy Present clinical examples of the uses of these techniques This research was supported by funding from The Canada Research Chair Program, Grants from CIHR and NIH (no. EB003268).; K. Hynynen, Canada Foundation for Innovation; Canadian Institutes of Health Research; Focused Ultrasound Surgery Foundation; Canada Research Chair Program; Natural Sciences and Engineering Research Council of Canada; Ontario Research Fund; National Institutes of Health; Canadian Cancer Society Research Institute; The Weston Brain Institute; Harmonic Medical; Focused Ultrasound Instruments.« less

  11. Battery drain in daily practice and medium-term projections on longevity of cardioverter-defibrillators: an analysis from a remote monitoring database.

    PubMed

    Boriani, Giuseppe; Ritter, Philippe; Biffi, Mauro; Ziacchi, Matteo; Diemberger, Igor; Martignani, Cristian; Valzania, Cinzia; Valsecchi, Sergio; Padeletti, Luigi; Gadler, Fredrik

    2016-09-01

    The longevity of generators is a crucial determinant of the cost-effectiveness of therapy with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D). We evaluated the trend of device-measured residual battery capacity and longevity projections over 5-year follow-up. We also investigated possible factors associated with battery drain. Data from 4851 patients in the European LATITUDE(®) database who were followed up for a minimum of 3 years were analysed. The factors associated with battery drain (i.e. year-to-year decrease in residual battery capacity), and thus potentially impacting on device longevity, were mainly the pacing parameters in CRT-D devices and the number of shocks delivered and diverted in both ICD and CRT-D (all P < 0.01 on linear regression analysis). Over the first 5 years, the longevity estimates provided by devices showed low intra-patient variability and increased with time. The estimates exceeded 10 years for CRT-D and 13 and 12 years for single- and dual-chamber ICDs, respectively. In CRT-D patients, the expected patient age on replacement was 80 ± 12 years, and the expected probability of undergoing device replacement was 63 ± 13% for New York Heart Association (NYHA) II patients and 37 ± 16% for NYHA III patients. For comparison, the probabilities of replacing a CRT-D lasting 5 years were 78 ± 8 and 59 ± 13%, respectively (both P < 0.001). Battery drain was mainly associated with pacing output in CRT-D devices and with the number of capacitor charges in both ICD and CRT-D devices. The longevity estimates provided by the devices were consistent and conservative. According to these estimates, among CRT-D recipients a low proportion of patients should require device replacement. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  12. Battery drain in daily practice and medium-term projections on longevity of cardioverter-defibrillators: an analysis from a remote monitoring database

    PubMed Central

    Boriani, Giuseppe; Ritter, Philippe; Biffi, Mauro; Ziacchi, Matteo; Diemberger, Igor; Martignani, Cristian; Valzania, Cinzia; Valsecchi, Sergio; Padeletti, Luigi; Gadler, Fredrik

    2016-01-01

    Aims The longevity of generators is a crucial determinant of the cost-effectiveness of therapy with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D). We evaluated the trend of device-measured residual battery capacity and longevity projections over 5-year follow-up. We also investigated possible factors associated with battery drain. Methods and results Data from 4851 patients in the European LATITUDE® database who were followed up for a minimum of 3 years were analysed. The factors associated with battery drain (i.e. year-to-year decrease in residual battery capacity), and thus potentially impacting on device longevity, were mainly the pacing parameters in CRT-D devices and the number of shocks delivered and diverted in both ICD and CRT-D (all P < 0.01 on linear regression analysis). Over the first 5 years, the longevity estimates provided by devices showed low intra-patient variability and increased with time. The estimates exceeded 10 years for CRT-D and 13 and 12 years for single- and dual-chamber ICDs, respectively. In CRT-D patients, the expected patient age on replacement was 80 ± 12 years, and the expected probability of undergoing device replacement was 63 ± 13% for New York Heart Association (NYHA) II patients and 37 ± 16% for NYHA III patients. For comparison, the probabilities of replacing a CRT-D lasting 5 years were 78 ± 8 and 59 ± 13%, respectively (both P < 0.001). Conclusion Battery drain was mainly associated with pacing output in CRT-D devices and with the number of capacitor charges in both ICD and CRT-D devices. The longevity estimates provided by the devices were consistent and conservative. According to these estimates, among CRT-D recipients a low proportion of patients should require device replacement. PMID:26847076

  13. [Technical advancement improves survival in patients with locally advanced non-small cell lung cancer (LA-NSCLC) receiving definitive radiotherapy].

    PubMed

    Wang, J B; Jiang, W; Ji, Z; Cao, J Z; Liu, L P; Men, Y; Xu, C; Wang, X Z; Hui, Z G; Liang, J; Lyu, J M; Zhou, Z M; Xiao, Z F; Feng, Q F; Chen, D F; Zhang, H X; Yin, W B; Wang, L H

    2016-08-01

    This study aimed to evaluate the impact of technical advancement of radiation therapy in patients with LA-NSCLC receiving definitive radiotherapy (RT). Patients treated with definitive RT (≥50 Gy) between 2000 and 2010 were retrospectively reviewed. Overall survival (OS), cancer specific survival (CSS), locoregional progression-free survival (LRPFS), distant metastasis-free survival (DMFS) and progression-free survival (PFS) were calculated and compared among patients irradiated with different techniques. Radiation-induced lung injury (RILI) and esophageal injury (RIEI) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0 (NCI-CTCAE 3.0). A total of 946 patients were eligible for analysis, including 288 treated with two-dimensional radiotherapy (2D-RT), 209 with three-dimensional conformal radiation therapy (3D-CRT) and 449 with intensity-modulated radiation therapy (IMRT) respectively. The median follow-up time for the whole population was 84.1 months. The median OS of 2D-RT, 3D-CRT and IMRT groups were 15.8, 19.7 and 23.3 months, respectively, with the corresponding 5-year survival rate of 8.7%, 13.0% and 18.8%, respectively (P<0.001). The univariate analysis demonstrated significantly inferior OS, LRPFS, DMFS and PFS of 2D-RT than those provided by 3D-CRT or IMRT. The univariate analysis also revealed that the IMRT group had significantly loger LRPFS and a trend toward better OS and DMFS compared with 3D-CRT. Multivariate analysis showed that TNM stage, RT technique and KPS were independent factors correlated with all survival indexes. Compared with 2D-RT, the utilization of IMRT was associated with significantly improved OS, LRPFS, DMFS as well as PFS. Compared with 3D-CRT, IMRT provided superior DMFS (P=0.035), a trend approaching significance with regard to LRPFS (P=0.073) but no statistically significant improvement on OS, CSS and PFS in multivariate analysis. The incidence rates of RILI were

  14. Variation in post-traumatic response: the role of trauma type in predicting ICD-11 PTSD and CPTSD symptoms.

    PubMed

    Hyland, Philip; Murphy, Jamie; Shevlin, Mark; Vallières, Frédérique; McElroy, Eoin; Elklit, Ask; Christoffersen, Mogens; Cloitre, Marylène

    2017-06-01

    The World Health Organization's 11th revision to the International Classification of Diseases manual (ICD-11) will differentiate between two stress-related disorders: PTSD and Complex PTSD (CPTSD). ICD-11 proposals suggest that trauma exposure which is prolonged and/or repeated, or consists of multiple forms, that also occurs under circumstances where escape from the trauma is difficult or impossible (e.g., childhood abuse) will confer greater risk for CPTSD as compared to PTSD. The primary objective of the current study was to provide an empirical assessment of this proposal. A stratified, random probability sample of a Danish birth cohort (aged 24) was interviewed by the Danish National Centre for Social Research (N = 2980) in 2008-2009. Data from this interview were used to generate an ICD-11 symptom-based classification of PTSD and CPTSD. The majority of the sample (87.1%) experienced at least one of eight traumatic events spanning childhood and early adulthood. There was some indication that being female increased the risk for both PTSD and CPTSD classification. Multinomial logistic regression results found that childhood sexual abuse (OR = 4.98) and unemployment status (OR = 4.20) significantly increased risk of CPTSD classification as compared to PTSD. A dose-response relationship was observed between exposure to multiple forms of childhood interpersonal trauma and risk of CPTSD classification, as compared to PTSD. Results provide empirical support for the ICD-11 proposals that childhood interpersonal traumatic exposure increases risk of CPTSD symptom development.

  15. Operational Assessment of ICDS Scheme at Grass Root Level in a Rural Area of Eastern India: Time to Introspect

    PubMed Central

    Sahoo, Jyotiranjan; Mahajan, Preetam B; Bhatia, Vikas; Patra, Abhinash K; Hembram, Dilip Kumar

    2016-01-01

    Introduction Integrated Child Development Service (ICDS), a flagship program of Government of India (GoI) for early childhood development hasn’t delivered the desired results since its inception four decades ago. This could be due to infrastructural problems, lack of awareness and proper utilization by the local people, inadequate program monitoring and corruption in food supplies, etc. This study is an audit of 36 Anganwadi centres at Khordha district, Odisha, to evaluate the implementation of the ICDS. Aim To assess operational aspects of ICDS program in a rural area of Odisha, in Eastern India. Materials and Methods A total of 36 out of 50 Anganwadi Centres (AWCs) were included in the study. We interviewed the Anganwadi Workers (AWW) and carried out observations on the AWCs using a checklist. We gathered information under three domains manpower resource, material resource and functional aspects of the AWC. Results Most of the AWCs were adequately staffed. Most of the AWWs were well educated. However, more than 85% of the AWCs did not have designated building for daily functioning which resulted in issues related to implementation of program. Water, toilet and electricity facilities were almost non-existent. Indoor air pollution posed a serious threat to the health of the children. Lack of play materials; lack of health assessment tools for promoting, monitoring physical and mental development; and multiple de-motivating factors within the work environment, eventually translated into lack of faith among the beneficiaries in the rural community. Conclusion Inadequate infrastructure and logistic supply were the most prominent issues found, which resulted in poor implementation of ICDS program. Strengthening of grass root level facilities based on need assessment, effective monitoring and supervision will definitely help in revamping the ICDS program in rural areas. PMID:28208890

  16. Single-coil and dual-coil defibrillator leads and association with clinical outcomes in a complete Danish nationwide ICD cohort.

    PubMed

    Larsen, Jacob M; Hjortshøj, Søren P; Nielsen, Jens C; Johansen, Jens B; Petersen, Helen H; Haarbo, Jens; Johansen, Martin B; Thøgersen, Anna Margrethe

    2016-03-01

    The best choice of defibrillator lead in patients with routine implantable cardioverter-defibrillator (ICD) is not settled. Traditionally, most physicians prefer dual-coil leads but the use of single-coil leads is increasing. The purpose of this study was to compare clinical outcomes in patients with single- and dual-coil leads. All 4769 Danish patients 18 years or older with first-time ICD implants from 2007 to 2011 were included from the Danish Pacemaker and ICD Register. Defibrillator leads were 38.9% single-coil leads and 61.1% dual-coil leads. The primary end point was all-cause mortality. Secondary end points were lowest successful energy at implant defibrillation testing, first shock failure in spontaneous arrhythmias, structural lead failure, and lead extraction outcomes. Single-coil leads were associated with lower all-cause mortality with an adjusted hazard ratio of 0.85 (95% confidence interval 0.73-0.99; P = .04). This finding was robust in a supplementary propensity score-matched analysis. However, dual-coil leads were used in patients with slightly higher preimplant morbidity, making residual confounding by indication the most likely explanation for the observed association between lead type and mortality. The lowest successful defibrillation energy was higher using single-coil leads (23.2 ± 4.3 J vs 22.1 ± 3.9 J; P < .001). No significant differences were observed for other secondary end points showing high shock efficacies and low rates of lead failures and extraction complications. Shock efficacy is high for modern ICD systems. The choice between single-coil and dual-coil defibrillator leads is unlikely to have a clinically significant impact on patient outcomes in routine ICD implants. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  17. Endoscopic therapy for early gastric cancer: Standard techniques and recent advances in ESD

    PubMed Central

    Kume, Keiichiro

    2014-01-01

    The technique of endoscopic submucosal dissection (ESD) is now a well-known endoscopic therapy for early gastric cancer. ESD was introduced to resect large specimens of early gastric cancer in a single piece. ESD can provide precision of histologic diagnosis and can also reduce the recurrence rate. However, the drawback of ESD is its technical difficulty, and, consequently, it is associated with a high rate of complications, the need for advanced endoscopic techniques, and a lengthy procedure time. Various advances in the devices and techniques used for ESD have contributed to overcoming these drawbacks. PMID:24914364

  18. Latest advances in the manufacturing of 3D rechargeable lithium microbatteries

    NASA Astrophysics Data System (ADS)

    Ferrari, Stefania; Loveridge, Melanie; Beattie, Shane D.; Jahn, Marcus; Dashwood, Richard J.; Bhagat, Rohit

    2015-07-01

    Recent advances in micro- and nano-electromechanical systems (MEMS/NEMS) technology have led to a niche industry of diverse small-scale devices that include microsensors, micromachines and drug-delivery systems. For these devices, there is an urgent need to develop Micro Lithium Ion Batteries (MLIBs) with dimensions on the scale 1-10 mm3 enabling on-board power delivery. Unfortunately, power limitations are inherent in planar 2D cells and only the advent of 3D designs and microarchitectures will lead to a real breakthrough in the microbattery technology. During the last few years, many efforts to optimise MLIBs were discussed in literature, both in the planar and 3D configurations. This review highlights the importance of 3D microarchitectured electrodes to fabricate batteries that can be device-integrated with exceptionally high specific power density coupled with exquisite miniaturisation. A wide literature overview is provided and recent advances in manufacturing routes to 3D-MLIBs comprising materials synthesis, device formulation, device testing are herein discussed. The advent of simple, economic and easily scalable fabrication processes such as 3D printing will have a decisive role in the growing field of micropower sources and microdevices.

  19. A Fusogenic Oncolytic Herpes Simplex Virus for Therapy of Advanced Ovarian Cancer

    DTIC Science & Technology

    2006-06-01

    killer and NKT cells play a critical role in innate protection against genital herpes simplex virus type 2 infection. J Virol 2003;77:10168-71. 8...AD_________________ Award Number: DAMD17-03-1-0434 TITLE: A Fusogenic Oncolytic Herpes Simplex...CONTRACT NUMBER A Fusogenic Oncolytic Herpes Simplex Virus for Therapy of Advanced Ovarian Cancer 5b. GRANT NUMBER DAMD17-03-1-0434 5c

  20. The impact of ICD-9 revascularization procedure codes on estimates of racial disparities in ischemic stroke.

    PubMed

    Boan, Andrea D; Voeks, Jenifer H; Feng, Wuwei Wayne; Bachman, David L; Jauch, Edward C; Adams, Robert J; Ovbiagele, Bruce; Lackland, Daniel T

    2014-01-01

    The use of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9) diagnostic codes can identify racial disparities in ischemic stroke hospitalizations; however, inclusion of revascularization procedure codes as acute stroke events may affect the magnitude of the risk difference. This study assesses the impact of excluding revascularization procedure codes in the ICD-9 definition of ischemic stroke, compared with the traditional inclusive definition, on racial disparity estimates for stroke incidence and recurrence. Patients discharged with a diagnosis of ischemic stroke (ICD-9 codes 433.00-434.91 and 436) were identified from a statewide inpatient discharge database from 2010 to 2012. Race-age specific disparity estimates of stroke incidence and recurrence and 1-year cumulative recurrent stroke rates were compared between the routinely used traditional classification and a modified classification of stroke that excluded primary ICD-9 cerebral revascularization procedures codes (38.12, 00.61, and 00.63). The traditional classification identified 7878 stroke hospitalizations, whereas the modified classification resulted in 18% fewer hospitalizations (n = 6444). The age-specific black to white rate ratios were significantly higher in the modified than in the traditional classification for stroke incidence (rate ratio, 1.50; 95% confidence interval [CI], 1.43-1.58 vs. rate ratio, 1.24; 95% CI, 1.18-1.30, respectively). In whites, the 1-year cumulative recurrence rate was significantly reduced by 46% (45-64 years) and 49% (≥ 65 years) in the modified classification, largely explained by a higher rate of cerebral revascularization procedures among whites. There were nonsignificant reductions of 14% (45-64 years) and 19% (≥ 65 years) among blacks. Including cerebral revascularization procedure codes overestimates hospitalization rates for ischemic stroke and significantly underestimates the racial disparity estimates in stroke