Remote management of heart failure using implantable electronic devices The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design. The effect of mere measurement from a cardiovascular examination program on physical activity and sedentary time in an adult population Gender differences in response to a physical activity intervention in overweight and obese children. Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up: The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) Trial Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial. Defibrillator shocks and their effect on objective and subjective patient outcomes: Results of the PainFree SST clinical trial. The Impact of Web-Based Feedback on Physical Activity and Cardiovascular Health of Nurses Working in a Cardiovascular Setting: A Randomized Trial An evaluation of a distributed medical device safety surveillance system: the DELTA network study. Heart Failure 2012 The impact of a point-of-care testing device on CVD risk assessment completion in New Zealand primary-care practice: A cluster randomised controlled trial and qualitative investigation Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort The IMPACT study. Exercise in obese pregnant women: positive impacts and current perceptions Longitudinal change in quality of life and impact on survival after left ventricular assist device implantation. Feasibility and Effectiveness of a Wearable Technology-Based Physical Activity Intervention in Preschoolers: A Pilot Study Randomized controlled trial on cardiovascular risk management by practice nurses supported by self-monitoring in primary care Biofeedback for treatment of awake and sleep bruxism in adults: systematic review protocol The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. Routine chest radiographs in pediatric intensive care units. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers. Correspondence between laboratory and ambulatory measures of cardiovascular reactivity: a multilevel modeling approach. Investigating children's physical activity and sedentary behavior using ecological momentary assessment with mobile phones. SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes [SMART-REHAB Trial]: a randomized controlled trial protocol
Abstract Aims Remote management of heart failure using implantable electronic devices ( REM-HF ) aim ed to assess the clinical and cost-effectiveness of remote monitoring ( RM ) of heart failure in patients with cardiac implanted electronic devices ( CIEDs ) . Methods and results Between 29 September 2011 and 31 March 2014 , we r and omly assigned 1650 patients with heart failure and a CIED to active RM or usual care ( UC ) . The active RM pathway included formalized remote follow-up protocol s , and UC was st and ard practice in nine recruiting centres in Engl and . The primary endpoint in the time to event analysis was the 1st event of death from any cause or unplanned hospitalization for cardiovascular reasons . Secondary endpoints included death from any cause , death from cardiovascular reasons , death from cardiovascular reasons and unplanned cardiovascular hospitalization , unplanned cardiovascular hospitalization , and unplanned hospitalization . REM-HF is registered with IS RCT N ( 96536028 ) . The mean age of the population was 70 years ( range 23–98 ) ; 86 % were male . Patients were followed for a median of 2.8 years ( range 0–4.3 years ) completing on 31 January 2016 . Patient adherence was high with a drop out of 4.3 % over the course of the study . The incidence of the primary endpoint did not differ significantly between active RM and UC groups , which occurred in 42.4 and 40.8 % of patients , respectively [ hazard ratio 1.01 ; 95 % confidence interval ( CI ) 0.87–1.18 ; P = 0.87 ] . There were no significant differences between the two groups with respect to any of the secondary endpoints or the time to the primary endpoint components . Conclusion Among patients with heart failure and a CIED , RM using weekly downloads and a formalized follow up approach does not improve outcomes BACKGROUND With the advent of remote monitoring , current models of implantable cardioverter defibrillators ( ICDs ) have the possibility of sending automatic alert messages that allow early diagnosis of events such as lung fluid overload , atrial fibrillation and device integrity issues . Timely treatment of these events has the potential to improve patient outcome , but this has not as yet been proven . METHODS The MORE-CARE study is a multicenter r and omized controlled trial evaluating the efficacy of advanced device diagnostics and remote monitoring in improving the outcome of patients with biventricular ICDs . Up to 1720 patients with a st and ard indication for a biventricular ICD will be r and omized to st and ard in-office follow-up , or to a remote monitoring strategy using the CareLink network and involving automatic alerts for lung fluid overload , atrial fibrillation , and device integrity issues . The first phase aims at evaluating the delay between an alert event , and clinical action to the event . The second phase of the study will evaluate whether the remote monitoring strategy results in a significant reduction of a combined end point of total mortality or cardiovascular and device-related hospitalization . The duration of the study will be event-driven due to its sequential design . CONCLUSION MORE-CARE will evaluate the efficacy of remote monitoring for improving patient outcome in patients implanted with a biventricular ICD Background Measuring physical activity ( PA ) and sedentary time ( ST ) by self-report or device as well as assessing related health factors may alter those behaviors . Thus , in intervention trials assessment s may bias intervention effects . The aim of our study was to examine whether leisure-time PA , transport-related PA , and overall ST measured via self-report vary after assessment s and whether a brief tailored letter intervention has an additional effect . Methods Among a sample of subjects with no history of myocardial infa rct ion , stroke , or vascular intervention , a number of 175 individuals participated in a study comprising multiple repeated assessment s. Of those , 153 were analyzed ( mean age 54.5 years , st and ard deviation = 6.2 ; 64 % women ) . At baseline , participants attended a cardiovascular examination ( st and ardized measurement of blood pressure and waist circumference , blood sample taking ) and wore an accelerometer for seven days . At baseline and after 1 , 6 , and 12 months , participants completed the International Physical Activity Question naire . A r and om sub sample received a tailored counseling letter intervention at month 1 , 3 , and 4 . Changes in PA and ST from baseline to 12-month follow-up were analyzed using r and om-effects modelling . Results From baseline to 1-month assessment , leisure-time PA did not change ( Incidence rate ratio = 1.13 , p = .432 ) , transport-related PA increased ( Incidence rate ratio = 1.45 , p = .023 ) , and overall ST tended to decrease ( b = − 1.96 , p = .060 ) . Further , overall ST decreased from month 6 to month 12 ( b = − 0.52 , p = .037 ) . Time trends of the intervention group did not differ significantly from those of the assessment -only group . Conclusions Results suggest an effect of measurements on PA and ST . Data of r and om-effects modelling results revealed an increase of transport-related PA after baseline to 1-month assessment . Decreases in overall ST may result from repeated assessment s. A brief tailored letter intervention seemed to have no additional effect . Thus , measurement effects should be considered when planning intervention studies and interpreting intervention effects . Trial registration Clinical Trials.gov NCT02990039 . Registered 7 December 2016 . Retrospectively registered BACKGROUND This study evaluated the effects of gender on response to a behavioral intervention that rewarded increases in  physical activity ( PA ) with increases in access to TV viewing . METHODS We performed a secondary analysis of a clinical trial that r and omized 30 overweight or obese , 8- to 12-year-old children to an intervention ( 8 boys , 6 girls ) or control ( 7 boys , 9 girls ) group . Participants wore accelerometers every day for 8 weeks and attended biweekly meetings to download the activity monitors . For the intervention group , accumulating 400 counts of PA on accelerometers earned 1 hour of TV time , which was controlled by a Token TV electronic device . Controls wore activity monitors but had free access to TV . RESULTS Compared with girls , boys in the intervention group exhibited greater increases in overall daily PA counts ( 110 % versus 40 % , P < .05 ) and minutes per day of moderate-to-vigorous physical activity ( MVPA ; + 18.1 versus + 2.7 , P < .05 ) . Neither boys nor girls in the control group showed significant changes in overall PA or intensity of PA . CONCLUSION Wearing an accelerometer in combination with rewarding PA with TV might be a more effective intervention for increasing overall PA and time spent in MVPA in overweight and obese boys than it is for overweight or obese girls Background — Monitoring implantable cardiac device function and patient condition is important . The Lumos-T Safely Reduces Routine Office Device Follow-Up ( TRUST ) trial tested the hypothesis that remote home monitoring with automatic daily surveillance ( HM ) is safe and effective for implantable cardioverter-defibrillator follow-up for 1 year and enables rapid physician evaluation of significant events . Methods and Results — In total , 1339 patients were r and omized 2:1 to HM or conventional follow-up . Follow-up checks occurred at 3 , 6 , 9 , 12 , and 15 months after implantation . HM was used before office visits at 3 and 15 months in the HM group . At 6 , 9 , and 12 months , HM only was used but was followed by office visits if necessary . Conventional patients were evaluated with office visits only . Scheduled office visits and unscheduled evaluations , incidence of morbidity , and time elapsed from first event occurrence in each patient to physician evaluation were tracked for each group .  HM and conventional patients were similar ( age , 63.3±12.8 versus 64.0±12.1 years ; gender , 72.0 % versus 73.1 % male ; New York Heart Association class II , 55.9 % versus 60.4 % ; pathology : left ventricular ejection fraction , 29.0±10.7 % versus 28.5±9.8 % ; coronary artery disease , 64.8 % versus 71.7 % ; primary prevention indication , 72.2 % versus 73.8 % ; and dual-chamber implants , 57.8 % versus 56.6 % ) . HM  reduced total in-hospital device evaluations by 45 % without affecting morbidity . In the HM group , 85.8 % of all 6- , 9- , and 12-month follow-ups were performed remotely only , indicating that HM provided sufficient assessment in the majority . Median time to evaluation was < 2 days in the HM group compared with 36 days in the conventional group ( P<0.001 ) for all arrhythmic events . Conclusions — HM is safe and allows more rapid detection of actionable events compared with conventional monitoring in patients with implantable electronic cardiac devices . Clinical Trials Registration — URL : http:/www . clinical trials.gov . Unique identifier : NCT00336284 INTRODUCTION Remote monitoring is increasingly becoming the new st and ard of care for implantable cardioverter defibrillator ( ICD ) follow-up . We sought to determine whether remote monitoring of ICDs improves patient outcomes compared with quarterly device interrogations in clinic . METHODS AND RESULTS In this single-center pilot clinical trial , adult patients with an ICD were r and omly assigned to remote monitoring versus quarterly device interrogations in clinic . The primary endpoint was a composite of cardiovascular hospitalization , emergency room visit for a cardiac cause , and unscheduled visit to the electrophysiology clinic for a device-related issue at 1 year . We also examined health-related quality of life , costs , and patient satisfaction with their ICD care . Of 151 patients enrolled in this trial , 76 were r and omized to remote monitoring and 75 to quarterly device  interrogations in clinic . There was no significant difference in the primary endpoint ( 32 % in the remote monitoring arm vs 34 % in the control arm ; P = 0.8 ) , mortality , or cost between the 2 arms . Quality of life and patient satisfaction were significantly better in the control arm than in the remote monitoring arm at 6 months ( 83 [ 25th , 75th percentiles 70 , 90 ] vs 75 [ 50 , 85 ] ; P = 0.002 and 88 [ 75 , 100 ] vs 75 [ 75 , 88 ] ; P = 0.03 , respectively ) , but not at 12 months . CONCLUSION We showed no significant reduction in cardiac-related re source utilization with remote monitoring of ICDs . However , given the small number of patients in our study , the real clinical and health economics impact of remote monitoring needs to be verified by a large , multicenter , r and omized clinical trial BACKGROUND The effect of  implantable cardioverter-defibrillator ( ICD ) shock  on device-measured activity and patient-reported outcomes is unknown . OBJECTIVE The purpose of this study was to analyze the acute and long-term effects of ICD shock on objective behavioral data ( ie , device-based physical activity ) and subjective patient-reported outcomes ( eg , quality of life and shock anxiety ) . METHODS The PainFree Smart Shock Technology ( SST ) clinical trial included 2770 patients with a single- or dual-chamber ICD or cardiac resynchronization therapy - defibrillator device who were followed for 22 ± 9 months . Participants completed measures of quality of life ( EuroQol-5D [ EQ-5D ] question naire ) and shock anxiety ( Florida Shock Anxiety Scale ) at baseline , biannual visits , and monthly for 6 months after an ICD shock . Daily physical activity data were obtained from a built-in device accelerometer . RESULTS The average daily activity was 185.3 ± 119.4 min/d . Activity was significantly reduced after an ICD shock ( P < .0001 ) and recovered to a normal level after ∼90 days . An ICD shock was also associated with decreased quality of life ( EQ5-D health score ) and increased EQ-5D anxiety scores , but it did not affect mobility , self-care , activity , or pain . Similarly , shock anxiety ( Florida Shock Anxiety Scale ) increased in shocked patients and remained significantly elevated at 24 months , regardless of appropriate or inappropriate shock delivery . CONCLUSION ICD shocks have a long-lasting adverse effect on both objective , device-measured physical activity and subjective patient-reported outcomes of quality of life and shock anxiety . Successful management of patients with an ICD requires attention to clinical ly relevant behavioral and psychological outcomes to expedite recovery and return to activities of daily living A disconcerting proportion of Canadian nurses are physically inactive and report poor cardiovascular health . Web-based interventions incorporating feedback and group features may represent opportune , convenient , and cost-effective methods for encouraging physical activity ( PA ) in order to improve the levels of PA and cardiovascular health of nurses . The purpose of this parallel-group r and omized trial was to examine the impact of an intervention providing participants with feedback from an activity monitor coupled with a web-based individual , friend or team PA challenge , on the PA and cardiovascular health of nurses working in a cardiovascular setting . Methods : Nurses were r and omly assigned in a 1:1:1 ratio to one of the following intervention “ challenge ” groups : ( 1 ) individual , ( 2 ) friend or ( 3 ) team . Nurses wore a Tractivity ® activity monitor throughout a baseline week and 6-week intervention . Height , body mass , body fat percentage , waist circumference , resting blood pressure ( BP ) and heart rate were assessed , and body mass index ( BMI ) was calculated , during baseline and within 1 week post-intervention . Data were analyzed using descriptive statistics and general linear model procedures for repeated measures . Results : 76 nurses ( 97 % female ; age : 46 ± 11 years ) participated . Weekly moderate-to-vigorous intensity PA ( MVPA ) changed over time ( F = 4.022 , df = 4.827 , p = 0.002 , η2 = 0.055 ) , and was greater during intervention week 2 when compared to intervention week 6 ( p = 0.011 ) . Daily steps changed over time ( F = 7.668 , df = 3.910 , p < 0.001 , η2 = 0.100 ) , and were greater during baseline and intervention weeks 1 , 2 , 3 , and 5 when compared to intervention week 6 ( p < 0.05 ) . No differences in weekly MVPA or daily steps were observed between groups ( p > 0.05 ) . No changes in body mass , BMI or waist circumference were observed within or between groups ( p > 0.05 ) . Decreases in body fat percentage ( −0.8 ± 4.8 % , p = 0.015 ) and resting systolic BP ( −2.6 ± 8.8 mmHg , p = 0.019 ) were observed within groups , but not between groups ( p > 0.05 ) . Conclusions : A web-based intervention providing feedback and a PA challenge initially impacted the PA , body fat percentage and resting systolic BP of nurses working in a cardiovascular setting , though increases in PA were short-lived . The nature of the PA challenge did not differentially impact outcomes . Alternative innovative strategies to improve and sustain  nurses ' PA  should be developed and their effectiveness evaluated BACKGROUND Post-market medical product safety surveillance is a complex task requiring st and ardized data collection , prompt adverse event reporting mechanisms and appropriate method ologies to identify low frequency safety threats and risk communication . PURPOSE To review the design of the DELTA ( Data Extraction and Longitudinal Trend Analysis ) network study of the medical device safety surveillance . METHODS This is a multicenter prospect i ve observational study design ed to evaluate the  safety  of new cardiovascular devices used during percutaneous coronary intervention ( PCI ) performed through continuous analysis of the routinely collected American College of Cardiology-National Cardiovascular Data Registry ( ACC-NCDR ) data elements . The primary endpoint of the study is detection of adverse event rates specific to several classes of new medical devices , including drug eluting coronary stents , embolic protection devices , and vascular closure devices in patients undergoing PCI . Secondary endpoints include the time-savings between the DELTA network detection of a true device safety alert and the time taken to detect the same outcome using conventional retrospective data analysis , overall sensitivity , specificity , positive predictive value and negative predictive value of the DELTA network surveillance system . RESULTS The details of the study are described including system design , eligibility criteria , methods and components of data collection , data security and statistical methods . In addition , the methods of adjudication and verification following an adverse event alert , overall study outcomes , end points , limitations and potential advantages are discussed . CONCLUSION This report describes the first multicenter prospect i ve study of a computerized safety surveillance system to monitor and evaluate the safety of new cardiovascular devices Heart failure has been named “ the growing epidemic . ” Over the last decade , the annual number of heart failure hospitalizations has almost doubled with approximately 50 % of patients being rehospitalized within 6 months of discharge [ 1 ] . The complex array of physiologic , psychological , social , and health care delivery issues makes it a challenging chronic disease to manage . Underst and ing the epidemiology and pathophysiology of the syndrome , identifying the predictors and their strength of association with outcomes , and using the available diagnostic modalities cost-effectively are essential in order to devise effective prevention interventions and implement novel therapeutic approaches to curb this epidemic . In this special issue , we have invited a few papers that address such issues and explain why despite the emergence of novel therapeutic approaches , that promise life prolongation and hospital length reduction , this patient population will still be needing rehospitalization and will often have a poor prognosis . This special issue is the extension of an effort that was initiated in 2011 with the first heart-failure-focused issue [ 2 ] . In the pathophysiology section , S. M. R. Kazemi-Bajestani et al. describe the opportunities and challenges of targeting the angiotensin converting enzyme 2 (ACE2)/Ang II/Ang1–7 and apelin/APJ pathways as novel therapeutic modalities in heart failure [ 3 ] . ACE2 and the apelin/APJ are two important peptide systems which exert diverse effects on the cardiovascular system . Dysregulation of such systems may be involved in the predisposition to cardiovascular diseases whereas enhancing their action may have important therapeutic effects . In the same section , D. Lindner et al. provide a comprehensive review on the protective function of signal transducer and activator of transcription 3 ( STAT3 ) in CVB3-induced myocarditis [ 4 ] . The transcription factor ( STAT3 ) is an important mediator of the inflammatory process , and in this original research the investigators examine the role of STAT3 in viral myocarditis and its possible role in the development to dilated cardiomyopathy . Considering the high mortality rate and the availability of life-saving therapies like transplantation and left ventricular assist devices , accurate prognosis determination in HF is clinical ly important . Taking into account the mediocre performance of current established prediction models , such as the Seattle Heart Failure Model [ 5–7 ] , the work by H. Fukuta et al. [ 8 ] on the prognostic value of left ventricular diastolic dysfunction in patients undergoing cardiac catheterization for coronary artery disease sheds light on this extremely important topic . A shared underst and ing of medical conditions between patients and their health care providers has been shown to improve self-care and outcomes [ 9 ] . In the comorbidity section , we demonstrate how certain comorbid conditions may affect patients ' decision-making capacity and interfere with their ability to comply with treatment requirements , recognize and self-manage disease worsening symptoms . Among others , cognitive impairment is increasingly recognized as a common adverse consequence of HF , whereby phenomena such as microembolism , chronic or intermittent cerebral hypoperfusion , and /or impaired cerebral vessel reactivity may lead to cerebral hypoxia and ischemic brain damage . Cognitive decline in HF is characterized by deficits in one or more cognition domains , including attention , memory , executive function , and psychomotor speed . E. Dardiotis et al. [ 10 ] , in a comprehensive review , underscore the importance for healthcare professionals to become familiar with assessment of cognitive performance using st and ardized screening instruments in their routine evaluations of HF patients . Another comorbidity gaining increasing attention in HF patients is depression . There are several pathophysiological mechanisms as well as behavioral processes linking depression and HF . Equally important is screening for depression and there are several valid and reliable screening tools to identify patients at greater risk . Consultation should be provided by a multidisciplinary team , consisting of cardiologists , psychiatrists , and hospital or community nurses so as to carefully plan , execute , and evaluate medical intervention and implement lifestyle changes . D. Mastrogiannis et al. [ 11 ] systematic ally review the existing knowledge regarding current definitions , prognostic implication s , pathophysiological mechanisms , and current and future treatment options in patients with depression and HF . Evidence from the literature supports the possibility of a pathophysiological relationship between cognitive impairment , depression , and HF . Yet , very few studies have sought to investigate this relationship . The paper by Z. N. Sohani and Z. Samaan review s current literature on the association between depression and cognitive impairment  in persons with HF and explores possible mechanisms explaining this complex triad [ 12 ] . Heart failure through neurohumoral activation induces alterations of cardiac metabolism , such as insulin resistance , and promotes increased utilization of noncarbohydrate substrates for energy production [ 13 , 14 ] . Fasting blood ketone bodies as well as fat oxidation have been shown to be increased in this patient population . The result is depletion of myocardial ATP , phosphocreatine , and creatine kinase , leading to decreased efficiency of mechanical work . A direct approach to manipulate cardiac energy metabolism consists in modifying substrate utilization by the failing heart . Trimetazidine , perhexiline , and ranolazine directly inhibit fatty acid oxidation and have been used to increase the ischemic threshold in patients with effort angina . Current research is supporting the concept that shifting the energy substrate preference away from fatty acid metabolism and toward glucose metabolism could be an effective adjunctive treatment in patients with HF . These agents have been shown to improve both glucose metabolism and left ventricular function in diabetic patients with left ventricular dysfunction . In the pharmacotherapy section , we provide a systematic review , in which N. Signoretta et al. [ 15 ] discuss the beneficial therapeutic effects of modulation of cardiac metabolic substrates utilization in patients with HF . In the advanced heart failure section , we provide a thorough review on the current status of mechanical circulatory support in patients with advanced HF . Management of the advanced HF patients with the numerous comorbidities [ 16 , 17 ] requires a significant amount of health care re sources and is becoming a major public health problem . As therapeutical strategies for HF have been refined , the number of patients suffering from the end-stage disease has exp and ed dramatically . Although heart transplantation still represents the gold st and ard therapeutical approach , the shortage of donors universally has made the implantation of mechanical circulatory support devices a well-established management for this disease . The systematic review by K. Spiliopoulos et al. [ 18 ] , outlines the current status of mechanical circulatory support in this patient population . In the chronic follow-up section , we deal with telemonitoring , a novel diagnostic modality that has been suggested to be beneficial for HF patients , targeting optimization of their chronic followup . Telemonitoring is viewed as a means of recording physiological data ( such as body weight , heart rate , arterial blood pressure electrocardiogram recordings , and other data ) by portable devices and transmitting these data remotely ( via a telephone line , a mobile phone , or a computer ) to a server where they can be stored , review ed , and analyzed by the research team . In a systematic review of all r and omized clinical trials evaluating telemonitoring in chronic HF , G. Giamouzis et al. [ 19 ] assess whether telemonitoring provides any substantial benefit in this patient population . We hope that the readers of the journal will find the topics as interesting and important as we did . Gregory Giamouzis George Giannakoulas Javed Butler John A. Elefteriades Carsten Tschope Filippos Objectives To assess the effect of a point of care ( POC ) device for testing lipids  and HbA1c in addition to testing by community laboratory facilities ( usual practice ) on the completion of cardiovascular disease ( CVD ) risk assessment s in general practice . Methods We conducted a pragmatic , cluster r and omised controlled trial in 20 New Zeal and general practice s stratified by size and rurality and r and omised to POC device plus usual practice or usual practice alone ( controls ) . Patients aged 35–79 years were eligible if they met national guideline criteria for CVD risk assessment . Data on CVD risk assessment s were aggregated using a web-based decision support programme common to each practice . Data entered into the on-line CVD risk assessment form could be saved pending blood test results . The primary outcome was the proportion of completed CVD risk assessment s. Qualitative data on practice processes for CVD risk assessment and feasibility of POC testing were collected at the end of the study by interviews and question naire . The POC testing was supported by a comprehensive quality assurance programme . Results A CVD risk assessment entry was recorded for 7421 patients in 10 POC practice s and 6217 patients in 10 control practice s ; 99.5 % of CVD risk assessment s had complete data in both groups ( adjusted odds ratio 1.02 [ 95%CI 0.61–1.69 ] ) . There were major external influences that affected the trial : including a national performance target for CVD risk assessment and changes to CVD guidelines . All practice s had invested in systems and dedicated staff time to identify and follow up patients to completion . However , the POC device was viewed by most as an additional tool rather than as an opportunity to review practice work flow and leverage the immediate test results for patient education and CVD risk management discussion s. Shortly after commencement , the trial was halted due to a change in the HbA1c test assay performance . The trial restarted after the manufacturing issue was rectified but this affected the end use of the device . Conclusions Performance incentives and external influences were more powerful modifiers of practice behaviours than the POC device in relation to CVD risk assessment completion . The promise of combining risk assessment , communication and management within one consultation was not realised . With shifts in policy focus , the utility of POC devices for patient engagement in CVD preventive care may be demonstrated if fully integrated into the clinical setting . Trial registration Australian New Zeal and Clinical Trials Registry Atrial fibrillation and atrial flutter are common cardiac arrhythmias associated with an increased risk of stroke in patients with additional risk factors .  Anticoagulation ameliorates stroke risk , but because these arrhythmias may occur intermittently without symptoms , initiation of prophylactic therapy is often delayed until electrocardiographic documentation is obtained . The IMPACT study is a multicenter , r and omized trial of remote surveillance technology in patients with implanted dual-chamber cardiac resynchronization therapy defibrillator ( CRT-D ) devices design ed to test the hypothesis that initiation and withdrawal of oral anticoagulant therapy guided by continuous ambulatory monitoring of the atrial electrogram improve clinical outcomes by reducing the combined rate of stroke , systemic embolism , and major bleeding compared with conventional clinical management . For those in the intervention group , early detection of atrial high-rate episodes ( AHRE ) generates an automatic alert to initiate anticoagulation based on patient-specific stroke risk stratification . Subsequently , freedom from AHRE for predefined periods prompts withdrawal of anticoagulation to avoid bleeding . Patients in the control arm are managed conventionally , the anticoagulation decision prompted by incidental detection of atrial fibrillation or atrial flutter during routine clinical follow-up . The results will help define the clinical utility of wireless remote cardiac rhythm surveillance and help establish the critical threshold of AHRE burden warranting anticoagulant therapy in patients at risk of stroke . In this report , we describe the study design and baseline demographic and clinical features of the initial cohort ( 227 patients ) Overweight and obesity have significant implication s during pregnancy and childbirth . The objective of this review was to provide a comprehensive overview of the effect of physical activity on pregnancy outcomes , the change of  physical activity during pregnancy , and women ’s perception of being physically active during pregnancy , with a particular focus on women who are overweight or obese . Many studies have investigated the beneficial effect of exercise during pregnancy , including reduced risk of gestational diabetes , preeclampsia , and operative birth , in addition to improved cardiovascular function , overall fitness , psychological well-being , and mood stability . Benefits for the infant include reduced risks of prematurity and improved fetal growth , although there is more limited information about longer-term health benefits for both women and infants . The existing literature examining physical activity patterns during pregnancy has generally focused on women of all body mass index categories , consistently indicating a reduction in activity over the course of pregnancy . However , the available literature evaluating physical activity during pregnancy among women who are overweight or obese is more limited and contradictory . A number of studies identified barriers preventing women from being active during pregnancy , including pregnancy symptoms , lack of time , access to child care , and concerns about their safety and that of their unborn baby . Conversely , significant enablers included positive psychological feelings , family influence , and receiving advice from health professionals . Very few studies have provided insights about perceptions of being active during pregnancy in the overweight and obese population . There is a need for a detailed description of physical activity patterns during pregnancy in women who are overweight or obese , and more r and omized trials evaluating exercise interventions for women who are overweight or obese , with a focus on clinical outcomes BACKGROUND The HeartMate vented electric left ventricular assist device has been approved for use as destination therapy . Thus , the study of quality -of-life outcomes , as well as morbidity and mortality , is imperative . The purpose of our study was to describe change with time ( from 1 month to 1 year ) in patients who received a HeartMate vented electric left ventricular assist device as a bridge to heart transplantation and to identify quality -of-life predictors of survival after left ventricular assist device implantation . METHODS A nonr and om sample of 78 patients who received a HeartMate vented electric left ventricular assist device ( primarily middle-aged , white married males ) who had quality -of-life data at 1 , 2 , 3 , 6 , 9 , or 12 months after implant was the subject of this report . The sample size decreased with time primarily because of heart transplantation . Patients completed the following booklets of question naires : Quality of Life Index , Rating Question Form , Heart Failure Symptom Checklist , and Sickness Impact Profile . Analyses included both descriptive analyses and modeling procedures ( mixed-effects models and Cox proportional hazards models ) . RESULTS Quality -of-life outcomes were fairly good and stable from 1 month to 1 year after HeartMate vented electric left ventricular assist device implantation . Both positive and negative changes were detected in all quality -of-life domains ( physical and occupational function , social interaction , somatic sensation , and psychological state ) after left ventricular assist device insertion . Items from the physical domain of quality of life , specifically walking and dressing oneself , were significantly associated with the risk of dying after left ventricular assist device implantation . CONCLUSIONS Identifying poor quality -of-life outcomes within 1 year after left ventricular assist device implantation provides direction to develop strategies to improve outcomes . Physical and occupational rehabilitation , psychosocial intervention , and monitoring symptom distress and physical disability may contribute to improved quality -of-life outcomes and survival after left ventricular assist device implantation The purpose of this pilot study was to evaluate the feasibility and the effectiveness of an intervention that employed a technology-based physical activity ( PA ) monitoring system and teacher-regulated strategies to promote PA  in preschoolers . A total of 93 preschoolers ( 53 % girls , 4.7 years ) from 5 child care centers were recruited for a one-week intervention and r and omly assigned into control ( 2 centers , n = 45 ) or intervention ( 3 centers , n = 48 ) group . Key intervention components included : ( 1 ) wearable device-based , real-time monitoring of children ’s PA by classroom teachers and ( 2 ) teacher-regulated strategies for providing more opportunities for PA . Sedentary behavior ( SED ) and PA were measured using accelerometers . Overall , children in the intervention group showed significantly lower level of SED ( 31.6 vs. 33.6 min/h ) and higher level of total PA ( 28.4 vs. 26.4 min/h ) than children in the control group , after adjusting for age , sex , race , parent education level , parent perception of their child ’s PA , BMI , and childcare centers . Teachers in the intervention group reported that the intervention was highly feasible to be implemented in their current classroom setting s. In conclusion , we observed high acceptability and initial effectiveness of the current intervention . Subsequent research at larger-scale is warranted to fully evaluate the effectiveness of the intervention strategies tested in this study Background Treatment goals for cardiovascular risk management are generally not achieved . Specialized practice nurses are increasingly facilitating the work of general practitioners and self-monitoring devices have been developed as counseling aid . The aim of this study was to compare st and ard treatment supported by self-monitoring with st and ard treatment without self-monitoring , both conducted by practice nurses , on cardiovascular risk and separate risk factors . Methods Men aged 50–75 years and women aged 55–75 years without a history of cardiovascular disease or diabetes , but with a SCORE 10-year risk of cardiovascular mortality ≥5 % and at least one treatable risk factor ( smoking , hypertension , lack of physical activity or overweight ) , were r and omized into two groups . The control group received st and ard treatment according to guidelines , the intervention group additionally received pro-active counseling and self-monitoring ( pedometer , weighing scale and / or blood pressure device ) . After one year treatment effect on 179 participants was analyzed . Results SCORE risk assessment decreased 1.6 % ( 95 % CI 1.0–2.2 ) for the control group and 1.8 % ( 1.2–2.4 ) for the intervention group , difference between groups was .2 % ( −.6–1.1 ) . Most risk factors tended to improve in both groups . The number of visits was higher and visits took more time in the intervention group ( 4.9 ( SD2.2 ) vs. 2.6 ( SD1.5 ) visits p < .001 and 27 ( P25 –P75:20–33 ) vs. 23 ( P25 –P75:19–30 ) minutes/visit p = .048 ) . Conclusions In both groups cardiovascular risk decreased significantly after one year of treatment by practice nurses . No additional effect of basing the pro-active counseling on self-monitoring was found , despite the extra time investment . Trial registration trialregister.nl Background Bruxism is a disorder of jaw-muscle activity characterised by repetitive clenching or grinding of the teeth which results in discomfort and damage to dentition . The two clinical manifestations of the condition ( sleep and awake bruxism ) are thought to have unrelated aetiologies but are palliated using similar techniques . The lack of a definitive treatment has prompted renewed interest in biofeedback , a behaviour change method that uses electronic detection to provide a stimulus whenever bruxism occurs . This systematic review aims to provide a comprehensive overview of the state of research into biofeedback for bruxism ; to assess the efficacy and acceptability of  biofeedback therapy in management of awake bruxism and , separately , sleep bruxism in adults ; and to compare findings between the two variants . Methods A systematic review of published literature examining biofeedback as an intervention directed at controlling primary bruxism in adults . We will search electronic data bases and the grey literature using a predefined search strategy to identify r and omised and non-r and omised studies , technical reports and patents . Search es will not be restricted by language or date and will be exp and ed through contact with authors and experts , and by following up reference lists and citations . Two authors , working independently , will conduct screening of search results , study selection , data extraction and quality assessment and a third will resolve any disagreements . The primary outcomes of acceptability and effectiveness will be assessed using only r and omised studies , segregated by bruxism subtype . A meta- analysis of these data will be conducted only if pre-defined conditions for quality and heterogeneity are met , otherwise the data will be summarized in narrative form . Data from non-r and omised studies will be used to augment a narrative synthesis of the state of technical developments and any safety-related issues . PROSPERO registration number : CRD42013006880 . Discussion Biofeedback is not new , but its place in the clinical management of bruxism remains unclear . New research , and the availability of miniaturized consumer- grade devices , makes a systematic review timely to guide treatment decisions and inform future research OBJECTIVES The primary objective was to determine if wireless remote monitoring with automatic clinician alerts reduces the time from a clinical event to a clinical decision in response to arrhythmias , cardiovascular ( CV ) disease progression , and device issues compared to patients receiving st and ard in-office care . A secondary objective was to compare the rates of CV health care utilization between patients in the remote and in-office arms . BACKGROUND In addition to providing life-saving therapy , implantable cardioverter-defibrillators collect advanced diagnostics on the progression of the patient 's heart disease . Device technology has progressed to allow wireless remote monitoring with automatic clinician alerts to replace some scheduled in-office visits . METHODS The CONNECT ( Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision ) study was a multicenter , prospect i ve , r and omized evaluation involving 1,997 patients from 136 clinical sites who underwent insertion of an implantable cardioverter-defibrillator ( including cardiac resynchronization therapy devices ) and were followed up for 15 months . Health care utilization data included all CV-related hospitalizations , emergency department visits , and clinic office visits . RESULTS The median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm ( p < 0.001 ) . The health care utilization data revealed a decrease in mean length of stay per CV hospitalization visit from 4.0 days in the in-office arm to 3.3 days in the remote arm ( p = 0.002 ) . CONCLUSIONS Wireless remote monitoring with automatic clinician alerts as compared with st and ard in-office follow-up significantly reduced the time to a clinical decision in response to clinical events and was associated with a significant reduction in mean length of CV hospital stay . ( Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision [ CONNECT ] ; NCT00402246 ) OBJECTIVES To determine whether interventions were performed based on portable routine morning chest x-rays ( CXRs ) in pediatric intensive care unit ( PICU ) patients and to identify patient subgroups for whom the routine CXR is most useful . DESIGN Prospect i ve multiinstitutional study . Setting . PICUs of 15 tertiary care hospitals . Patients . PICU patients who received a routine morning CXR were included in the study . OUTCOME MEASURES Recorded data included : weight , diagnosis , presence of active cardiopulmonary problems , length of stay , and number and type of devices . The number and types of interventions based on the interpretation of the CXR were recorded . RESULTS Five hundred twelve routine CXRs were evaluated . The majority of the routine chest radiographs were obtained on patients who were admitted for cardiovascular disease ( 195/512 ; 38 % ) or respiratory failure ( 186/512 ; 36 % ) , and 465/512 of the routine CXRs ( 91 % ) were performed on patients with one or more devices . Two hundred thirty-one of the 512 routine CXRs ( 45 % ) result ed in 1 or more interventions . One hundred fifty-five of the 284 routine CXRs ( 55 % ) obtained in children < /=10 kg result ed in one or more interventions , compared with 61/152 ( 40 % ) and 15/76 ( 20 % ) of routine CXRs obtained in children 10 to 40 kg and > /=40 kg , respectively . The frequency of interventions increased from 19 % in children with no devices to > 50 % in children with 2 or more devices . One or more interventions were performed in 27 % of routine CXRs when no active cardiopulmonary problems were present , compared with 51 % of routine CXRs when active cardiopulmonary problems were present . Diagnosis and length of intensive care unit stay at the time the routine CXR was obtained did not affect the percentage of CXRs that result ed in interventions . CONCLUSIONS Routine CXRs are more likely to result in interventions in the smaller , critically ill child with one or more devices and if active cardiopulmonary problems are present OBJECTIVES The purpose of this study was to evaluate remote pacemaker interrogation for the earlier diagnosis of clinical ly actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation . BACKGROUND Pacemaker patient follow-up procedures have evolved from evaluating devices with little programmability and diagnostic information solely in person to transtelephonic rhythm strip recordings that allow monitoring of basic device function . More recently developed remote monitoring technology leverages exp and ed device capabilities , augmenting traditional transtelephonic monitoring to evaluate patients via full device interrogation . METHODS The time to first diagnosis of a clinical ly actionable event was compared in patients who were followed by remote interrogation ( Remote )  and those who were followed per st and ard of care with office visits augmented by transtelephonic monitoring ( Control ) . Patients were r and omized 2:1 . Remote arm  patients transmitted pacemaker information at 3-month intervals .  Control arm patients with a single-chamber pacemaker transmitted at 2-month intervals . Control arm patients with dual-chamber devices transmitted at 2-month intervals with an office visit at 6 months . All patients were seen in office at 12 months . RESULTS The mean time to first diagnosis of clinical ly actionable events was earlier in the Remote arm ( 5.7 months ) than in the Control arm ( 7.7 months ) . Three ( 2 % ) of the 190 events in the Control arm and 446 ( 66 % ) of 676 events in the Remote arm were identified remotely . CONCLUSIONS The strategic use of remote pacemaker interrogation follow-up detects actionable events that are potentially important more quickly and more frequently than transtelephonic rhythm strip recordings . The use of transtelephonic rhythm strips for pacemaker follow-up is of little value except for battery status determinations . ( PREFER [ Pacemaker Remote Follow-up Evaluation and Review ] ; NCT00294645 ) We examined the correspondence between laboratory measures of cardiovascular reactivity ( CVR ) and within-person changes in cardiovascular activity during the challenges of daily life , after adjustment for posture , activity , and other effects . Healthy adults ( n = 335 ) were administered laboratory measures of CVR along with 6 days of  ambulatory blood pressure monitoring and electronic diary reports . Compared with low reactors , high laboratory systolic blood pressure ( SBP ) reactors showed larger increases in SBP during periods of high task dem and or low decisional control in daily life . High diastolic blood pressure ( DBP ) reactors showed larger increases in ambulatory DBP during situations rated as both low control and high dem and . This multilevel modeling approach may enhance our ability to detect the correspondence between laboratory and ambulatory measures of CVR , and to identify the circumstances under which it may be most clearly observed The risk of obesity during childhood can be significantly reduced through increased physical activity and decreased sedentary behavior . Recent technological advances have created opportunities for the real-time measurement of these behaviors . Mobile phones are ubiquitous and easy to use , and thus have the capacity to collect data from large numbers of people . The present study tested the feasibility , acceptability , and validity of an electronic ecological momentary assessment ( EMA ) protocol using electronic surveys administered on the display screen of mobile phones to assess children 's physical activity and sedentary behaviors .  A total of 121 children ( ages 9 - 13 , 51 % male , 38 % at risk for overweight/overweight ) participated in EMA monitoring from Friday afternoon to Monday evening during children 's nonschool time , with 3 - 7 surveys/day . Items assessed current activity ( e.g. , watching TV/movies , playing video games , active play/sports/exercising ) . Children simultaneously wore an Actigraph GT2 M accelerometer . EMA survey responses were time-matched to total step counts and minutes of moderate-to-vigorous physical activity ( MVPA ) occurring in the 30 min before each EMA survey prompt . No significant differences between answered and unanswered EMA surveys were found for total steps or MVPA . Step counts and the likelihood of 5 + min of MVPA were significantly higher during EMA-reported physical activity ( active play/sports/exercising ) vs. sedentary behaviors ( reading/computer/homework , watching TV/movies , playing video games , riding in a car ) ( P < 0.001 ) . Findings generally support the acceptability and validity of a 4-day EMA protocol using mobile phones to measure physical activity and sedentary behavior in children during leisure time Background There are well-documented treatment gaps in secondary prevention of coronary heart disease and no clear guidelines to assist early physical activity after acute coronary syndromes ( ACS ) . Smartphone technology may provide an innovative platform to close these gaps . This paper describes the study design of a r and omized controlled trial assessing whether a smartphone-based secondary prevention program can facilitate early physical activity and improve cardiovascular health in patients with ACS . Methods We have developed a multi-faceted , patient-centred smartphone-based secondary prevention program emphasizing early physical activity with a graduated walking program initiated on discharge from ACS admission . The program incorporates ; physical activity tracking through the smartphone ’s accelerometer with interactive feedback and goal setting ; a dynamic dashboard to review and optimize cardiovascular risk factors ; educational messages delivered twice weekly ; a photographic food diary ; pharmacotherapy review ; and support through a short message service . The primary endpoint of the trial is change in exercise capacity , as measured by the change in six-minute walk test distance at 8-weeks when compared to baseline . Secondary endpoints include improvements in cardiovascular risk factor status , psychological well-being and quality of life , medication adherence , uptake of cardiac rehabilitation and re-hospitalizations . Discussion This r and omized controlled trial will use a smartphone-phone based secondary prevention program to emphasize early physical activity post-ACS . It will provide evidence regarding the feasibility and utility of this innovative platform in closing the treatment gaps in secondary prevention . Trial registration The trial was retrospectively registered in the Australian New Zeal and Clinical Trials Registry ( ANZCTR ) on April 4 , 2016 . The registration number is ACTRN12616000426482
CONCLUSIONS Current evidence suggests that D-PA may be useful for assessing physical activity and predicting clinical outcomes in patients with cardiovascular implantable electronic devices when combined with other device parameters .
BACKGROUND  Physical activity  is predictive of cardiovascular outcomes in patients with cardiovascular implantable electronic devices , yet it is not regularly assessed in routine care .
Current-generation cardiovascular implantable electronic devices , however , continuously monitor patient activity through a built-in accelerometer , which provides new opportunities to remotely assess patient activity , detect changes in clinical status , and incorporate these data in risk stratification models .
This review critically examines the literature on device-measured physical activity ( D-PA ) , with a focus on identifying method ological issues that may affect interpretation of study results .