A Nordic Perspective on Patient Online Record Access and the European Health Data Space.

The Nordic countries are, together with the United States, forerunners in online record access (ORA), which has now become widespread. The importance of accessible and structured health data has also been highlighted by policy makers internationally. To ensure the full realization of ORA's potential in the short and long term, there is a pressing need to study ORA from a cross-disciplinary, clinical, humanistic, and social sciences perspective that looks beyond strictly technical aspects. In this viewpoint paper, we explore the policy changes in the European Health Data Space (EHDS) proposal to advance ORA across the European Union, informed by our research in a Nordic-led project that carries out the first of its kind, large-scale international investigation of patients' ORA-NORDeHEALTH (Nordic eHealth for Patients: Benchmarking and Developing for the Future). We argue that the EHDS proposal will pave the way for patients to access and control third-party access to their electronic health records. In our analysis of the proposal, we have identified five key principles for ORA: (1) the right to access, (2) proxy access, (3) patient input of their own data, (4) error and omission rectification, and (5) access control. ORA implementation today is fragmented throughout Europe, and the EHDS proposal aims to ensure all European citizens have equal online access to their health data. However, we argue that in order to implement the EHDS, we need more research evidence on the key ORA principles we have identified in our analysis. Results from the NORDeHEALTH project provide some of that evidence, but we have also identified important knowledge gaps that still need further exploration.

Relationship between ICD implantation volume and treatment parameters of patients receiving an ICD with remote monitoring.

BACKGROUND: Both highly specialized heart centres and less specialized hospitals care for patients with implantable ICDs/CRT-Ds with remote monitoring. OBJECTIVE: To investigate potential differences in patient treatment according to centre's ICD implantation volume. METHODS: Based on their 2012 ICD/CRT-D implantation volume, centres enrolled in the NORDIC ICD trial in Germany were assigned to one of three groups: high- (HV, n= 345), medium- (MV, n= 340) or low-volume (LV, n= 189). RESULTS: The HV-centres had a significant higher CRT-D proportion (41.7%; LV: 36.5%; MV: 23.2%; P𝑔𝑙𝑜𝑏𝑎𝑙< 0.001), significant shorter median procedure duration (49 min; MV: 58 min; LV: 60 min; P𝑔𝑙𝑜𝑏𝑎𝑙< 0.001) but significant longer median hospital stay (4 days; MV and LV: 3 days; P𝑔𝑙𝑜𝑏𝑎𝑙< 0.001) compared to MV- and LV-centres. The X-ray exposure was shorter in MV/HV-centres (MV: 3.4 min; HV: 3.6 min; LV: 5.5 min; P𝑔𝑙𝑜𝑏𝑎𝑙< 0.001). Only 3.5% (LV: 2.6%; HV: 3.5%; MV: 4.1%) patients received at least one delivered inappropriate shock and 2.5% (HV: 2.0%; LV: 2.6%; MV: 2.9%) patients had withheld inappropriate ICD shocks without subsequent inappropriate shock delivery within 24.5 months of median follow-up. CONCLUSION: Implantation volume-dependent differences were observed in the device selection, procedure duration and x-ray exposure duration. Remote monitoring in combination with adequate response pattern prevented imminent inappropriate shocks in all three groups.

The NORDeHEALTH 2022 Patient Survey: Cross-Sectional Study of National Patient Portal Users in Norway, Sweden, Finland, and Estonia.

BACKGROUND: Although many surveys have been conducted on patients accessing their own health records in recent years, there is a limited amount of nationwide cross-country data available on patients' views and preferences. To address this gap, an international survey of patient users was conducted in the Nordic eHealth project, NORDeHEALTH. OBJECTIVE: We aimed to investigate the sociodemographic characteristics and experiences of patients who accessed their electronic health records (EHRs) through national patient portals in Norway, Sweden, Finland, and Estonia. METHODS: A cross-sectional web-based survey was distributed using the national online health portals. The target participants were patients who accessed the national patient portals at the start of 2022 and who were aged ≥15 years. The survey included a mixture of close-ended and free-text questions about participant sociodemographics, usability experience, experiences with health care and the EHR, reasons for reading health records online, experience with errors, omissions and offense, opinions about security and privacy, and the usefulness of portal functions. In this paper, we summarized the data on participant demographics, past experience with health care, and the patient portal through descriptive statistics. RESULTS: In total, 29,334 users completed the survey, of which 9503 (32.40%) were from Norway, 13,008 (44.35%) from Sweden, 4713 (16.07%) from Finland, and 2104 (7.17%) from Estonia. National samples were comparable according to reported gender, with about two-thirds identifying as women (19,904/29,302, 67.93%). Age distributions were similar across the countries, but Finland had older users while Estonia had younger users. The highest attained education and presence of health care education varied among the national samples. In all 4 countries, patients most commonly rated their health as "fair" (11,279/29,302, 38.48%). In Estonia, participants were more often inclined to rate their health positively, whereas Norway and Sweden had the highest proportion of negative health ratings. Across the whole sample, most patients received some care in the last 2 years (25,318/29,254, 86.55%). Mental health care was more common (6214/29,254, 21.24%) than oncological care (3664/29,254, 12.52%). Overall, most patients had accessed their health record "2 to 9 times" (11,546/29,306, 39.4%), with the most frequent users residing in Sweden, where about one-third of patients accessed it "more than 20 times" (4571/13,008, 35.14%). CONCLUSIONS: This is the first large-scale international survey to compare patient users' sociodemographics and experiences with accessing their EHRs. Although the countries are in close geographic proximity and demonstrate similar advancements in giving their residents online records access, patient users in this survey differed. We will continue to investigate patients' experiences and opinions about national patient-accessible EHRs through focused analyses of the national and combined data sets from the NORDeHEALTH 2022 Patient Survey.

Do electronic and economic empowerment protect women from intimate partner violence (IPV) in India?

BACKGROUND: Intimate partner violence (IPV) is a major public health problem. Electronic empowerment has several positive impacts on health. No study has examined whether electronic empowerment prevents intimate partner violence. Economic empowerment has positive and negative effects on IPV victimization. The current study was conducted to investigate whether economic and electronic empowerment of women act as protective factors against IPV in India. METHODS: A national representative sample of 66,013 ever-married women from 36 member states and union territories of India has been used from the National Family Health Survey 2015 to 2016. Emotional, physical and sexual violence against women by husbands were target variables. We used bivariate and multivariate analyses. RESULTS: The prevalence of emotional violence was 13%, physical violence was 28% and sexual violence was 7%. IPV against women was as follows: The prevalence was higher among women living in rural areas, belonging to Hindu religion and those belonging to Scheduled Castes. Higher education and higher socio-economic status were found to be protective factors against IPV. The prevalence of IPV was higher among the working women, among those having knowledge of business loans for women and the recipients of such business loans. Exposure to media was found to reduce IPV. The women who used mobile phones and SMS facility experienced less violence. CONCLUSION: Economic independence of women was found to be a risk factor for IPV in India, whereas electronic empowerment was a protective factor. In the Indian context, policymakers should make use of mobile phones and support SMS use in the IPV awareness programs. Women empowerment, combined with gender equity, can reduce the prevalence of violence against women.

An Integrated Care Platform System (C3-Cloud) for Care Planning, Decision Support, and Empowerment of Patients With Multimorbidity: Protocol for a Technology Trial.

BACKGROUND: There is an increasing need to organize the care around the patient and not the disease, while considering the complex realities of multiple physical and psychosocial conditions, and polypharmacy. Integrated patient-centered care delivery platforms have been developed for both patients and clinicians. These platforms could provide a promising way to achieve a collaborative environment that improves the provision of integrated care for patients via enhanced information and communication technology solutions for semiautomated clinical decision support. OBJECTIVE: The Collaborative Care and Cure Cloud project (C3-Cloud) has developed 2 collaborative computer platforms for patients and members of the multidisciplinary team (MDT) and deployed these in 3 different European settings. The objective of this study is to pilot test the platforms and evaluate their impact on patients with 2 or more chronic conditions (diabetes mellitus type 2, heart failure, kidney failure, depression), their informal caregivers, health care professionals, and, to some extent, health care systems. METHODS: This paper describes the protocol for conducting an evaluation of user experience, acceptability, and usefulness of the platforms. For this, 2 "testing and evaluation" phases have been defined, involving multiple qualitative methods (focus groups and surveys) and advanced impact modeling (predictive modeling and cost-benefit analysis). Patients and health care professionals were identified and recruited from 3 partnering regions in Spain, Sweden, and the United Kingdom via electronic health record screening. RESULTS: The technology trial in this 4-year funded project (2016-2020) concluded in April 2020. The pilot technology trial for evaluation phases 3 and 4 was launched in November 2019 and carried out until April 2020. Data collection for these phases is completed with promising results on platform acceptance and socioeconomic impact. We believe that the phased, iterative approach taken is useful as it involves relevant stakeholders at crucial stages in the platform development and allows for a sound user acceptance assessment of the final product. CONCLUSIONS: Patients with multiple chronic conditions often experience shortcomings in the care they receive. It is hoped that personalized care plan platforms for patients and collaboration platforms for members of MDTs can help tackle the specific challenges of clinical guideline reconciliation for patients with multimorbidity and improve the management of polypharmacy. The initial evaluative phases have indicated promising results of platform usability. Results of phases 3 and 4 were methodologically useful, yet limited due to the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT03834207; https://clinicaltrials.gov/ct2/show/NCT03834207. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/21994.

Toward Improved Treatment and Empowerment of Individuals With Parkinson Disease: Design and Evaluation of an Internet of Things System.

BACKGROUND: Parkinson disease (PD) is a chronic degenerative disorder that causes progressive neurological deterioration with profound effects on the affected individual's quality of life. Therefore, there is an urgent need to improve patient empowerment and clinical decision support in PD care. Home-based disease monitoring is an emerging information technology with the potential to transform the care of patients with chronic illnesses. Its acceptance and role in PD care need to be elucidated both among patients and caregivers. OBJECTIVE: Our main objective was to develop a novel home-based monitoring system (named EMPARK) with patient and clinician interface to improve patient empowerment and clinical care in PD. METHODS: We used elements of design science research and user-centered design for requirement elicitation and subsequent information and communications technology (ICT) development. Functionalities of the interfaces were the subject of user-centric multistep evaluation complemented by semantic analysis of the recorded end-user reactions. The ICT structure of EMPARK was evaluated using the ICT for patient empowerment model. RESULTS: Software and hardware system architecture for the collection and calculation of relevant parameters of disease management via home monitoring were established. Here, we describe the patient interface and the functional characteristics and evaluation of a novel clinician interface. In accordance with our previous findings with regard to the patient interface, our current results indicate an overall high utility and user acceptance of the clinician interface. Special characteristics of EMPARK in key areas of interest emerged from end-user evaluations, with clear potential for future system development and deployment in daily clinical practice. Evaluation through the principles of ICT for patient empowerment model, along with prior findings from patient interface evaluation, suggests that EMPARK has the potential to empower patients with PD. CONCLUSIONS: The EMPARK system is a novel home monitoring system for providing patients with PD and the care team with feedback on longitudinal disease activities. User-centric development and evaluation of the system indicated high user acceptance and usability. The EMPARK infrastructure would empower patients and could be used for future applications in daily care and research.

Information and Communications Technology-Based Interventions Targeting Patient Empowerment: Framework Development.

BACKGROUND: Empowerment of patients is often an explicit goal of various information and communications technology (ICT) (electronic, digital) interventions where the patients themselves use ICT tools via the internet. Although several models of empowerment exist, a comprehensive and pragmatic framework is lacking for the development of such interventions. OBJECTIVE: This study proposes a framework for digital interventions aiming to empower patients that includes a methodology that links objectives, strategies, and evaluation. METHODS: This study is based on a literature review and iterated expert discussions including a focus group to formulate the proposed model. Our model is based on a review of various models of empowerment and models of technology intervention. RESULTS: Our framework includes the core characteristics of the empowerment concept (control, psychological coping, self-efficacy, understanding, legitimacy, and support) as well as a set of empowerment consequences: expressed patient perceptions, behavior, clinical outcomes, and health systems effects. The framework for designing interventions includes strategies to achieve empowerment goals using different ICT services. Finally, the intervention model can be used to define project evaluations where the aim is to demonstrate empowerment. The study also included example indicators and associated measurement instruments. CONCLUSIONS: This framework, which includes definitions, can be useful for the design and evaluation of digital interventions targeting patient empowerment and assist in the development of methods to measure results in this dimension. Further evaluation in the form of interventional studies will be needed to assess the generalizability of the model.

Localisation, Personalisation and Delivery of Best Practice Guidelines on an Integrated Care and Cure Cloud Architecture: The C3-Cloud Approach to Managing Multimorbidity.

BACKGROUND: C3-Cloud is an integrated care ICT infrastructure offering seamless patient-centered approach to managing multimorbidity, deployed in three European pilot sites. Challenge: The digital delivery of best practice guidelines unified for multimorbidity, customized to local practice, offering the capability to improve patient personalization and benefit. METHOD: C3-Cloud has adopted a co-production approach to developing unified multimorbidity guidelines, by collating and reconciling best practice guidelines for each condition. Clinical and technical teams at pilot sites and the C3-Cloud consortium worked in tandem to create the specification and technical implementation. RESULTS: C3-Cloud offers CDSS for diabetes, renal failure, depression and congenital heart failure, with over 300 rules and checks that deliver four best practice guidelines in parallel, customized for each pilot site. CONCLUSIONS: The process provided a traceable, maintainable and audited digitally delivered collated and reconciled guidelines.

User-Centered Design of the C3-Cloud Platform for Elderly with Multiple Diseases - Functional Requirements and Application Testing.

The number of patients with multimorbidity has been steadily increasing in the modern aging societies. The European C3-Cloud project provides a multidisciplinary and patient-centered "Collaborative Care and Cure-system" for the management of elderly with multimorbidity, enabling continuous coordination of care activities between multidisciplinary care teams (MDTs), patients and informal caregivers (ICG). In this study various components of the infrastructure were tested to fulfill the functional requirements and the entire system was subjected to an early application testing involving different groups of end-users. MDTs from participating European regions were involved in requirement elicitation and test formulation, resulting in 57 questions, distributed via an internet platform to 48 test participants (22 MDTs, 26 patients) from three pilot sites. The results indicate a high level of satisfaction with all components. Early testing also provided feedback for technical improvement of the entire system, and the paper points out useful evaluation methods.

A Collaborative Platform for Management of Chronic Diseases via Guideline-Driven Individualized Care Plans.

Older age is associated with an increased accumulation of multiple chronic conditions. The clinical management of patients suffering from multiple chronic conditions is very complex, disconnected and time-consuming with the traditional care settings. Integrated care is a means to address the growing demand for improved patient experience and health outcomes of multimorbid and long-term care patients. Care planning is a prevalent approach of integrated care, where the aim is to deliver more personalized and targeted care creating shared care plans by clearly articulating the role of each provider and patient in the care process. In this paper, we present a method and corresponding implementation of a semi-automatic care plan management tool, integrated with clinical decision support services which can seamlessly access and assess the electronic health records (EHRs) of the patient in comparison with evidence based clinical guidelines to suggest personalized recommendations for goals and interventions to be added to the individualized care plans. We also report the results of usability studies carried out in four pilot sites by patients and clinicians.

Clinical Course of Dual-Chamber Implantable Cardioverter-Defibrillator Recipients followed by Cardiac Remote Monitoring: Insights from the LION Registry.

Patients receiving dual-chamber implantable cardioverter-defibrillator (DR-ICD) therapy are at risk of developing atrial arrhythmia because of the increased rate of ventricular pacing and the progression of heart failure. Remote monitoring (RM) may identify the patients at highest risk of adverse events such as atrial arrhythmias. A total of 283 patients with 91,632 remote transmissions during a 15-month follow-up (FU) period enrolled in the LION registry were analysed. The parameters retrieved included the pacing mode, lower rate limit, percentage of atrial (%AP) and ventricular pacing (%VP), and percentage of atrial arrhythmia burden (%AB). In 92.7% of patients, the devices were initially programmed in DDD(R) or DDI(R), with changes of the pacing mode in 19.3% only. The lower rate limit remained stable in 80.4% of patients. At the first transmission, 8.7% of patients suffered from RM-detected atrial arrhythmia, which reached 36% during FU. The %AP was not associated with increased AB (p = 0.67), but the %VP was different in patients developing RM-detected atrial arrhythmia (26.9% vs. 13.7%, p < 0.00001). The %VP increased in 105 patients (significance level of α = 0.05), and 11 patients crossed the border of 50% VP. The LION substudy supports the concept of using RM in a real-world DR-ICD population. Remote monitoring of DR-ICDs allows for the quantification of the course of the pacing parameters and AB. Based on these observations, device parameters can be adjusted and optimized.

Mobile health treatment support intervention for HIV and tuberculosis in Mozambique: Perspectives of patients and healthcare workers.

BACKGROUND: Studies have been conducted in developing countries using SMS to communicate with patients to reduce the number of missed appointments and improve retention in treatment, however; very few have been scaled up. One possible reason for this could be that patients or staff are dissatisfied with the method in some way. This paper reports a study of patients' and healthcare workers' (HCW) views on an mHealth intervention aiming to support retention in antiretroviral therapy (ART) and tuberculosis (TB) treatment in Mozambique. METHODS: The study was conducted at five healthcare centres in Mozambique. Automated SMS health promotions and reminders were sent to patients in a RCT. A total of 141 patients and 40 HCWs were interviewed. Respondents rated usefulness, perceived benefits, ease of use, satisfaction, and risks of the SMS system using a Likert scale questionnaire. A semi-structured interview guide was followed. Interviews were transcribed and thematic analysis was conducted. RESULTS: Both patients and HCW found the SMS system useful and reliable. Most highly rated positive effects were reducing the number of failures to collect medication and avoiding missing appointments. Patients' confidence in the system was high. Most perceived the system to improve communication between health-care provider and patient and assist in education and motivation. The automatic recognition of questions from patients and the provision of appropriate answers (a unique feature of this system) was especially appreciated. A majority would recommend the system to other patients or healthcare centres. Risks also were mentioned, mostly by HCW, of unintentional disclosure of health status in cases where patients use shared phones. CONCLUSIONS: The results suggest that SMS technology for HIV and TB should be used to transmit reminders for appointments, medications, motivational texts, and health education to increase retention in care. Measures must be taken to reduce risks of privacy intrusion, but these are not a main obstacle for scaling up systems of this kind.

Mobile health treatment support intervention for HIV and tuberculosis in Mozambique: perspectives of patients and healthcare workers

Background Studies have been conducted in developing countries using SMS to communicate with patients to reduce the number of missed appointments and improve retention in treatment, however; very few have been scaled up. One possible reason for this could be that patients or staff are dissatisfied with the method in some way. This paper reports a study of patients' and healthcare workers' (HCW) views on an mHealth intervention aiming to support retention in antiretroviral therapy (ART) and tuberculosis (TB) treatment in Mozambique. Methods The study was conducted at five healthcare centres in Mozambique. Automated SMS health promotions and reminders were sent to patients in a RCT. A total of 141 patients and 40 HCWs were interviewed. Respondents rated usefulness, perceived benefits, ease of use, satisfaction, and risks of the SMS system using a Likert scale questionnaire. A semi-structured interview guide was followed. Interviews were transcribed and thematic analysis was conducted. Results Both patients and HCW found the SMS system useful and reliable. Most highly rated positive effects were reducing the number of failures to collect medication and avoiding missing appointments. Patients' confidence in the system was high. Most perceived the system to improve communication between health-care provider and patient and assist in education and motivation. The automatic recognition of questions from patients and the provision of appropriate answers (a unique feature of this system) was especially appreciated. A majority would recommend the system to other patients or healthcare centres. Risks also were mentioned, mostly by HCW, of unintentional disclosure of health status in cases where patients use shared phones. Conclusions The results suggest that SMS technology for HIV and TB should be used to transmit reminders for appointments, medications, motivational texts, and health education to increase retention in care. Measures must be taken to reduce risks of privacy intrusion, but these are not a main obstacle for scaling up systems of this kind.

Mobile health treatment support intervention for HIV andtuberculosis in Mozambique: Perspectives of patients and healthcare workers

Studies have been conducted in developing countries using SMS to communicate with patients to reduce the number of missed appointments and improve retention in treatment, however; very few have been scaled up. One possible reason for this could be that patients or staff are dissatisfied with the method in some way. This paper reports a study of patients' andhealthcare workers' (HCW) views on an mHealth intervention aiming to support retention in antiretroviral therapy (ART) and tuberculosis (TB) treatment in Mozambique. Methods Thestudy wasconducted atfive healthcare centres in Mozambique. Automated SMS health promotions and reminders were sent to patients in a RCT. A total of 141 patients and 40 HCWswereinterviewed. Respondents rated usefulness, perceived benefits, ease of use, satisfaction, and risks of the SMS system using a Likert scale questionnaire. A semi-structured interview guide was followed. Interviews were transcribed and thematic analysis was conducted. Results Both patients and HCWfoundtheSMSsystemusefulandreliable. Most highly rated positive effects were reducing the number of failures to collect medication and avoiding missing appointments. Patients' confidence in the system was high. Most perceived the system to improve communication between health-care provider and patient and assist in education andmotivation. The automatic recognition of questions from patients and the provision of appropriate answers (a unique feature of this system) was especially appreciated. A majority would recommend the system to other patients or healthcare centres. Risks also were mentioned, mostly by HCW, of unintentional disclosure of health status in cases where patients use shared phones. Conclusions Theresults suggest that SMS technology for HIV and TB should be used to transmit reminders for appointments, medications, motivational texts, and health education to increase retention in care. Measures must be taken to reduce risks of privacy intrusion, but these are not a mainobstacle for scaling up systems of this kind.

Fluid status telemedicine alerts for heart failure: a randomized controlled trial.

AIMS: Hospital admissions are frequently preceded by increased pulmonary congestion in heart failure (HF) patients. This study evaluated whether early automated fluid status alert notification via telemedicine improves outcome in HF patients. METHODS AND RESULTS: Patients recently implanted with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy were eligible if one of three conditions was met: prior HF hospitalization, recent diuretic treatment, or recent brain natriuretic peptide increase. Eligible patients were randomized (1:1) to have fluid status alerts automatically transmitted as inaudible text message alerts to the responsible physician or to receive standard care (no alerts). In the intervention arm, following a telemedicine alert, a protocol-specified algorithm with remote review of device data and telephone contact was prescribed to assess symptoms and initiate treatment. The primary endpoint was a composite of all-cause death and cardiovascular hospitalization. We followed 1002 patients for an average of 1.9 years. The primary endpoint occurred in 227 patients (45.0%) in the intervention arm and 239 patients (48.1%) in the control arm [hazard ratio, HR, 0.87; 95% confidence interval (CI), 0.72-1.04; P = 0.13]. There were 59 (11.7%) deaths in the intervention arm and 63 (12.7%) in the control arm (HR, 0.89; 95% CI, 0.62-1.28; P = 0.52). Twenty-four per cent of alerts were not transmitted and 30% were followed by a medical intervention. CONCLUSION: Among ICD patients with advanced HF, fluid status telemedicine alerts did not significantly improve outcomes. Adherence to treatment protocols by physicians and patients might be challenge for further developments in the telemedicine field.

Smart Glasses--A New Tool in Medicine.

Smart glasses, defined as a computerized communicator with a transparent screen and a video camera, wearable as a pair of glasses, have started to be tested for a variety of health related applications. This poster reviews some of the early experiences and gives a series of proposals for possible uses in medicine with a particular emphasis on medical education.

Cardiac resynchronization therapy improves psycho-cognitive performance in patients with heart failure.

BACKGROUND: Reduced cognitive performance and high prevalence of depression have been reported in patients with congestive heart failure (CHF) and severe left ventricular dysfunction. However, effects of contemporary device therapy on cognitive performance and depression symptoms have not been studied thoroughly. METHODS: Seventy-four consecutive CHF patients-45 receiving a biventricular defibrillator (CRT-D) and 29 receiving an implantable single or dual-chamber defibrillator (ICD) as a control group-were enrolled in this investigator-initiated, prospective, controlled, and investigator-blinded study. A set of neuropsychological tests (mini-mental state examination, DemTect, age-concentration test, and Beck depression inventory) was performed before, at 3 and at 6 months after device implantation. RESULTS: DemTect-score improved significantly (F = 7.8; P = 0.007) after CRT-D-implantation compared with ICD. Age-concentration test revealed better concentration ability after CRT-D-implantation (F = 8.3; P = 0.005) compared with ICD. Under CRT-D mini-mental state examination showed a significant improvement (F = 4.2; P = 0.043). CRT with defibrillator therapy also improved depression revealed by beck depression inventory (F = 14.7; P< 0.001) compared with ICD. CONCLUSION: This prospective study is the first to demonstrate psycho-cognitive improvement by resynchronization therapy in CHF patients with severe left ventricular dysfunction. In contrast to ICD therapy, the beneficial effect of CRT-D on psycho-cognitive performance might be attributed to improved cardiac function and haemodynamics.

Comparison of 'anatomically designed' and 'point-by-point' catheter ablations for human atrial fibrillation in terms of procedure timing and costs in German hospitals.

AIMS: The purpose of the FAST-PVI study was to compare 'traditional' ablation tools based on 'point-by-point' technology with the new 'anatomically designed' technologies in terms of procedure times and related costs for the treatment of paroxysmal atrial fibrillation. METHODS AND RESULTS: Four hundred and fifty-two consecutive ablation procedures (222 'anatomically designed', 136 Arctic Front® and 86 PVAC®) and 230 'point-by-point' ablations (100 CARTO XP and 130 NavX navigation systems) performed by nine university centres across Germany from 2006 to 2010 were evaluated retrospectively. Staffing and resources times for each procedure were documented together with patient morbidities, complications, and pulmonary veins isolations. On the basis of DRG data from 2006 to 2010, human resources use and equipment maintenance costs were assigned to ablation procedure and calendar year. All procedural times were significantly higher in 'point-by-point' technologies compared with 'anatomically designed' ablations [average lab occupancy time 185.30 vs. 280.28 min; physician time 152.21 vs. 238.04 min; support time 183.43 vs. 278.34 min and fluoroscopy time 29.11 vs. 40.72 min; P < 0.001 (95% confidence interval, CI)]. For each ablation procedure human resource use per operating minute resulted in lower costs for 'anatomically designed' ablations [€744.24 per patient; P < 0.001 (95% CI)]. Savings due to reduced duration in 'anatomically designed' technologies accrued to 20% lower human resource costs. Sensitivity analyses did not lead to any significant variations on the outcomes parameter cost per minute. CONCLUSION: FAST-PVI showed reductions in ablation procedural time may lead to increased hospital capacity and non-device-related cost-savings, while maintaining quality.

Home monitoring of implantable cardioverter-defibrillators: interpretation reliability of the second-generation "IEGM Online" system.

AIMS: Intracardiac electrograms (IEGMs) are essential for the assessment of implantable cardioverter-defibrillator (ICD) function. The Biotronik Home Monitoring systems transmit an 'IEGM Online' that is shorter than the full-length programmer IEGM due to technical constrains. The aim of this study was to evaluate the accuracy of the physician's classification of the underlying rhythm based on the second-generation IEGM Online. METHODS AND RESULTS: In total, 1533 patients treated with single- and dual-chamber ICDs and cardiac resynchronization therapy defibrillators were enrolled at 67 investigational sites and followed for 15 months. The investigators classified the rhythm shown in IEGM Online as ventricular tachycardia, ventricular fibrillation, atrial fibrillation, other supraventricular tachyarrhythmia, oversensing due to lead failure, T-wave oversensing, or other rhythm. At the next in-office follow-up, the investigators classified independently the rhythm seen in the corresponding programmer IEGM. The two rhythm classifications were compared thereafter. Both IEGM Online and programmer IEGM were available in 2099 arrhythmic or oversensing events, of which 146 (7.0%) were classified as other rhythm or artefacts and were excluded as inconclusive or atypical. The remaining 1953 events, affecting 352 patients (23.0%), were classified correctly in 1803 cases (92.3%). The accuracy of rough rhythm classification as ventricular, supraventricular, or oversensing was 97.2%. CONCLUSION: The Lumax and IEGM Online HD Evaluation study demonstrates that remote IEGM analysis is reasonably accurate in a remote monitoring system that transmits shorter IEGM than the full-length programmer IEGM for the sake of frequent, fully automatic data transmission.

Cost-effectiveness of cryoballoon ablation for the management of paroxysmal atrial fibrillation.

AIMS: Cryoballoon ablation is an established treatment option for the management of patients with atrial fibrillation. We sought to evaluate the cost-effectiveness of cryoablation, compared with second-line anti-arrhythmic drug (AAD) therapy in patients with paroxysmal atrial fibrillation (PAF), from a UK payer perspective. METHODS AND RESULTS: We developed a state-transition (Markov) model to calculate the total costs and quality-adjusted life-years (QALYs) associated with cryoablation and AAD therapy in patients with PAF. A 5-year horizon was used for the base-case. Data from a recent study of cryoballoon ablation in patients with PAF were used to model short-term health outcomes and costs, together with longer term external evidence to populate subsequent time periods. Total discounted costs were £21 162 and £17 627 for the cryoballoon ablation and AAD arms, respectively. Total QALYs of 3.565 and 3.404 therefore led to an incremental cost-effectiveness ratio of £21 957 per QALY gained. Sensitivity analysis suggested that the key drivers of the results were the model time horizon, the costs of follow-up care in patients with recurrent AF, and the costs of the ablation procedure. CONCLUSION: Cryoballoon ablation provides increased quality-adjusted life expectancy compared with AAD at reasonable additional cost, representing good value for money in patients with PAF.