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Background: Left ventricular (LV) global longitudinal strain (GLS) has been proposed as a sensitive marker of myocardial damage in patients with chronic severe aortic regurgitation (AR) and preserved LV ejection fraction (LVEF). However, LV GLS does not take into account the afterload. Noninvasive LV myocardial work is a novel parameter of LV myocardial performance, which integrates measurements of myocardial deformation and noninvasive blood pressure (afterload). The aims of this study were (1) to assess noninvasive LV myocardial work in patients with chronic AR and preserved LVEF and its correlation with other echocardiographic parameters, (2) to evaluate changes of LV myocardial work after aortic valve replacement or repair (AVR), and (3) to assess the relationship between LV myocardial work and postoperative LV reverse remodeling.Methods: Fifty-seven patients (53 6 16 years; 67% men) with moderate or severe chronic AR and preserved LVEF treated by AVR were included. Noninvasive LV myocardial work indices were measured at baseline and postoperatively (between 2 and 12 months after surgery) and compared with previously reported normal reference ranges.Results: Based on normal reference values, patients with chronic AR and preserved LVEF had preserved or increased values of LV global work index (GWI; 82% and 18%, respectively) and LV global constructive work (GCW; 74% and 25%, respectively) and preserved LV global work efficiency (GWE). Left ventricular GWI and GCW showed a positive correlation with markers of AR severity and parameters of LV systolic function. Left ventricular GWI, GCW, and GWE decreased after AVR (P

Samenvatting E-health maakt het mogelijk om goede poliklinische zorg aan hartinfarctpatiënten te leveren, zelfs gedurende de huidige COVID-19-pandemie. We deden een haalbaarheidsonderzoek om te kijken of e-health kan worden ingezet als een bruikbaar alternatief voor fysieke polikliniekbezoeken bij het leveren van poliklinische zorg. We verdeelden 200 hartinfarctpatiënten at random over een e-health-interventie of standaard follow-up. De primaire uitkomst was bloeddrukregulatie, secundaire uitkomsten waren patiënttevredenheid en klinische opnamen. Tussen beide groepen waren er geen significante verschillen in uitkomsten. E-health produceert daarmee gelijke uitkomsten.

Innovative ways of healthcare delivery like m-Health, the practice of medicine by mobile devices and wearable devices are the promising new technique that may lead to improvement in quality of care at lower costs. While fully acknowledging the importance of m-Health development, there are challenges on privacy legislation. We address the legal framework, especially the General Data Protection Regulation, applied to m-Health and its implications for m-Health developments in Europe. We discuss how these rules are applied using a representative example of an m-Health programme with remote monitoring in the Netherlands. We consider informing patients about the data processing and obtaining their explicit consent as main responsibilities of healthcare providers introducing m-Health in their practice.

Aims Right ventricular myocardial work (RVMW) is a novel method for non-invasive assessment of right ventricular (RV) function utilizing RV pressure–strain loops. This study aimed to explore the relationship between RVMW and invasive indices of right heart catheterization (RHC) in a cohort of patients with heart failure with reduced left ventricular ejection fraction (HFrEF), and to compare values of RVMW with those of a group of patients without cardiovascular disease. Methods and results Non-invasive analysis of RVMW was performed in 22 HFrEF patients [median age 63 (59–67) years] who underwent echocardiography and invasive RHC within 48 h. Conventional RV functional measurements, RV global constructive work (RVGCW), RV global work index (RVGWI), RV global wasted work (RVGWW), and RV global work efficiency (RVGWE) were analysed and compared with invasively measured stroke volume and stroke volume index. Non-invasive analysis of RVMW was also performed in 22 patients without cardiovascular disease to allow for comparison between groups. None of the conventional echocardiographic parameters of RV systolic function were significantly correlated with stroke volume or stroke volume index. In contrast, one of the novel indices derived non-invasively by pressure–strain loops, RVGCW, demonstrated a moderate correlation with invasively measured stroke volume and stroke volume index (r = 0.63, P = 0.002 and r = 0.59, P = 0.004, respectively). RVGWI, RVGCW, and RVGWE were significantly lower in patients with HFrEF compared to a healthy cohort, while values of RVGWW were significantly higher. Conclusion RVGCW is a novel parameter that provides an integrative analysis of RV systolic function and correlates more closely with invasively measured stroke volume and stroke volume index than other standard echocardiographic parameters.

Importance Smart technology via smartphone-compatible devices might improve blood pressure (BP) regulation in patients after myocardial infarction. Objectives To investigate whether smart technology in clinical practice can improve BP regulation and to evaluate the feasibility of such an intervention. Design, Setting, and Participants This study was an investigator-initiated, single-center, nonblinded, feasibility, randomized clinical trial conducted at the Department of Cardiology of the Leiden University Medical Center between May 2016 and December 2018. Two hundred patients, who were admitted with either ST-segment elevation myocardial infarction or non–ST-segment acute coronary syndrome, were randomized in a 1:1 fashion between follow-up groups using smart technology and regular care. Statistical analysis was performed from January 2019 to March 2019. Interventions For patients randomized to regular care, 4 physical outpatient clinic visits were scheduled in the year following the initial event. In the intervention group, patients were given 4 smartphone-compatible devices (weight scale, BP monitor, rhythm monitor, and step counter). In addition, 2 in-person outpatient clinic visits were replaced by electronic visits. Main Outcomes and Measures The primary outcome was BP control. Secondary outcomes, as a parameter of feasibility, included patient satisfaction (general questionnaire and smart technology–specific questionnaire), measurement adherence, all-cause mortality, and hospitalizations for nonfatal adverse cardiac events. Results In total, 200 patients (median age, 59.7 years [interquartile range, 52.9-65.6 years]; 156 men [78%]) were included, of whom 100 were randomized to the intervention group and 100 to the control group. After 1 year, 79% of patients in the intervention group had controlled BP vs 76% of patients in the control group (P = .64). General satisfaction with care was the same between groups (mean [SD] scores, 82.6 [14.1] vs 82.0 [15.1];P = .88). The all-cause mortality rate was 2% in both groups (P > .99). A total of 20 hospitalizations for nonfatal adverse cardiac events occurred (8 in the intervention group and 12 in the control group). Of all patients, 32% sent in measurements each week, with 63% sending data for more than 80% of the weeks they participated in the trial. In the intervention group only, 90.3% of patients were satisfied with the smart technology intervention. Conclusions and Relevance These findings suggest that smart technology yields similar percentages of patients with regulated BP compared with the standard of care. Such an intervention is feasible in clinical practice and is accepted by patients. More research is mandatory to improve patient selection of such an intervention. Trial Registration ClinicalTrials.gov Identifier:NCT02976376

Background Mobile health (mHealth) is an emerging field of scientific interest worldwide. Potential benefits include increased patient engagement, improved clinical outcomes, and reduced health care costs. However, mHealth is often studied in projects or trials, and structural implantation in clinical practice is less common. Objective The purpose of this paper is to outline the design of the Box and its implementation and use in an outpatient clinic setting. The impact on logistical outcomes and patient and provider satisfaction is discussed. Methods In 2016, an mHealth care track including smartphone-compatible devices, named the Box, was implemented in the cardiology department of a tertiary medical center in the Netherlands. Patients with myocardial infarction, rhythm disorders, cardiac surgery, heart failure, and congenital heart disease received devices to measure daily weight, blood pressure, heart rate, temperature, and oxygen saturation. In addition, professional and patient user comments on the experience with the care track were obtained via structured interviews. Results From 2016 to April 2020, a total of 1140 patients were connected to the mHealth care track. On average, a Box cost €350 (US $375), not including extra staff costs. The median patient age was 60.8 (IQR 52.9-69.3) years, and 73.59% (839/1140) were male. A median of 260 (IQR 105-641) measurements was taken on a median of 189 (IQR 98-372) days. Patients praised the ease of use of the devices and felt more involved with their illness and care. Professionals reported more productive outpatient consultations as well as improved insight into health parameters such as blood pressure and weight. A feedback loop from the hospital to patient to focus on measurements was commented as an important improvement by both patients and professionals. Conclusions In this study, the design and implementation of an mHealth care track for outpatient follow-up of patients with various cardiovascular diseases is described. Data from these 4 years indicate that mHealth is feasible to incorporate in outpatient management and is generally well-accepted by patients and providers. Limitations include the need for manual measurement data checks and the risk of data overload. Moreover, the tertiary care setting in which the Box was introduced may limit the external validity of logistical and financial end points to other medical centers. More evidence is needed to show the effects of mHealth on clinical outcomes and on cost-effectiveness.

Introduction Smartphone-compatible blood pressure devices may be a good alternative to enable self-measurement of blood pressure by patients. Furthermore, automatic transferral of data to the hospital allows for remote monitoring. To our knowledge, no study has compared four of these smartphone-compatible blood pressure devices. Methods Patients who were followed up for acute myocardial infarction were asked to participate during their outpatient clinic visit. After five minutes of rest, six blood pressure devices were applied. The order was randomised. Four devices were smartphone-compatible. One device was an automated oscillometric device. One device was a handheld aneroid sphygmomanometer (reference device). All measurements were compared using a linear mixed model. Results A total of 43 patients (62.7 ± 11.3 years, 79% male) were included. Compared to the reference device, four blood pressure monitors yielded a significant higher mean systolic blood pressure and four monitors yielded a significant higher diastolic BP. One device yielded a non-significant lower mean systolic blood pressure and one device yielded a non-significant higher mean diastolic blood pressure. Except for one blood pressure device, all mean differences were smaller than 5 mmHg. Conclusion In this study, average inter-device variability was shown to be statistically significant, however four devices remained within the predefined range of 5 mmHg for both systolic and diastolic blood pressures.

Left ventricular (LV) global longitudinal strain (GLS) can detect subclinical myocardial systolic dysfunction in individuals with diabetes. The present study investigates the clinical usefulness and incremental net benefit of identifying subclinical myocardial systolic dysfunction in individuals with diabetes. A cohort of 397 type 2 diabetic individuals was followed up for the occurrence of all-cause mortality. Clinical and echocardiographic data of diabetic patients were assessed retrospectively. LV GLS was evaluated on transthoracic echocardiography using speckle tracking imaging. Subclinical LV systolic dysfunction was defined as LV GLS > -17.0% from 104 healthy volunteers recruited from the community. A total of 178 (44.8%) diabetic individuals had evidence of subclinical LV systolic dysfunction and 46 (11.6%) died during follow-up. The presence of subclinical LV systolic dysfunction was independently associated with all-cause mortality on follow-up (hazard ratio [HR] 2.83, 95% confidence interval [CI] 1.40 to 5.71, p = 0.004). Diabetic individuals without subclinical LV systolic dysfunction had similar survival as the general population (standardized mortality ratio 0.94, 95% CI 0.52 to 1.58). Decision curve analysis showed identification of subclinical LV systolic dysfunction and quantification of LV GLS provided an incremental net clinical benefit at risk stratifying patients for risk of death at 5 years. In conclusion, subclinical LV systolic dysfunction is independently associated with all-cause mortality in diabetic patients. Decision curve analyses suggest use of LV GLS and identification of subclinical LV systolic dysfunction is clinically useful, and provided incremental net clinical benefit for diabetic individuals. (C) 2019 The Authors. Published by Elsevier Inc.

Background: Polysomnography is the gold standard for detection of central sleep apnea in patients with stable heart failure. However, this procedure is costly, time consuming, and a burden to the patient and therefore unsuitable as a screening method. An electronic health (eHealth) app to measure overnight oximetry may be an acceptable screening alternative, as it can be automatically analyzed and is less burdensome to patients. Objective: This study aimed to assess whether overnight pulse oximetry using a smartphone-compatible oximeter can be used to detect central sleep apnea in a population with stable heart failure. Methods: A total of 26 patients with stable heart failure underwent one night of both a polygraph examination and overnight saturation using a smartphone-compatible oximeter. The primary endpoint was agreement between the oxygen desaturation index (ODI) above or below 15 on the smartphone-compatible oximeter and the diagnosis of the polygraph. Results: The median age of patients was 66.4 (interquartile range, 62-71) years and 92% were men. The median body mass index was 27.1 (interquartile range, 24.4-30.8) kg/m2. Two patients were excluded due to incomplete data, and two other patients were excluded because they could not use a smartphone. Seven patients had central sleep apnea, and 6 patients had obstructive sleep apnea. Of the 7 (of 22, 32%) patients with central sleep apnea that were included in the analysis, 3 (13%) had an ODI≥15. Of all patients without central sleep apnea, 8 (36%) had an ODI

Cardiovascular disease is one of the main causes of morbidity and mortality worldwide. Despite the availability of highly effective treatments, the contemporary burden of disease remains huge. Digital health interventions hold promise to improve further the quality and experience of cardiovascular care. This position paper provides a brief overview of currently existing digital health applications in different cardiovascular disease settings. It provides the reader with the most relevant challenges for their large-scale deployment in Europe. The potential role of different stakeholders and related challenges are identified, and the key points suggestions on how to proceed are given. This position paper was developed by the European Society of Cardiology (ESC) e-Cardiology working group, in close collaboration with the ESC Digital Health Committee, the European Association of Preventive Cardiology, the European Heart Rhythm Association, the Heart Failure Association, the European Association of Cardiovascular Imaging, the Acute Cardiovascular Care Association, the European Association of Percutaneous Cardiovascular Interventions, the Association of Cardiovascular Nursing and Allied Professions and the Council on Hypertension. It relates to the ESC's action plan and mission to play a pro-active role in all aspects of the e-health agenda in support of cardiovascular health in Europe and aims to be used as guiding document for cardiologists and other relevant stakeholders in the field of digital health. The author(s) received no financial support for the research, authorship, and/or publication of this article.

e-Health encompasses the use of information and communication technologies (ICTs) in the support of health and health-related activity.1 It can be subdivided into several domains, listed in Table 1 .2 View this table: Table 1 The domains of e-health, involving healthcare administration and support, education, healthcare delivery, and research e-Health has the potential to provide innovate solutions to health issues, and is often viewed by politicians and healthcare professionals as a key ‘enabling’ technology to improve care and the experience of care for the those living with chronic conditions, particularly at a time of constrained healthcare funding. Behind all of this stands the individual/citizen/patient/customer, who is increasingly familiar with ICT and expects to find it supporting modern healthcare delivery, facilitating more personalized and person-centred care at the right time and in the right place. In theory, technological innovation should bring better inter-professional co-operation, information sharing, decision support, and flexibility to the healthcare system. However, there are important societal and professional constraints that reduce the impact of such innovation, including legal, ethical, and data protection issues. Healthcare professionals may be resistant to such innovation, particularly if the technologies are considered to be ‘solutions seeking a problem’ and where the evidence for the impact on quality of care is seen as less than robust. Indeed, ensuring proper integration of new technologies into the healthcare system is often difficult, requiring process redesign or ‘disruption’.6 Regulatory bodies, reimbursement authorities, and national and international political bodies often find it difficult to react quickly, or consistently, to this rapidly changing area. The European Union has an e-health action plan for 2012–2020, which states that the promise of ICT to increase efficiency, improve quality …

Medication adherence is of key importance in the treatment of cardiovascular disease. Studies consistently show that a substantial proportion of patients is non-adherent.For this review, telemedicine solutions that can potentially improve medication adherence in patients with cardiovascular disease were reviewed. A total of 475 PubMed papers were reviewed, of which 74 were assessed.Papers showed that evidence regarding telemedicine solutions is mostly conflictive. Simple SMS reminders might work for patients who do not take their medication because of forgetfulness. Educational interventions and coaching interventions, primarily delivered by telephone or via a web-based platform can be effective tools to enhance medication adherence. Finally, it should be noted that current developments in software engineering may dramatically change the way non-adherence is addressed in the nearby future.

Background: Recent evidence suggests that frequent monitoring using smartphone-compatible wearable technologies might improve clinical effectiveness and patient satisfaction of care. Objective: The aim of this study is to investigate the clinical effectiveness and patient satisfaction of a smart technology intervention in patients admitted with a ST elevation myocardial infarction (STEMI) or non-ST acute coronary syndrome (NST-ACS). Methods: In this single center, open, randomized controlled trial patients who suffered from STEMI or NST-ACS will be randomized 1:1 to an intervention group or control group. Both groups will be followed up to one year after the index event. The intervention group will take daily measurements with a smartphone-compatible electrocardiogram device, blood pressure (BP) monitor, weight scale, and activity tracker. Furthermore, two of four outpatient clinic visits will be replaced by electronic visits (1 and 6 months after index event). The control group will receive regular care, consisting of four outpatient clinic visits (1, 3, 6, and 12 months after index event). All patients will be asked to fill in validated questionnaires about patient satisfaction, quality of life, propensity of medication adherence, and physical activity. Results: The primary outcome of this trial will be percentage of patients with controlled BP. Secondary outcomes include patient satisfaction, health care utilization, major adverse cardiac events, medication adherence, physical activity, quality of life, and percentage of patients in which a sustained arrhythmia is detected. Conclusions: Smart technology could potentially improve care in postmyocardial infarction patients. This trial will investigate whether usage of smart technology can improve clinical- and cost-effectiveness of care. Trial Registration: Clinicaltrials.gov NCT02976376; https://clinicaltrials.gov/ct2/show/NCT02976376 (Archived by WebCite at http://www.webcitation.org/6tcvAdbdH) [JMIR Res Protoc 2017;6(9):e186]

Myocardial infarction (MI) is a major risk factor for heart failure (HF). The ECG is known to change during the acute and the healing phases of MI, and it stabilizes in the chronic phase. We expect that further ECG changes in the chronic period actually signify a worsening clinical condition / emergence of HF. One major characteristic that signifies an ECG change is the spatial QRS-T angle (SA). It is generally believed that a worsening ECG is accompanied by an enlargement of SA, but we have seen that some patients who developed HF after MI showed a decrease of SA. In the current study we aim to demonstrate that development of HF after MI is accompanied by a change in SA, but irrespective its sign. We retrospectively studied 81 control patients (67/14 male/female, mean±SD age 64±10 years) and 48 cases (38/10 male/female mean±SD age 60±12 years). Control patients had a healed MI and had, thereafter, two elective ECGs (baseline and follow-up) made >1 year apart. Case patients had a healed MI but presented later at our HF outpatient clinic with HF symptoms. Their baseline ECG was made at least 6 months post MI; the ECG made when presenting at the HF outpatient clinic was called follow-up ECG. In each ECG, we computed SA, and in each patient we computed the difference between the baseline and follow-up SAs. Finally we performed a ROC analysis on the signed and unsigned individual SA differences. ROC analysis revealed an area-under-the-curve (AUC) of 0.71 for signed SA differences, and 0.78 for unsigned SA differences. Both AUCs were significantly larger than 0.5, but the difference between these two curves did not reach statistical significance. In conclusion our study suggests that the best case-control separation can be attained by considering absolute SA changes, but a larger study is needed to demonstrate that SA changes irrespective the sign are performing significantly better than signed SA changes. The absolute change in SA is a promising ECG feature to detect emerging HF in post-MI patients.

Background: Young patients with congenital heart disease reaching adulthood face mandatory transition to adult cardiology. Their new cardiologist needs to assess the chances of major future events such as surgery. Using a large national registry, we assessed if patient characteristics at the age of 18 years could predict the chance of congenital heart surgery in adulthood.Design and methods: Of 10,300 patients from the CONCOR national registry, we used general patient characteristics at age 18 years, underlying congenital heart defect, history of complications, and interventions in childhood as potential predictors of congenital heart surgery occurring from age 18 years up to age 40 and 60 years. Cox regression was used to calculate hazard ratios with 95% confidence intervals. Analyses were performed separately for all congenital heart surgery and for valvular surgery alone.Results: Altogether 2427 patients underwent congenital heart surgery after age 18 years, 1389 of whom underwent valvular surgery. Underlying heart defect, male sex, multiple defects, childhood endocarditis, supraventricular arrhythmia, aortic complications and paediatric cardiovascular surgery, independently predicted adult congenital heart surgery. The mean chance of congenital heart surgery was 22% up to age 40 and 43% up to age 60 years; individual chances spanned from 9-68% up to age 40 and from 19-93% up to age 60 years.Conclusion: At the time of transition from paediatric to adult cardiology, an easily obtainable set of characteristics of patients with congenital heart disease can meaningfully inform cardiologists about the patient's individual chance of surgery in adulthood. Our findings warrant validation in other cohorts.

Background Recently published randomised clinical trials indicate that prolonged electrocardiom (ECG) monitoring might enhance the detection of paroxysmal atrial fibrillation (AF) in cryptogenic stroke or transient ischaemic attack (TIA) patients. A device that might be suitable for prolonged ECG monitoring is a smartphone-compatible ECG device (Kardia Mobile, Alivecor, San Francisco, CA, USA) that allows the patient to record a single-lead ECG without the presence of trained health care staff. The MOBILE-AF trial will investigate the effectiveness of the ECG device for AF detection in patients with cryptogenic stroke or TIA. In this paper, the rationale and design of the MOBILE-AF trial is presented. Methods For this international, multicentre trial, 200 patients with cryptogenic stroke or TIA will be randomised. One hundred patients will receive the ECG device and will be asked to record their ECG twice daily during a period of 1 year. One hundred patients will receive a 7-day Holter monitor. Discussion The primary outcome of this study is the percentage of patients in which AF is detected in the first year after the index ischaemic stroke or TIA. Secondary outcomes include markers for AF prediction, orally administered anticoagulation therapy changes, as well as the incidence of recurrent stroke and major bleeds. First results can be expected in mid-2019. Trial registration ClinicalTrials.gov, ID: NCT02507986. Registered on 15 July 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2131-0) contains supplementary material, which is available to authorized users.

Background— This large multicenter, international bicuspid aortic valve (BAV) registry aimed to define the sex differences in prevalence, valve morphology, dysfunction (aortic stenosis/regurgitation), aortopathy, and complications (endocarditis and aortic dissection). Methods and Results— Demographic, clinical, and echocardiographic data at first presentation of 1992 patients with BAV (71.5% men) were retrospectively analyzed. BAV morphology and valve function were assessed; aortopathy configuration was defined as isolated dilatation of the sinus of Valsalva or sinotubular junction, isolated dilatation of the ascending aorta distal to the sinotubular junction, or diffuse dilatation of the aortic root and ascending aorta. New cases of endocarditis and aortic dissection were recorded. There were no significant sex differences regarding BAV morphology and frequency of normal valve function. When presenting with moderate/severe aortic valve dysfunction, men had more frequent aortic regurgitation than women (33.8% versus 22.2%, P P P P P =0.037) and aortic dissections (0.5% versus 0%, P Conclusions— Although there is a male predominance among patients with BAV, men with BAV had more frequently moderate/severe aortic regurgitation at first presentation compared with women, whereas women presented more often with moderate/severe aortic stenosis compared with men. Furthermore, men had more frequent aortopathy than women.

Smartphones, mobile applications ('apps'), social media, analytics, and the cloud are profoundly changing the practice of medicine and the way health decisions are made. With the constant progress of technology, the measurement of vital signals becomes easier, cheaper, and practically a standard approach in clinical practice. The interest in measuring vital signals goes beyond medical professionals to the general public, patients, informal caregivers, and healthy individuals, who frequently lack any formal medical training. On smartphone platforms such as iOS and Android, a proliferation of health or medical 'apps' acquire and analyse a variety of vital signs through embedded sensors, interconnected devices or peripherals utilising on occasion analytics and social media. Smartphone vendors compete with traditional medical device manufacturers in the grey area between health care, wellness, and fitness, as US and EU regulatory bodies are setting and revising rules for these new technologies. On the other hand, in the absence of robust validation results, clinicians are hesitant to trust measurements by apps or recommend specific apps to their patients, partly also due to lack of a cost reimbursement policy. This review focuses on the acquisition and analysis on smartphones of three important vital signs in the cardiovascular and respiratory field as well as in rehabilitation i.e. heart or pulse rate, blood pressure, and blood oxygenation. The potential, pitfalls, and perspectives on mobile devices and smartphone apps for health management by patients and healthy individuals are discussed.

Aims Mortality and ventricular arrhythmias are reduced in patients responding to cardiac resynchronization therapy (CRT). This response is accompanied by improvement in LVEF, and some patients even outgrow original eligibility criteria for implantable cardioverter-defibrillator (ICD) implantation. It is however unclear if these patients still benefit from ICD treatment. The current study aimed to evaluate if the incidence of ICD therapy is related to the extent of CRT response. Methods and results All patients who underwent primary prevention CRT-defibrillator implantation were included. They were divided into subgroups according to the reduction in LV end-systolic volume (LVESV) 6 months after implantation. Pre-defined subgroups were: negative responders (increased LVESV), non-responders (decreased LVESV 0–14%), responders (decreased LVESV 15–29%), and super-responders (decreased LVESV ≥30%). During a median follow-up of 57 months (25th–75th percentile 39–84), 512 patients were studied [101 (20%) negative responders, 101 (20%) non-responders, 149 (29%) responders, and 161 (31%) super-responders]. In the first year of follow-up super-responders received significantly less appropriate ICD therapy (3% vs. 12%; P

Background— Limited data are available on efficacy, safety, and long-term prognosis after cardiac resynchronization therapy (CRT) in elderly patients. We aimed at evaluating the effect of CRT, device-related adverse events, and long-term outcome after CRT among elderly patients. Methods and Results— A total of 798 CRT recipients (208 elderly: age, ≥75 years; 590 nonelderly: age, P =0.552), early (within 30 days; P =0.984), and long-term adverse events (entire follow-up; hazard ratio, 0.90; P =0.620) were observed between groups. During long-term follow-up (median, 38.6 months; interquartile range, 22.5–61.8 months), all-cause mortality rate was significantly higher among the elderly patients. However, the differences in cumulative event rates started after 4 years of follow-up ( P =0.013), and the cause of death was mainly noncardiac (29% in the elderly versus 19% in nonelderly; P P =0.019), impaired renal function (hazard ratio, 0.975; P =0.006), and reduced 6-minute walk distance (hazard ratio, 0.996; P Conclusions— CRT efficacy and device-related adverse events in elderly patients were comparable with that of nonelderly patients. However, after 4 years of follow-up, elderly patients showed worse survival and the cause of death was mainly noncardiac. Diabetes mellitus, impaired renal function, and reduced 6-minute walk distance were independently associated with all-cause mortality of elderly patients.

Background Although randomized trials have shown the beneficial effect on survival of an implantable cardioverter defibrillator (ICD) as primary prevention therapy in selected patients, data concerning the cost-effectiveness in routine clinical practice remain scarce. Accordingly, the purpose of this study was to assess the cost-effectiveness of primary prevention ICD implantation in the real world. Methods Patients receiving primary prevention single-chamber or dual-chamber ICD implantation at the Leiden University Medical Center were included in the study. Using a Markov model, lifetime cost, life years (LYs), and gained quality-adjusted life years (QALYs) were estimated for device recipients and control patients. Data on mortality, complication rates, and device longevity were retrieved from our center and entered into the Markov model. To account for model assumptions, one-way deterministic and probabilistic sensitivity analyses were performed. Importantly, calculations for the estimated incremental cost-effectiveness rate (ICER) per QALY gained are based on several numbers of assumptions, and accordingly findings may have over- or underestimated the cost-effectiveness of ICD therapy. Results Primary prevention ICD implantation adds an estimated mean of 2.07 LYs and 1.73 QALYs. Increased lifetime cost for single-chamber and dual-chamber ICD recipients were estimated at €60,788 and €64,216, respectively. This resulted for single-chamber ICD recipients, in an estimated ICER of €35,154 per QALY gained. In dual-chamber ICD recipients, an estimated ICER of €37,111 per QALY gained was calculated. According to the probabilistic sensitivity analysis, estimated cost per QALY gained are €35,837 (95% confidence interval [CI]: €28,368–€44,460) for single-chamber and €37,756 (95% CI: €29,055–€46,050) for dual-chamber ICDs. Conclusions On the basis of data and detailed costs, derived from routine clinical practice, ICD therapy in selected patients with a reduced left ventricular ejection fraction appears to be cost-effective.

Demographic changes, progress in medicine technology and regional problems in providing healthcare to low density populations are posing great challenges to our healthcare systems. Rapid progress in computer sciences and information technologies have a great impact on the way healthcare will be delivered in the near future. This article describes opportunities and challenges of eHealth and telemedicine in the framework of our health systems and, in particular, in the context of today's cardiology services. The most promising applications of eHealth and telemedicine include: (a) prevention and lifestyle interventions; (b) chronic disease management including hypertension, diabetes and heart failure; (c) arrhythmia detection including early detection of atrial fibrillation and telemonitoring of devices such as pacemaker, internal cardioverter defibrillators and implantable rhythm monitoring devices; (d) telerehabilitation. Major obstacles to the integration of eHealth and telemedicine into daily clinical practice include limited large-scale evidence, in particular, for cost-effectiveness, as well as lack of interoperability, inadequate or fragmented legal frameworks and lack of reimbursement. An important challenge for those involved in these new technologies will be to keep the main focus on patient's individual needs and to carefully evaluate the evidence behind the practice.

Recent developments in implantable cardioverter-defibrillators (ICDs) and smartphone technology have increased the possibilities for remote monitoring. It is the purpose of this review to give an overview of these new possibilities.Remote monitoring in ICD allows for early detection of lead fractures and remote follow-up of patients. Possible limitations are the lack of standardization and the possible unsafety of the data stored on the ICD. Secondly, remote monitoring of health parameters using smartphone compatible wearables and smartphone medical apps is addressed. Possible limitations include the fact that the majority of smartphone apps are unregulated by the regulatory authorities and privacy issues such as selling of app-generated data to third parties. Lastly, clinical studies with smartphone apps are discussed. Expert commentary: New technologies in ICDs and smartphones have the potential to be used for remote monitoring. However, unreliability of smartphone technology, inadequate legislation and lack of reimbursement impede implementation.

This study sought to identify an ECG variable that can be used to detect emerging heart failure (HF) in patients after myocardial infarction (MI). We adopted the spatial QRS-T angle (SA) as a measure of ECG concordance, and hypothesized that the ECG of patients who develop HF becomes less concordant. We computed SA in ECGs of 20 patients (15/5 male/female, mean±SD age 64±10 yrs), at baseline (6 months after MI) and 3.8±2.4 yrs later, when they presented with HF. SA increased from 97±36° to 119±34° (P=0.003). SA decreased only in 4 pts. We conclude that SA is potentially a suitable ECG monitoring variable for early detection of HF after MI.

The European Heart Rhythm Association (EHRA), a branch of the European Society of Cardiology (ESC), in observance to its mission - To improve the quality of life of the European population by reducing the impact of cardiac arrhythmias and reduce sudden cardiac death – is proudly announcing the launch of a Supplement to EP Europace Journal dedicated to the EHRA White Book entitled: Statistics on the Use of Cardiac Electronic Devices and Electrophysiological Procedures in the ESC 54 countries: 2012 Report from the European Heart Rhythm Association . The report represents a structured analysis of data collected in the EHRA White Book, an important monograph published by EHRA since 2008. The current report brings together the most up-to-date statistics on electrophysiological procedures including the implantation of cardiovascular electronic devices in the 54 ESC countries and includes all data of the first five Editions of the EHRA White Book. The report has been arranged to present the full information about the historical perspective of the EHRA White Book, the methodological aspects of the data collection and analysis of major treatments of heart rhythm disorders: Implantable Pulse Generators (IPGs), Implantable Cardioverter Defibrilators (ICDs), Cardiac Resynchronization Therapy (CRTs) and Catheter Ablation Procedures. Moreover, the increasing relevance of societal and economic implications of life-saving therapies led EHRA to give particular emphasis to them in a section of the current report. The figures and tables of this report speak by themselves and clearly highlight significant inequalities in healthcare In Europe, with an additional very large treatment gradient from West to East. These inequalities in healthcare are not specific of one treatment but equally apply to all therapies considered in the EHRA White Book. Barrier to access to different therapies are not only represented by the heterogeneous reimbursement system in ESC countries or by other country-specific …

Objectives To construct a risk score out of baseline variables to estimate the risk of death without prior implantable cardioverter defibrillator (ICD) in primary prevention ICD patients with ischaemic heart disease. Design Retrospective cohort study. Setting Tertiary care facility in The Netherlands. Patients All patients with ischaemic heart disease who received an ICD for primary prevention of sudden cardiac death at the Leiden University Medical Center, Leiden, The Netherlands in the period 1996–2009. Main outcome measure All-cause mortality without prior appropriate ICD therapy (anti-tachycardia pacing or shock). Results 900 patients (87% men, mean age 64±10 years) were included in the analysis. During a median follow-up of 669 days (IQR 363–1322 days), 150 patients (17%) died and 191 (21%) patients received appropriate device therapy. 114 (13%) patients died without prior appropriate therapy. Stratification of the risk for death without prior appropriate therapy resulted in risk categorisation of patients as low, intermediate or high risk. NYHA ≥III, advanced age, diabetes mellitus, left ventricular ejection fraction ≤25% and a history of smoking were significant independent predictors of death without appropriate ICD therapy. 5-year cumulative incidence for death without prior appropriate therapy ranged from 10% (95% CI 6% to 16%) in low-risk patients to 41% (95% CI 33% to 51%) in high-risk patients. Conclusions The risk of death without prior appropriate ICD therapy can be predicted in primary prevention ICD patients with ischaemic heart disease, which facilitates patient-tailored risk estimation.

BACKGROUND: One of the major drawbacks of implantable cardioverter-defibrillator (ICD) treatment is the limited device service life. Thus far, data concerning ICD longevity under clinical circumstances are scarce. In this study, the ICD service life was assessed in a large cohort of ICD recipients. OBJECTIVE: To assess the battery longevity of ICDs under clinical circumstances. METHODS: All patients receiving an ICD in the Leiden University Medical Center were included in the analysis. During prospectively recorded follow-up visits, reasons for ICD replacement were assessed and categorized as battery depletion and non-battery depletion. Device longevity and battery longevity were calculated. The impact of device type, generation, manufacturer, the percentage of pacing, the pacing output, and the number of shocks on the battery longevity was assessed. RESULTS: Since 1996, 4673 ICDs were implanted, of which 1479 ICDs (33%) were replaced. Mean device longevity was 5.0 ± 0.1 years. A total of 1072 (72%) ICDs were replaced because of battery depletion. Mean battery longevity of an ICD was 5.5 ± 0.1 years. When divided into different types, mean battery longevity was 5.5 ± 0.2 years for single-chamber ICDs, 5.8 ± 0.1 for dual-chamber ICDs, and 4.7 ± 0.1 years for cardiac resynchronization therapy-defibrillators (P

Background: The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long-term follow-up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA). Methods: Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow-up 3.4 ± 1.5 years), 165 8-French (F) Riata leads (follow-up 4.6 ± 2.6 years), and 30 7-F Riata leads (follow-up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow-up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation. Results: During follow-up, the yearly lead failure rate of the Sprint Fidelis lead, 7-F Riata lead, 8-F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4–5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0–18.0, P < 0.05) for the 7-F Riata lead. One cardiac perforation was observed (3.3%) in the 7-F Riata group versus none in the 8-F Riata and Sprint Fidelis lead population. Conclusion: The current update demonstrates that the risk of lead failure during long-term follow-up is significantly increased for both the Sprint Fidelis and the 7-F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred. (PACE 2012; 35:652–658)

With recent advances in medical and surgical management, most patients with congenital heart disease (CHD) survive to reproductive age. Current guidelines recommend counseling about inheritance and transmission of CHD to offspring. We evaluated whether adult CHD patients recalled having received information about the inheritance of their CHD, patients' knowledge about inheritance and their concerns in this regard. A questionnaire was sent to 486 non-syndromic CHD patients aged 20-45 years. We received 332 useful questionnaires (response rate 68%). One-third (33%) of patients recalled receiving information about inheritance of CHD from their cardiologist, and 13% had consulted a clinical geneticist. Eight percent of patients who were considering having children estimated the recurrence risk for their own offspring to be 1% or lower, whereas one-fourth (25%) estimated it to be higher than 10%. According to our classification, 44% estimated the recurrence risk in a correct range of magnitude. Additional information about inheritance of CHD was desired by 41% of patients. Forty-two percent of patients considering having children reported concerns about transmitting CHD to offspring. We conclude that a substantial proportion of adult CHD patients lacks knowledge and desires more information about inheritance, indicating a need for better patient education. Current guidelines and/or their implementation do not seem to meet the needs of these patients. A dedicated program of counseling for adults with CHD has to be developed to optimize knowledge and satisfaction with information provision and to reduce or manage concerns regarding inheritance of CHD.

Background: Statistics on cause-specific mortality are important for prognostic research. The aim of this study was to assess the utility of the national mortality registry in research on causes of death in adult patients with congenital heart disease (CHD).Methods: The CONCOR registry of over 10,000 adults with CHD was used to verify the causes of death provided by the WHO guidelines based national mortality registry, by linkage.Results: Of 7277 patients linked to the national mortality registry, 196 (2.4%) were recorded deceased, versus 228 deceased patients (3.1%) recorded in the CONCOR registry, during a follow-up of 25,900 patient years. Median age at death was 48.9 years. Of all deaths in the CONCOR registry, 77% had a cardiovascular origin; nearly 50% were due to progressive heart failure and arrhythmias. The national mortality registry recorded death due to progressive heart failure and arrhythmias in only 8.5%. Moreover, this registry recorded death with an 'unspecified' cause in approximately 30%, primarily containing patients who died due to progressive heart failure and arrhythmias according to their medical records.Conclusion: WHO guidelines based national mortality registries lack the specificity and completeness needed for accurate research on causes of death in adult patients with CHD. (C) 2010 Elsevier Ireland Ltd. All rights reserved.

Background Three quarters of patients with 22q11.2 Deletion Syndrome (22q11.2DS) have congenital heart disease (CHD), typically conotruncal heart defects. Although it is currently common practice to test all children with typical CHD for 22q11.2DS, many adult patients have not been tested in the past and therefore 22q11.2DS might be under-recognised in adults. Objectives To determine the prevalence of 22q11.2DS in adults with tetralogy of Fallot (TOF) and pulmonary atresia (PA)/ventricular septal defect (VSD) and to assess the level of recognition of the syndrome in adult patients. Methods Patients were identified from CONCOR, a nationwide registry for adult patients with CHD. Inclusion criteria were diagnosis of TOF or PA/VSD and the availability of DNA. Patients with syndromes other than 22q11.2DS were excluded. Multiplex ligation-dependent probe amplification was used to detect 22q11.2 microdeletions. Results 479 patients with TOF and 79 patients with PA/VSD (56% male, median age 34.7 years) were included and analysed. Twenty patients were already known to have 22q11.2DS. A 22q11.2 microdeletion was detected in a further 24 patients. Thirty-one patients with TOF (6.5%) had 22q11.2DS, whereas 13 patients with PA/VSD had 22q11.2DS (16.5%). Of all 22q11.2 microdeletions, 54% (24/44) were unknown before this study. Conclusion This study shows that although the prevalence of 22q11.2DS in adults with TOF and PA/VSD is substantial, it is unrecognised in more than half of patients. As the syndrome has important clinical and reproductive implications, a diagnostic test should be considered in all adult patients with TOF and PA/VSD.

Background— Despite the positive effect on mortality in selected patients, implantable cardioverter-defibrillator therapy is also associated with potential malfunction of the implanted system. The present study provides the long-term lead failure rate in a large single-center cohort. Methods and Results— Since 1992, a total of 2068 implantable cardioverter-defibrillator patients with 2161 defibrillation leads were prospectively collected. Data of the implant procedure and all follow-up visits were recorded. All cases of lead removal or capping or placing of an additional pace or sense lead were noted and analyzed. Lead models were grouped by manufacturer and approximate lead diameter in French. During a mean follow-up of 36 months, 82 (3.8%) cases of lead failure were identified. Cumulative incidence of lead failure at 1 year was 0.6%; at 5 years, 6.5%; and at 10 years, 16.4%. The highest risk of lead failure was found in small-diameter leads. Adjusted hazard ratio was 6.4 (95% CI, 3.2 to 12.8) for Medtronic 7F leads, when compared with all other leads. Conclusions— In this large single-center experience, the overall incidence of lead failure was 1.3 (95% CI, 1.0 to 1.6) per 100 lead-years. Comparison of different groups of leads shows major differences in event rates. Specific manufacturer’s small-diameter defibrillation leads may have a higher risk of early lead failure.

Background and objectives Cardiac resynchronization therapy (CRT) is a well established heart failure treatment that has shown to improve renal function. However, landmark CRT trials excluded patients with severe renal dysfunction. Therefore, this study evaluated the effect of CRT on renal function and long-term prognosis in patients with stage 4 CKD. Design, setting, participants, & measurements This study evaluated 73 consecutive CRT patients (71±10 years) with stage 4 CKD who underwent echocardiographic and renal function evaluation at baseline and 6-month follow-up between 2000 and 2012. As a control group, 18 patients with stage 4 CKD who received an implantable cardioverter defibrillator (ICD) were selected. CRT recipients with ≥15% reduction in left ventricular end-systolic volume at 6-month follow-up were classified as CRT responders. During long-term follow-up (median, 33 months), appropriate defibrillator therapy, heart failure hospitalizations, and all-cause mortality (combined end point) were recorded. Results At 6-month follow-up, a significant reduction in left ventricular end-systolic volume was observed in CRT patients compared with patients with ICD (from 159±78 to 145±78 ml in CRT patients and from 126±54 to 119±49 ml in ICD patients; P =0.05), and CRT response was observed in 22 patients (30%). Compared with ICD patients, eGFR improved among CRT patients (from 25±4 to 30±9 ml/min per 1.73 m 2 ; interaction time and group, P =0.04) and was more pronounced among CRT responders (25±3 to 34±9 ml/min per 1.73 m 2 ; P P =0.03). More importantly, CRT response was independently associated with improved survival free from the combined end point (hazard ratio, 0.51; 95% confidence interval, 0.27 to 0.98; P =0.04) after adjustment for clinical and echocardiographic parameters. Conclusions Response to CRT occurs in approximately 30% of patients with stage 4 CKD, which is less than in the average CRT population. CRT was associated with better clinical outcome, and particularly, CRT response was associated with improvement in eGFR and better long-term prognosis.

Out-of-office blood pressure (BP) monitoring is advocated by the guidelines for various reasons. Recently developed smartphone compatible BP monitors are potentially very useful for out-of-office BP monitoring. This study is ought to compare performances of these BP monitors.

Background Information technology has transformed the way healthcare is carried out and documented. Presently, the practice of healthcare generates, exchanges and stores huge amounts of patient-specific information. In addition to the traditional clinical narrative information, databases in modern health centres automatically capture structured data relating to all aspects of care, including: diagnosis, medication, laboratory test results, imaging data and many other.

Mortality and ventricular arrhythmias are reduced in patients responding to cardiac resynchronization therapy (CRT). This response is accompanied by improvement in LVEF, and some patients even outgrow original eligibility criteria for implantable cardioverter-defibrillator (ICD) implantation. It is however unclear if these patients still benefit from ICD treatment. The current study aimed to evaluate if the incidence of ICD therapy is related to the extent of CRT response.All patients who underwent primary prevention CRT-defibrillator implantation were included. They were divided into subgroups according to the reduction in LV end-systolic volume (LVESV) 6 months after implantation. Pre-defined subgroups were: negative responders (increased LVESV), non-responders (decreased LVESV 0-14%), responders (decreased LVESV 15-29%), and super-responders (decreased LVESV ≥30%). During a median follow-up of 57 months (25th-75th percentile 39-84), 512 patients were studied [101 (20%) negative responders, 101 (20%) non-responders, 149 (29%) responders, and 161 (31%) super-responders]. In the first year of follow-up super-responders received significantly less appropriate ICD therapy (3% vs. 12%; P 0.001). The 5-year cumulative incidence of appropriate ICD therapy was 31% [95% confidence interval (CI) 19-43] in negative responders, 39% (95% CI 25-53) in non-responders, 34% (95% CI 25-43) in responders, and 27% (95% CI 18-35) in super-responders, respectively (p = 0.13).The extent of CRT response was associated with a parallel reduction of appropriate device therapy during the first year of follow-up. Thereafter, no association was observed. Furthermore, 23% of super-responders were treated for potentially life-threatening arrhythmias and benefit from ICD treatment.

Although the presence of an RV lead is a potential cause of tricuspid regurgitation (TR), the clinical impact of significant lead-induced TR is unknown.To evaluate the effect of significant lead-induced TR on cardiac performance and long-term outcome after cardioverter-defibrillator (ICD) or pacemaker implantation.A retrospective cohort of 239 ICD (n=191) or pacemaker (n=48) recipients (age 60±14 years, 77% male) from a tertiary care university hospital, with an echocardiographic evaluation before and within 1-1.5 years after device implantation were included. Significant lead-induced TR was defined as TR worsening, reaching a grade ≥2 at follow-up echocardiography. During long-term follow-up (median 58, IQR 35-76 months), all-cause mortality and heart failure related events were recorded.Before device implantation, most patients had TR grade 1 or 2 (64.0%) or no TR (33.9%), but after lead placement, significant TR was seen in 91 patients (38%). Changes in cardiac volumes and function at follow-up were similar between patients with and without significant lead-induced TR, except for larger RV diastolic area (17±6mm(2) vs 16±5mm(2), p=0.009), larger right atrial diameter (39±10 mm vs 36±8 mm, p0.001) and higher pulmonary arterial pressures (41±15 mm Hg vs 33±10 mm Hg, p0.001) in patients with significant lead-induced TR. Patients with significant lead-induced TR had worse long-term survival (HR=1.687, p=0.040) and/or more heart failure related events (HR=1.641, p=0.019). At multivariate analysis, significant lead-induced TR was independently associated with all-cause mortality (HR=1.749, p=0.047) together with age, LVEF and percentage RV pacing.Significant lead-induced TR is associated with poor long-term prognosis.

Inhibition of nitric oxide (NO) production may reduce post-hypoxic-ischemic (HI) neonatal brain damage, but may also induce pulmonary hypertension by inhibiting endogenous NO production in the pulmonary vascular bed. The aim of this study was to evaluate the effect of nitric oxide inhibition on pulmonary artery pressure and oxygen need after hypoxic ischemia. Severe HI was produced in 18 newborn lambs. After completion of HI the lambs were divided into three groups of 6 animals receiving either placebo (Cont), low dose Nω-nitro-L-arginine (10mg/kg i.v., NLA-10) or high dose (40mg/kg i.v., NLA-40) to block NO production. Pulmonary artery pressure (Pap), aortic pressure, blood gases, inspiratory oxygen concentration and ventilator settings were recorded before and 15, 60, 120 and 180 min after HI. Mean Pap rose initially significantly as compared to baseline in all groups at 15 min post-HI, decreased to normal in Cont but not in treated animals; 180 min post-HI mean Pap was significantly higher in both treated groups as compared to control (NLA-10: 32 mm Hg, NLA-40: 34 mm Hg, Cont: 25 mm Hg, p < 0.05 for NLA-10 and NLA-40 vs. Cont). Moreover, in both NLA-treated groups the oxygenation index was significantly elevated 120 and 180 min post-HI as compared to those of the Cont group. NO synthase inhibition after HI causes a prolonged increase in pulmonary artery pressure leading to a higher oxygen need.

Since an excessive production of nitric oxide upon reperfusion/reoxygenation may play an important role in post-hypoxic-ischemic (HI) brain injury, we investigated whether immediate post-HI blockade of nitric oxide synthesis by N-ω-nitro-L-arginine (NLA) may reduce this injury. In 18 newborn lambs, subjected to severe HI, changes from pre-HI values were measured for carotid blood flow (Qcar [ml/min]) as a measure of changes in brain blood flow, (relative) cerebral metabolic rate of oxygen (CMRO2), and electrocortical brain activity (ECBA) at 15, 60, 120 and 180 min after HI. Upon completion of HI, at the onset of reperfusion and reoxygenation, 6 lambs received a placebo (control group), 6 low-dose NLA (10 mg/kg i.v., NLA-10 group), and 6 high-dose NLA (40 mg/kg i.v., NLA-40 group). Histological damage to cerebellar Purkinje cells was assessed after termination of the experiment. Only the control group showed a distinct initial post-HI cerebral hyperperfusion. From 60 min after HI onward Qcar was decreased to about 75% of pre-HI Qcar in all 3 groups, although none of these changes in Qcar reached statistical significance. Despite the decreased Qcar in all 3 groups, only the control group showed a significantly decreased CMRO2 ECBA and its bandwidth decreased in all groups, but only recovered in the NLA-10 group 180 min after HI. The brain to body mass ratio (%) and percentage necrotic Purkinje cells were, respectively: 15.3 ± 0.8 and 56 ± 10 (control group); 12.5 ± 1.2 and 36 ± 9(NLA-10 group), and 11.3 ± 1.0 (p < 0.05 vs. the control group) and 35 ± 14 (NLA-40 group). Since post-HI reperfusion injury of the brain has been characterized by a decreased CMRO2 and electrical brain activity, we conclude that preservation of CMRO2 in both NLA groups, but a recovery of ECBA and its bandwidth only in the NLA-10 group, suggests that NLA, and especially low-dose NLA, may reduce post-HI brain injury.

To assess differences in clinical outcome of implantable cardioverter-defibrillator (ICD) treatment in men and women.Prospective cohort study.University Medical Center.1946 primary prevention ICD recipients (1528 (79%) men and 418 (21%) women). Patients with congenital heart disease were excluded for this analysis.All-cause mortality, ICD therapy (antitachycardia pacing and shock) and ICD shock.During a median follow-up of 3.3 years (25th-75th percentile 1.4-5.4), 387 (25%) men and 76 (18%) women died. The estimated 5-year cumulative incidence for all-cause mortality was 20% (95% CI 18% to 23%) for men and 14% (95% CI 9% to 19%) for women (log rank p0.01). After adjustment for potential confounding covariates all-cause mortality was lower in women (HR 0.65; 95% CI 0.49 to 0.84; p0.01). The 5-year cumulative incidence for appropriate therapy in men was 24% (95% CI 21% to 28%) as compared with 20% (95% CI 14% to 26%) in women (log rank p=0.07). After adjustment, a non-significant trend remained (HR 0.82; 95% CI 0.64 to 1.06; p=0.13).In clinical practice, 21% of primary prevention ICD recipients are women. Women have lower mortality and tend to experience less appropriate ICD therapy as compared with their male peers.

Objective To assess the proportion of current implantable cardioverter defibrillator (ICD) recipients who would be suitable for a subcutaneous lead ICD (S-ICD). Design A retrospective cohort study. Setting Tertiary care facility in the Netherlands. Patients All patients who received a single- or dual-chamber ICD in the Leiden University Medical Center between 2002 and 2011. Patients with a pre-existent indication for cardiac pacing were excluded. Main outcome measure Suitability for an S-ICD defined as not reaching one of the following endpoints during follow-up: (1) an atrial and/or right ventricular pacing indication, (2) successful antitachycardia pacing without a subsequent shock or (3) an upgrade to a CRT-D device. Results During a median follow-up of 3.4 years (IQR 1.7–5.7 years), 463 patients (34% of the total population of 1345 patients) reached an endpoint. The cumulative incidence of ICD recipients suitable for an initial S-ICD implantation was 55.5% (95% CI 52.0% to 59.0%) after 5 years. Significant predictors for the unsuitability of an S-ICD were: secondary prevention, severe heart failure and prolonged QRS duration. Conclusions After 5 years of follow-up, approximately 55% of the patients would have been suitable for an S-ICD implantation. Several baseline clinical characteristics were demonstrated to be useful in the selection of patients suitable for an S-ICD implantation.

Remote follow-up of implanted implantable cardioverter defibrillators (ICDs) may offer a solution to the problem of overcrowded outpatient clinics, and may also be effective in detecting clinical events early. Data obtained from remote follow up systems, as developed by all major device companies, are stored in a central database system, operated and owned by the device company. A problem now arises that the patient's clinical information is partly stored in the local electronic health record (EHR) system in the hospital, and partly in the remote monitoring database, which may potentially result in patient safety issues.To address the requirement of integrating remote monitoring data in the local EHR, the Integrating the Healthcare Enterprise (IHE) Implantable Device Cardiac Observation (IDCO) profile has been developed. This IHE IDCO profile has been adapted by all major device companies.In our hospital, we have implemented the IHE IDCO profile to import data from the remote databases from two device vendors into the departmental Cardiology Information System (EPD-Vision). Data is exchanged via a HL7/XML communication protocol, as defined in the IHE IDCO profile.By implementing the IHE IDCO profile, we have been able to integrate the data from the remote monitoring databases in our local EHRs. It can be expected that remote monitoring systems will develop into dedicated monitoring and therapy platforms. Data retrieved from these systems should form an integral part of the electronic patient record as more and more out-patient clinic care will shift to personalized care provided at a distance, in other words at the patient's home.