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1.
  • Barra, Sérgio, et al. (författare)
  • Sex-specific outcomes with addition of defibrillation to resynchronisation therapy in patients with heart failure
  • 2017
  • Ingår i: Heart. - : BMJ. - 1355-6037 .- 1468-201X. ; 103:10, s. 753-760
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective Among primary prevention patients with heart failure receiving cardiac resynchronisation therapy (CRT), the impact of additional implantable cardioverter defibrillator (ICD) treatment on outcomes and its interaction with sex remains uncertain. We aim to assess whether the addition of the ICD functionality to CRT devices offers a more pronounced survival benefit in men compared with women, as previous research has suggested. Methods Observational multicentre cohort study of 5307 consecutive patients with ischaemic or nonischaemic dilated cardiomyopathy and no history of sustained ventricular arrhythmias having CRT implantation with (cardiac resynchronisation therapy defibrillator (CRT-D), n=4037) or without (cardiac resynchronisation therapy pacemaker (CRT-P), n=1270) defibrillator functionality. Using propensity score (PS) matching and weighting and cause-of-death data, we assessed and compared the outcome of patients with CRT-D versus CRT-P. This analysis was stratified according to sex. Results After a median follow-up of 34 months (interquartile range 22-60 months) no survival advantage, of CRT-D versus CRT-P was observed in both men and women after PS matching (HR=0.95, 95% CI 0.77 to 1.16, p=0.61, and HR=1.30, 95% CI 0.83 to 2.04, p=0.25, respectively). With inverse-probability weighting, a benefit of CRT-D was seen in male patients (HR 0.78, 95% CI 0.65 to 0.94, p=0.012) but not in women (HR 0.87, 95% CI 0.63 to 1.19, p=0.43). The excess unadjusted mortality of patients with CRT-P compared with CRT-D was related to sudden cardiac death in 7.4% of cases in men but only 2.2% in women. Conclusions In primary prevention patients with CRT indication, the addition of a defibrillator might convey additional benefit only in well-selected male patients.
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2.
  • Barra, Sérgio, et al. (författare)
  • Very long-term survival and late sudden cardiac death in cardiac resynchronization therapy patients
  • 2019
  • Ingår i: European Heart Journal. - : Oxford University Press (OUP). - 1522-9645 .- 0195-668X. ; 40:26, s. 2121-2127
  • Tidskriftsartikel (refereegranskat)abstract
    • AIMS: The very long-term outcome of patients who survive the first few years after receiving cardiac resynchronization therapy (CRT) has not been well described thus far. We aimed to provide long-term outcomes, especially with regard to the occurrence of sudden cardiac death (SCD), in CRT patients without (CRT-P) and with defibrillator (CRT-D).METHODS AND RESULTS: A total of 1775 patients, with ischaemic or non-ischaemic dilated cardiomyopathy, who were alive 5 years after CRT implantation, were enrolled in this multicentre European observational cohort study. Overall long-term mortality rates and specific causes of death were assessed, with a focus on late SCD. Over a mean follow-up of 30 months (interquartile range 10-42 months) beyond the first 5 years, we observed 473 deaths. The annual age-standardized mortality rates of CRT-D and CRT-P patients were 40.4 [95% confidence interval (CI) 35.3-45.5] and 97.2 (95% CI 85.5-109.9) per 1000 patient-years, respectively. The adjusted hazard ratio (HR) for all-cause mortality was 0.99 (95% CI 0.79-1.22). Twenty-nine patients in total died of late SCD (14 with CRT-P, 15 with CRT-D), corresponding to 6.1% of all causes of death in both device groups. Specific annual SCD rates were 8.5 and 5.8 per 1000 patient-years in CRT-P and CRT-D patients, respectively, with no significant difference between groups (adjusted HR 1.0, 95% CI 0.45-2.44). Death due to progressive heart failure represented the principal cause of death (42.8% in CRT-P patients and 52.6% among CRT-D recipients), whereas approximately one-third of deaths in both device groups were due to non-cardiovascular death.CONCLUSION: In this first description of very long-term outcomes among CRT recipients, progressive heart failure death still represented the most frequent cause of death in patients surviving the first 5 years after CRT implant. In contrast, SCD represents a very low proportion of late mortality irrespective of the presence of a defibrillator.
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3.
  • Bongiorni, Maria G, et al. (författare)
  • 2018 EHRA expert consensus statement on lead extraction : recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS
  • 2018
  • Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 20:7
  • Tidskriftsartikel (refereegranskat)abstract
    • The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Transvenous lead extraction (TLE), as a part of an overall lead management strategy, has also been increasing, not only as a consequence of this growth, but also because of increasing rates of infection, lead failure, awareness of indications for lead management, and development of extraction tools. Clinical research is essential for understanding efficacy and risks of TLE, which has important implications regarding decision-making and therapeutic strategies in patients who are candidates for this procedure. Data on TLE have mainly come from retrospective series, with variable reporting of endpoints. Recently, the ELECTRa registry conducted by the European Heart Rhythm Association (EHRA), has reported the largest prospective experience on lead extraction published to date in 3555 patients recruited from 19 European countries. There remain unresolved issues, which is a strong incentive for conducting further specifically-designed clinical trials to answer important questions in this area. In addition to clinical studies, national registries are potentially useful for evaluating epidemiology of TLE as well as for quality control and understanding resource implications. Standardization of definitions and reporting of parameters are paramount in order to analyse, compare, and pool data for scientific purposes. Expert consensus statements on lead extraction have been published by the Heart Rhythm Society (HRS) in 2009 and 2017, and by EHRA in 2012. Experience from the ELECTRa registry has been valuable for identifying challenges faced with conducting scientific studies in this field, and provides a framework for future endeavours.This writing group has been commissioned by EHRA to provide recommendations for designing scientific studies, reports and registries relating to lead extraction.
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4.
  • Guerra, Federico, et al. (författare)
  • The use of social media for professional purposes by healthcare professionals : the #intEHRAct survey
  • 2022
  • Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 24:4, s. 691-696
  • Tidskriftsartikel (refereegranskat)abstract
    • Social media (SoMe) represents a medium of communication in everyday life and has gained importance for professional use among clinicians. In the #intEHRAct survey, we aimed to describe the use of SoMe by the healthcare community in a professional setting. The EHRA e-Communication Committee and the Scientific Initiatives Committee prepared a questionnaire and distributed it via newsletters, Twitter, LinkedIn, and Facebook. The survey consisted of 19 questions made on an individual basis and collected anonymously. Two hundred and eighty-five responders from 35 countries (72.3% male, age 49 +/- 11 years old) completed the survey. Most respondents (42.7%) declared to use SoMe as passive users while 38.3% and 19.0% declared to share content on a non-daily and daily basis, respectively. The respondents estimated they spent a median of 5 (Q1-Q3: 2-10) h per week on SoMe. The most widely used SoMe was LinkedIn (60.8%), but the use of each platform was heterogeneous between countries. Among the advantages of SoMe, respondents indicated the chance of being updated on recent publications (66.0%), networking (48.5%), and the availability of rare or interesting cases (47.9%) as the most useful. Regarding the disadvantages of SoMe, the respondents underlined the loss of personal contact (40.7%), the inability to get 'hands-on' training (38.7%), and the lack of control regarding quality of scientific evidence (37.1%). Social media is increasingly used for professional purposes for scientific updating, networking, and case-based learning. The results of this survey encourage scientific societies, journals, and authors to enhance the quality, reach and impact of scientific content provided through SoMe.
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5.
  • Guerra, Federico, et al. (författare)
  • Use and misuse of instant messaging in clinical data sharing : the EHRA-SMS survey
  • 2021
  • Ingår i: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 23:8, s. 1326-1330
  • Tidskriftsartikel (refereegranskat)abstract
    • Instant messaging (IM) enables medical professionals to quickly share clinical data to their peers for counselling. Purpose of this survey is to assess the habits related to IM, their application in clinical practice and the perceived pros and cons. An online survey was distributed to the medical community via newsletters, Twitter, Linkedin, and Facebook. The survey consisted of 22 questions made on an individual-basis and collected anonymously on SurveyMonkey. A total of 287 subjects from 33 countries responded to the survey (mean age 43 years, 74.8% male). Of all respondents, 88.3% routinely send and 90.3% receive clinical data through IM which was second only to face-to-face contact as the preferred method for sharing clinical data. Twelve-lead electrocardiograms (88.6%), medical history (61.4%), and echo loops (55.7%) were the data shared most often. Nearly half of the clinical data that are sent (43%) or received (44%) are not anonymized. In the same way, 29.3% of the respondents were not aware of the European General Data Protection Regulation (GDPR) at the time of the survey. IM apps are used by medical professionals worldwide to share and discuss clinical data and are preferred to many other methods of data sharing, being second only to face-to-face contact. IM are often used to share many different types of clinical data, being perceived as a fast and easy way of communication. Medical professionals should be aware of the appropriate use of IM to prevent legal and privacy issues.
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6.
  • Haugaa, Kristina H., et al. (författare)
  • Implantable cardioverter defibrillator use for primary prevention in ischaemic and non-ischaemic heart disease-indications in the post-DANISH trial era : results of the European Heart Rhythm Association survey
  • 2017
  • Ingår i: Europace. - : OXFORD UNIV PRESS. - 1099-5129 .- 1532-2092. ; 19:4, s. 660-664
  • Tidskriftsartikel (refereegranskat)abstract
    • Implantable cardioverter-defibrillator (ICD) is the standard of care for prevention of sudden cardiac death (SCD) in high-risk patients. For primary prevention of SCD, in patients with ischaemic heart disease, there is more robust data on the effect of ICD therapy compared with patients with non-ischaemic heart disease, but current real-life practice may differ substantially. The aim of this European Heart Rhythm Association survey was to evaluate the clinical practice regarding implantation of ICD for primary prevention among European countries in patients with non-ischaemic and ischaemic heart disease. Furthermore, we wanted to investigate the impact of the results of the recently published DANISH trial on clinical practice among European countries. In total, 48 centres from 17 different countries responded to the questionnaire. The majority did not implant ICD for primary prevention on a regular basis in patients with non-ischaemic heart disease despite current guidelines. Also, centres have changed their indications after the recent report on the efficacy of ICD in these patients. In patients with ischaemic heart disease, the guidelines for primary prevention ICD were followed on a regular basis, and no relevant change in indications were reported.
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7.
  • Haugaa, Kristina Hermann, et al. (författare)
  • Patients' knowledge and attitudes regarding living with implantable electronic devices : results of a multicentre, multinational patient survey conducted by the European Heart Rhythm Association
  • 2018
  • Ingår i: Europace. - : OXFORD UNIV PRESS. - 1099-5129 .- 1532-2092. ; 20:2, s. 386-391
  • Tidskriftsartikel (refereegranskat)abstract
    • The purpose of this patient survey was to analyse the knowledge, experiences, and attitudes regarding cardiac implantable electronic devices (CIED) in patients with pacemakers, implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization devices. Of the 1644 patients with CIEDs from seven European countries, 88% were over 50 years of age. Most patients (90%) knew what device they were implanted with and felt sufficiently informed about the indications for therapy. As many as 42% of patients needed additional information on the battery replacement and limitations in physical activity. The self-reported incidence of complications was 9%, and among these, a quarter of the respondents felt insufficiently informed about the possibility of complications and their management. The majority of patients (83%) were followed by face-to-face visits, which was the most commonly preferred follow-up strategy by the patients. Nearly 75% of the patients reported improved quality of life after device implantation, but about 40% had worries about their device. Less than 20% had discussed with their physician or thought about device handling in the end-of-life circumstances or end-stage disease. Notably, almost 20% of the ICD patients did not wish to answer the question regarding what they wanted to be done with their ICD in case of end-stage disease, indicating the challenges in approaching these issues.
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8.
  • Heidbuchel, Hein, et al. (författare)
  • Recommendations for participation in leisure-time physical activity and competitive sports of patients with arrhythmias and potentially arrhythmogenic conditions. Part 2: ventricular arrhythmias, channelopathies, and implantable defibrillators.
  • 2021
  • Ingår i: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. - : Oxford University Press (OUP). - 1532-2092. ; 23:1, s. 147-148
  • Tidskriftsartikel (refereegranskat)abstract
    • This paper belongs to a series of recommendation documents for participation in leisure-time physical activity and competitive sports by the European Association of Preventive Cardiology (EAPC). Together with an accompanying paper on supraventricular arrhythmias, this second text deals specifically with those participants in whom some form of ventricular rhythm disorder is documented, who are diagnosed with an inherited arrhythmogenic condition, and/or who have an implanted pacemaker or cardioverter defibrillator. A companion text on recommendations in athletes with supraventricular arrhythmias is published in the European Journal of Preventive Cardiology. Since both texts focus on arrhythmias, they are the result of a collaboration between EAPC and the European Heart Rhythm Association (EHRA). The documents provide a framework for evaluating eligibility to perform sports, based on three elements, i.e. the prognostic risk of the arrhythmias when performing sports, the symptomatic impact of arrhythmias while performing sports, and the potential progression of underlying structural problems as the result of sports.
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9.
  • Providencia, Rui, et al. (författare)
  • Usefulness of a clinical risk score to predict the response to cardiac resynchronization therapy
  • 2018
  • Ingår i: International Journal of Cardiology. - : Elsevier BV. - 0167-5273. ; 260, s. 82-87
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Almost 1/3 of heart failure patients fail to respond to cardiac resynchronization therapy (CRT). A simple clinical score to predict who these patients are at the moment of referral or at time of implant may be of importance for early optimization of their management. Methods: Observational study. A risk score was derived from factors associated to CRT response. The derivation cohort was composed of 1301 patients implanted with a CRT defibrillator in a multi-center French cohort-study. External validation of this score and assessment of its association with CRT response and all-cause mortality and/or heart transplant was performed in 1959 CRT patients implanted in 4 high-volume European centers. Results: Independent predictors of CRT response in the derivation cohort were: female gender (OR = 2.08, 95% CI 1.26–3.45), NYHA class ≤ III (OR = 2.71, 95% CI 1.63–4.52), left ventricular ejection fraction ≥ 25% (OR = 1.75, 95% CI 1.27–2.41), QRS duration ≥ 150 ms (OR = 1.70, 95% CI 1.25–2.30) and estimated glomerular filtration rate ≥ 60 mL/min (OR = 2.01, 95% CI 1.48–2.72). Each was assigned 1 point. External validation showed good calibration (Hosmer–Lemeshow test-P = 0.95), accuracy (Brier score = 0.19) and discrimination (c-statistic = 0.67), with CRT response increasing progressively from 37.5% in patients with a score of 0 to 91.9% among those with score of 5 (Gamma for trend = 0.44, P < 0.001). Similar results were observed regarding all-cause mortality or heart transplant. Conclusion: The ScREEN score (Sex category, Renal function, ECG/QRS width, Ejection fraction and NYHA class) is composed of widely validated, easy to obtain predictors of CRT response, and predicts CRT response and overall mortality. It should be helpful in facilitating early consideration of alternative therapies for predicted non-responders to CRT therapy.
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10.
  • Schnabel, Renate B, et al. (författare)
  • Early diagnosis and better rhythm management to improve outcomes in patients with atrial fibrillation : the 8th AFNET/EHRA consensus conference
  • 2023
  • Ingår i: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 25:1, s. 6-27
  • Tidskriftsartikel (refereegranskat)abstract
    • Despite marked progress in the management of atrial fibrillation (AF), detecting AF remains difficult and AF-related complications cause unacceptable morbidity and mortality even on optimal current therapy. This document summarizes the key outcomes of the 8th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). Eighty-three international experts met in Hamburg for 2 days in October 2021. Results of the interdisciplinary, hybrid discussions in breakout groups and the plenary based on recently published and unpublished observations are summarized in this consensus paper to support improved care for patients with AF by guiding prevention, individualized management, and research strategies. The main outcomes are (i) new evidence supports a simple, scalable, and pragmatic population-based AF screening pathway; (ii) rhythm management is evolving from therapy aimed at improving symptoms to an integrated domain in the prevention of AF-related outcomes, especially in patients with recently diagnosed AF; (iii) improved characterization of atrial cardiomyopathy may help to identify patients in need for therapy; (iv) standardized assessment of cognitive function in patients with AF could lead to improvement in patient outcomes; and (v) artificial intelligence (AI) can support all of the above aims, but requires advanced interdisciplinary knowledge and collaboration as well as a better medico-legal framework. Implementation of new evidence-based approaches to AF screening and rhythm management can improve outcomes in patients with AF. Additional benefits are possible with further efforts to identify and target atrial cardiomyopathy and cognitive impairment, which can be facilitated by AI.
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