| 1. |
- Barra, Sérgio, et al.
(författare)
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Very long-term survival and late sudden cardiac death in cardiac resynchronization therapy patients
- 2019
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Ingår i: European Heart Journal. - : Oxford University Press (OUP). - 1522-9645 .- 0195-668X. ; 40:26, s. 2121-2127
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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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| 2. |
- Batra, Gorav, et al.
(författare)
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Data standards for atrial fibrillation/flutter and catheter ablation : The European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart)
- 2023
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Ingår i: European Heart Journal - Quality of Care and Clinical Outcomes. - : Oxford University Press. - 2058-5225 .- 2058-1742. ; 9:6, s. 609-620
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: Standardized data definitions are essential for monitoring and assessment of care and outcomes in observational studies and randomized controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart) project of the European Society of Cardiology aimed to develop contemporary data standards for atrial fibrillation/flutter (AF/AFL) and catheter ablation.METHODS AND RESULTS: We used the EuroHeart methodology for development of data standards and formed a Working Group comprising 23 experts in AF/AFL and catheter ablation registries, as well as representatives from the European Heart Rhythm Association and EuroHeart. We conducted a systematic literature review of AF/AFL and catheter ablation registries and data standard documents to generate candidate variables. We used a modified Delphi method to reach consensus on a final variable set. For each variable, the Working Group developed permissible values and definitions, and agreed as to whether the variable was mandatory (Level 1) or additional (Level 2). In total, 70 Level 1 and 92 Level 2 variables were selected and reviewed by a wider Reference Group of 42 experts from 24 countries. The Level 1 variables were implemented into the EuroHeart IT platform as the basis for continuous registration of individual patient data.CONCLUSION: By means of a structured process and working with international stakeholders, harmonized data standards for AF/AFL and catheter ablation for AF/AFL were developed. In context of the EuroHeart project, this will facilitate country-level quality of care improvement, international observational research, registry-based RCTs and post-marketing surveillance of devices and pharmacotherapies.
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| 3. |
- Bongiorni, Maria G, et al.
(författare)
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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
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 20:7
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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. |
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| 5. |
- Chen, Jian, et al.
(författare)
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Catheter ablation for atrial fibrillation : results from the first European Snapshot Survey on Procedural Routines for Atrial Fibrillation Ablation (ESS-PRAFA) Part II
- 2015
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 17:11, s. 1727-1732
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Tidskriftsartikel (refereegranskat)abstract
- The European Snapshot Survey on Procedural Routines in Atrial Fibrillation Ablation (ESS-PRAFA) is a prospective, multicentre snapshot survey collecting patient-based data on current clinical practices during atrial fibrillation (AF) ablation. The participating centres were asked to prospectively enrol consecutive patients during a 6-week period (from September to October 2014). A web-based case report form was employed to collect information of patients and data of procedures. A total of 455 eligible consecutive patients from 13 countries were enrolled (mean age 59 ± 10.8 years, 28.8% women). Distinct strategies and endpoints were collected for AF ablation procedures. Pulmonary vein isolation (PVI) was performed in 96.7% and served as the endpoint in 91.3% of procedures. A total of 52 (11.5%) patients underwent ablation as first-line therapy. The cryoballoon technique was employed in 31.4% of procedures. Procedure, ablation, and fluoroscopy times differed among various types of AF ablation. Divergences in patient selection and complications were observed among low-, medium-, and high-volume centres. Adverse events were observed in 4.6% of AF ablation procedures. In conclusion, PVI was still the main strategy for AF ablation. Procedure-related complications seemed not to have declined. The centre volume played an important role in patient selection, strategy choice, and had impact on the rate of periprocedural complication.
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| 6. |
- Ding, Wern Yew, et al.
(författare)
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Clinical utility and prognostic implications of the novel 4S-AF scheme to characterize and evaluate patients with atrial fibrillation : a report from ESC-EHRA EORP-AF Long-Term General Registry
- 2022
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 24:5, s. 721-728
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Tidskriftsartikel (refereegranskat)abstract
- Aims: The 4S-AF classification scheme comprises of four domains: stroke risk (St), symptoms (Sy), severity of atrial fibrillation (AF) burden (Sb), and substrate (Su). We sought to examine the implementation of the 4S-AF scheme in the EORP-AF General Long-Term Registry and compare outcomes in AF patients according to the 4S-AF-led decision-making process.Methods and results: Atrial fibrillation patients from 250 centres across 27 European countries were included. A 4S-AF score was calculated as the sum of each domain with a maximum score of 9. Of 6321 patients, 8.4% had low (St), 47.5% EHRA I (Sy), 40.5% newly diagnosed or paroxysmal AF (Sb), and 5.1% no cardiovascular risk factors or left atrial enlargement (Su). Median follow-up was 24 months. Using multivariable Cox regression analysis, independent predictors of all-cause mortality were (St) [adjusted hazard ratio (aHR) 8.21, 95% confidence interval (CI): 2.60-25.9], (Sb) (aHR 1.21, 95% CI: 1.08-1.35), and (Su) (aHR 1.27, 95% CI: 1.14-1.41). For CV mortality and any thromboembolic event, only (Su) (aHR 1.73, 95% CI: 1.45-2.06) and (Sy) (aHR 1.29, 95% CI: 1.00-1.66) were statistically significant, respectively. None of the domains were independently linked to ischaemic stroke or major bleeding. Higher 4S-AF score was related to a significant increase in all-cause mortality, CV mortality, any thromboembolic event, and ischaemic stroke but not major bleeding. Treatment of all 4S-AF domains was associated with an independent decrease in all-cause mortality (aHR 0.71, 95% CI: 0.55-0.92). For each 4S-AF domain left untreated, the risk of all-cause mortality increased substantially (aHR 1.35, 95% CI: 1.16-1.56).Conclusion: Implementation of the novel 4S-AF scheme is feasible, and treatment decisions based on this scheme improve mortality rates in AF.
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| 7. |
- Ding, Wern Yew, et al.
(författare)
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Impact of ABC (Atrial Fibrillation Better Care) pathway adherence in high-risk subgroups with atrial fibrillation : A report from the ESC-EHRA EORP-AF long-term general registry
- 2023
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Ingår i: European journal of internal medicine. - : Elsevier. - 0953-6205 .- 1879-0828. ; 107, s. 60-65
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Tidskriftsartikel (refereegranskat)abstract
- Background: Effects of Atrial Fibrillation Better Care (ABC) adherence among high-risk atrial fibrillation (AF) subgroups remains unknown. We aimed to evaluate the impact of ABC adherence on clinical outcomes in these high-risk patients.Methods: EORP-AF General Long-Term Registry is a prospective, observational registry from 250 centres across 27 European countries. High-risk patients were defined as those with either CKD (eGFR <60 mL/min/1.73m2), elderly patients (>= 75 years) or prior thromboembolism. Primary outcome was a composite event of all-cause death, thromboembolism and acute coronary syndrome.Results: 6646 patients with AF were screened (median age was 70 [IQR 61 - 77] years; 40.2% females). There were 3304 (54.2%) patients with either CKD (n = 1750), older age (n = 2236) or prior thromboembolism (n = 728). Among these, 924 (28.0%) were managed as adherent to ABC. At 2-year follow-up, 966 (14.5%) patients reported the primary outcome. The incidence of the primary outcome was significantly lower in high-risk patients managed as adherent to ABC pathway (IRR 0.53 [95%CI, 0.43 - 0.64]). Consistent results were obtained in the individual subgroups. Using multivariable Cox proportional hazards analysis, ABC adherence in the high-risk cohort was independently associated with a lower risk of the primary outcome (aHR 0.64 [95%CI, 0.51 - 0.80]), as well as in the CKD (aHR 0.51 [95%CI, 0.37 - 0.70]) and elderly subgroups (aHR 0.69 [95%CI, 0.53 - 0.90]). Overall, there was greater reduction in the risk of primary outcome as more ABC criteria were fulfilled, both in the overall high-risk patients (aHR 0.39 [95%CI, 0.25 - 0.61]), as well as in the individual subgroups.Conclusion: In a large, contemporary cohort of patients with AF, we demonstrate that adherence to the ABC pathway was associated with a significant benefit among high-risk patients with either CKD, advanced age (>75 years old) or prior thromboembolism.
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| 8. |
- Ding, Wern Yew, et al.
(författare)
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Impact of diabetes on the management and outcomes in atrial fibrillation : an analysis from the ESC-EHRA EORP-AF Long-Term General Registry
- 2022
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Ingår i: European journal of internal medicine. - : Elsevier. - 0953-6205 .- 1879-0828. ; 103, s. 41-49
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Tidskriftsartikel (refereegranskat)abstract
- Background: The prevalence of atrial fibrillation(AF) and diabetes mellitus is rising to epidemic proportions. We aimed to assess the impact of diabetes on the management and outcomes of patients with AF. Methods: The EORP-AF General Long-Term Registry is a prospective, observational registry from 250 centres across 27 European countries. Outcomes of interest were as follows: i)rhythm control interventions; ii)quality of life; iii)healthcare resource utilisation; and iv)major adverse events. Results: Of 11,028 patients with AF, the median age was 71 (63-77) years and 2537 (23.0%) had diabetes. Median follow-up was 24 months. Diabetes was related to increased use of anticoagulation but less rhythm control interventions. Using multivariable analysis, at 2-year follow-up, patients with diabetes were associated with greater levels of anxiety (p = 0.038) compared to those without diabetes. Overall, diabetes was associated with worse health during follow-up, as indicated by Health Utility Score and Visual Analogue Scale. Healthcare resource utilisation was greater with diabetes in terms of length of hospital stay (8.1 (+/- 8.2) vs. 6.1 (+/- 6.7) days); cardiology and internal medicine/general practitioner visits; and emergency room admissions. Diabetes was an independent risk factor of major adverse cardiovascular event (MACE; HR 1.26 [95% CI, 1.04-1.52]), all-cause mortality (HR 1.28 [95% CI, 1.08-1.52]), and cardiovascular mortality (HR 1.41 [95% CI, 1.09-1.83]). Conclusion: In this contemporary AF cohort, diabetes was present in 1 in 4 patients and it served as an independent risk factor for reduced quality of life, greater healthcare resource utilisation and excess MACE, all-cause mortality and cardiovascular mortality. There was increased use of anticoagulation therapy in diabetes but with less rhythm control interventions.
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| 9. |
- Ding, Wern Yew, et al.
(författare)
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Impact of renal impairment on atrial fibrillation : ESC-EHRA EORP-AF Long-Term General Registry.
- 2022
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Ingår i: European Journal of Clinical Investigation. - : Wiley. - 0014-2972 .- 1365-2362. ; 52:6
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Atrial fibrillation (AF) and renal impairment share a bidirectional relationship with important pathophysiological interactions. We evaluated the impact of renal impairment in a contemporary cohort of patients with AF.METHODS: We utilised the ESC-EHRA EORP-AF Long-Term General Registry. Outcomes were analysed according to renal function by CKD-EPI equation. The primary endpoint was a composite of thromboembolism, major bleeding, acute coronary syndrome and all-cause death. Secondary endpoints were each of these separately including ischaemic stroke, haemorrhagic event, intracranial haemorrhage, cardiovascular death and hospital admission.RESULTS: A total of 9,306 patients were included. The distribution of patients with no, mild, moderate and severe renal impairment at baseline were 16.9%, 49.3%, 30.0% and 3.8%, respectively. AF patients with impaired renal function were older, more likely to be females, had worse cardiac imaging parameters and multiple comorbidities. Among patients with an indication for anticoagulation, prescription of these agents was reduced in those with severe renal impairment,p<0.001. Over 24 months, impaired renal function was associated with significantly greater incidence of the primary composite outcome and all secondary outcomes. Multivariable Cox regression analysis demonstrated an inverse relationship between eGFR and the primary outcome (HR 1.07[95% CI,1.01-1.14] per 10 mL/min/1.73m2 decrease), that was most notable in patients with eGFR <30mL/min/1.73m2 (HR 2.21[95% CI,1.23-3.99] compared to eGFR ≥90mL/min/1.73m2 ).CONCLUSION: A significant proportion of patients with AF suffer from concomitant renal impairment which impacts their overall management. Furthermore, renal impairment is an independent predictor of major adverse events including thromboembolism, major bleeding, acute coronary syndrome and all-cause death in patients with AF.
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| 10. |
- Ding, Wern Yew, et al.
(författare)
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Outcomes of digoxin vs. beta-blocker in atrial fibrillation : report from ESC-EHRA EORP-AF Long-Term General Registry
- 2022
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Ingår i: European Heart Journal - Cardiovascular Pharmacotherapy. - : Oxford University Press. - 2055-6837 .- 2055-6845. ; 8:4, s. 372-382
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Tidskriftsartikel (refereegranskat)abstract
- Aims: The safety of digoxin therapy in atrial fibrillation (AF) remains ill-defined. We aimed to evaluate the effects of digoxin over beta-blocker therapy in AF.Methods and results: Patients with AF who were treated with either digoxin or beta-blocker from the ESC-EHRA EORP-AF General Long-Term Registry were included. Outcomes of interest were all-cause mortality, cardiovascular (CV) mortality, non-CV mortality, quality of life and number of patients with unplanned hospitalisations. Of 6377 patients, 549(8.6%) were treated with digoxin. Over 24 months, there were 550(8.6%) all-cause mortality events and 1304(23.6%) patients with unplanned emergency hospitalisations. Compared to beta-blocker, digoxin therapy was associated with increased all-cause mortality (HR 1.90 [95%CI,1.48-2.44], CV mortality (HR 2.18 [95%CI,1.47-3.21] and non-CV mortality (HR 1.68 [95%CI,1.02-2.75] with reduced quality of life (Health Utility Score 0.555[±0.406] vs. 0.705[±0.346], P<0.001) but no differences in emergency hospitalisations (HR 1.00 [95%CI,0.56-1.80]) or AF-related hospitalisations (HR 0.95 [95%CI,0.60-1.52]).On multivariable analysis, there were no differences in any of the outcomes between both groups, after accounting for potential confounders. Similar results were obtained in the subgroups of patients with permanent AF and coexisting heart failure. There was no differences in outcomes between AF patients receiving digoxin with and without chronic kidney disease.Conclusion: Poor outcomes related to the use of digoxin over beta-blocker therapy in terms of excess mortality and reduced quality of life are associated with the presence of other risk factors rather than digoxin per se. The choice of digoxin or beta-blocker therapy had no influence on the incidence of unplanned hospitalisations.
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