Same Day Discharge vs. Overnight Stay Following Catheter Ablation for Atrial Fibrillation - A Comprehensive Review and Meta-Analysis by the EHRA Health Economics Committee.

AIMS: Same-day discharge (SDD) after catheter ablation of atrial fibrillation (AF) may may address the growing socio-economic health burden of the increasing demand for interventional AF-therapies. This systematic review and meta-analysis analyzes the current evidence on clinical outcomes in SDD after AF-ablation compared to overnight stay (ONS). METHODS AND RESULTS: A systematic search of the PubMed-database was performed. Predefined endpoints were complications at short-term (24-96h) and 30 days post-discharge, re-hospitalization and/or emergency room (ER)-visits at 30 days post-discharge, and 30-day-mortality. Twenty-four studies (154,716 patients) were included. Random-effects models were applied for meta-analyses of pooled endpoint prevalence in the SDD cohort and for comparison between SDD- and ONS-cohorts. Pooled estimates for complications after SDD were low both for short-term- (2%; 95%CI:1-5%, I2:89%) and 30-day-follow-up (2%; 95%CI:1-4%, I2:91%). There was no significant difference in complications rates between SDD and ONS (short-term: RR:1.62, 95%CI:0.52-5.01, I2:37%; 30-days: RR:0.65, 95%CI:0.42-1.00, I2:95%). Pooled rates of re-hospitalization/ER-visits after SDD were 4% (95%CI:1-10%, I2:96%) with no statistically significant difference between SDD and ONS (RR:0.86, 95%CI:0.58-1.27, I2:61%). Pooled 30-day-mortality was low after SDD (0%, 95%CI:0-1%, I2:33%). All studies were subject to a relevant risk of bias, mainly due to study design. CONCLUSION: In this meta-analysis including a large contemporary cohort, SDD after AF-ablation was associated with low prevalence of post-discharge complications, re-hospitalizations/ER-visits and mortality, and a similar risk compared to ONS. Due to limited quality of current evidence, further prospective, randomized trials are needed to confirm safety of SDD and define patient- and procedure-related prerequisites for successful and safe SDD-strategies.

Risk assessment in patients with symptomatic and asymptomatic pre-excitation.

AIMS: Controversy remains as to whether the exercise stress test (EST) is sufficient for risk evaluation in patients with pre-excitation. This study aims to clarify the usefulness of EST in risk stratification in both asymptomatic and symptomatic patients presenting with pre-excitation. METHODS AND RESULTS: This prospective study includes consecutive asymptomatic and symptomatic patients with pre-excitation referred for risk assessment. All participants performed an incremental EST (bicycle) prior to an electrophysiology study (EPS). Primary data from the EST included loss of pre-excitation during exercise, and primary data from the EPS included the measurement of accessory pathway effective refractory period (APERP), shortest pre-excited RR interval (SPERRI), and inducible arrhythmia with the use of a beta-adrenergic receptor agonist if deemed necessary. One hundred and sixty-four patients (59 asymptomatic, 105 symptomatic) completed an EST and EPS. Forty-five patients (27%) demonstrated low-risk findings on EST, of which 19 were asymptomatic and 26 were symptomatic. Six patients with low-risk EST findings had SPERRI/APERP ≤ 250 ms at EPS, and two of them were asymptomatic. The sensitivity, specificity, positive predictive value, negative predictive value (NPV), and accuracy of low-risk EST for excluding patients with SPERRI/APERP ≤ 250 ms were 40, 91, 87, 51, and 60%, respectively. The number of patients with inducible arrhythmia at EPS was similar in the asymptomatic (36, 69%) and symptomatic (73, 61%) groups. CONCLUSION: Sudden loss of pre-excitation during EST has a low NPV in excluding high-risk APs. The EPS with the use of isoproterenol should be considered to accurately assess the risk of patients with pre-excitation regardless of symptoms (ClinicalTrials.gov Identifier: NCT03301935).

Cardiac tamponades related to interventional electrophysiology procedures are associated with higher risk of short-term hospitalization for pericarditis but favourable long-term outcome.

AIMS: To investigate the association of iatrogenic cardiac tamponades as a complication of invasive electrophysiology procedures (EPs) and mortality as well as serious cardiovascular events in a nationwide patient cohort during long-term follow-up. METHODS: From the Swedish Catheter Ablation Registry between 2005 and 2019, a total of 58 770 invasive EPs in 44 497 patients were analysed. From this, all patients with periprocedural cardiac tamponades related to invasive EPs were identified (n = 200; tamponade group) and matched (1:2 ratio) to a control group (n = 400). Over a follow-up of 5 years, the composite primary endpoint-death from any cause, acute myocardial infarction, transitory ischaemic attack (TIA)/stroke, and hospitalization for heart failure-revealed no statistically significant association with cardiac tamponade [hazard ratio (HR) 1.22 (95% CI, 0.79-1.88)]. All single components of the primary endpoint as well as cardiovascular death revealed no statistically significant association with cardiac tamponade. Cardiac tamponade was associated with a significantly higher risk with hospitalization for pericarditis [HR 20.67 (95% CI, 6.32-67.60)]. CONCLUSION: In this nationwide cohort of patients undergoing invasive EPs, iatrogenic cardiac tamponade was associated with an increased risk of hospitalization for pericarditis during the first months after the index procedure. In the long-term, however, cardiac tamponade revealed no significant association with mortality or other serious cardiovascular events.

Remote monitoring of cardiac implantable electronic devices and disease management.

This reviews the transition of remote monitoring of patients with cardiac electronic implantable devices from curiosity to standard of care. This has been delivered by technology evolution from patient-activated remote interrogations at appointed intervals to continuous monitoring that automatically flags clinically actionable information to the clinic for review. This model has facilitated follow-up and received professional society recommendations. Additionally, continuous monitoring has provided a new level of granularity of diagnostic data enabling extension of patient management from device to disease management. This ushers in an era of digital medicine with wider applications in cardiovascular medicine.

Length of hospital stay for elective electrophysiological procedures: a survey from the European Heart Rhythm Association.

AIMS: Electrophysiological (EP) operations that have traditionally involved long hospital lengths of stay (LOS) are now being undertaken as day case procedures. The coronavirus disease-19 pandemic served as an impetus for many centres to shorten LOS for EP procedures. This survey explores LOS for elective EP procedures in the modern era. METHODS AND RESULTS: An online survey consisting of 27 multiple-choice questions was completed by 245 respondents from 35 countries. With respect to de novo cardiac implantable electronic device (CIED) implantations, day case procedures were reported for 79.5% of implantable loop recorders, 13.3% of pacemakers (PMs), 10.4% of implantable cardioverter defibrillators (ICDs), and 10.2% of cardiac resynchronization therapy (CRT) devices. With respect to CIED generator replacements, day case procedures were reported for 61.7% of PMs, 49.2% of ICDs, and 48.2% of CRT devices. With regard to ablations, day case procedures were reported for 5.7% of atrial fibrillation (AF) ablations, 10.7% of left-sided ablations, and 17.5% of right-sided ablations. A LOS ≥ 2 days for CIED implantation was reported for 47.7% of PM, 54.5% of ICDs, and 56.9% of CRT devices and for 54.5% of AF ablations, 42.2% of right-sided ablations, and 46.1% of left-sided ablations. Reimbursement (43-56%) and bed availability (20-47%) were reported to have no consistent impact on the organization of elective procedures. CONCLUSION: There is a wide variation in the LOS for elective EP procedures. The LOS for some procedures appears disproportionate to their complexity. Neither reimbursement nor bed availability consistently influenced LOS.

Changes in cardiac output, rhythm regularity, and symptom severity after electrical cardioversion of atrial fibrillation.

OBJECTIVES: Symptoms in atrial fibrillation (AF) range from none to disabling. The physiological correlates of AF symptoms are not well characterized. This study investigated the association between physiological parameters and symptom severity before and after electrical cardioversion (EC) of AF. DESIGN: We studied 44 patients with persistent AF (age 66.2 ± 7.9 years, 16% females) 4 ± 2 days before and 5 ± 2 days after EC. Physiological parameters included cardiac output (CO; non-invasive inert gas rebreathing), heart rate (HR), RR variability and resting and ambulatory blood pressure (BP). Symptoms and quality of life (QoL) were assessed by the modified European Heart Rhythm Association score (mEHRA), the Atrial Fibrillation Effect on Quality of Life (AFEQT) and the Symptom Checklist for frequency and severity of symptoms (SCL). RESULTS: 28 of 44 patients were still in sinus rhythm (SR) at post EC evaluation. Those in SR had a decreased HR (-15.4 ± 13.1 bpm, p < 0.001), and an increased CO (+0.8 ± 0.7 L/min, p < 0.001) as compared to those with recurrent AF. Changes in CO after EC correlated with symptom improvement as scored by AFEQT (r = 0.36; p < 0.05), AFEQT symptoms subscore (r = 0.46; p < 0.01), SCL for frequency (r = 0.62; p < 0.01) and severity (r = 0.33; p < 0.05) of symptoms, and the mEHRA score (r = 0.50; p < 0.01). A decrease in RR variability showed similar correlations with these measures of symptom improvement. CONCLUSIONS: Improvements in symptoms and quality of life experienced by patients after electrical conversion of atrial fibrillation are correlated with an increase in CO and a decreased RR variability.

A systematic review and meta-analysis of beta-blockers and renin-angiotensin system inhibitors for preventing left ventricular dysfunction due to anthracyclines or trastuzumab in patients with breast cancer.

AIMS: Trastuzumab and anthracyclines, often used in the treatment of breast cancer, may impair myocardial function, and reduce left ventricular ejection fraction (LVEF), potentially causing heart failure. Randomized controlled trials (RCTs) have evaluated the effects of beta-blockers (BBs), angiotensin receptor blockers (ARBs), and angiotensin-converting enzyme inhibitors (ACEI) on trastuzumab- and anthracycline-associated cardiotoxicity. We report a meta-analysis of these RCTs in patients with breast cancer. METHODS AND RESULTS: The primary analysis was on the effect of BBs and ACEI/ARBs on LVEF in patients treated with either trastuzumab or anthracyclines. A secondary analysis was done investigating the effect of BBs or ACEI/ARBs on LVEF in trastuzumab and anthracycline treatments. Only RCTs were included using the search term 'ARBs, ACEIs, BBs, anthracyclines, trastuzumab, and breast cancer' in PubMed, Embase, and CENTRAL up to 31 March 2021. A meta-analysis was conducted to estimate the mean difference (MD) in LVEF between intervention and placebo groups at follow-up. A total of nine RCTs (n = 1362) were included in the analysis. All patients were women. BBs and ACEI/ARBs were shown to attenuate the decline in LVEF during trastuzumab and anthracycline treatments [MD: 2.4; 95% confidence interval (CI): 0.3-4.2 and MD: 1.5; 95% CI: -0.6 to 3.7]. Compared with placebo, LVEF was significantly higher in patients assigned to BB or ACEI/ARB on trastuzumab (MD: 2.3; 95% CI: 0.0-4.6) but not on anthracyclines (MD: 1.9; 95% CI: -0.5 to 4.2). CONCLUSION: Both BB and ACEI/ARB therapies were associated with the preservation of LVEF during trastuzumab and anthracycline-containing regimens as compared with placebo, suggesting both to be beneficial.

Cardiac resynchronization therapy with or without defibrillator in patients with heart failure.

AIMS: Randomized data on the efficacy/safety of cardiac resynchronization therapy with vs. without defibrillator (CRT-D,-P) in heart failure with reduced ejection fraction (HFrEF) are scarce. We aimed to evaluate survival associated with use of CRT-D vs. CRT-P in a contemporary cohort with HFrEF. METHODS AND RESULTS: Patients from Swedish HF Registry treated with CRT-D/CRT-P and fulfilling criteria for primary prevention defibrillator use were included. Logistic regression was used to evaluate predictors of CRT-D non-use. All-cause mortality was compared in CRT-D vs. CRT-P by Cox regression in a 1 : 1 propensity-score-matched cohort. Of 1988 patients with CRT, 1108 (56%) had CRT-D and 880 (44%) CRT-P. Older age, higher ejection fraction (EF), female sex, and the lack of referral to HF nurse-led outpatient clinic were major determinants of CRT-D non-use. After matching, 645 CRT-D patients were compared with 645 with CRT-P. The CRT-D use was associated with lower 1- and 3-year all-cause mortality [hazard ratio (HR):0.76, 95% confidence interval (CI):0.58-0.98; HR: 0.82, 95% CI: 0.68-0.99, respectively]. Results were consistent in all pre-specified subgroups except for CRT-D use being associated with lower 3-year mortality in patients with an EF < 30% but not in those with an EF ≥ 30% (HR: 0.73, 95% CI: 0.59-0.89 and HR: 1.24, 95% CI: 0.83-1.85, respectively; P-interaction = 0.02). CONCLUSION: In a contemporary HFrEF cohort, CRT-D was associated with lower mortality compared with CRT-P. The CRT-D use was less likely in older patients, females, and in patients not referred to HF nurse-led outpatient clinic. Our findings support the use of CRT-D vs. CRT-P in HFrEF, in particular with severely reduced EF.

Feasibility of a novel algorithm for automated reconstruction of the left atrial anatomy based on intracardiac echocardiography.

BACKGROUND: Intracardiac echocardiography (ICE) is frequently used to guide electrophysiology procedures. The novel automated algorithm Cartosoundfam is a model-based algorithm which reconstructs a 3D anatomy of the left atrium (LA) based on a set of 2D intracardiac echocardiography (ICE) frames, without the need to manually annotate ultrasound (US) contours. OBJECTIVE: The aim of this study was to determine the feasibility of the Cartosoundfam module in routine clinical setting. METHODS: We included 16 patients undergoing LA mapping/catheter ablation. Two-dimensional US frames were acquired from the right atrium (RA) and the right ventricular outflow tract. The Cartosoundfam map was validated in two steps: (1) identification of anatomical structures (pulmonary veins [PV] and LA body and appendage) by alignment of the ablation catheter to the automated map; and (2) analysis of the automated lesion tags (Visitag) location in relation to the PV antrum of the Cartosoundfam map in nine patients with paroxysmal atrial fibrillation (AF) undergoing first time pulmonary vein isolation (PVI). RESULTS: Mean 2D US frames per patient were 29 ± 6 and acquisition time was 16 ± 4 min. All anatomical structures were correctly identified in all patients (step 1). In the step 2 validation, the median distance to the map was 2.0 (IQR: 2.4) mm and the majority of the Visitags were classified as satisfactory (69%) but all PV segments had some Visitags classified as unsatisfactory. CONCLUSION: The automated ICE-based algorithm correctly identified the LA anatomical structures in all patients with a 69% anatomical accuracy of the Visitags alignments to the PV antrum segments.

Cryoablation of atypical atrioventricular nodal reentry tachycardia.

AIM: Data on ablation for atypical recurrent atrioventricular nodal reentry tachycardia (AVNRT) and long-term follow-up are generally sparse. Furthermore, the rate of recurrence and safety of cryoablation for atypical AVNRT has not been established. We compared patients cryoablated for atypical AVNRT and typical AVNRT during long-term follow-up. METHODS: All patients (n = 2612) who underwent catheter ablation for AVNRT at the Karolinska University Hospital between January 2009 and August 2019 were analyzed. A total of 91 patients undergoing first-time cryoablation for atypical AVNRT were included. A control group with first-time cryoablation for typical AVNRT was matched in a 1:1 ratio. Patients were followed-up for recurrences for a median of 5.0 years (interquartile range: 3.1-7.5 years). RESULTS: After 5 years, AVNRT recurrence occurred in 10 patients (11.0%) in the atypical AVNRT group and in 8 patients (8.8%) in the typical AVNRT group (hazard ratio: 1.31 [95% confidence interval: 0.52-3.32]; p = 0.568). The duration of the index procedure was significantly longer for atypical compared to typical AVNRT ablation (132.1 ± 49.2 min vs. 110.1 ± 38.8 min; p = 0.001). Transient AV blocks occurred in a similar fashion in the atypical compared to typical group (11 [12.1%] vs. 4 [4.9%]; p = 0.103). However, no ablation induced persistent AV block developed in either group. CONCLUSION: Cryoablation for atypical AVNRT showed similar rate of recurrences and safety compared to typical AVNRT during long-term follow-up.

Low incidence of major complications after the first six hours post atrial fibrillation ablation: Is same-day discharge safe and feasible in most patients?

AIMS: This study evaluates the incidence of procedural complications related to catheter ablation of atrial fibrillation (AF) to assess the potential feasibility and safety of same-day discharge in a large cohort. METHODS: We performed an analysis of prospectively collected data of complications of all patients staying overnight after undergoing AF ablation between 2001 and 2020 at a tertiary center. Using medical records, we analyzed complications occurring intraprocedurally until 6 h postablation and between 6 h postablation and discharge the day after the ablation procedure. RESULTS: In 5414 AF ablations, we identified a total of 108 (2.0%) major complications occurring intraprocedural or before discharge. Most major complications occurred intraprocedurally or within 6 h after the procedure (n = 96, 1.8%). Twelve (0.2%) major complications occurred between 6 h Postablation and discharge. The most common of these major complications were congestive heart failure (n = 6) and transient ischemic attack (TIA, n = 4). During this time span, 61 (1.1%) minor complications occurred. Factors independently associated with major complications intraprocedurally and until discharge were body mass index (BMI) ≥ 30 kg/m2 (p = .009), significant valvular disease (p = .001), cardiomyopathy (p < .001), prior stroke or TIA (p = .014), first-time procedure versus repeat procedure (p = .013), cryoablation versus radiofrequency (p < .001), and procedure duration (p < .001). CONCLUSION: After AF ablation, very few complications occurred between 6 h postprocedure and discharge the next day. Therefore, same-day discharge is a safe option for a majority of patients.

EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemakers and implantable cardioverter-defibrillators: endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin-American Heart Rhythm Society (LAHRS).

With the global increase in device implantations, there is a growing need to train physicians to implant pacemakers and implantable cardioverter-defibrillators. Although there are international recommendations for device indications and programming, there is no consensus to date regarding implantation technique. This document is founded on a systematic literature search and review, and on consensus from an international task force. It aims to fill the gap by setting standards for device implantation.

Association Between Use of Primary-Prevention Implantable Cardioverter-Defibrillators and Mortality in Patients With Heart Failure: A Prospective Propensity Score-Matched Analysis From the Swedish Heart Failure Registry.

BACKGROUND: Most randomized trials on implantable cardioverter-defibrillator (ICD) use for primary prevention of sudden cardiac death in heart failure with reduced ejection fraction enrolled patients >20 years ago. We investigated the association between ICD use and all-cause mortality in a contemporary heart failure with reduced ejection fraction cohort and examined relevant subgroups. METHODS: Patients from the Swedish Heart Failure Registry fulfilling the European Society of Cardiology criteria for primary-prevention ICD were included. The association between ICD use and 1-year and 5-year all-cause and cardiovascular (CV) mortality was assessed by Cox regression models in a 1:1 propensity score-matched cohort and in prespecified subgroups. RESULTS: Of 16 702 eligible patients, only 1599 (10%) had an ICD. After matching, 1305 ICD recipients were compared with 1305 nonrecipients. ICD use was associated with a reduction in all-cause mortality risk within 1 year (hazard ratio, 0.73 [95% CI, 0.60-0.90]) and 5 years (hazard ratio, 0.88 [95% CI, 0.78-0.99]). Results were consistent in all subgroups including patients with versus without ischemic heart disease, men versus women, those aged <75 versus ≥75 years, those with earlier versus later enrollment in the Swedish heart failure registry, and patients with versus without cardiac resynchronization therapy. CONCLUSIONS: In a contemporary heart failure with reduced ejection fraction population, ICD for primary prevention was underused, although it was associated with reduced short- and long-term all-cause mortality. This association was consistent across all the investigated subgroups. These results call for better implementation of ICD therapy.

Early recurrences of atrial tachyarrhythmias post pulmonary vein isolation.

AIMS: To investigate the significance of early recurrence (ER) of atrial tachyarrhythmias after pulmonary vein isolation (PVI) on the development of late recurrence (LR) and to redefine the blanking period during which an ER is considered nonspecific. METHODS: Data of 713 patients undergoing their first PVI for paroxysmal or persistent atrial fibrillation between January 2012 and December 2017 were included. All patients were followed-up for 12 months according to clinical and outpatient routine and were screened for any atrial tachyarrhythmia lasting >30 seconds occurring during the first 3 months postablation (ER) and after the 3 months blanking period (LR). RESULTS: Patients with ER compared to those without ER had significantly more LR (74.5% vs 16.5% vs, P < .001). The occurrence of ER during the first, second and third months showed increasing LR rates of 35.2%, 67.9%, and 94.8%, respectively (P < .001). Receiver operator characteristic analysis revealed a blanking period of 46 days with the highest sensitivity (68.1%) and specificity (96.5%). Later timing and longer time span of ER were independent predictors for LR in multivariable analysis. CONCLUSION: ER is a strong predictor for LR. Our study advocates a shortening of the post-PVI blanking period followed by a "gray zone" up to 3 months where individualized therapeutic decisions based on additional risk factors should be considered. We suggest that the ER time span might serve as such a predictor identifying patients at the highest risk for LR.

Long-term outcome of patients with invasive electrophysiology procedure-related cardiac tamponade.

AIMS: Iatrogenic cardiac tamponades are a rare but dreaded complication of invasive electrophysiology procedures (EPs). Their long-term impact on clinical outcomes is unknown. This study analysed the risk of death or serious cardiovascular events in patients suffering from EP-related cardiac tamponade requiring pericardiocentesis during long-term follow-up. METHODS AND RESULTS: Out of 19 997 invasive EPs at the Karolinska University Hospital between January 1998 and September 2018, all patients with EP-related periprocedural cardiac tamponade were identified (n = 60) and matched (1:3 ratio) to a control group (n = 180). After a follow-up of 5 years, the composite primary endpoint - death from any cause, acute myocardial infarction, transitory ischaemic attack (TIA)/stroke, and hospitalization for heart failure - occurred in significantly more patients in the tamponade than in the control group [12 patients (20.0%) vs. 19 patients (10.6%); hazard ratio (HR) 2.53 (95% confidence interval, CI 1.15-5.58); P = 0.021]. This was mainly driven by a higher incidence of TIA/stroke in the tamponade than in the control group [HR 3.75 (95% CI 1.01-13.97); P = 0.049]. Death from any cause, acute myocardial infarction, and hospitalization for heart failure did not show a significant difference between the groups. Hospitalization for pericarditis occurred in significantly more patients in the tamponade than in the control group [HR 36.0 (95% CI 4.68-276.86); P = 0.001]. CONCLUSION: Patients with EP-related cardiac tamponade are at higher risk for cerebrovascular events during the first 2 weeks and hospitalization for pericarditis during the first months after index procedure. Despite the increased risk for early complications tamponade patients have a good long-term prognosis without increased risk for mortality or other serious cardiovascular events.

Remote monitoring of implantable cardioverter-defibrillators and resynchronization devices to improve patient outcomes: dead end or way ahead?

Remote monitoring (RM) has become a new standard of care in the follow-up of patients with implantable pacemakers and defibrillators. While it has been consistently shown that RM enables earlier detection of clinically actionable events compared with traditional in-patient evaluation, this advantage did not translate into improved patient outcomes in clinical trials of RM except one study using daily multiparameter telemonitoring in heart failure (HF) patients. Therefore, this review, focusing on RM studies of implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators in patients with HF, discusses possible explanations for the differences in trial outcomes. Patient selection may play an important role as more severe HF and concomitant atrial fibrillation have been associated with improved outcomes by RM. Furthermore, the technical set-up of RM may have an important impact as a higher level of connectivity with more frequent data transmission can be linked to better outcomes. Finally, there is growing evidence as to the need of effective algorithms ensuring a fast and well-structured clinical response to the events detected by RM. These factors re-emphasize the potential of remote management of device patients with HF and call for continued clinical research and technical development in the field.

EHRA White Paper: knowledge gaps in arrhythmia management-status 2019.

Clinicians accept that there are many unknowns when we make diagnostic and therapeutic decisions. Acceptance of uncertainty is essential for the pursuit of the profession: bedside decisions must often be made on the basis of incomplete evidence. Over the years, physicians sometimes even do not realize anymore which the fundamental gaps in our knowledge are. As clinical scientists, however, we have to halt and consider what we do not know yet, and how we can move forward addressing those unknowns. The European Heart Rhythm Association (EHRA) believes that scanning the field of arrhythmia / cardiac electrophysiology to identify knowledge gaps which are not yet the subject of organized research, should be undertaken on a regular basis. Such a review (White Paper) should concentrate on research which is feasible, realistic, and clinically relevant, and should not deal with futuristic aspirations. It fits with the EHRA mission that these White Papers should be shared on a global basis in order to foster collaborative and needed research which will ultimately lead to better care for our patients. The present EHRA White Paper summarizes knowledge gaps in the management of atrial fibrillation, ventricular tachycardia/sudden death and heart failure.

Improved Stroke Prevention in Atrial Fibrillation After the Introduction of Non-Vitamin K Antagonist Oral Anticoagulants.

Background and Purpose- The purpose of this study was to investigate the impact of improved antithrombotic treatment in atrial fibrillation after the introduction of non-vitamin K antagonist oral anticoagulants on the incidence of stroke and bleeding in a real-life total population, including both primary and secondary care. Methods- All resident and alive patients with a recorded diagnosis for atrial fibrillation during the preceding 5 years in the Stockholm County Healthcare database (Vårdanalysdatabasen) were followed for clinical outcomes during 2012 (n=41 008) and 2017 (n=49 510). Results- Pharmacy claims for oral anticoagulants increased from 51.6% to 73.8% (78.7% among those with CHA2DS2-VASc ≥2). Non-vitamin K antagonist oral anticoagulant claims increased from 0.4% to 34.4%. Ischemic stroke incidence rates decreased from 2.01 per 100 person-years in 2012 to 1.17 in 2017 (incidence rate ratio, 0.58; 95% CI, 0.52-0.65). The largest increases in oral anticoagulants use and decreases in ischemic strokes were seen in patients aged ≥80 years who had the highest risk of stroke and bleeding. The incidence rates for major bleeding (2.59) remained unchanged (incidence rate ratio, 1.00; 95% CI, 0.92-1.09) even in those with a high bleeding risk. Poisson regression showed that 10% of the absolute ischemic stroke reduction was associated with increased oral anticoagulants treatment, whereas 27% was related to a generally decreased risk for all stroke. Conclusions- Increased oral anticoagulants use contributed to a marked reduction of ischemic strokes without increasing bleeding rates between 2012 and 2017. The largest stroke reduction was seen in elderly patients with the highest risks for stroke and bleeding. These findings strongly support the adoption of current guideline recommendations for stroke prevention in atrial fibrillation in both primary and secondary care.

Sex differences in outcomes of primary prevention implantable cardioverter-defibrillator therapy: combined registry data from eleven European countries.

Aims: Therapy with an implantable cardioverter defibrillator (ICD) is established for the prevention of sudden cardiac death (SCD) in high risk patients. We aimed to determine the effectiveness of primary prevention ICD therapy by analysing registry data from 14 centres in 11 European countries compiled between 2002 and 2014, with emphasis on outcomes in women who have been underrepresented in all trials. Methods and results: Retrospective data of 14 local registries of primary prevention ICD implantations between 2002 and 2014 were compiled in a central database. Predefined primary outcome measures were overall mortality and first appropriate and first inappropriate shocks. A multivariable model enforcing a common hazard ratio for sex category across the centres, but allowing for centre-specific baseline hazards and centre specific effects of other covariates, was adjusted for age, the presence of ischaemic cardiomyopathy or a CRT-D, and left ventricular ejection fraction ≤25%. Of the 5033 patients, 957 (19%) were women. During a median follow-up of 33 months (IQR 16-55 months) 129 women (13%) and 807 men (20%) died (HR 0.65; 95% CI: [0.53, 0.79], P-value < 0.0001). An appropriate ICD shock occurred in 66 women (8%) and 514 men (14%; HR 0.61; 95% CI: 0.47-0.79; P = 0.0002). Conclusion: Our retrospective analysis of 14 local registries in 11 European countries demonstrates that fewer women than men undergo ICD implantation for primary prevention. After multivariate adjustment, women have a significantly lower mortality and receive fewer appropriate ICD shocks.