Edoxaban versus warfarin in vitamin K antagonist experienced and naïve patients from the edoxaban versus warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomised trial.

BACKGROUND: In ENSURE-AF study, edoxaban had similar efficacy and safety profile versus enoxaparin-warfarin (enox-warf) in patients undergoing electrical cardioversion of non-valvular atrial fibrillation. OBJECTIVES: To evaluate the efficacy and safety of edoxaban versus enox-warf in patients who were vitamin K antagonists (VKA) naïve or experienced at time of randomisation into ENSURE-AF trial. METHODS: The primary efficacy endpoint was a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death during the overall study period, 28 days on study drug after cardioversion and 30 days follow-up. The primary safety endpoint was the composite of major and clinically relevant nonmajor bleeding during the on-medication period from time of first dose to last dose of study drug taken + 3 days. RESULTS: Of 2199 patients enrolled in ENSURE-AF, 1095 were randomised to edoxaban and 1104 to enox-warf. There were numerically fewer primary efficacy endpoint events with edoxaban than enox-warf irrespective of whether VKA experienced or naïve (0.5% vs. 0.9%, 0.3% vs. 1.4%, respectively). There were no significant differences in the primary safety endpoint [odds ratio (OR) 2.09, 95% confidence interval (CI) 0.72-6.81 in anticoagulant experienced patients, OR 0.77, 95% CI 0.15-3.60 in anticoagulant naïve patients] and in major bleeding rates regardless of treatment or VKA experience (OR 0.69, 95%CI 0.06-6.04, OR 0.48, 95% CI 0.01-9.25, respectively). CONCLUSIONS: Edoxaban had comparable efficacy and safety to optimized anticoagulation with enox-warf. The primary efficacy and safety endpoint outcomes were broadly similar between VKA experienced or naïve patients.

Associations between common ECG abnormalities and out-of-hospital cardiac arrest.

Background: Out-of-hospital cardiac arrest (OHCA) is often the first manifestation of unrecognised cardiac disease. ECG abnormalities encountered in primary care settings may be warning signs of OHCA. Objective: We examined the association between common ECG abnormalities and OHCA in a primary care setting. Methods: We cross-linked individuals who had an ECG recording between 2001 and 2011 in a primary care setting with the Danish Cardiac Arrest Registry and identified OHCAs of presumed cardiac cause. Results: A total of 326 227 individuals were included and 2667 (0,8%) suffered an OHCA. In Cox regression analyses, adjusted for age and sex, the following ECG findings were strongly associated with OHCA: ST-depression without concomitant atrial fibrillation (HR 2.79; 95% CI 2.45 to 3.18), left bundle branch block (LBBB; HR 3.44; 95% CI 2.85 to 4.14) and non-specific intraventricular block (NSIB; HR 3.15; 95% CI 2.58 to 3.83). Also associated with OHCA were atrial fibrillation (HR 1.89; 95% CI 1.63 to 2.18), Q-wave (HR 1.75; 95% CI 1.57 to 1.95), Cornell and Sokolow-Lyon criteria for left ventricular hypertrophy (HR 1.56; 95% CI 1.33 to 1.82 and HR 1.27; 95% CI 1.12 to 1.45, respectively), ST-elevation (HR 1.40; 95% CI 1.09 to 1.54) and right bundle branch block (HR 1.29; 95% CI 1.09 to 1.54). The association between ST-depression and OHCA diminished with concomitant atrial fibrillation (HR 1.79; 95% CI 1.42 to 2.24, p < 0.01 for interaction). Among patients suffering from OHCA, without a known cardiac disease at the time of the cardiac arrest, 14.2 % had LBBB, NSIB or ST-depression. Conclusions: Several common ECG findings obtained from a primary care setting are associated with OHCA.

Significant regional variation in use of implantable cardioverter-defibrillators in Denmark.

AIMS: Implantable cardioverter-defibrillator (ICD) treatment prevents sudden cardiac death in high-risk patients. This study examined geographical variation in ICD implantation rates in Denmark and potential causes of variation. METHODS AND RESULTS: We obtained numbers of ICD implantations in the 5 Danish regions and 98 municipalities during 2007-13 from the Danish Pacemaker and ICD Registry. Standardized implantation rates (SIRs) were computed as ICD implantations per 1 000 000 person-years, and age- and gender-standardized to the Danish population. We examined associations of the municipal SIR with mean age and Charlson Comorbidity Index score of ICD recipients, percentage of implantations with primary prophylactic indication, and distance from patient residency to ICD implanting centre. Based on 7192 ICD implantations, the nationwide SIR was 186 [95% confidence interval (CI) 182-190], ranging from 170 (95% CI 158-183) in the North Denmark Region to 206 (95% CI 195-218) in the Region of Zealand. Municipalities with higher patient comorbidity scores, higher percentages of implantations with primary prophylactic indication, and shorter distances to ICD implanting centres, had higher SIRs [differences between SIRs of municipalities in highest and lowest quartiles 22 (95% CI 10-34), 45 (95% CI 33-58), and 35 (95% CI 24-47), respectively]. Regional differences in SIRs decreased over time and had become insignificant during 2011-13. CONCLUSION: Implantable cardioverter-defibrillator implantation rates in Denmark varied significantly between regions but variation decreased during 2007-13. Geographical variation was associated with differences in patient comorbidity score, variation in use of primary prophylactic ICD treatment, and distance to ICD implanting centre.

Single and dual coil shock efficacy and predictors of shock failure in patients with modern implantable cardioverter defibrillators-a single-center paired randomized study.

PURPOSE: Implantable cardioverter defibrillators (ICDs) can treat life-threatening tachyarrhythmia with high-voltage shocks. The aims were to compare the efficacy of single and dual coil shock vectors in modern ICDs and to identify predictors of shock failure. METHODS: This is a single-center paired randomized study including 216 patients with mixed indications and ICDs from four manufacturers. All patients underwent two implant defibrillation tests using single and dual coil vectors with the test order randomized. Tested shock energy differed slightly between manufacturers because of differences in device programmability: first shock approximately 15 J below maximal output-if failed, second shock approximately 10 J below maximal output-if failed, third shock at maximal output. RESULTS: First shock success rate was 399/432 (92.4%). Comparing single and dual coil vectors, no differences were seen in first shock efficacy (91.7% vs. 93.1%, P = 0.629) or lowest tested succesfully stored energy (27.2 J vs. 27.1 J, P = 0.620). All successive internal shocks failed in 4/432 (0.9%) of inductions requiring external rescue shocks to restore circulation. Multivariate predictors of first shock failure were QRS duration (relative risk 0.81 per 10 ms, P = 0.001), amiodarone treatment (relative risk 3.30, P = 0.003), and body height (relative risk 1.70 per 10 cm, P = 0.019). CONCLUSIONS: Implant defibrillation testing of modern intravenous ICD systems demonstrates high shock efficacy with no difference between single and dual coil vectors.

Remote monitoring and clinical outcomes: details on information flow and workflow in the IN-TIME study.

AIMS: Randomized clinical trials investigating a possible outcome effect of remote monitoring in patients with implantable defibrillators have shown conflicting results. This study analyses the information flow and workflow details from the IN-TIME study and discusses whether differences of message content, information speed and completeness, and workflow may contribute to the heterogeneous results. METHODS AND RESULTS: IN-TIME randomized 664 patients with an implantable cardioverter/defibrillator indication to daily remote monitoring vs. control. After 12 months, a composite clinical score and all-cause mortality were improved in the remote monitoring arm. Messages were received on 83.1% of out-of-hospital days. Daily transmissions were interrupted 2.3 times per patient-year for more than 3 days. During 1 year, absolute transmission success declined by 3.3%. Information on medical events was available after 1 day (3 days) in 83.1% (94.3%) of the cases. On all working days, a central monitoring unit informed investigators of protocol defined events. Investigators contacted patients with a median delay of 1 day and arranged follow-ups, the majority of which took place within 1 week of the event being available. CONCLUSION: Only limited data on the information flow and workflow have been published from other studies which failed to improve outcome. However, a comparison of those data to IN-TIME suggest that the ability to see a patient early after clinical events may be inferior to the set-up in IN-TIME. These differences may be responsible for the heterogeneity found in clinical effectiveness of remote monitoring concepts.

Percutaneous versus thoracoscopic ablation of symptomatic paroxysmal atrial fibrillation: a randomised controlled trial - the FAST II study.

BACKGROUND: The most efficient first-time invasive treatment, for achieving sinus rhythm, in symptomatic paroxysmal atrial fibrillation has not been established. We aimed to compare percutaneous catheter and video-assisted thoracoscopic pulmonary vein radiofrequency ablation in patients referred for first-time invasive treatment due to symptomatic paroxysmal atrial fibrillation. The primary outcome of interest was the prevalence of atrial fibrillation with and without anti-arrhythmic drugs at 12 months. METHODS: Ninety patients were planned to be randomised to either video-assisted thoracoscopic radiofrequency pulmonary vein ablation with concomitant left atrial appendage excision or percutaneous catheter pulmonary vein ablation. Episodes of atrial fibrillation were defined as more than 30 s of atrial fibrillation observed on Holter monitoring/telemetry or clinical episodes documented by ECG. RESULTS: The study was terminated prematurely due to a lack of eligible patients. Only 21 patients were randomised and treated according to the study protocol. Thoracoscopic pulmonary vein ablation was performed in 10 patients, and 11 patients were treated with catheter ablation. The absence of atrial fibrillation without the use of anti-arrhythmic drugs throughout the follow-up was observed in 70% of patients following thoracoscopic pulmonary vein ablation and 18% after catheter ablation (p < 0.03). CONCLUSION: Thoracoscopic pulmonary vein ablation may be superior to catheter ablation for first-time invasive treatment of symptomatic paroxysmal atrial fibrillation with regard to obtaining sinus rhythm off anti-arrhythmic drugs 12 months postoperative. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01336075 . Registered April 15th, 2011.

Disease progression after ablation for atrial flutter compared with atrial fibrillation: A nationwide cohort study.

AIMS: The aim of this study was to study the risk of death and development of arrhythmia and/or subsequently heart failure after an atrial flutter ablation procedure compared with an atrial fibrillation (AF) ablation procedure. METHODS: This observational study is based on data from Danish nationwide health databases. Patients with a first-time ablation procedure for either atrial flutter or AF in the period 2000-2016 were included. Rates of renewed arrhythmia, heart failure or death were compared and reported as adjusted hazard ratios (HR). RESULTS: The study population consisted of 2,004 and 3,803 patients with an incident atrial flutter or AF ablation procedure, respectively. All-cause mortality among atrial flutter patients was significantly higher compared with the AF group (HR 1.80, 95% confidence interval [CI] 1.39-2.35). The incidence of renewed arrhythmia without heart failure was lower in atrial flutter (HR 0.76, 95% CI 0.69-0.84). Renewed atrial flutter ablation and pacemaker implantations were significantly more frequent (HR 2.42, 95% CI 2.02-2.91 and HR 1.42, 95% CI 1.13-1.79, respectively) in atrial flutter compared with AF. The risk of heart failure was higher for atrial flutter, both after the initial ablation (HR 1.48, 95% CI 1.08-2.03), and after a further arrhythmia management event (HR 1.98, 95% CI 1.33-2.94). CONCLUSION: There was a higher mortality risk after atrial flutter ablation procedures compared with patients undergoing AF ablation. Rates of heart failure and further renewed (non-AF) arrhythmia management were higher in atrial flutter.

Edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources: an analysis from the EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) study.

Aims: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) (NCT02072434) study was a multicentre prospective, randomized, open-label, blinded-endpoint evaluation (PROBE) trial comparing edoxaban with enoxaparin/warfarin followed by warfarin alone in 2199 non-valvular atrial fibrillation patients undergoing electrical cardioversion and showed comparable rates of bleeding and thromboembolism between treatments. This prespecified ancillary analysis investigated the impact of edoxaban therapy on treatment satisfaction and utilization of healthcare services. Methods and results: The Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) was completed by study patients on Day 28 post-cardioversion. Higher scores represent greater satisfaction. Healthcare resource utilizations were collected from randomization to Day 28 post-cardioversion. Data from patients who received at least one dose of study drugs were analysed. Patients treated with edoxaban were more satisfied than enoxaparin/warfarin in both PACT-Q treatment satisfaction and convenience scores (P < 0.001 for both). Differences in treatment satisfaction scores were greater in patients who underwent non-transoesophageal echocardiography (TOE)-guided cardioversion than in patients who underwent TOE-guided cardioversion. Edoxaban was associated with fewer clinic visits (4.75 visits vs. 7.60 visits; P < 0.001) and fewer hospital days (3.43 days vs. 5.41 days; P < 0.05). Rates of hospitalizations and emergency room visits were not significantly different. Overall, edoxaban therapy was estimated to reduce healthcare costs by €107.73, €437.92, €336.75, and $246.32 per patient in German, Spanish, Italian, and US settings, respectively. Conclusions: The convenience of edoxaban therapy over warfarin in patients undergoing cardioversion may provide greater treatment satisfaction and cost savings to the healthcare system.

Atrial fibrillation in patients with severe mental disorders and the risk of stroke, fatal thromboembolic events and bleeding: a nationwide cohort study.

OBJECTIVES: Outcomes of atrial fibrillation (AF) in patients with severe mental disorders are largely unknown. We compared rates of stroke, fatal thromboembolic events and bleeding in patients with AF with and without mental disorders. DESIGN: Nationwide registry-based cohort study. SETTING: Denmark (population 5.6 million), 2000-2015. PARTICIPANTS: Patients with AF with schizophrenia (n=534), severe depression (n=400) or bipolar disease (n=569) matched 1:5 on age, sex and calendar time to patients with AF without mental disorders. EXPOSURE: Inpatient or hospital-based outpatient diagnosis of schizophrenia, severe depression or bipolar disease. PRIMARY AND SECONDARY OUTCOME MEASURES: HRs for stroke, fatal thromboembolic events and major bleeding comparing patients with and without mental disorders estimated by Cox regression with sequential adjustment for risk factors for stroke and bleeding, comorbidity and initiation of oral anticoagulant therapy (OAT). RESULTS: Compared with matched comparisons, crude 5-year HRs of ischaemic stroke were 1.37 (95% CI 0.88 to 2.14) for schizophrenia, 1.36 (95% CI 0.89 to 2.08) for depression and 1.04 (95% CI 0.69 to 1.56) for bipolar disease. After adjusting for risk factors, comorbidity and OAT, these HRs declined towards the null. Crude HRs of fatal thromboembolic events were 3.16 (95% CI 1.78 to 5.61) for schizophrenia, 1.31 (95% CI 0.67 to 2.56) for depression and 1.53 (95% CI 0.93 to 2.53) for bipolar disease. Rates of major bleeding were increased in patients with schizophrenia (crude HR 1.37, 95% CI 0.99 to 1.90) and severe depression (HR 1.25, 95% CI 0.87 to 1.78) but not bipolar disease (HR 0.82, 95% CI 0.58 to 1.15). CONCLUSION: Patients with AF with schizophrenia or severe depression experienced increased rates of stroke and major bleeding compared with matched comparisons. This increase was largely explained by differences in the prevalence of risk factors for stroke and bleeding, comorbidity and initiation of OAT during follow-up. Patients with AF with schizophrenia further experienced higher mortality following thromboembolic events than matched comparisons without mental disorders.

Mortality and risk of cardiac complications among immediate survivors of accidental electric shock: a Danish nationwide cohort study.

OBJECTIVE: Exposure to electric shock has been associated with an increased risk of developing delayed cardiac arrhythmias and cardiac diseases. We examined whether electric shock patients have an increased risk of developing cardiac disease, cardiac arrhythmias or death compared with the general Danish population. DESIGN: Matched cohort study. SETTING: A nationwide study in Denmark from 1994 to 2011. PARTICIPANTS: We identified 11 462 Danish patients who visited an emergency ward or were admitted to a hospital due to electric shock from 1994 to 2011. Each patient was matched for age and sex with five random controls from the Danish population. MAIN OUTCOME MEASURES: Mortality, cardiac procedures and cardiac diseases following electric shock. RESULTS: A total of 7390 electric shock patients were seen at an emergency ward and 4072 electric shock patients were admitted to a hospital. The median patient age was 28.6 years (Q1-Q3, 21.3-37.7) for the emergency ward patients and 26.4 years (Q1-Q3, 18.3-37.4) for admitted patients. In both groups, most patients were male (74.0% and 76.8%). Few of the electric shock patients had a record of cardiovascular disease at baseline (364/11 462, 3.2%). The 5-year cumulative incidence of death was 0.47% (95% CI 0.29% to 0.65%) for emergency ward patients and 1.04% (95% CI 0.71% to 1.37%) for admitted patients. No difference in 5-year survival was observed compared with matched controls (emergency ward, p=0.10; admitted patients, p=0.80). Fewer than four patients received a pacemaker within 30 days. CONCLUSIONS: This nationwide study did not demonstrate an increase in mortality among patients seen at hospitals after accidental electric shock compared with a background population. Cardiac procedures and diseases following electric shock were very rare. We suggest that nearly all patients can be discharged safely from the emergency room after electric shock without further observation.

Risk factors of cardiac device infection: Glove contamination during device procedures.

BACKGROUND: Infections in cardiac implantable electronic devices (CIEDs) constitute a serious complication. We sought to identify contamination of gloves before handling the device in primary and replacement CIED procedures. METHODS: Two groups of 30 patients underwent primary CIED implantation or replacement. Before the device entered the surgical field, surgeon and assistant imprinted their outer gloves on aerobe and anaerobe agar plates, and a wound swab was performed. Samples were cultured, and the presence of bacteria was identified, counted as the number of colony forming units, and characterized to the level of genus and species. RESULTS: Samples from 40 (67%) procedures revealed bacteria on surgeons' or assistants' gloves. Contamination occurred in 80% of replacements and 67% of primary implantations (risk difference, 13%; 95% confidence interval [CI], -8.8 to 35.5). Contamination of surgeons' and assistants' gloves occurred in 55% and 44% of procedures, respectively. Coagulase-negative Staphylococcus (CNS) occurred in 52%, and Propionibacterium spp (PS) occurred in 84% of positive cases. For every 15 minutes of procedure time, colony levels increased by 7.4% (95% CI, 1.4%-13.4%). CONCLUSIONS: Contamination of gloves is common during CIED procedures before handling the device. Therefore, devices are often handled with contaminated gloves. The most prevalent bacteria were PS and CNS, which are associated with clinical CIED infections. Changing outer gloves before handling the device might improve sterile state and lower infection risk.

Bystander Defibrillation for Out-of-Hospital Cardiac Arrest in Public vs Residential Locations.

Importance: Bystander-delivered defibrillation (hereinafter referred to as bystander defibrillation) of patients with out-of-hospital cardiac arrests (OHCAs) remains limited despite the widespread dissemination of automated external defibrillators (AEDs). Objective: To examine calendar changes in bystander defibrillation and subsequent survival according to a public or a residential location of the cardiac arrest after nationwide initiatives in Denmark to facilitate bystander-mediated resuscitative efforts, including bystander defibrillation. Design, Setting, and Participants: This nationwide study identified 18 688 patients in Denmark with first-time OHCA from June 1, 2001, to December 31, 2012, using the Danish Cardiac Arrest Registry. Patients had a presumed cardiac cause of arrest that was not witnessed by emergency medical services personnel. Data were analyzed from April 1, 2015, to December 10, 2016. Exposures: Nationwide initiatives to facilitate bystander resuscitative efforts, including bystander defibrillation, consisted of resuscitation training of Danish citizens, dissemination of on-site AEDs, foundation of an AED registry linked to emergency medical dispatch centers, and dispatcher-assisted guidance of bystander resuscitation efforts. Main Outcomes and Measures: The proportion of patients who received bystander defibrillation according to the location of the cardiac arrest and their subsequent 30-day survival. Results: Of the 18 688 patients with OHCAs (67.8% men and 32.2% women; median [interquartile range] age, 72 [62-80] years), 4783 (25.6%) had a cardiac arrest in a public location and 13 905 (74.4%) in a residential location. The number of registered AEDs increased from 141 in 2007 to 7800 in 2012. The distribution of AED location was consistently skewed in favor of public locations. Bystander defibrillation increased in public locations from 3 of 245 (1.2%; 95% CI, 0.4%-3.5%) in 2001 to 78 of 510 (15.3%; 95% CI, 12.4%-18.7%) in 2012 (P < .001) but remained unchanged in residential locations from 7 of 542 (1.3%; 95% CI, 0.6%-2.6%) in 2001 to 21 of 1669 (1.3%; 95% CI, 0.8%-1.9%) in 2012 (P = .17). Thirty-day survival after bystander defibrillation increased in public locations from 8.3% (95% CI, 1.5%-35.4%) in 2001/2002 to 57.5% (95% CI, 48.6%-66.0%) in 2011/2012 (P < .001) in residential locations, from 0.0% (95% CI, 0.0%-19.4%) in 2001/2002 to 25.6% (95% CI, 14.6%-41.1%) in 2011/2012 (P < .001). Conclusions and Relevance: Initiatives to facilitate bystander defibrillation were associated with a marked increase in bystander defibrillation in public locations, whereas bystander defibrillation remained limited in residential locations. Concomitantly, survival increased after bystander defibrillation in residential and public locations.

Venous thromboembolism in patients with implantable cardioverter-defibrillators.

AIMS: To examine the incidence of venous thromboembolism (VTE) and its risk factors among patients with implantable cardioverter-defibrillators (ICDs). METHODS AND RESULTS: All first-time ICD recipients in Denmark during 2000-12 were identified from medical databases. Incident VTEs were ascertained, overall and according to gender, age, Charlson Comorbidity Index score (no, moderate, or severe comorbidity), prior pacemaker or cardiac resynchronization therapy (CRT-D) implantation, and ICD type (single-chamber, dual-chamber, or CRT-D). We computed the risk of VTE within 3 months and 5 years of implantation, taking death into account as a competing risk. We used Cox proportional hazards regression to compute hazard ratios as estimates of incidence rate ratios (IRRs). Among 8132 ICD recipients, 136 VTEs were diagnosed during up to 13 years of follow-up (median = 3.0 years). The VTE incidence rate was thus 4.5 per 1000 person-years [95% confidence interval (CI): 3.7-5.2]. Venous thromboembolism risk was 0.3% (95% CIs ranging from 0.1 to 0.7%) within 3 months following ICD implantation regardless of comorbidity level. Within 5 years following implantation it was 1.4% (95% CI: 0.8-2.3%), 1.3% (1.0-1.8%), and 3.2% (95% CI: 2.4-4.1%) for patients with no, moderate, and severe comorbidity, respectively. Overall, severe comorbidity conferred a 2.7-fold higher incidence rate ratio than no comorbidity (95% CI: 1.6-4.6). Incidence rate ratios did not differ by gender, age, or ICD type. CONCLUSION: Three-month risk of VTE following ICD implantation was 0.3% regardless of comorbidity level. Five-year risk of VTE following ICD implantation was 1.9% and more than twice as high for patients with severe comorbidity as for patients without comorbidity.

Death and thrombo-embolic risk after ablation of atrial flutter compared with atrial fibrillation: a nationwide cohort study.

AIMS: The aim of this study was to investigate whether there is a similar mortality and thrombo-embolic risk, after an atrial ablation procedure, compared with an atrial fibrillation (AF) procedure. METHODS AND RESULTS: Using data from nationwide Danish health registries, we identified patients aged 18-75 years undergoing a first-time atrial flutter or an AF ablation procedure in the period 2000-13. Cox proportional hazards regression was used to calculate hazard ratios (HRs) after 5 years of follow-up, adjusting for concomitant risk factors. A total of 1096 and 2266 patients underwent an ablation for atrial flutter or AF, respectively. Age distribution was similar in the two, but atrial flutter patients had more co-morbidities. During 5 years of follow-up, we observed 38 and 36 deaths in the atrial flutter and AF groups, corresponding to an almost two-fold higher mortality rate among atrial flutter patients [crude HR 1.92, 95% confidence interval (CI) 1.22-3.03]. The higher mortality rate persisted after adjustment for age, sex, diabetes mellitus, and hypertension (adjusted HR 1.68, 95% CI 1.05-2.69). The rate of thrombo-embolic events was similar in the two groups (crude HR 1.34, 95% CI 0.71-2.56; adjusted HR 1.22, 95% CI 0.62-2.41). CONCLUSION: In this observational study, patients with atrial flutter had a significantly higher all-cause mortality rate compared with those with AF after an ablation procedure, but similar thrombo-embolic event rates. Future studies should elucidate the reason for this difference in mortality.

Single-coil and dual-coil defibrillator leads and association with clinical outcomes in a complete Danish nationwide ICD cohort.

BACKGROUND: The best choice of defibrillator lead in patients with routine implantable cardioverter-defibrillator (ICD) is not settled. Traditionally, most physicians prefer dual-coil leads but the use of single-coil leads is increasing. OBJECTIVE: The purpose of this study was to compare clinical outcomes in patients with single- and dual-coil leads. METHODS: All 4769 Danish patients 18 years or older with first-time ICD implants from 2007 to 2011 were included from the Danish Pacemaker and ICD Register. Defibrillator leads were 38.9% single-coil leads and 61.1% dual-coil leads. The primary end point was all-cause mortality. Secondary end points were lowest successful energy at implant defibrillation testing, first shock failure in spontaneous arrhythmias, structural lead failure, and lead extraction outcomes. RESULTS: Single-coil leads were associated with lower all-cause mortality with an adjusted hazard ratio of 0.85 (95% confidence interval 0.73-0.99; P = .04). This finding was robust in a supplementary propensity score-matched analysis. However, dual-coil leads were used in patients with slightly higher preimplant morbidity, making residual confounding by indication the most likely explanation for the observed association between lead type and mortality. The lowest successful defibrillation energy was higher using single-coil leads (23.2 ± 4.3 J vs 22.1 ± 3.9 J; P < .001). No significant differences were observed for other secondary end points showing high shock efficacies and low rates of lead failures and extraction complications. CONCLUSION: Shock efficacy is high for modern ICD systems. The choice between single-coil and dual-coil defibrillator leads is unlikely to have a clinically significant impact on patient outcomes in routine ICD implants.

Regional differences in referral, procedures, and outcome after ablation for atrial fibrillation in Europe: a report from the Atrial Fibrillation Ablation Pilot Registry of the European Society of Cardiology.

AIMS: Ablation is an effective treatment of symptomatic and drug refractory atrial fibrillation (AF). Using data from the European AF Ablation Pilot Registry comprising 1410 patients from 10 European countries, we prospectively investigated regional differences in AF ablation regarding patient selection, ablation strategy, and outcome. METHODS AND RESULTS: Countries were divided into three regions: South (Greece, Italy, Spain), East (Czech Republic, Poland), and West/North (Belgium, Denmark, France, Germany, and the Netherlands). One-year success was defined as patient survival free from atrial arrhythmia, with or without antiarrhythmic drugs (AAD). In all regions, patients were symptomatic and treated extensively with beta-blockers and AAD pre-ablation. Patients in East had more co-morbidity, increased thromboembolic risk, were more likely to have paroxysmal AF, and they underwent more left atrial linear ablations. Adverse events remained within expected levels, albeit with a significantly higher reporting of adverse cardiovascular events in the West/North (4.7 vs. 1.4 and 1.5% in South and East, P = 0.0032). There was no significant difference in peripheral/vascular, neurological, pulmonary, gastrointestinal, or general adverse events. The 1-year success rate after ablation differed non-statistically between regions ranging from 69.1 to 74.7%. A second ablation was performed in 23.2% in West/North compared with 10.5 and 16.5% in South and East. The proportion of patients still on AADs was highest in the South region (51.6 vs. 42.3 and 38.8% in East and West/North). CONCLUSION: This study with all-comer patients shows that patient selection for ablation follows current guidelines but reveals significant differences regarding co-morbidity, medication, and ablation strategy. Despite this, 1-year outcomes are without significant differences and in line with previously published clinical trials.

New strict left bundle branch block criteria reflect left ventricular activation differences.

AIMS: Pacing lead electrical delays and strict left bundle branch block (LBBB) criteria were assessed against cardiac resynchronization therapy (CRT) outcome. METHODS: Forty-nine patients with LBBB and QRS duration >130 milliseconds underwent CRT-implantation. Sensed right ventricular to left ventricular electrical delay (RV-LV-IED) was measured. Response to CRT was defined as ≥15% decrease in left ventricular end-systolic volume. RESULTS: Eighteen of 20 (90%) patients with non-ischemic dilated cardiomyopathy (DCM) and 18 of 29 (62%) with ischemic heart disease (IHD) responded to CRT, p<0.01. When applying new strict ECG criteria subsequent rates of response in DCM were 18/19 (95%) and in IHD of 18/23 (78%) respectively, p<0.05 between IHD groups. Correspondingly, RV-LV-IED was longer in DCM compared to IHD patients and in responders compared to non-responders, p=0.017 and p<0.001, respectively. CONCLUSION: Interventricular electrical delay predicts left ventricular remodeling after CRT and new, strict ECG criteria of LBBB are superior in predicting remodeling.

Atrial flutter and thromboembolic risk: a systematic review.

Atrial flutter confers a thromboembolic risk, but contrary to atrial fibrillation the relationship has only been addressed in few studies. This study performs an up to date systematic review of the literature to investigate the association between atrial flutter and thromboembolic events. Articles were found by MEDLINE, EMBASE search and a manual search of references list in included articles. International guidelines, meta-analyses, reviews, case reports, studies reporting thromboembolic events in relation to ablation, or cardioversion procedures, echocardiography, and observational studies were found eligible in this review. A total of 52 articles were included in this review. During cardioversion, thromboembolic event rates varied from 0% to 6% with a follow-up from 1 week to 6 years. Echocardiographic studies reported prevalence of thrombus material from 0% to 38% and a prevalence of spontaneous echo contrast (SEC) from 21% to 28%. One ablation study in non-anticoagulated patients reported thromboembolic events at 13.9%. Observational studies reported an overall elevated stroke risk (risk ratio 1.4, 95% CI 1.35 to 1.46) and mortality risk (HR 1.9, 95% CI 1.2 to 3.1) with long time follow-up compared with a control group in both studies. Given the limitations and heterogeneity of the data, a meta-analysis was not a part of this systematic review. Notwithstanding the limitations of observational studies and indirect data from echocardiographic studies, this systematic review confirms that clinical thromboembolic events, left atrial thrombus and SEC are highly prevalent in atrial flutter.

Thirteen-year nationwide trends in use of implantable cardioverter-defibrillators and subsequent long-term survival.

BACKGROUND: Long-term trends in use of implantable cardioverter-defibrillators (ICDs) and outcomes are rare. OBJECTIVE: We examined 13-year nationwide trends in ICD implantation and survival rates in Denmark. METHODS: Using medical databases, we identified all first time ICD recipients in Denmark during 2000-2012 (N = 8460) and ascertained all-cause mortality. We computed standardized annual implantation rates and mortality rate ratios according to age, sex, comorbidity level, indication, and device type. RESULTS: The standardized annual implantation rate increased from 42 per million persons in 2000 to 213 per million persons in 2012 (from 34 to 174 for men and from 8 to 39 for women). The increase was driven by secondary prophylactic ICDs until 2006 and primary prophylactic ICDs thereafter. The increase occurred particularly in older patients and those with a high level of comorbidity. Independent of indication, 76% of all patients with ICD were alive after 5 years. Men had a higher mortality rate compared with women (mortality rate ratio 1.28; 95% confidence interval 1.10-1.49). Compared with low comorbidity level, moderate, severe, and very severe comorbidity levels were associated with 1.6-, 2.5-, and 4.9-fold increased mortality rates, respectively. The most influential individual comorbidities were heart failure, diabetes, liver disease, and renal disease. CONCLUSION: The annual implantation rate of ICDs increased 5-fold in Denmark between 2000 and 2012. The rate increase occurred for both men and women, but particularly in the elderly and patients with severe comorbidity. Five-year survival probability was high, but severe comorbidity and male sex were associated with shorter survival.

Groin hematoma after electrophysiological procedures-incidence and predisposing factors.

OBJECTIVES: We evaluated the incidence and predisposing factors of groin hematomas after electrophysiological (EP) procedures. DESIGN: Prospective, observational study, enrolling consecutive patients after EP procedures (Atrial fibrillation: n = 151; Supraventricular tachycardia/Diagnostic EP: n = 82; Ventricular tachycardia: n = 18). Patients underwent manual compression for 10 min and 3 h post procedural bed rest. AF ablations were performed with INR 2-3, ACT > 300, and no protamine sulfate. Adhesive pressure dressings (APDs) were used if sheath size ≥ 10F; procedural time > 120 min; and BMI > 30. Patient-reported hematomas were recorded by a telephone follow-up after 2 weeks. RESULTS: Hematoma developed immediately in 26 patients (10%) and after 14 days significant hematoma was reported in 68 patients (27%). Regression analysis on sex, age, BMI 25, ACT 300, use of APD, sheath size and number, and complicated venous access was not associated with hematoma, either immediately after the procedure or after 14 days. Any hematoma presenting immediately after procedures was associated with patient-reported hematomas after 14 days, odds ratio 18.7 (CI 95%: 5.00-69.8; P < 0.001). CONCLUSIONS: Any hematoma immediately after EP procedures was the sole predictor of patient-reported hematoma after 2 weeks. Initiatives to prevent groin hematoma should focus on the procedure itself as well as post-procedural care.