Patient selection, peri-procedural management, and ablation techniques for catheter ablation of atrial fibrillation: an EHRA survey.

Catheter ablation (CA) of atrial fibrillation (AF) is the therapy of choice for the maintenance of sinus rhythm in patients with symptomatic AF. Time towards interventional treatment and peri-procedural management of patients undergoing AF ablation may vary in daily practice. The scope of this European Heart Rhythm Association (EHRA) survey was to report the current clinical practice regarding the management of patients undergoing AF ablation and physician's adherence to the European Society of Cardiology Guidelines and the EHRA/HRS/ECAS expert consensus statement on the CA for AF. This physician-based survey was conducted among EHRA members, using an internet-based questionnaire developed by the EHRA Scientific Initiatives Committee. A total of 258 physicians participated in the survey. In patients with paroxysmal or persistent AF, 42 and 9% of the physicians would routinely perform AF ablation as first-line therapy respectively, whereas 71% of physicians would consider ablation as first-line therapy in patients with symptomatic AF and left ventricular ejection fraction <35%. Only 14% of the respondents manage cardiovascular risk factors in patients referred for CA using a dedicated AF risk factor management programme. Radiofrequency CA is the preferred technology for first-time AF (56%), followed by cryo-balloon CA (40%). This EHRA survey demonstrated a considerable variation in the management of patients undergoing AF ablation in routine practice and deviations between guideline recommendations and clinical practice.

Role of Soluble ST2 Biomarker in Predicting Recurrence of Atrial Fibrillation after Electrical Cardioversion or Pulmonary Vein Isolation.

This study aims to determine the predictive value of the soluble suppression of tumorigenicity 2 (sST2) biomarker in atrial fibrillation (AF) recurrence. This prospective, observational study included patients with AF referred for electrical cardioversion (ECV) or pulmonary vein isolation (PVI) procedures. Baseline characteristics were collected, and sST2 was determined at baseline and at 3 and 6 months of follow-up. sST2 was determined at baseline in a matched control group. Left atrial voltage mapping was performed in patients undergoing PVI. The sST2 maximal predictive capacity of AF recurrence was at the 3-month FU in the cohort of patients undergoing ECV with respect to 6-month AF recurrence with an AUC of 0.669, a cut-off point of 15,511 pg/mL, a sensitivity of 60.97%, and a specificity of 69.81%. The ROC curve of the sST2 biomarker at baseline and 3 months in the cohort of patients undergoing PVI showed AUCs of 0.539 and 0.490, respectively. The logistic regression model identified the rhythm (AF) and the sST2 biomarker at 3 months as independent factors for recurrence at 6 months in the ECV cohort. In the logistic regression model, sST2 was not an independent factor for recurrence at 6 months of follow-up in the PVI cohort. In patients who underwent ECV, sST2 values at 3 months may provide utility to predict AF recurrence at 6 months of follow-up. In patients who underwent PVI, sST2 had no value in predicting AF recurrence at 6 months of follow-up.

Plasma miR-486-5p Expression Is Upregulated in Atrial Fibrillation Patients with Broader Low-Voltage Areas.

Atrial fibrillation (AF) is the most common arrhythmia worldwide, affecting 1% of the population over 60 years old. The incidence and prevalence of AF are increasing globally, representing a relevant health problem, suggesting that more advanced strategies for predicting risk stage are highly needed. miRNAs mediate several processes involved in AF. Our aim was to identify miRNAs with a prognostic value as biomarkers in patients referred for AF ablation and its association with LVA extent, based on low-voltage area (LVA) maps. In this study, we recruited 44 AF patients referred for catheter ablation. We measured the expression of 84 miRNAs in plasma from peripheral blood in 3 different groups based on LVA extent. Expression analysis showed that miR-486-5p was significantly increased in patients with broader LVA (4-fold, p = 0.0002; 5-fold, p = 0.0001). Receiver operating characteristic curve analysis showed that miR-486-5p expression could predict atrium LVA (AUC, 0.8958; p = 0.0015). Also, miR-486-5p plasma levels were associated with AF-type (AUC, 0.7137; p = 0.0453). In addition, miR-486-5p expression was positively correlated with LVA percentage, left atrial (LA) area, and LA volume (r = 0.322, p = 0.037; r = 0.372, p = 0.015; r = 0.319, p = 0.045, respectively). These findings suggest that miR-486-5p expression might have prognostic significance in LVA extent in patients with AF.

Antithrombotic therapy and clinical outcomes at 1 year in the Spanish cohort of the EORP-AF Long-term General Registry.

BACKGROUND: Atrial fibrillation (AF) increases the risk of thromboembolism. We investigate the efficacy and safety of oral anticoagulation (OAC) therapy and explored the number needed to treat for net effect (NNTnet) of OAC in the Spanish cohort of the EURObservational Research Programme-AF (EORP-AF) Long-term General Registry. METHODS: The EORP-AF General Registry is a prospective, multicentre registry conducted in ESC countries, including consecutive AF patients. For the present analysis, we used the Spanish cohort, and the primary outcome was any thromboembolism (TE)/acute coronary syndrome (ACS)/cardiovascular death during the first year of follow-up. RESULTS: 729 AF patients were included (57.1% male, median age 75 [IQR 67-81] years, median CHA2 DS2 -VASc and HAS-BLED of 3 [IQR 2-5] and 2 [IQR 1-2], respectively). 548 (75.2%) patients received OAC alone (318 [43.6%] on VKAs and 230 [31.6%] on DOACs). After 1 year, the use of OAC alone showed lower rates of any TE/ACS/cardiovascular death (3.0%/year; p < 0.001) compared to other regimens, and non-use of OAC alone (HR 4.18, 95% CI 2.12-8.27) was independently associated with any TE/ACS/cardiovascular death. Balancing the effects of treatment, the NNTnet to provide an overall benefit of OAC therapy was 24. The proportion of patients on OAC increased at 1 year (87% to 88.1%), particularly on DOACs (33.6% to 39.9%) (p = 0.015), with low discontinuation rates. CONCLUSIONS: In this contemporary cohort of AF patients, OAC therapy was associated with better clinical outcomes at 1 year and positive NNTnet. OAC use slightly increased during the follow-up, with low discontinuation rates and higher prescription of DOACs.

Characterization of atrial fibrillation in real-world patients: testing the 4S-AF scheme in the Spanish and French cohorts of the EORP-AF Long-Term General Registry.

AIMS: The 4S-AF scheme [Stroke risk, Symptom severity, Severity of atrial fibrillation (AF) burden, Substrate severity] has recently been described as a novel approach to in-depth characterization of AF. We aim to determine if the 4S-AF scheme would be useful for AF characterization and provides prognostic information in real-world AF patients. METHODS AND RESULTS: The Spanish and French cohorts of the EORP-AF Long-Term General Registry were included. The baseline 4S-AF scheme was calculated and related to the primary management strategy (rhythm or rate control). Follow-up was performed at 1-year with all-cause mortality and the composite of ischaemic stroke/transient ischaemic attack/systemic embolism, major bleeding, and all-cause death, as primary endpoints. A total of 1479 patients [36.9% females, median age 72 interquartile range (IQR 64-80) years] were included. The median 4S-AF scheme score was 5 (IQR 4-7). The 4S-AF scheme, as continuous and as categorical, was associated with the management strategy decided for the patient (both P < 0.001). The predictive performances of the 4S-AF scheme for the actual management strategy were appropriate in its continuous [c-index 0.77, 95% confidence interval (CI) 0.75-0.80] and categorical (c-index 0.75, 95% CI 0.72-0.78) forms. Cox regression analyses showed that 'red category' classified patients in the 4S-AF scheme had a higher risk of all-cause death (aHR 1.75, 95% CI 1.02-2.99) and composite outcomes (aHR 1.60, 95% CI 1.05-2.44). CONCLUSION: Characterization of AF by using the 4S-AF scheme may aid in identifying AF patients that would be managed by rhythm or rate control and could also help in identifying high-risk AF patients for worse clinical outcomes in a 'real-world' setting.

The Role of Fatty Acid-Binding Protein 4 in the Characterization of Atrial Fibrillation and the Prediction of Outcomes after Catheter Ablation.

Aims: The utility of biomarkers in characterizing atrial cardiomyopathy is unclear. We aim to test the ability of biomarkers of fibrosis (galectin-3 (Gal-3)) and adiposity (fatty acid-binding protein 4 (FABP4) and leptin) to predict: (1) the presence of low-voltage areas (LVA) in the electroanatomic voltage mapping; and (2) the recurrence of atrial fibrillation (AF) after pulmonary vein isolation (PVI). Methods: Patients referred for PVI were enrolled. Areas of bipolar voltage < 0.5 mV were considered as LVA. An aggregate score incorporating AF pattern (paroxysmal, persistent and long-standing persistent) and peripheral levels of FABP4 (>20 ng/mL) was developed. Results: 299 patients were included. AF was paroxysmal in 100 (33%), persistent in 130 (43%) and long-standing persistent in 69 (23%). Multivariable analysis revealed age, left atrium area, and the proposed score as independent predictors of LVA. During a mean follow-up period of 972 ± 451 days, freedom from AF recurrence was 63%. The score incorporating AF pattern and FABP4 levels accurately predicted freedom from AF recurrence, stratifying risk into ranges from 28% (score of 1) to 68% (score of 3). Cox regression models identified the score including AF pattern + FABP4 as the best model for AF recurrence (hazard ratio 2.32; 95% CI, 1.19 to 4.5; p = 0.014). Conclusions: Traditional clinical classification of atrial cardiomyopathy may be improved by markers of adiposity (FABP4). The combination allows better prediction of the presence of LVA and AF recurrence post-PVI. Gal-3 provided no added predictive value.

Conventional single-chamber pacemakers versus transcatheter pacing systems in a "real world" cohort of patients: A comparative prospective single-center study.

PURPOSE: Despite the developments in conventional transvenous pacemakers (VVI-PM), the procedure is still associated with significant complications. Although there are no prospective clinical trials that compared VVI-PM with transcatheter pacemaker systems (TPS). METHODS: This is a prospective, observational, single-center study that included all patients with an indication for a single-chamber pacemaker implant within a 4-year period. All clinical, ECG and echocardiographic characteristics at implant, electrical parameters, associated complications and mortality were analyzed. A Cox survival model and a Bayesian cohort analysis were performed for differences in complication rates between groups. RESULTS: There were 443 patients included (198 TPS and 245 VVI-PM). The mean age was 81.5 years (TPS group, 79.2 ± 6.6 years; VVI-PM group, 83.5 ± 8.9 years). There was a male predominance in TPS group (123, 62.1% vs. 67, 27.3%; p < 0.001). The presence of systolic dysfunction and renal insufficiency were more frequent in VVI-PM group than in TPS patients. Mean follow-up was 22.3 ± 15.9 months. In a multivariable paired data the TPS group presented fewer complications than VVI-PM group (HR = 0.39 [0.15-0.98], p-value 0.013), but major complications were not different (6, 3% vs 14, 5.6% respectively, p = 0.1761). There was no difference in the mortality rate between the groups. The TPS group had less risk than VVI-PM group to have a complication, with a 96% of probability. CONCLUSIONS: TPS patients had a lower overall complication rate than VVI-PM patients including matched-pair samples using a Bayesian analysis. These results confirm the safety profile of TPS in clinical practice.

Quality of life of patients undergoing conventional vs leadless pacemaker implantation: A multicenter observational study.

BACKGROUND: Leadless pacemakers (L-PM) are an emerging effective and safe technology that offer an alternative to conventional pacemakers (C-PM) for right ventricular stimulation. However, there is little information about their potential benefits for quality of life (QoL) in patients with L-PM. We compared QoL between patients with L-PM and C-PM. METHODS: The study population comprised patients undergoing single chamber pacemaker implantation from December 2016 to March 2018. The SF-36 questionnaire was used to evaluate QoL at baseline and at 6 months of followup. We also used a questionnaire consisted of 10 specific questions related to the implant procedure. RESULTS: A total of 106 patients (64 C-PM; 42 L-PM) were included. There were no differences in baseline characteristics between the groups (C-PM vs L-PM), except for age (81.5 vs 77.3 years; P = .012) and diabetes (38% vs 17%; P = .021). Baseline SF-36 scores did not differ between the groups. At 6 months followup, patients in the L-PM group scored significantly higher on physical function (63 vs 42; P < .001), physical role (64 vs 36; P = .004), and mental health (75 vs 65; P = .017), even after adjusting for covariates. Pacemaker-related discomfort and physical restrictions were significantly lower for the L-PM group. CONCLUSION: L-PM is associated with better QoL than C-PM in both physical and mental health. Patients undergoing L-PM implantation reported less procedure-related discomfort, physical restriction, and preoccupation.

Cholinergic activity regulates the secretome of epicardial adipose tissue: Association with atrial fibrillation.

Botulinum toxin injection on epicardial fat, which inhibits acetylcholine (ACh) release, reduced the presence of atrial fibrillation (AF) in patients after heart surgery. Thus, we wanted to study the profile of the released proteins of epicardial adipose tissue (EAT) under cholinergic activity (ACh treatment) and their value as AF predictors. Biopsies, explants, or primary cultures were obtained from the EAT of 85 patients that underwent open heart surgery. The quantification of muscarinic receptors (mAChR) by real-time polymerase chain reaction or western blot showed their expression in EAT. Moreover, mAChR Type 3 was upregulated after adipogenesis induction (p < 0.05). Cholinergic fibers in EAT were detected by vesicular ACh transporter levels and/or acetylcholinesterase activity. ACh treatment modified the released proteins by EAT, which were identified by nano-high-performance liquid chromatography and TripleTOF analysis. These differentially released proteins were involved in cell structure, inflammation, or detoxification. After testing the plasma levels of alpha-defensin 3 (inflammation-involved protein) of patients who underwent open heart surgery ( n = 24), we observed differential levels between the patients who developed or did not develop postsurgery AF (1.58 ± 1.61 ng/ml vs. 6.2 ± 5.6 ng/ml; p < 0.005). The cholinergic activity on EAT might suggest a new mechanism for studying the interplay among EAT, autonomic nervous system dysfunction, and AF.

Leadless pacemaker implant in patients with pre-existing infections: Results from the Micra postapproval registry.

INTRODUCTION: Leadless pacemakers may provide a safe and attractive pacing option to patients with cardiac implantable electronic device (CIED) infection. We describe the characteristics and outcomes of patients with a recent CIED infection undergoing Micra implant attempt. METHODS AND RESULTS: Patients with prior CIED infection and device explant with Micra implant within 30 days, were identified from the Micra post approval registry. Procedure characteristics and outcomes were summarized. A total of 105 patients with prior CIED infection underwent Micra implant attempt ≤30 days from prior system explant (84 [80%] pacemakers and 13 [12%] ICD/CRT-D). All system components were explanted in 93% of patients and explant occurred a median of 6 days before Micra implant, with 37% occurring on the day of Micra implant. Micra was successfully implanted in 99% patients, mean follow-up duration was 8.5 ± 7.1 months (range 0-28.5). The majority of patients (91%) received IV antibiotics preimplant, while 42% of patients received IV antibiotics postprocedure. The median length of hospitalization following Micra implant was 2 days (IQR, 1-7). During follow-up, two patients died from sepsis and four patients required system upgrade, of which two patients received Micra to provide temporary pacing support. There were no Micra devices explanted due to infection. CONCLUSION: Implantation of the Micra transcatheter pacemaker is safe and feasible in patients with a recent CIED infection. No recurrent infections that required Micra device removal were seen. Leadless pacemakers appear to be a safe pacing alternative for patients with CIED infection who undergo extraction.

Antithrombotic treatment in patients with atrial fibrillation and acute coronary syndromes: results of the European Heart Rhythm Association survey.

The management of an acute coronary syndrome (ACS) in a patient with existing atrial fibrillation (AF) often presents a management dilemma both in the acute phase and post-ACS, since the majority of AF patients will already be receiving oral anticoagulation (OAC) for stroke prevention and will require further antithrombotic treatment to reduce the risk of in-stent thrombosis or recurrent cardiac events. Current practice recommendations are based largely on consensus option as there is limited evidence from randomized controlled trials. Prior to the launch of the new European Heart Rhythm Association (EHRA) consensus document, a survey was undertaken to examine current clinical management of these patients across centres in Europe. Forty-seven centres submitted valid responses, with the majority (70.2%) being university hospitals. This EHRA survey demonstrated overall the management of ACS in AF patients is consistent with the available guidance. Most centres would use triple therapy for a short duration (4 weeks) and predominantly utilize a strategy of OAC (vitamin K antagonist, VKA or non-vitamin K antagonist oral anticoagulant, NOAC) plus aspirin and clopidogrel, followed by dual therapy [(N)OAC plus clopidogrel] until 12 months post-percutaneous coronary intervention, followed by (N)OAC monotherapy indefinitely. Where NOAC was used in combination with antiplatelet(s), the lower dose of the respective NOAC was preferred, in accordance with current recommendations.

Relevance of Dementia in Atrial Fibrillation Patients within a Specific European Health Care Area.

INTRODUCTION: Atrial fibrillation might increase the risk of dementia. We aim to test the hypothesis that dementia could reclassify the actual risk of stroke and death predicted by the CHA2DS2-VASc in patients with atrial fibrillation (AF). METHODS: A prospective study performed in a specific health care area. RESULTS: From our health care area (n = 348,985), throughout 2013, AF was codified in 7,990 (2.08%). Mean age was 76.83 ± 10.5, mean CHA2DS2-VASc = 3.5, 4,056 (50.8%) were females and 287 (3.6%) were diagnosed to have dementia. Patients with dementia were older and presented a higher rate of all the components of the CHA2DS2-VASc-expect vasculopathy. Differences in overall mortality were observed but not in stroke and haemorrhagic events. After propensity score matched analysis, dementia was independently associated with all-cause mortality. Addition of dementia to CHA2DS2-VASc reclassified 7.7 and 16.6% of the cohort with regard to thromboembolic events and death risk respectively. CONCLUSIONS: Patients with dementia presented a more adverse risk profile, with significant differences in all-cause mortality.

Long-term prognosis of patients with life-threatening ventricular arrhythmias induced by coronary artery spasm.

Aims: Coronary artery spasm (CAS) is associated with ventricular arrhythmias (VA). Much controversy remains regarding the best therapeutic interventions for this specific patient subset. We aimed to evaluate the clinical outcomes of patients with a history of life-threatening VA due to CAS with various medical interventions, as well as the need for ICD placement in the setting of optimal medical therapy. Methods and results: A multicentre European retrospective survey of patients with VA in the setting of CAS was aggregated and relevant clinical and demographic data was analysed. Forty-nine appropriate patients were identified: 43 (87.8%) presented with VF and 6 (12.2%) with rapid VT. ICD implantation was performed in 44 (89.8%). During follow-up [59 (17-117) months], appropriate ICD shocks were documented in 12. In 8/12 (66.6%) no more ICD therapies were recorded after optimizing calcium channel blocker (CCB) therapy. SCD occurred in one patient without ICD. Treatment with beta-blockers was predictive of appropriate device discharge. Conversely, non-dihydropyridine CCB therapy was significantly protective against VAs. Conclusion: Patients with life-threatening VAs secondary to CAS are at particularly high-risk for recurrence, especially when insufficient medical therapy is administered. Non-dihydropyridine CCBs are capable of suppressing episodes, whereas beta-blocker treatment is predictive of VAs. Ultimately, in spite of medical intervention, some patients exhibited arrhythmogenic events in the long-term, suggesting that ICD implantation may still be indicated for all.

Acute and long-term outcomes of simultaneous atrioventricular node ablation and leadless pacemaker implantation.

AIMS: Leadless pacemaker (LDP) allows implantation using a femoral approach. This access could be utilized for conventional atrioventricular nodal ablation (AVNA). It could facilitate unifying the two procedural components. Data regarding its feasibility and long-term outcomes remain lacking. We aim to evaluate the feasibility and long-term outcomes of sequential LDP and AVNA. METHODS: Prospective, observational multicenter study including consecutive patients with indication for single-chamber pacemaker placement. In those with additional indication for AVNA, ablation was performed immediately after the LPD through the same sheath. RESULTS: A total of 137 patients were included. Mean age was 77.9 ± 10.5 years; 74 (54%) were men. Immediately following LDP implantation, 27 patients (19.7%) underwent concurrent AVNA. There were six (5.5%) complications in patients referred for LDP procedures and three (11%) in those who underwent a combined approach. None of these complications were solely attributable to the added AVNA component. No mechanical dislodgement, electrical damage to any device, or electromagnetic interference ever took place. During a mean follow-up period of 123 ± 48 days, three patients (3.6%) died of noncardiovascular causes. The remaining population stayed alive without significant arrhythmias. There were no relevant differences with regard to sensing and pacing thresholds between patients in the two groups. CONCLUSIONS: AVNA can safely be performed immediately following LDP. A combined approach obviates the need for additional vascular access and optimizes feasibility and comfort for patients and healthcare providers. It offers an acceptable safety and efficacy profile, both acutely and upon intermediate-term follow-up.

Prognostic value of nutrition status in the response of cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) is indicated in symptomatic heart failure (HF) patients after achieving optimal medical therapy. However, there are still a large percentage of patients who do not respond to CRT. Malnutrition is a frequent comorbidity in patients with HF, and it is associated with a poorer prognosis. Here, we evaluate the nutritional status of patients assessed by Controlling Nutritional Status (CONUT) score and its association with structural remodeling and cardiovascular events. METHODS: We investigated the effect of CONUT on HF/death in 302 consecutive patients with a CRT device implanted between 2005 and 2015 in a single tertiary center. We categorized the patients into three groups: normal nutritional status (CONUT 0-1), mild malnutrition (CONUT 2-4) and moderate-severe malnutrition (CONUT ≥ 5). Changes in nutritional status were assessed in patients with mild-to-severe malnutrition prior to CRT. RESULTS: One hundred and forty-eight patients exhibited normal nutritional status (49.0%), 99 patients exhibited mild malnutrition (32.8%) and 55 patients exhibited moderate-severe malnutrition (18.2%). CONUT scores of at least 2 were associated with higher risk of HF/death compared with CONUT 0-1. Significant left ventricular (LV) reverse remodeling was noted in patients with better nutritional status. In addition, those malnutrition patients at baseline that improved nutritional state exhibited fewer HF/death events at follow-up. CONCLUSION: CONUT score prior to CRT was an independent risk factor of death/HF and was correlated with LV reverse remodeling. Improvements in CONUT score during long-term follow-up were associated with a reduction in the rate of HF/death.

Impact of previous cardiac surgery on long-term outcome of cavotricuspid isthmus-dependent atrial flutter ablation.

AIMS: The aim of this study was to determine the acute and long-term outcome of radiofrequency catheter ablation (RFCA) for cavotricuspid isthmus-dependent atrial flutter (CTI-AFL) in adults with and without previous cardiac surgery (PCS), and predictors of these outcomes. Structural alterations of the anatomical substrate of the CTI-AFL are observed in post-operative patients, and these may have an impact on the acute success of the ablation and in the long-term. METHODS AND RESULTS: Clinical records of consecutive adults undergoing RFCA of CTI-AFL were analysed. Two main groups were considered: No PCS and PCS patients, who were further subdivided into acquired heart disease (AHD: ischaemic heart disease and valvular/mixed heart disease) and congenital heart disease [CHD: ostium secundum atrial septal defect (OS-ASD) and complex CHD]. Multivariate analysis identified clinical and procedural factors that predicted acute and long-term outcomes. A total of 666 patients (73% men, age 65 ± 12 years) were included: 307 of them with PCS. Ablation was successful in 647 patients (97%), 96% in the PCS group and 98% in the No PCS group (P = 0.13). Regression analysis showed that surgically corrected complex CHD was related to failure of the procedure [odds ratio 5.6; 95% confidence interval (CI) 1.6-18, P = 0.008]. After a follow-up of 45 ± 15 months, recurrences were observed in 90 patients (14%), more frequently in the PCS group: absolute risk of recurrence 18 vs. 10.5%, relative risk 1.71, 95% CI: 1.2-2.5, P = 0.006. Multivariate analysis indicated that the types of PCS [OS-ASD vs. No PCS: hazard ratio (HR) 2.57; 95% CI: 1.1-6.2, P = 0.03 and complex CHD vs. No PCS: HR 2.75; 95% CI: 1.41-5.48, P = 0.004], female gender (HR 1.55; 95% CI: 1.04-2.4, P = 0.048), and severe LV dysfunction (HR 1.36; 95% CI: 1.06-1.67, P = 0.04) were independent predictors of long-term recurrence. CONCLUSION: Radiofrequency catheter ablation of CTI-AFL after surgical correction of AHD and CHD is associated with high acute success rates. The severity of the structural alterations of the underlying heart disease and consequently the type of surgical correction correlates with higher risk for recurrence.

Long-term clinical effects of ventricular pacing reduction with a changeover mode to minimize ventricular pacing in a general pacemaker population.

AIM: Right ventricular pacing (VP) has been hypothesized to increase the risk in heart failure (HF) and atrial fibrillation (AF). The ANSWER study evaluated, whether an AAI-DDD changeover mode to minimize VP (SafeR) improves outcome compared with DDD in a general dual-chamber pacemaker population. METHODS AND RESULTS: ANSWER was a randomized controlled multicentre trial assessing SafeR vs. standard DDD in sinus node disease (SND) or AV block (AVB) patients. After a 1-month run-in period, they were randomized (1 : 1) and followed for 3 years. Pre-specified co-primary end-points were VP and the composite of hospitalization for HF, AF, or cardioversion. Pre-specified secondary end-points were cardiac death or HF hospitalizations and cardiovascular hospitalizations. ANSWER enrolled 650 patients (52.0% SND, 48% AVB) at 43 European centres and randomized in SafeR (n = 314) or DDD (n = 318). The SafeR mode showed a significant decrease in VP compared with DDD (11.5 vs. 93.6%, P < 0.0001 at 3 years). Deaths and syncope did not differ between randomization arms. No significant difference between groups [HR = 0.78; 95% CI (0.48-1.25); P = 0.30] was found in the time to event of the co-primary composite of hospitalization for HF, AF, or cardioversion, nor in the individual components. SafeR showed a 51% risk reduction (RR) in experiencing cardiac death or HF hospitalization [HR = 0.49; 95% CI (0.27-0.90); P = 0.02] and 30% RR in experiencing cardiovascular hospitalizations [HR = 0.70; 95% CI (0.49-1.00); P = 0.05]. CONCLUSION: SafeR safely and significantly reduced VP in a general pacemaker population though had no effect on hospitalization for HF, AF, or cardioversion, when compared with DDD.

Comparison between CHA2DS2-VASc and the new R2CHADS2 and ATRIA scores at predicting thromboembolic event in non-anticoagulated and anticoagulated patients with non-valvular atrial fibrillation.

BACKGROUND: Accurate risk stratification is considered the first and most important step in the management of patients with non-valvular atrial fibrillation (NVAF). We compared the performance of the widely used CHA2DS2-VASc and the recently developed R2CHADS2 and ATRIA scores, for predicting thromboembolic (TE) event in either non-anticoagulated or anticoagulated patients with NVAF. METHODS: The non-anticoagulated cohort was comprised of 154 patients, whereas 911 patients formed the cohort of patients on vitamin-K-antagonist. The scores were computed using the criteria mentioned in their developmental cohorts. Measures of performance for the risk scores were evaluated at predicting TE event. RESULTS: In the non-anticoagulated cohort, 9 TE events occurred during 11 ± 2.7 months. CHA2DS2-VASc showed significant association with TE occurrence: hazard ratio (HR) = 1.58 (95 % confidence interval [95 % IC] 1.01-2.46), but R2CHADS2 and ATRIA did not (HR = 1.23 (95 % CI 0.86-1.77) and 1.20 (95 % CI 0.93-1.56), respectively. In the anticoagulated cohort, after 10 ± 3 months of follow up, 18 TE events were developed. In that cohort, the three scores showed similar association with TE risk: HR = 1.49 (95 % CI 1.13-1.97), 1.41 (95 % CI 1.13-1.77) and 1.37 (95 % CI 1.12-1.66) for CHA2DS2-VASc, R2CHADS2 and ATRIA, respectively. In both cohorts, no TE event occurred in patients classified in the low risk category according to CHA2DS2-VASc or R2CHADS2. CONCLUSIONS: In this study of NVAF patients, CHA2DS2-VASc has better association with TE events than the new R2CHADS2 and ATRIA risk scores in the non-anticoagulated cohort. CHA2DS2-VASc and R2CHADS2 can identify patients at truly low risk regardless of the anticoagulation status.

Assessment of long-term quality of life after cavotricuspid isthmus ablation for typical atrial flutter.

BACKGROUND: Cavotricuspid isthmus (CTI) ablation is the treatment of choice in preventing recurrences of typical atrial flutter (AFl). However, little is known about long-term quality of life (QoL) after CTI ablation. METHODS AND RESULTS: From 01/2003 to 05/2005, 94 patients who consecutively underwent typical AFl ablation were included in the study. An SF-36 health questionnaire was self-administered before ablation and at follow-up. Transformed scores were calculated, adjusted for age and sex and then normalized and standardized for the Spanish population. Additionally, the minimal important differences (MID) were calculated to assess the smallest change in QoL that patients perceived as positive. A linear regression model was constructed to assess long-term QoL predictors. All SF-36 scales were lower than Spanish population scores. After a mean (SD) follow-up of 6.25 (0.5) years, all scales, except Bodily Pain, were higher than baseline. There was a significant difference for Physical Role (46.4 vs. 38.6, p < 0.001), Vitality (44.4 vs. 41.9, p = 0.038) and Mental Health (46.1 vs. 42.0, p = 0.001). However, only Physical Role achieved the criteria for MID. Recurrence of AFl, basal QoL, history of diabetes mellitus, atrial fibrillation and oral anticoagulation were predictors of long-term QoL. CONCLUSION: CTI ablation provides a significant improvement in long-term QoL for the dimensions of Physical Role, Vitality and Mental Health, although the smallest positive change that patients perceive as positive was only observed for Physical Role. Previous diabetes mellitus, atrial fibrillation, oral anticoagulation, basal QoL and AFl recurrence were determinants of a worse long-term QoL.