Influence of Age and Gender on Complications of Catheter Ablation for Atrial Fibrillation

Background: Despite catheter ablation (CA) has become an accepted treatment option for symptomatic, drug-resistant atrial fibrillation (AF), safety of this procedure continues to be cause for concern. Objective: Aim of the present multicenter study was to assess the influence of age and gender on incidence and severity of early CA complications. Methods: From January 1, 2011 to December 31, 2011, data from 2,323 consecutive patients who underwent CA (mean age 59.1+10.9; 72.3% male) for AF in 29 Italian centres were collected. All complications occurring to the patients from admission to 30th post-procedural day were recorded. Results: Complications occurred in 94 patients (4.0%); of these 7 (0.30%) developed permanent sequelae. There was a significant trend toward a greater incidence of complications with increasing age-group. In particular, the incidence of complications was 35/1066 (3.3%) in patients 60 year-old (p=0.03). All 7 patients with permanent sequeale were older than 60. Females had a higher incidence of complications both among younger [13/231 (5.6%) vs 22/915 (2.5%), p=0.02] and older patients [32/405 (7.9%) vs 27/739 (3.5%) p=0.001]. In subjects older than 60, 5/405 (1.2%) females and 2/176 (0.3%) males (p=0.04) suffered from permanent sequelae. Conclusions: Older patients and females are a subgroup at higher risk of complications during AF ablation. A particular care should be taken when performing CA in this clinical setting

Low incidence of permanent complications during catheter ablation for atrial fibrillation using open-irrigated catheters: A multicentre registry

Aims Despite catheter ablation (CA) has become an accepted treatment option for symptomatic, drug-resistant atrial fibrillation (AF), the safety of this procedure continues to be cause for concern. The aim of the present study was to assess the incidence of complications with permanent sequelae of CA for AF using open-irrigated catheters in a contemporary, unselected population of consecutive patients. Methods and results From 1 January 2011 to 31 December 2011, data from 2167 consecutive patients who underwent CA for AF using an open-irrigated catheter in 29 Italian centres were collected. All the complications occurring to the patient from admission to the 30th post-procedural day were recorded. No procedure-related death was observed. Complications occurred in 81 patients (3.7%): 46 patients (2.1%) suffered vascular access complications; 13 patients (0.6%) cardiac tamponade, successfully drained in all the cases; six patients (0.3%) arterial thromboembolism (four transient ischaemic attack and two ischaemic strokes); five (0.2%) patients conservatively treated pericardial effusion; three patients (0.1%) phrenic nerve paralysis; three patients (0.1%) pericarditis; three patients (0.1%) haemothorax, and two patients (0.1%) other isolated adverse events. At multivariate analysis, only female sex [odds ratio (OR) 2.5, confidence interval (CI): 1.5-3.7, P < 001] and the operator experience (OR 0.5, CI: 0.4-0.7, P < 001) related to the complications. Only five (0.2%) patients developed permanent sequelae from their complications. Conclusion Catheter ablation for AF with the use of open-irrigated catheters is currently affected by a very low rate of complications leading to permanent sequelae. \uc2\ua9 2014 Published on behalf of the European Society of Cardiology

Rationale and current perspective for early rhythm control therapy in atrial fibrillation

Atrial fibrillation (AF) is the most common sustained arrhythmia and an important source for mortality and morbidity on a population level. Despite the clear association between AF and death, stroke, and other cardiovascular events, there is no evidence that rhythm control treatment improves outcome in AF patients. The poor outcome of rhythm control relates to the severity of the atrial substrate for AF not only due to the underlying atrial remodelling process but also due to the poor efficacy and adverse events of the currently available ion-channel antiarrhythmic drugs and ablation techniques. Data suggest, however, an association between sinus rhythm maintenance and improved survival. Hypothetically, sinus rhythm may also lead to a lower risk of stroke and heart failure. The presence of AF, thus, seems one of the modifiable factors associated with death and cardiovascular morbidity in AF patients. Patients with a short history of AF and the underlying heart disease have not been studied before. It is fair to assume that abolishment of AF in these patients is more successful and possibly also safer, which could translate into a prognostic benefit of early rhythm control therapy. Several trials are now investigating whether aggressive early rhythm control therapy can reduce cardiovascular morbidity and mortality and increase maintenance of sinus rhythm. In the present paper we describe the background of these studies and provide some information on their design

Systematic, early rhythm control strategy for atrial fibrillation in patients with or without symptoms: the EAST-AFNET 4 trial.

AIMS: Clinical practice guidelines restrict rhythm control therapy to patients with symptomatic atrial fibrillation (AF). The EAST-AFNET 4 trial demonstrated that early, systematic rhythm control improves clinical outcomes compared to symptom-directed rhythm control. METHODS AND RESULTS: This prespecified EAST-AFNET 4 analysis compared the effect of early rhythm control therapy in asymptomatic patients (EHRA score I) to symptomatic patients. Primary outcome was a composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome, analyzed in a time-to-event analysis. At baseline, 801/2633 (30.4%) patients were asymptomatic [mean age 71.3 years, 37.5% women, mean CHA2DS2-VASc score 3.4, 169/801 (21.1%) heart failure]. Asymptomatic patients randomized to early rhythm control (395/801) received similar rhythm control therapies compared to symptomatic patients [e.g. AF ablation at 24 months: 75/395 (19.0%) in asymptomatic; 176/910 (19.3%) symptomatic patients, P = 0.672]. Anticoagulation and treatment of concomitant cardiovascular conditions was not different between symptomatic and asymptomatic patients. The primary outcome occurred in 79/395 asymptomatic patients randomized to early rhythm control and in 97/406 patients randomized to usual care (hazard ratio 0.76, 95% confidence interval [0.6; 1.03]), almost identical to symptomatic patients. At 24 months follow-up, change in symptom status was not different between randomized groups (P = 0.19). CONCLUSION: The clinical benefit of early, systematic rhythm control was not different between asymptomatic and symptomatic patients in EAST-AFNET 4. These results call for a shared decision discussing the benefits of rhythm control therapy in all patients with recently diagnosed AF and concomitant cardiovascular conditions (EAST-AFNET 4; ISRCTN04708680; NCT01288352; EudraCT2010-021258-20)

Ablation of Stable VTs Versus Substrate Ablation in Ischemic Cardiomyopathy the VISTA Randomized Multicenter Trial

Background Catheter ablation reduces ventricular tachycardia (VT) recurrence and implantable cardioverter defibrillator shocks in patients with VT and ischemic cardiomyopathy. The most effective catheter ablation technique is unknown. Objectives This study determined rates of VT recurrence in patients undergoing ablation limited to clinical VT along with mappable VTs ("clinical ablation") versus substrate-based ablation. Methods Subjects with ischemic cardiomyopathy and hemodynamically tolerated VT were randomized to clinical ablation (n = 60) versus substrate-based ablation that targeted all "abnormal" electrograms in the scar (n = 58). Primary endpoint was recurrence of VT. Secondary endpoints included periprocedural complications, 12-month mortality, and rehospitalizations. Results At 12-month follow-up, 9 (15.5%) and 29 (48.3%) patients had VT recurrence in substrate-based and clinical VT ablation groups, respectively (log-rank p < 0.001). More patients undergoing clinical VT ablation (58%) were on antiarrhythmic drugs after ablation versus substrate-based ablation (12%; p < 0.001). Seven (12%) patients with substrate ablation and 19 (32%) with clinical ablation required rehospitalization (p = 0.014). Overall 12-month mortality was 11.9%; 8.6% in substrate ablation and 15.0% in clinical ablation groups, respectively (log-rank p = 0.21). Combined incidence of rehospitalization and mortality was significantly lower with substrate ablation (p = 0.003). Periprocedural complications were similar in both groups (p = 0.61). Conclusions An extensive substrate-based ablation approach is superior to ablation targeting only clinical and stable VTs in patients with ischemic cardiomyopathy presenting with tolerated VT

A roadmap to improve the quality of atrial fibrillation management:proceedings from the fifth Atrial Fibrillation Network/European Heart Rhythm Association consensus conference

At least 30 million people worldwide carry a diagnosis of atrial fibrillation (AF), and many more suffer from undiagnosed, subclinical, or 'silent' AF. Atrial fibrillation-related cardiovascular mortality and morbidity, including cardiovascular deaths, heart failure, stroke, and hospitalizations, remain unacceptably high, even when evidence-based therapies such as anticoagulation and rate control are used. Furthermore, it is still necessary to define how best to prevent AF, largely due to a lack of clinical measures that would allow identification of treatable causes of AF in any given patient. Hence, there are important unmet clinical and research needs in the evaluation and management of AF patients. The ensuing needs and opportunities for improving the quality of AF care were discussed during the fifth Atrial Fibrillation Network/European Heart Rhythm Association consensus conference in Nice, France, on 22 and 23 January 2015. Here, we report the outcome of this conference, with a focus on (i) learning from our 'neighbours' to improve AF care, (ii) patient-centred approaches to AF management, (iii) structured care of AF patients, (iv) improving the quality of AF treatment, and (v) personalization of AF management. This report ends with a list of priorities for research in AF patients

Early Rhythm-Control Therapy in Patients with Atrial Fibrillation.

BACKGROUND: Despite improvements in the management of atrial fibrillation, patients with this condition remain at increased risk for cardiovascular complications. It is unclear whether early rhythm-control therapy can reduce this risk. METHODS: In this international, investigator-initiated, parallel-group, open, blinded-outcome-assessment trial, we randomly assigned patients who had early atrial fibrillation (diagnosed ≤1 year before enrollment) and cardiovascular conditions to receive either early rhythm control or usual care. Early rhythm control included treatment with antiarrhythmic drugs or atrial fibrillation ablation after randomization. Usual care limited rhythm control to the management of atrial fibrillation-related symptoms. The first primary outcome was a composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome; the second primary outcome was the number of nights spent in the hospital per year. The primary safety outcome was a composite of death, stroke, or serious adverse events related to rhythm-control therapy. Secondary outcomes, including symptoms and left ventricular function, were also evaluated. RESULTS: In 135 centers, 2789 patients with early atrial fibrillation (median time since diagnosis, 36 days) underwent randomization. The trial was stopped for efficacy at the third interim analysis after a median of 5.1 years of follow-up per patient. A first-primary-outcome event occurred in 249 of the patients assigned to early rhythm control (3.9 per 100 person-years) and in 316 patients assigned to usual care (5.0 per 100 person-years) (hazard ratio, 0.79; 96% confidence interval, 0.66 to 0.94; P = 0.005). The mean (±SD) number of nights spent in the hospital did not differ significantly between the groups (5.8±21.9 and 5.1±15.5 days per year, respectively; P = 0.23). The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care. Symptoms and left ventricular function at 2 years did not differ significantly between the groups. CONCLUSIONS: Early rhythm-control therapy was associated with a lower risk of cardiovascular outcomes than usual care among patients with early atrial fibrillation and cardiovascular conditions. (Funded by the German Ministry of Education and Research and others; EAST-AFNET 4 ISRCTN number, ISRCTN04708680; ClinicalTrials.gov number, NCT01288352; EudraCT number, 2010-021258-20.)