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Aims: Ablation index (AI) is a marker of lesion quality during catheter ablation that incorporates contact force, time, and power in a weighted formula. This index was originally developed for pulmonary vein isolation as well as other left atrial procedures. The aim of our study is to evaluate the feasibility and efficacy of the AI for the ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical atrial flutter (AFL)., Methods and Results: This prospective multicentre non-randomized study enrolled 412 consecutive patients with typical AFL undergoing AI-guided cavotricuspid isthmus ablation. The procedure was performed targeting an AI of 500 and an inter-lesion distance measurement of ≤6 mm. The primary endpoints were CTI 'first-pass' block and persistent block after a 20-min waiting time. Secondary endpoints included procedural and radiofrequency duration and fluoroscopic time. A total of 412 consecutive patients were enrolled in 31 centres (mean age 64.9 ± 9.8; 72.1% males and 27.7% with structural heart disease). The CTI bidirectional 'first-pass' block was reached in 355 patients (88.3%), whereas CTI block at the end of the waiting time was achieved in 405 patients (98.3%). Mean procedural, radiofrequency, and fluoroscopic time were 56.5 ± 28.1, 7.8 ± 4.8, and 1.9 ± 4.8 min, respectively. There were no major procedural complications. There was no significant inter-operator variability in the ability to achieve any of the primary endpoints., Conclusion: AI-guided ablation with an inter-lesion distance ≤6 mm represents an effective, safe, and highly reproducible strategy to achieve bidirectional block in the treatment of typical AFL., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Aims: The aims of this study were to determine the rate and the predictors of early recurrences of atrial fibrillation (ERAF) after cryoballoon (CB) ablation and to evaluate whether ERAF correlate with the long-term outcome., Methods and Results: Three thousand, six hundred, and eighty-one consecutive patients (59.9 ± 10.5 years, female 26.5%, and 74.3% paroxysmal AF) were included in the analysis. Atrial fibrillation recurrence, lasting at least 30 s, was collected during and after the 3-month blanking period. Three-hundred and sixteen patients (8.6%) (Group A) had ERAF during the blanking period, and 3365 patients (Group B) had no ERAF. Persistent AF and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of ERAF. After a mean follow-up of 16.8 ± 16.4 months, 923/3681 (25%) patients had at least one AF recurrence. The observed freedom from AF recurrence, at 24-month follow-up from procedure, was 25.7% and 64.8% in Groups A and B, respectively (P < 0.001). ERAF, persistent AF, and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of AF. In a propensity score matching, the logistic model showed that ERAF 1 month after ablation are the best predictor of long-term AF recurrence (P = 0.042)., Conclusion: In patients undergoing CB ablation for AF, ERAF are rare and are a strong predictor of AF recurrence in the follow-up, above all when occur >30 days after the ablation., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Aims: A prolonged PR interval is known to be associated with increased mortality and a higher risk of developing atrial fibrillation (AF). We tested the hypothesis that cardiac resynchronization therapy (CRT) is superior to conventional dual-chamber pacing with algorithms for right ventricular pacing avoidance (DDD-VPA) in preserving systolic and diastolic function and in preventing new-onset AF in patients with normal systolic function, indication for pacing and prolonged atrioventricular conduction (PR interval ≥220 ms)., Methods and Results: We randomly assigned 82 patients with ejection fraction >35%, indication for pacing and PR interval ≥220 ms to CRT or to DDD-VPA. On 12-month follow-up examination, the study and control arms did not differ in terms of left ventricular end-systolic volume (44 ± 17 mL vs. 47 ± 16 mL, P = 0.511) or ejection fraction (55 ± 6% vs. 57 ± 8%, P = 0.291). The E to A mitral wave amplitude ratio was higher in the CRT arm (1.3 ± 1.3 vs. 0.8 ± 0.4, P = 0.046) and the E wave deceleration time was longer (262 ± 83 ms vs. 205 ± 51 ms, P = 0.027). Left atrial volume was smaller in the CRT arm (64 ± 17 mL vs. 84 ± 25 mL, P = 0.035). Moreover, the functional class was lower in CRT patients (1.4 ± 0.6 vs. 1.8 ± 0.5, P = 0.010). During follow-up, CRT was associated with a lower risk of new-onset AF [hazard ratio = 0.37 (0.13-0.98), P = 0.046]., Conclusion: Cardiac resynchronization therapy proved superior to DDD-VPA in terms of better diastolic function, less left atrial enlargement and lower risk of new-onset AF, at 12 months. These data need to be confirmed in a larger trial with longer follow-up., Clinical Trial Registration: URL: http://clinicaltrials.gov/ Identifier: NCT02150538., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Aims: The benefit of prolonged implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy following device replacement is hindered by clinical and procedure-related adverse events (AEs). Adverse events rate is highest in more complex devices and at upgrades, as per the REPLACE registry experience, but is changing owing to the improvement in device technology and medical care. We aimed at understanding the extent and type of AEs in a contemporary Italian population., Methods and Results: Detect long-term complications after ICD replacement (DECODE) was a prospective, single-arm, multicentre cohort study aimed at estimating medium- to long-term AEs in a large population of patients undergoing ICD/cardiac resynchronization defibrillator replacement/upgrade from 2013 to 2015. We prospectively analysed all clinical and device-related AEs at 12-month follow-up (FU) of 983 consecutive patients (median age 71 years, 76% male, 55% ischaemic, 47% CRT-D) followed for 353 ± 49 days. Seven percent of the patients died (60.6% for cardiovascular reasons), whereas 104 AEs occurred; 43 (4.4%) patients needed at least one surgical action to treat the AE. Adverse events rates were 3.3/100 years lead-related, 3.4/100 years bleedings, and 1.6/100 years infective. The primary endpoint was predicted by hospitalization in the month prior to the procedure [hazard ratio (HR) = 2.23, 1.16-4.29; 0.0169] and by upgrade (HR = 1.75, 1.02-2.99, 0.0441). One hundred and twelve (11.4%) patients met the combined endpoint of death from any cause, cardiac implantable electronic device (CIED)-related infection, and surgical action/hospitalization required to treat the AE. Hospitalization within 30 days prior to the procedure (HR = 2.07, 1.13-3.81; 0.0199), anticoagulation (HR = 1.97, 1.26-3.07; 0.003), and ischaemic cardiomyopathy (HR = 1.67, 95% confidence interval 1.06-2.63; P = 0.0276) were associated with the combined endpoint during FU., Conclusions: Adverse events following CIED replacement/upgrade are lower than previously reported, possibly owing to improved patients care. Hospitalization in the month prior to the procedure, upgrade, and clinical profile (anticoagulation, ischaemic cardiomyopathy) hint to increased risk, suggesting an individualized planning of the procedure to minimize overall AEs., Clinical Trial Registration: URL: http://clinicaltrials.gov/ Identifier: NCT02076789., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Aims: Pulmonary vein isolation (PVI), the standard for atrial fibrillation (AF) ablation, is most commonly applied with radiofrequency (RF) energy, although cryoballoon technology (CRYO) has gained widespread use. The aim was to compare the second-generation cryoballoon and the irrigated RF energy regarding outcomes and safety., Methods and Results: Of 4657 patients undergoing their first AF ablation, 982 with CRYO and 3675 with RF energy were included from the Swedish catheter ablation registry and the Atrial Fibrillation Ablation Long-Term registry of the European Heart Rhythm Association of the European Society of Cardiology. The primary endpoint was repeat AF ablation. The major secondary endpoints included procedural duration, tachyarrhythmia recurrence, and complication rate. The re-ablation rate after 12 months was significantly lower in the CRYO vs. the RF group, 7.8% vs. 11%, P = 0.005, while freedom from arrhythmia recurrence (30 s duration) did not differ between the groups, 70.2 % vs. 68.2%, P = 0.44. The result was not influenced by AF type and lesion sets applied. In the Cox regression analysis, paroxysmal AF had significantly lower risk for re-ablation with CRYO, hazard ratio 0.56 (P = 0.041). Procedural duration was significantly shorter with CRYO than RF, (mean ± SD) 133.6 ± 45.2 min vs. 174.6 ± 58.2 min, P < 0.001. Complication rates were similar; 53/982 (5.4%) vs. 191/3675 (5.2%), CRYO vs. RF, P = 0.806., Conclusion: The lower re-ablation rates and shorter procedure times observed with the cryoballoon as compared to RF ablation may have important clinical implications when choosing AF ablation technique despite recognized limitations with registries., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com.)

Aims: Heart failure (HF) patients with implantable cardioverter-defibrillators (ICD) require admissions for disease management and out-patient visits for disease management and assessment of device performance. These admissions place a significant burden on the National Health Service. Remote monitoring (RM) is an effective alternative to frequent hospital visits. The EFFECT study was a multicentre observational investigation aiming to evaluate the clinical effectiveness of RM compared with in-office visits standard management (SM). The present analysis is an economic evaluation of the results of the EFFECT trial., Methods and Results: The present analysis considered the direct consumption of healthcare resources over 12-month follow-up. Standard tariffs were applied to hospitalizations, in-office visits and remote device interrogations. Economic comparisons were also carried out by means of propensity score (PS) analysis to take into account the lack of randomization in the study design. The analysis involved 858 patients with ICD or CRT-D. Of these, 401 (47%) were followed up via an SM approach, while 457 (53%) were assigned to RM. The rate of hospitalizations was 0.27/year in the SM group and 0.16/year in the RM group (risk reduction =0.59; P = 0.0004). In the non-adjusted analysis, the annual cost for each patient was €817 in the SM group and €604 in the RM group (P = 0.014). Propensity score analysis, in which 292 RM patients were matched with 292 SM patients, confirmed the results of the non-adjusted analysis (€872 in the SM group vs. €757 in the RM group; P < 0.0001)., Conclusion: There is a reduction in direct healthcare costs of RM for HF patients with ICDs, particularly CRT-D, compared with standard monitoring., Clinical Trial Registration: http://clinicaltrials.gov/Identifier, NCT01723865., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For Permissions, please email: journals.permissions@oup.com.)

Aims: Patients receiving cardiac resynchronization therapy defibrillators (CRT-Ds) are likely to undergo one or more device replacements, mainly for battery depletion. We assessed the economic impact of battery depletion on the overall cost of CRT-D treatment from the perspectives of the healthcare system and the hospital. We also compared devices of different generations and from different manufacturers in terms of therapy cost., Methods and Results: We analysed data on 1792 CRT-Ds implanted in 1399 patients in 9 Italian centres. We calculated the replacement probability and the total therapy cost over 6 years, stratified by device generation and manufacturer. Public tariffs from diagnosis-related groups were used together with device prices and hospitalization costs. Generators were from 3 manufacturers: Boston Scientific (667, 37%), Medtronic (973, 54%), and St Jude Medical (152, 9%). The replacement probability at 6 years was 83 and 68% for earlier- and recent-generation devices, respectively. The need for replacement increased total therapy costs by more than 50% over the initial implantation cost for hospitals and by more than 30% for healthcare system. The improved longevity of recent-generation CRT-Ds reduced the therapy cost by ∼6% in both perspectives. Among recent-generation CRT-Ds, the replacement probability of devices from different manufacturers ranged from 12 to 70%. Consequently, the maximum difference in therapy cost between manufacturers was 40% for hospitals and 19% for the healthcare system., Conclusions: Differences in CRT-D longevity strongly affect the overall therapy cost. While the use of recent-generation devices has reduced the cost, significant differences exist among currently available systems., (© The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Internet-based remote interrogation systems have been shown to reduce emergency department and in-office visits in patients with implantable cardioverter defibrillators (ICDs), resulting in increased efficiency for healthcare providers. Nonetheless, studies sized to demonstrate the impact of remote monitoring on patients' outcome have been lacking., Methods and Results: The EFFECT study was a multicentre clinical trial aimed at measuring and comparing the outcome of ICD patients conventionally followed-up by means of in-clinic visits (Standard arm) or by remote monitoring (Remote arm) in the clinical practice of 25 Italian centres. From 2011 to 2013, 987 consecutive patients were enrolled and followed up for at least 12 months. The primary endpoint was the rate of death and cardiovascular hospitalizations. Remote monitoring was adopted by 499 patients. Patients in the Standard and Remote arms did not differ significantly in terms of baseline clinical characteristics, except for a more frequent use of ICD with cardiac resynchronization therapy (CRT-D) in the Remote arm (48 vs. 36%, P < 0.001). One-year rates of the primary combined endpoint were 0.27 events/year for patients in the Standard arm and were 0.15 events/year for those in the Remote arm (incident rate ratio, 0.55; 95% CI, 0.41-0.73; P < 0.001). The endpoint rates in the Standard and Remote arms were 0.27 and 0.08 events/year, respectively, among CRT-D recipients (P < 0.001), and 0.28 vs. 0.21 among ICD patients (P = 0.094). The rates of in-office visits were 1.9 per year in the Standard arm and 1.7 per year in the Remote arm., Conclusion: Compared with the standard follow-up through in-office visits, remote monitoring is associated with reduced death and cardiovascular hospitalizations in patients with ICD in clinical practice., Clinical Trial Registration: URL: http://clinicaltrials.gov/ Identifier: NCT01723865., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Aims: Device replacement at the time of battery depletion of implantable cardioverter-defibrillators (ICDs) may carry a considerable risk of complications and engenders costs for healthcare systems. Therefore, ICD device longevity is extremely important both from a clinical and economic standpoint. Cardiac resynchronization therapy defibrillators (CRT-D) battery longevity is shorter than ICDs. We determined the rate of replacements for battery depletion and we identified possible determinants of early depletion in a series of patients who had undergone implantation of CRT-D devices., Methods and Results: We retrieved data on 1726 consecutive CRT-D systems implanted from January 2008 to March 2010 in nine centres. Five years after a successful CRT-D implantation procedure, 46% of devices were replaced due to battery depletion. The time to device replacement for battery depletion differed considerably among currently available CRT-D systems from different manufacturers, with rates of batteries still in service at 5 years ranging from 52 to 88% (log-rank test, P < 0.001). Left ventricular lead output and unipolar pacing configuration were independent determinants of early depletion [hazard ratio (HR): 1.96; 95% 95% confidence interval (CI): 1.57-2.46; P < 0.001 and HR: 1.58, 95% CI: 1.25-2.01; P < 0.001, respectively]. The implantation of a recent-generation device (HR: 0.57; 95% CI: 0.45-0.72; P < 0.001), the battery chemistry and the CRT-D manufacturer (HR: 0.64; 95% CI: 0.47-0.89; P = 0.008) were additional factors associated with replacement for battery depletion., Conclusion: The device longevity at 5 years was 54%. High left ventricular lead output and unipolar pacing configuration were associated with early battery depletion, while recent-generation CRT-Ds displayed better longevity. Significant differences emerged among currently available CRT-D systems from different manufacturers., (© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.)

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., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Aims: Catheter-tissue contact is critical for effective lesion creation in radiofrequency catheter ablation (RFCA). In a multicentre prospective study, we assessed the effect of direct contact force (CF) measurement on acute procedural parameters during RFCA of atrial fibrillation (AF)., Methods and Results: A new open-irrigated tip catheter with CF sensing (SmartTouch™, Biosense Webster Inc.) was used. All the patients underwent the first ablation procedure for paroxysmal AF with antral pulmonary vein (PV) isolation, aiming at entry and exit conduction block in all PVs. Ninety-five patients were enroled in nine centres and successfully underwent ablation. Overall procedure time, fluoroscopy time, and ablation time were 138.0 ± 67.0, 14.3 ± 11.2, and 33.8 ± 19.4 min, respectively. The mean CF value during ablation was 12.2 ± 3.9 g. Force time integral (FTI) analysis showed that patients achieving a value below the median of 543.0gs required longer procedural (158.0 ± 74.0 vs. 117.0 ± 52.0 min, P = 0.004) and fluoroscopy (17.5 ± 13.0 vs. 11.0 ± 7.7 min, P = 0.007) times as compared with those in whom FTI was above this value. Patients in whom the mean CF during ablation was >20 g required shorter procedural time (92.0 ± 23.0 vs. 160.0 ± 67.0 min, P = 0.01) as compared with patients in whom this value was <10 g. Four groin haematomas were the only complications observed., Conclusion: Contact force during RFCA for PV isolation affects procedural parameters, in particular procedural and fluoroscopy times, without increasing complications.

Aims: Catheter ablation of atrial fibrillation (AF) focuses on pulmonary vein (PV) ablation with or without additional atrial substrate modification. These procedures require significant fluoroscopy exposure. A new 3D non-fluoroscopic navigation system (CARTO(®) 3 System, Biosense Webster, CA, USA) that allows precise location visualization of diagnostic and ablation catheters was evaluated for its impact on fluoroscopic exposure during AF ablation procedures., Methods and Results: Two groups of patients were treated by our centres for drug refractory AF. One group was treated using the new CARTO(®) 3 system to guide catheter ablation (Group A, 117 patients). The other group was treated using the CARTO(®) XP system (Biosense Webster) 3 months previously (Group B, 123 patients). For both groups, circumferential PV ostia ablation was performed; PV isolation was validated using a circular catheter placed at each ostium. There was no difference in any clinical characteristics (age, sex, AF type, left atrium diameter and volume, and heart disease) among the two study groups. The mean number of PVs identified and isolated per patient was similar in both groups, as were the mean procedural duration and radiofrequency time. However, mean fluoroscopic time was significantly reduced in Group A (15.9±12.3 min) as compared with Group B (26±15.1 min) (P < 0.001)., Conclusion: This multicentre observational study demonstrates a significant reduction of fluoroscopy exposure using a new 3D non-fluoroscopic mapping system to guide AF catheter ablation.

Aims In the last decade, several approaches to ablating triggers and substrates of atrial fibrillation (AF) have been developed. However, most studies have reported data only on short- or medium-term follow-up. The aim of this study was to investigate whether the 1-year efficacy of catheter ablation for AF is predictive of long-term clinical success. Methods and results Between February 2001 and October 2003, 229 consecutive patients affected by drug-refractory paroxysmal or persistent AF underwent a single radiofrequency catheter ablation procedure (anatomical approach in 146 patients and electrophysiologically guided approach in 83 patients). Of these patients, 177 (mean age 59.1 +/- 10.5 years, 57.6% with paroxysmal AF) were free from any atrial arrhythmia recurrence after 12 months. These 177 patients were subsequently followed up for at least another 24 months, by means of electrocardiogram and 24 h Holter monitoring. After a mean follow-up of 49.7 +/- 13.3 months (range 36-83 months), 58.2% of the patients were free from any atrial arrhythmia recurrence (39.5% without antiarrhythmic drugs). The actuarial atrial arrhythmia recurrence rate was 13.0% at 2 years, 21.8% at 3 years, 35.0% at 4 years, 46.8% at 5 years, and 54.6% at 6 years. Atrial arrhythmia-free survival was similar in patients with paroxysmal or persistent AF, with and without antiarrhythmic drugs during the follow-up, who underwent electrophysiologically guided pulmonary vein (PV) isolation or anatomical PV ablation. Conclusion Even patients in whom catheter ablation prevents AF recurrence for 1 year should not be considered 'cured', since >40% of them will suffer AF recurrence over a long-term clinical follow-up.

Aims: The aim of this study was to investigate whether circumferential pulmonary vein (PV) isolation guided by image integration improves the procedural and clinical outcomes of atrial fibrillation (AF) ablation in comparison with segmental PV isolation and circumferential PV isolation guided by three-dimensional (3D) electroanatomical mapping alone., Methods and Results: Procedural and clinical outcomes of 573 patients who underwent their first catheter ablation for paroxysmal AF between January 2005 and April 2007 were collected from 12 centres. We evaluated three techniques: segmental ostial PV isolation (SOCA group, 240 patients), circumferential PV isolation guided by electroanatomical mapping (CARTO group, 107 patients), and circumferential PV isolation guided by electroanatomical mapping integrated with magnetic resonance/computed tomographic images of the left atrium (MERGE group, 226 patients). Procedure duration proved to be shorter in MERGE group patients than in CARTO group patients (P < 0.04), but longer than in SOCA group patients (P < 0.0001). During follow-up, atrial tachyarrhythmias relapsed more frequently in SOCA group patients (44.6%) and CARTO group patients (41.7%) than in MERGE group patients (22.6%; P < 0.0001)., Conclusion: In patients with paroxysmal AF, circumferential PV isolation guided by image integration significantly improves clinical outcome in comparison with both circumferential PV isolation guided by 3D mapping alone and with segmental electrophysiologically guided PV isolation.

Aims: Catheter Ablation for the Cure of Atrial Fibrillation 2 study is a prospective, randomized trial aimed to demonstrate the efficacy of catheter ablation with combined lesions in the right and left atria, in preventing atrial fibrillation (AF) recurrences among patients with recurrent persistent AF refractory to one antiarrhythmic drug, in comparison with the best pharmacological therapy., Methods and Results: Enrolment is limited to patients aged between 18 and 70 years who have experienced at least one documented relapse of persistent AF during antiarrhythmic drug therapy. One hundred and twenty-six patients will be randomized to ablation or antiarrhythmic drug therapy in a 2 : 1 manner. In the ablation group, the patients will undergo right and left atrial linear ablation. Control group patients will be treated with the best antiarrhythmic drug. After an initial blanking period of 2 months patients will be followed for 24 months. Primary endpoint of the study is the absence of documented persistent atrial tachyarrhythmias relapse during the first 24 months after the blanking period. Enrolment is scheduled in 14 centres in Italy, UK, Austria, and Finland. Seventy-two patients have currently been enrolled., Conclusion: This study will provide important data about the efficacy of catheter ablation in comparison with antiarrhythmic drugs for the treatment of persistent AF.