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Atrial fibrillation (AF) is an uncommon arrhythmia in young adults without structural heart disease, and cryoballoon pulmonary vein isolation (CB-PVI) is an important therapeutic strategy for rhythm control in patients with drug-refractory AF. The aim of this analysis was to evaluate efficacy and safety of CB-PVI in a large cohort of young patients in comparison with middle-aged adults in a real-world setting.From 2012 to 2020, a total of 3033 patients with AF underwent CB-PVI and were followed prospectively in the framework of the 1STOP Clinical Service project, involving 34 Italian centers. Out of 3033 total 1STOP project subjects, a subgroup of 1318 patients were defined which included a YOUNG group (age ≤ 45 years; n = 368) and a MIDDLE-AGED group (age 60-65 years; n = 950).The acute success rate of PVI did not differ between the two cohorts (99.9 ± 1.3% vs. 99.8 ± 3.2%, p = 0.415). There was no difference in procedural characteristics, and periprocedural complication rates were similar among the two cohort (1.9% vs. 2.3%, p = 0.646). The 12-month freedom from AF recurrence was 88.9% (95% confidence interval [CI]: 84.7-92.0) in the YOUNG cohort and 85.6% (95% CI: 82.9-88.0) in the MIDDLE-AGED group. At 36-month follow-up, freedom from AF recurrence was 72.4% (65.5%-78.2%) and 71.8% (67.7%-75.6%), respectively with no significant difference among groups (p = 0.550).CB-PVI had similar efficacy and safety in YOUNG and MIDDLE-AGED patients. Younger age did not affect acute procedural results, complication rate, or AF recurrence after a single procedure.

It has been observed that the fourth-generation cryoballoon (CB4) ablation catheter increased the rate of acute real-time recordings of pulmonary vein isolation (PVI) during the ablation for the treatment of atrial fibrillation (AF). The aim of this analysis was to compare the long-term outcome results between patients treated with the CB4 and second-generation cryoballoon (CB2).In total, 492 patients suffering from AF, underwent PVI ablation with either the CB2 or CB4 catheter within this examination of the 1STOP real-world Italian project and were included in the analysis. Specifically, 246 consecutive patients treated by CB4 were compared to 246 propensity-matched control patients who underwent PVI using CB2.When comparing the patient cohorts treated with CB2 versus CB4, acute success rate (99.6 ± 4.7% vs. 99.7 ± 3.6%, p = .949) and peri-procedural complications (3.7% vs.1.2%, p = .080) were similar in both groups, respectively. However, procedure time (100 vs.75 min, p .001) and fluoroscopy duration (21 vs.17 min, p .001) were all significantly lower in the CB4 treated patient cohort. At the 12-month follow-up, the freedom from AF recurrence after a 90-day blanking period was significant higher in the CB4 as compared with the CB2 group (93.3% vs.81.3%, p .001).In summary, usage of the CB4 ablation catheter increased the rate of acute PVI recording capability and resulted in a higher rate of long-term PVI success, as demonstrated by the reduced rate of AF recurrence in comparison to the CB2 cohort at the 12-month follow-up period.

Purpose Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have emerged as a viable real-time indicator of tissue characteristics and the consequent durability of the lesions created. We investigated the impact of catheter-tissue contact force (CF) on LI behavior during pulmonary vein isolation (PVI). Methods Forty-five consecutive patients of the CHARISMA registry undergoing de novo AF radiofrequency (RF) catheter ablation with a novel open-irrigated-tip catheter endowed with CF and LI measurement capabilities (Stablepoint™ catheter, Boston Scientific) were included. Results A total of 2895 point-by-point RF applications were analyzed (RF delivery time (DT) = 8.7±4s, CF = 13 ±±8 g, LI drop = 23 ±±7 Ω). All PVs were successfully isolated in an overall procedure time of 118 ±±34 min (fluoroscopy time = 13 ±±8 min). The magnitude of LI drop weakly correlated with CF (r = 0.13, 95% confidence interval (CI): 0.09 to 0.16, p < 0.0001), whereas both CF and LI drop inversely correlated with DT (r = −0.26, 95%CI: −0.29 to −0.22, p < 0.0001 for CF; r = −0.36, 95%CI: −0.39 to −0.33, p < 0.0001 for LI). For each 10 g of CF, LI drop markedly increased from 22.4 ± 7 Ω to 24.0 ± 8 Ω at 5 to 25 g CF intervals (5–14 g of CF vs 15–24 g of CF, p < 0.0001), whereas it showed smooth transition over 25 g (24.8 ± 7Ω at ≥ 25 g CF intervals, p = 0.0606 vs 15–24 g of CF). No major complications occurred during the procedures or within 30 days. Conclusions CF significantly affects LI drop and probable consequent lesion formation during RF PVI. The benefit of higher contact (> 25 g) between the catheter and the tissue appears to have less impact on LI drop. Trial registration Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998

BACKGROUND: The coronavirus disease-19 (COVID-19) outbreak has been recently associated with lower hospitalization rates for acute coronary syndromes. Aim of the study was to investigate whether a similar behaviour is observed in admissions for urgent pacemaker implant. METHODS: This retrospective study included 1315 patients from 18 hospitals in Northern Italy with a high number of COVID-19 cases. Hospitalization rates for urgent pacemaker implant were compared between the following periods: 20 February to 20 April 2020 (case period); from 1 January to 19 February 2020 (intra-year control period); from 20 February to 20 April 2019 (inter-year control period). RESULTS: The incidence rate of urgent implants was 5.0/day in the case period, 6.0/day in the intra-year control period and 5.8/day in the inter-year control period. Incidence rate in the case period was significantly lower than both the intra-year [incidence rate ratio (IRR): 0.81, 95% CI 0.67-0.99, P = 0.040] and inter-year control periods (IRR: 0.79, 95% CI 0.66-0.95, P = 0.012); this reduction was highest after the national lockdown (IRR 0.68, 95% CI 0.52-0.91, P = 0.009). The prevalence of residents in rural areas undergoing urgent pacemaker implant was lower in the case period (36%) than in both the intra-year (47%, P = 0.03) and inter-year control periods (51%, P = 0.002). Elective pacemaker implants also decreased in the case period, with the incidence rate here being 3.5/day vs. 6.4/day in the intra-year (-45%) and 6.9/day in the inter-year period (-49%). CONCLUSION: Despite severe clinical patterns, the COVID-19 outbreak has negatively affected the population presentation to Emergency Departments for bradyarrhythmias requiring urgent pacemaker implant in Northern Italy. This mainly occurred after the national lockdown and concerned patients living in rural areas.

Transvenous pacing is nowadays the cornerstone of interventional management of bradyarrhythmias. It is still associated, however, with significant complications, mostly related to indwelling transvenous leads or device pocket. In order to reduce these complications, leadless pacemakers have been recently introduced into clinical practice, but no guidelines are yet available to indicate who are those patients that might benefit the most and whether leadless pacing should be preferred in the old or young population. This survey aims to describe the use of leadless pacemaker devices in a real-world setting.Eleven arrhythmia centers in the Lombardy region (out of a total of 17 participating centers) responded to the proposed questionnaire regarding patient characteristics and indications to leadless pacing.Out of a total of 411 patients undergoing leadless pacing during 4.2 ± 0.98 years, the median age was 77 years, with 0.18% of patients having less than 18 years, 29.9% 18-65 years, 34.3% 65-80 years and 35.6%80 years. The most common indication was slow atrial fibrillation (49% of patients), followed by atrioventricular block and sinoatrial dysfunction. Two centers reported in-hospital complications.Leadless pacemakers proved to be a safe pacing strategy actually destined mostly to elderly patients.

BACKGROUND: The efficacy of posterior wall isolation (PWI) on top of pulmonary vein isolation (PVI) in patients affected by persistent atrial fibrillation (AF) is still controversial and little is known about the impact of contact-force (CF) technology. OBJECTIVE: In this retrospective study, we present our experience with PWI using CF sensing catheters and its efficacy and safety as an adjunctive ablation strategy on top of PVI for management of patients with persistent and longstanding persistent AF. METHODS: A total of 73 consecutive patients (20.5% female) affected by persistent atrial fibrillation (10.9% long-standing) underwent PWI as an adjunctive therapy to PVI using CF sensing catheters. Outcomes were reported as incidence of atrial arrhythmic recurrences (ARs) lasting >30 seconds at follow up and in addition, in patients provided with insertable cardiac monitors (ICM), as burden of AF or atrial tachycardias (AT) at relevant time points. RESULTS: PWI was successfully achieved in 65 (89.0%) patients. Two (2.7%) minor vascular procedural complications were observed. At 1 and 2-year follow-up, ARs free survival was observed in 80.5% and 64.1% of patients, respectively with 75.3% of patients off antiarrhythmic drugs at the last follow-up. Ten patients underwent repeat ablations during the follow-up. At multivariate analysis, early ARs within 3 months after procedure, were associated with a two-fold increased risk of late ARs at follow-up. Among patients provided with ICM, PWI on top of PVI was able to reduce the mean AT/AF burden of more than 50% compared with pre-ablation time, reporting very low levels (≤ 5%) over 2 years. CONCLUSIONS: In persistent atrial fibrillation, PWI on top of PVI using CF sensing catheters is safe and effective, providing great reduction of burden of ARs. Early ARs are associated with a greater risk of late recurrences.

Funding Acknowledgements Type of funding sources: None. Background The continual pursuit of more durable pulmonary vein isolation (PVI) has led ablationists to evaluate many different techniques for confirming isolation. One such technique involves using the ablation catheter to pace along the ablation lines, ensuring loss of pace capture. Initial observations from a small cohort of patients suggested that a high-density, grid style mapping catheter (HD Grid) enabling simultaneous recording of adjacent bipolar EGMs in two directions (HD Wave) may identify residual gaps that are missed when using the technique of pacing the ablation line in isolation. The true incidence of these residual gaps as identified in a large patient population has not been previously reported. Purpose To quantify in a large cohort of AF ablation patients, the presence of residual gaps identified by HD Grid which are missed by a technique of pacing along the ablation lines with the ablation catheter. Methods Self-reported data was prospectively collected in AF radiofrequency ablation procedures in which PVI was first confirmed by pacing along the ablation line followed by assessment using the HD Grid. Procedural characteristics and acute outcomes, including the incidence and location of gaps post-ablation, were analyzed. Results Data was collected in 111 AF ablation procedures performed in 18 centers across the United States and Europe. Paroxysmal (PAF), persistent (PersAF), and longstanding persistent AF (LsPersAF) accounted for 60.4%, 33.3%, and 6.3% of cases, respectively. Overall, 64.0% of ablations were de novo procedures. Following ablation, PVI was confirmed in all cases by pacing the ablation line with an average output of 9.1 ± 2.6mA and pulse width of 2.1 ± 0.5ms. Adenosine was administered in 3.6% of cases, isoproterenol in 3.6%, and a combination in 0.9%. PVI was then reassessed with HD Grid using a variety of techniques including exit block (91.0%), voltage mapping (82.0%), loss of pace capture along the ablation lines (47.7%), and entrance block (27.0%); note: total exceeds 100% as more than one technique may be used in a single case. A second dose of adenosine was administered in 2.7% of cases; isoproterenol in 2.7%. The HD Wave configuration was used in 96.4% of cases. HD Grid identified a total of 130 gaps in 65 (58.6%) patients, which were missed by pacing the ablation line (Figure 1). Conclusions In over half of the patients evaluated, the HD Grid identified residual PVI gaps that were missed when isolation was confirmed by using the ablation catheter to pace the ablation lines. These results suggest that the pacing technique, used in isolation, is not sufficient for complete gap detection. One limitation of this analysis was the use of a workflow which consistently assessed PVI with the HD Grid following confirmation of isolation by pacing the ablation lines. Despite this limitation, the rate at which residual gaps were identified is noteworthy and likely warrants additional study. Abstract Figure.

Background Our aim was to evaluate the clinical outcome of paroxysmal atrial fibrillation (AF) ablation with contact force technology, using an automated lesion tagging system (VISITAGTM module) with strict criteria of catheter stability.Methods and Results:We enrolled 200 consecutive patients who underwent pulmonary vein isolation (PVI) in 11 centers and were followed up for 12 months. The stability setting was within 3 mm for ≥10 s and for ≥15 s in 47% and 53% of patients, respectively. A mean of 67.2±21.9 VISITAGs was acquired. Freedom from atrial tachyarrhythmias at follow-up was 77.5% (155/200), and the contiguity between lesions was associated with a higher chronic success rate (96% vs. 77.1%; log-rank P=0.036). Radiofrequency (RF), fluoroscopy times, and recurrence rates at the 12-month follow-up were significantly lower than in a comparison group of 80 patients without VISITAGTM module (42.7±14.5 vs. 50.9±23.6 min; P=0.032; 11.6±7.8 vs. 18.4±12.8 min; P=0.003 and 22.5% vs. 41.2%; P=0.02). Two major complications (1 cardiac tamponade and 1 minor stroke) were observed only in the control group. Conclusions Paroxysmal AF ablation with contact force technology and strict criteria of stability using the VISITAG module was a safe procedure, associated with an improvement in efficiency and a reduction of atrial tachyarrhythmia recurrence at the 12-month follow-up compared with manual annotation. Contiguity between lesions seemed to enhance effectiveness outcomes.

Background Continuous monitoring by implantable loop recorder (ILR) can provide information relevant to rhythm control and oral anticoagulation (OAC) after atrial fibrillation (AF) ablation, but there is little agreement on patients' selection and appropriate management strategy. Methods An expert panel (EP) made up of eight Italian electrophysiologists with expertise in AF ablation, gathered to define an algorithm to guide continuous rhythm monitoring in AF patients who have undergone ablation. The process included a review of the current literature and two EP face-to-face meetings. Between the two meetings, an on-line survey was sent to 50 Italian electrophysiologists practicing AF ablation. Agreement level was considered reached when ≥70% of respondents agreed or were neutral. Results Two algorithms were developed to define patients for whom the ILR would be suggested support for (OAC) therapy discontinuation and rhythm management after AF ablation. Thirty-three out of 50 physicians responded to on-line survey (66% response rate). Together with EP members the responders accounted for electrophysiology centers performing about 50% of total yearly Italian AF ablation procedures. Agreement level was reached at the first survey round on all the questions, so the algorithms were not further modified and re-tested. Conclusions EP developed two algorithms for ECG monitoring to guide OAC therapy discontinuation and rhythm management after AF ablation. These suggestions, validated by wide feedback and consensus of physicians performing AF ablations, might support the decision on the choice and the use of ECG monitoring techniques, based on specific patient characteristics.

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 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.

Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. Yet tools and techniques used for confirmation of PVI vary greatly, and it is unclear whether the use of any particular combination of tools and techniques provides greater sensitivity for identifying gaps periprocedurally. It has been suggested the use of a high-density mapping catheter, which enables simultaneous recording of adjacent bipolar EGMs in two directions, may provide improved sensitivity for gap identification. Anonymized, acute procedural data was prospectively collected in AF ablation cases utilizing various workflows for confirmation of PVI. Post-hoc analysis was performed to evaluate the incidence of gaps detected by different diagnostic catheter technologies, including a high-density mapping catheter and circular mapping catheters (CMCs), and common techniques such as pacing the ablation lines. A total of 139 cases were included across three subgroup analyses: 99 cases were included in an indirect comparison of three mapping catheter technologies, revealing gaps in 36.7%, 38.9%, and 81.8% of cases utilizing a 10-pole CMC, 20-pole CMC, and a high-density mapping catheter, respectively; a direct comparison of diagnostic catheter technologies in 18 cryoballoon ablation cases revealed residual gaps in 22.2% of patients identified by high-density mapping which were missed previously with the use of a 3.3F CMC; in 22 cases utilizing a technique of pacing the ablation lines, high-density mapping identified residual gaps in 68.2% of patients. This proof of concept analysis demonstrated that the use of a high-density catheter which records orthogonal bipoles simultaneously, appears to improve acute detection of gaps in PVI lines relative to other commonly utilized techniques and technologies. The long-term impact of ablating these concealed gaps remains unclear. Further study, including direct comparison of diagnostic catheter technologies in a randomized setting with long-term followup, is warranted.

Aims This registry was created to describe the experience of 76 Italian centres with a large cohort of recipients of multipoint pacing (MPP) capable cardiac resynchronization therapy (CRT) devices. Methods and results A total of 507 patients in whom these devices had been successfully implanted were enrolled between August 2013 and May 2015. We analysed: (i) current clinical practices for the management of such patients, and (ii) the impact of MPP on heart failure clinical composite response and on the absolute change in ejection fraction (EF) at 6 months. Multipoint pacing was programmed to ‘ON’ in 46% of patients before discharge. Methods of optimizing MPP programming were most commonly based on either the greatest narrowing of the QRS complex (38%) or the electrical delays between the electrodes (34%). Clinical and echocardiographic follow-up data were evaluated in 232 patients. These patients were divided into two groups according to whether MPP was programmed to ‘ON’ ( n = 94) or ‘OFF’ ( n = 138) at the time of discharge. At 6 months, EF was significantly higher in the MPP group than in the biventricular-pacing group (39.1 ± 9.6 vs. 34.7 ± 7.6%; P < 0.001). Even after adjustments, early MPP activation remained an independent predictor of absolute increase in LVEF of ≥5% (odds ratio 2.5; P = 0.001). At 6 months, an improvement in clinical composite score was recorded in a greater proportion of patients with MPP-ON than in controls (56 vs. 38%; P = 0.009). On comparing optimal MPP and conventional vectors, QRS was also seen to have decreased significantly ( P < 0.001). Conclusion This study provides information that is essential in order to deal with the expected increase in the number of patients receiving MPP devices in the coming years. The results revealed different practices among centres, and establishing the optimal programming that can maximize the benefit of MPP remains a challenging issue. Compared with conventional CRT, MPP improved clinical status and resulted in an additional increase in EF. Clinical Trial Registration . Unique identifier: [NCT02606071][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02606071&atom=%2Feuropace%2Fearly%2F2016%2F05%2F16%2Feuropace.euw094.atom

Pulmonary vein isolation (PVI) is the most widely adopted strategy for paroxysmal atrial fibrillation (PAF) ablation. Limited evidence on acute results and late outcomes of cryoballoon (CB)-PVI in patients with structural heart disease (SHD) exist. The aim of this analysis was to compare acute procedural results and the 1-year recurrence rate of a single CB-PVI procedure in a PAF population with and without SHD.From April 2012 to May 2017, a total of 2,031 patients with AF underwent CB-PVI and were followed prospectively in the framework of the One Shot TO Pulmonary vein isolation (1STOP) ClinicalService project, involving 36 Italian cardiology centres. We identified patients with SHD according to criteria proposed by current ESC guidelines: left ventricular (LV) systolic or diastolic dysfunction, long-standing hypertension with LV hypertrophy, and/or other structural heart disease. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated.Our population consisted of 1,452 patients, of whom 282 (19.4%) were classified as having SHD. Compared to non-SHD patients, the SHD cohort was older (mean ± standard deviation, 62.9 ± 9.0 vs 58.2 ± 11.4 years; p 0.001), was more frequently male (79.1% vs 69.8%; p 0.002), had a higher thrombo-embolic risk (CHACB-PVI was extensively applied to treat patients with PAF. Unlike previous PVI experiences, the acute success and recurrence rate after a single procedure was not related to the presence of SHD or to the degree of cardiac remodelling. Further studies are required to define whether CB-PVI has a useful role in patients with a significantly reduced ejection fraction as those patients were under-represented in the current population.

Interventricular Electrical Delay. Introduction: The left ventricular (LV) pacing site and the magnitude of the electrical delay within the LV, as expressed by prolonged QRS duration, are major determinants of cardiac resynchronization therapy (CRT) efficacy. We investigated the incremental value of positioning the LV lead in areas of late activation in order to enhance the response to CRT in patients with different degrees of QRS complex lengthening. Methods and Results: This analysis was performed on 301 heart failure patients who received a CRT defibrillator. On implantation, theright ventricular (RV)-to-LVinterval was measured as the delay between localactivationsrecordedthroughtheRVandLVleadsinthefinalposition.After1year,171(57%)patients displayed reverse LV remodeling, as measured by a 15% reduction in the LV end-systolic volume. Both the RV-to-LV interval and its percentage value corrected for the QRS duration were significantly associated with a positive response to CRT. An RV-to-LV interval >80 milliseconds and an RV-to-LV interval/QRS >58% yielded the best prediction of reverse remodeling. Although the response to CRT decreased with shorter QRS duration in the overall population, patients with an RV-to-LV interval >80 milliseconds showed a response rate >65% in all QRS subgroups. Conclusion: A longer RV-to-LV interval is associated with reverse LV remodeling after CRT. On implantation attempts could be made to maximize it when selecting the LV lead position, especially in patients with shorter QRS duration, and thus less likely to respond positively to CRT. (J Cardiovasc Electrophysiol

Rhythm-Symptom Correlation in Patients on Continuous Monitoring Introduction Correlation between symptoms and atrial fibrillation (AF) episodes after catheter ablation may have clinical relevance, especially for anticoagulation usage. The aim of our project was to analyze the relationship between symptoms and AF recurrences in unselected patients following AF catheter ablation during long-term follow-up. Methods and Results One hundred and forty-three consecutive patients (mean age 59 ± 9 years, 85% male) were implanted with a continuous cardiac monitor (RevealXT, Medtronic Inc., Minneapolis, MN, USA) following first pulmonary vein ablation procedure. Device data were downloaded every 3 months and correlated to patients’ symptom diary. AF was paroxysmal in 55% and persistent in 45%. At a mean follow-up of 14 ± 6 months, 98/143 (69%) patients had at least one AF recurrence. Among these, 53 (54%) reported AF-related symptoms while 45 (46%) were totally asymptomatic. Conversely, 13 (29%) out of 45 patients without AF recurrences reported symptoms. Globally, a significant reduction of symptoms (from 82% at baseline to 44% at last follow-up; P

BACKGROUND Radiofrequency catheter ablation (RFCA) of atrial fibrillation is an effective and definitive treatment. The methods used to guide RFCA have evolved over the years from a purely electrophysiological approach, in which anatomical lesions were guided solely by fluoroscopy and angiographic imaging of the pulmonary veins, to an approach guided by modern nonfluoroscopic electroanatomical mapping, integrated or not with computed tomography (CT). The aim of this study was, therefore, to compare radiation exposure of RFCA based on a fast three-dimensional nonfluoroscopic mapping system with 'traditional' mapping integrated with CT imaging. METHODS Thirty consecutive patients with atrial fibrillation who underwent RFCA were treated with two different approaches: 3D-Fast-Anatomical-Mapping and One-Map tool (FAM-One Map group, 21 patients) vs. 3D-Fast-Anatomical-Mapping integrated with CT images (MERGE-CT group, nine patients). Fluoroscopy time and radiation doses (expressed in milliGray) were compared. RESULTS No statistically significant difference was detectable between FAM-One Map group and MERGE-CT group considering RFCA success rates and fluoroscopy times. Radiation exposure was higher in the MERGE-CT group (965 ± 138 mGy MERGE-CT group vs. 532 ± 216 mGy FAM-One Map group, P

Vitamin K antagonists have been the only available orally active anticoagulants for decades. Although effective, their numerous limitations have driven the introduction of new oral anticoagulants (NOAs) that showed effectiveness at fixed doses without the need for routine coagulation monitoring. However, the safety and efficacy observed in controlled clinical trials may be hard to translate in clinical practice. Clinical conditions as well as drug interactions may considerably impact on patient outcomes. Moreover, the inability to monitor the pharmacological activity of NOAs and the absence of any antidote in the setting of bleeding or emergent invasive procedures may limit their use. Vitamin K antagonists will be still used in many circumstances, including patients with an optimal control of the INR, with mechanical heart valves, and other indications for which these new agents have not been investigated. Nevertheless, these new agents will reduce the burden of anticoagulation management at the patient as well as Health Care level.

CRT Patient Characteristics and Outcomes. Introduction: The characteristics and outcomes of patients who undergo cardiac resynchronization therapy (CRT) device implantation in current clinical practice may differ from those of reference trial populations. Study objectives were to assess 2-year outcomes in a population implanted with a CRT plus defibrillator device in accordance with the standard of care and to evaluate any independent association between clinical variables and outcome. Methods and Results: A total of 406 patients enrolled at 35 centers in Italy were followed up prospectively for 2 years. All patient management decisions were left to the treating physician's discretion, in accordance with clinical practice. ACTION-HF patients had a better baseline clinical status than patients enrolled in the COMPANION study: shorter HF history (1 vs 3.5 years, P

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.

Silent brain lesions due to thrombogenicity of the procedure represent recognized side effects of atrial fibrillation (AF) catheter ablation. Embolic risk is higher if anticoagulation is inadequate and recent studies suggest that uninterrupted anticoagulation, ACT levels above 300 seconds and administration of a pre-transeptal bolus of heparin might significantly reduce the incidence of silent cerebral ischemia (SCI) to 2%. Asymptomatic new lesions during AF ablation should suggest worse neuropsychological outcome as a result of the association between silent cerebral infarcts and increased long-term risk of dementia in non-ablated AF patients. However, the available data are discordant. To date, no study has definitely linked post-operative asymptomatic cerebral events to a decline in neuropsychological performance. Larger volumes of cerebral lesions have been associated with cognitive decline but are uncommon findings acutely in post-ablation AF patients. Of note, the majority of acute lesions have a small or medium size and often regress at a medium-term follow-up. Successful AF ablation has the potential to reduce the risk of larger SCI that may be considered as part of the natural course of AF. Although the long-term implications of SCI remain unclear, it is conceivable that strategies to reduce the risk of SCI may be beneficial.

Non-linear parameters were computed to assess the extent of spatial organization in the atria in terms of coupling/synchronization between electrograms recorded in different atrial sites. Recordings of 9 patients suffering from paroxysmal atrial fibrillation were tested during four clinical experimental conditions: sinus rhythm and atrial fibrillation, both before and after isoproterenol infusion, a drug mimicking adrenergic activation. Two non-linear metrics were investigated: an index of non-linear association (NLA) and a synchronization (S) index based on the cross-conditional entropy. Results evidence the presence of reduced coupling after drug infusion in both sinus rhythm and atrial fibrillation. Moreover, passing from the NLA to the S index, the capability of the parameter to capture the subtle changes due to isoproterenol administration increased.

Left ventricular outflow tract (LVOT) may be a source of repeated premature ventricular complexes (PVCs). In symptomatic patients, radiofrequency catheter ablation (RFCA) can be effective, either from endocardial or from epicardial sites. A 50-year-old patient, with dilated cardiomyopathy (DCM) and severe left ventricular (LV) dysfunction, left bundle branch block (LBBB), New York Heart Association (NYHA) class IV, received a biventricular implantable cardioverter/defibrillator (ICD) in 2002. Despite drug therapy, PVCs were frequent (21.019/24 h) including prolonged runs, prompting ICD intervention. Premature ventricular complexes showed an inferior axis morphology, with an R / S ratio in V3>1, suggesting an LVOT origin. Despite the cardiac resynchronization therapy (CRT) device, successful RFCA was performed through the anterior venous branch, with a favourable clinical outcome. To our knowledge, this is the first case describing epicardial RFCA of a PVC focus from cardiac veins in the presence of a CRT device.

Since cardiac resynchronization therapy (CRT) improves LV function at the cost of low energetic expenditure, the authors hypothesized that it may increase the threshold of drug refractory angina in selected patients with CHF and CAD who are not amenable to myocardial revascularization. From October 1999 to April 2002, 75 patients with CHF and CAD were treated with CRT. Drug refractory angina occurred nearly daily in 8 of the 75 patients. The mean age of these eight men was 71 years, mean NYHA functional Class 3.4 +/- 0.5, mean QRS duration (QRSd) 168 +/- 20 ms, and mean left ventricular ejection fraction (LVEF) 0.29 +/- 0.4. Diffuse CAD not amenable to myocardial revascularization was confirmed on angiography. At baseline, no patient was able to complete a 6-minute walk test because of angina. In the 6 months before CRT, the mean number of hospitalizations per patient for management of CHF or angina was 3.1 +/- 0.3. All patients underwent successful CRT. Mean QRSd decreased to 141 +/- 16 ms (P = 0.01 vs baseline). After 9 +/- 6.1 months, LVEF increased to 0.317 +/- 0.028 (P = 0.03 vs baseline), while the NYHA class decreased to 2.6 +/- 0.5 (P = 0.02 vs baseline). All patients also experienced a marked decrease in angina episodes, from a mean of 8.3 +/- 11.6 to 0.6 +/- 1.3 episodes/week (P < 0.05), and completed a 6-minute walk test, covering a mean distance of 337 +/- 68 m (vs 237 +/- 136 m at baseline, P = 0.007). No further hospitalization was necessary. The beneficial effects of CRT on overall cardiac function may include a better control of angina in severely symptomatic patients.

Congestive heart failure (CHF) patients with LBBB and QRS duration > 150 ms are considered the best candidates to biventricular pacing (Biv-P). However, patients with a narrow (120-150 ms) QRS may also benefit from Biv-P since true ventricular dyssynchrony may be underestimated by considering only QRS enlargement. From October 1999 to April 2002, 158 CHF patients (121 men, mean age 65 years, mean LVEF 0.29, mean QRS width 174 ms) underwent successful Biv-P implantation and were then followed for a mean time of 11.2 months. According to basal QRS duration, patients were divided in two groups, with wide QRS (> or = 150 ms, 128 patients, 81%) and with narrow QRS (< 150 ms, 30 patients, 19%). In the wide QRS group, LVEF improved from 29% to 39% (P < 0.0001), 6-minute walk test from 311 to 463 m (P < 0.0001), while NYHA Class III-IV patients decreased from 86% to 8% (P < 0.0001). In the narrow QRS group LVEF improved from 30% to 38% (P < 0.0001), 6-minute walk test from 370 to 506 m (P < 0.0001), and NYHA Class III-IV patients decreased from 60% to 0% (P < 0.0001). The data showed that in wide and narrow QRS patients, Biv-P significantly improved clinical parameters (NYHA class, 6-minute walk test, quality-of-life, and hospitalization rate) and main echocardiographic indicators. Furthermore, narrow QRS patients had a better survival rate, rapidly regained left ventricular function, and only a few patients remained in a higher NYHA class during follow-up. These patients should not be excluded "a priori" from cardiac resynchronization therapy.

Small single-center comparative studies suggest improved outcomes in cardiac resynchronization therapy (CRT) patients implanted with a quadripolar left ventricular (LV) lead in comparison with non-quadripolar (bipolar) leads. This study represents the first large multicenter prospective registry comparing implant and 6-month postoperative lead performance following CRT-defibrillator (CRT-D) implantation with quadripolar vs. bipolar leads.During a 39-month period, 418 consecutive patients having CRT-D implantation attempts with either a quadripolar (n = 230) or bipolar LV lead (n = 188) were enrolled in the registry. The primary outcome of the study was LV lead failure defined as any abnormality, excluding infection, resulting in surgical lead revision or CRT termination. Additionally, operative and follow-up data were analyzed for significant difference between groups.Baseline characteristics of both groups were similar. In 72.9 % of quadripolar leads versus 65.0 % of bipolar leads, the LV lead successfully engaged the predefined ideal target side branch (p = 0.47). Implant duration and fluoroscopy times were significantly shorter when a quadripolar lead was used (p = 0.007 and p = 0.001, respectively). The primary end point occurred in six patients (2.7 %) in the quadripolar group and in 14 patients (8.0 %) in the bipolar group (p = 0.02). Clinically significant phrenic nerve stimulation (PNS) occurred in 4.6 vs. 14.2 % of quadripolar vs. bipolar patients, respectively (p = 0.002); all PNS were resolved noninvasively through programming in the quadripolar group vs. 84 % in bipolar group (p = 0.75). The use of a bipolar lead was associated with a higher risk of surgical LV lead revision (6.3 vs. 2.3 %; p = 0.057) and a higher incidence of dislodgment (5.7 vs. 2.7 %; p = 0.16).This multicenter study demonstrates that the use of a quadripolar LV lead results in significantly lower rates of lead-related problems and reduced procedural and fluoroscopic times for biventricular system implantation. This has important implications for LV pacing lead choice.

Biventricular pacing results in significant haemodynamic improvements in most patients with chronic heart failure and intra-ventricular conduction delay, especially those with left bundle branch block. A growing body of experience indicates that the pacing site and the choice of atrioventricular/intraventricular delay are crucial to short-term improvement in left ventricular (LV) function. In patients with left bundle branch block, the mid-lateral and mid-postero-lateral wall of the left ventricle have been identified as the regions at which the latest activation occurs. Thus, they present the most effective pacing sites on the left ventricle. The importance of an appropriately timed atrial contraction for ventricular loading is well established, because prolongation of the atrioventricular interval (common in patients with chronic heart failure) provokes a reduction in the LV active filling phase, a shortening in passive diastolic filling and onset of a ventriculo-atrial gradient, thus initiating diastolic mitral regurgitation. Atrioventricular delay optimization can limit these deleterious haemodynamic effects, although the influence of atrioventricular delay appears to be less important than proper choice of LV pacing site. The latest generation of biventricular pacing devices are equipped with two separate channels for the right ventricular and LV leads, thus allowing the interventricular timing of pacing to be varied, obtaining haemodynamic benefits even from a non-optimal LV site.

Right atrial linear ablation has been used for the treatment of refractory atrial fibrillation (AF), with conflicting results. Conventional mapping techniques that have thus far been used for this purpose have resulted in lengthy procedure times and radiation exposure, while proving unsatisfactory in verifying the completeness of block lines. Alternative advanced three-dimensional non-fluoroscopic mapping systems that have recently been introduced may prove to be advantageous in transcatheter linear ablation to cure AF. This is because of their ability to improve the accuracy of ablation, to provide a highly detailed analysis of the atrial activation pattern once linear lesions have been created, and to reduce X-ray exposure time. Notwithstanding the lack of information on long-term follow up, the treatment of idiopathic drug-resistant AF using right atrial linear ablation guided by an advanced mapping system is, in our experience, both feasible and safe; a desirable clinical outcome may be achieved in more than two-thirds of patients, with some patients experiencing complete abolition of AF and others a statistically significant reduction in the number of symptomatic AF episodes. The use of advanced mapping systems in conjunction with atrial pacing on both sides of the lines of ablation is essential in order to assess completeness of the bidirectional block. Because procedural risks are very low, a first-step approach employing right atrial compartmentalization appears justified in selected patients with drug-refractory AF, who exhibit no evidence of focal substrates from which AF might initiate.

OBJECTIVE—To assess the incidence of arterial embolic events in patients with high rate, drug resistant, severely symptomatic paroxysmal and chronic atrial fibrillation who have undergone atrioventricular (AV) node ablation and permanent pacing. DESIGN—Multicentre retrospective cohort study. PATIENTS AND MANAGEMENT—From May 1987 to January 1997, AV node ablation was performed in 585 severely symptomatic patients (mean (SD) age 66 (11) years) with high rate, drug resistant paroxysmal atrial fibrillation (308) or chronic atrial fibrillation (277). Lone atrial fibrillation was present in 133 patients, while the remaining 452 suffered from dilated, ischaemic, or valvar heart disease. Patients underwent VVIR (454) or DDDR (131) pacemaker implantation, after AV node ablation. Antiplatelet agents were given to 202 patients, warfarin to 187 patients. RESULTS—During a follow up of 33.6 (24.2) months, thromboembolic events were observed in 17 patients (3%); the actuarial occurrence rates of thromboembolism were 1.1%, 3%, 4.2%, and 7.4% after one, three, five, and seven years, respectively. Among five variables, univariate analysis showed that only the presence of chronic atrial fibrillation at the time of ablation (relative risk (RR) = 1.8, 95% confidence interval (CI) = 1.02 to 3.20, p = 0.04) and the need for warfarin treatment (RR = 1.6, 95% CI 1.00 to 2.71, p = 0.048) were associated with a significantly higher risk of occurrence of thromboembolic events. On multivariate analysis the only predictor of embolic events during the follow up was the presence of chronic atrial fibrillation. CONCLUSIONS—Data from this large cohort of patients indicate a fairly low incidence (1.04% per year) of thromboembolic events after AV node ablation and pacing for drug refractory, high rate atrial fibrillation. Keywords: atrial fibrillation; embolism; atrioventricular node ablation; pacemaker implantation

Graft Failure and Recipient Atrial Tachycardia. We describe the case of a 30-year-old female patient who developed an interatrial tachycardia from the recipient to the donor atrium associated with signs of congestive heart failure 5 years after orthotopic heart transplantation. The patient underwent catheter mapping followed by successful radiofrequency (RF) ablation at the site of the presumed electrical connection between the recipient and the donor atria, through the interatrial surgical suture line, with stable recovery of sinus rhythm and disappearance of signs of left ventricular dysfunction. RF catheter ablation is confirmed to be feasible and safe in the treatment of heart transplant patients even in the presence of rare forms of arrhythmias, thus offering a cure for tachycardia to these patients.

The left ventricular (LV) pacing site and the magnitude of the electrical delay within the LV, as expressed by prolonged QRS duration, are major determinants of cardiac resynchronization therapy (CRT) efficacy. We investigated the incremental value of positioning the LV lead in areas of late activation in order to enhance the response to CRT in patients with different degrees of QRS complex lengthening.This analysis was performed on 301 heart failure patients who received a CRT defibrillator. On implantation, the right ventricular (RV)-to-LV interval was measured as the delay between local activations recorded through the RV and LV leads in the final position. After 1 year, 171 (57%) patients displayed reverse LV remodeling, as measured by a ≥15% reduction in the LV end-systolic volume. Both the RV-to-LV interval and its percentage value corrected for the QRS duration were significantly associated with a positive response to CRT. An RV-to-LV interval80 milliseconds and an RV-to-LV interval/QRS58% yielded the best prediction of reverse remodeling. Although the response to CRT decreased with shorter QRS duration in the overall population, patients with an RV-to-LV interval80 milliseconds showed a response rate65% in all QRS subgroups.A longer RV-to-LV interval is associated with reverse LV remodeling after CRT. On implantation attempts could be made to maximize it when selecting the LV lead position, especially in patients with shorter QRS duration, and thus less likely to respond positively to CRT.

Whether and to what extent patients with asymptomatic atrial fibrillation (AF) would benefit from catheter ablation has not been investigated. This is the first multicenter prospective study reporting on the outcome of catheter ablation in patients with asymptomatic AF. Consecutive patients (n = 545) referred for AF ablation were prospectively enrolled in a multicenter Italian registry. Of these patients, 54 have asymptomatic AF and composed our patient population. At 24 month follow-up, catheter ablation in asymptomatic AF patients resulted to be as safe and effective as in patients with drug refractory symptomatic AF. Our study provides significant insights on the role of AF ablation in asymptomatic patients. Further studies in much larger cohorts are needed to validate our conclusions.

Objectives. The goal of this study was to assess the hypothesis that transdermal scopolamine would increase vagal activity in patients after myocardial infarction. Background. In postmyocardial infarction patients, low heart rate variability and reduced baroreceptor reflex sensitivity are associated with increased mortality. Accordingly, there is an increasing interest in a mechanism for shifting the sympathovagal balance toward vagal dominance. Methods. The effects of transdermal administration of scopolamine on heart rate variability and baroreceptor reflex sensitivity were assessed in 20 patients (mean age 59 ± 11 years) by pharmacologic washout 14 ± 3 days after myocardial infarction. Heart rate variability and baroreceptor reflex sensitivity were measured 24 h after application of the scopolamine patch and compared with the values measured before scopolamine and after application of a placebo patch. The following variables were derived from a 15-min electrocardiographic recording: the mean RR interval and its standard deviation, the mean square successive difference, the percent of intervals differing >50 ms from the preceding RR interval and the low and high frequency areas resulting from power spectral analysis. Results. The placebo patch had no effect on the variables measured. Scopolamine increased both heart rate variability and baroreceptor reflex sensitivity significantly. Specifically, the mean RR interval and its standard deviation increased by 7.1% (p = 0.01) and 25% (p = 0.004), respectively. The mean square successive difference increased by 38% (p = 0.0003) and the percent of intervals differing >50 ms from the preceding interval by 100% (p = 0.001). The ratio of low to high frequency areas of the power spectrum decreased by 24% (p = 0.02), and baroreceptor reflex sensitivity increased by 42% (p = 0.0006). These effects were also evident in patients with very low initial values. Side effects were minimal. Conclusions. Transdermal scopolamine increased measures of heart rate variability and baroreceptor reflex sensitivity in patients with a recent myocardial infarction toward values associated with a better prognosis. Pharmacologic modulation of the autonomic balance by scopolamine or related drugs deserves evaluation as a new and promising approach to reduce risk after myocardial infarction.

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.

BACKGROUND Whether cooling catheters should be preferred for atrial fibrillation (AF) ablation is not yet clear. METHODS From April 2005 to October 2006, 991 (74% men) consecutive patients who underwent AF ablation were prospectively enrolled in 10 Italian centers. For the present subanalysis, patients were ranked in the two study groups on the basis of the catheter system chosen: 8-mm tip was used in 86 patients (9% conventional group) and open-irrigated tip in 905 patients (91% cooled group). RESULTS The registry clinical data of both groups showed marked heterogeneity due to the fact that the higher number of patients of the cooled group had longer AF history (4.9+/-4.1 versus 1.2+/-1.8 years; P=0.0001), permanent/persistent AF (41.2 versus 27.9%; P=0.01), and larger left atrium (LA) size (44.1+/-6.2 versus 33.4+/-10.5 mm; P

Background A novel catheter design (HD Mesh ablator, Bard) combining high-density circumferential mapping and direct radiofrequency (RF) energy delivery has been developed to map and isolate the pulmonary veins (PVs). Objective The purpose of this study was to assess the feasibility of the Mesh catheter for PV isolation in patients with paroxysmal atrial fibrillation (AF). Methods Twenty consecutive patients (mean age 56.4 ± 12.2 years; 16 men) with paroxysmal drug-refractory AF were referred for ablation. The procedure was performed in a stepwise manner: PV isolation was initially attempted with the Mesh ablator, and if that was not successful, a conventional ablation approach was then used. Results A total of 73 PVs including seven veins with left common ostium were targeted. Successful deployment of the Mesh was achieved in all but four veins (94.5%). Using the Mesh catheter for ablation, PV isolation was achieved in 46 (63%) of the 73 PVs. The mean (RF) ablation time required to achieve complete isolation was 12.4 ± 6.1 minutes per PV. The Mesh-only approach allowed isolation of all veins in eight (40%) patients. In combination with conventional ablation, successful PV isolation was achieved in 71 (97%) of 73 PVs. No complications attributable to the Mesh ablator occurred in this series. Conclusions PV isolation using the Mesh catheter is feasible and may simplify the current PV isolation procedures. With the current catheter design, PV isolation could be achieved in 63% of PVs. A larger Mesh diameter with an over-the-wire design may help improve the acute success rate.