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Aims: The safety and efficacy of leadless intracardiac-permanent pacemaker (L-PM) have been demonstrated in multiple clinical trials, but data on comparisons with conventional transvenous-permanent pacemaker (T-PM) collected in a consecutive, prospective fashion are limited. The aim of this analysis was to compare the rate and the nature of device-related complications between patients undergoing L-PM vs. T-PM implantation., Methods and Results: Prospective, multicentre, observational project enrolling consecutive patients who underwent L-PM or T-PM implantation. The rate and nature of device-related complications were analysed and compared between the two groups. Individual 1:1 propensity matching of baseline characteristics was performed. A total of 2669 (n = 665 L-PM) patients were included and followed for a median of 39 months, L-PM patients were on average older and had more co-morbidities. The risk of device-related complications at 12 months was significantly lower in the L-PM group (0.5% vs. 1.9%, P = 0.009). Propensity matching yielded 442 matched pairs. In the matched cohort, L-PM patients trended toward having a lower risk of overall device-related complications (P = 0.129), had a similar risk of early complications (≤30 days) (P = 1.000), and had a significantly lower risk of late complications (>30 days) (P = 0.031). All complications observed in L-PM group were early. Most (75.0%) of complications observed in T-PM group were lead- or pocket-related., Conclusion: In this analysis, the risk of device-related complications associated with L-PM implantation tended to be lower than that of T-PM. Specifically, the risk of early complications was similar in two types of PMs, while the risk of late complications was significantly lower for L-PM than T-PM., Competing Interests: Conflict of interest: P.P. reports no conflicts with regard to the content of the present work, outside this work small speaker fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Novartis; M.Z. reports no conflicts with regard to the content of the present work, outside this work small speaker fees from Abbott, Boston Scientific, and Biotronik. No other conflicts of interest were reported., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: 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., Methods: 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)., Results: 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)., Conclusion: 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., (© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: 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)., Methods: 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., Results: 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)., Conclusions: 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., (© 2022 Wiley Periodicals LLC.)

The aim of this research was to evaluate if patients with chronic kidney disease (CKD) and mild or mild to moderate depression of renal function have an increased risk of atrial fibrillation (AF) recurrences after cryoballoon (CB) ablation. We performed a retrospective analysis of AF patients undergoing pulmonary vein isolation (PVI) by CB. The cohort was divided according to the KDIGO CKD-EPI classification into a (1) normal, (2) mildly decreased, or (3) mild to moderate reduction in estimated glomerular filtration rate (eGFR). Freedom from AF recurrences was the primary endpoint. A total of 1971 patients were included (60 ± 10 years, 29.0% females, 73.6% paroxysmal AF) in the study. Acute success and complication rates were 99.2% and 3.7%, respectively, with no significant differences among the three groups. After a follow-up of 24 months, AF recurrences were higher in the mildly and mild to moderate CKD groups compared to the normal kidney function group (23.4% vs. 28.3% vs. 33.5%, p < 0.05). Mild to moderate CKD was an independent predictor of AF recurrences after the blanking period (hazard ratio:1.38, 95% CI 1.02−1.86, p = 0.037). In conclusion, a multicenter analysis of AF patients treated with cryoablation revealed mild to moderate reductions in renal functions were associated with a higher risk of AF recurrences. Conversely, the procedural success and complication rates were similar in patients with normal, mildly reduced, or mild to moderate reduction in eGFR.

Background: The real-world efficacy and safety of atrial fibrillation (AF) ablation in particularly young and elderly patients are still under debate. The aim of the analysis was to investigate the effect of age on the efficacy and safety of cryoballoon ablation (CBA)., Methods: 2,534 patients underwent pulmonary vein isolation (PVI) by way of CBA for paroxysmal or persistent drug-resistant and symptomatic AF. The population was divided into age quartiles for evaluation, including (1) <53 years, (2) ≥53 and <61 years, (3) ≥61 and <67 years, and (4) ≥67 years. Furthermore, outcomes were analyzed in patients <41 years, ≥41 and ≤74, and >74 years old. Procedural data and complications were collected, and atrial fibrillation recurrences were evaluated during follow-up., Results: Procedural-related complications (4.1%) were similar in the four subgroups according to age. At the 12-month follow-up, freedom from AF recurrence was 79.2%, 77.4%, 76.8%, and 75.2% ( p =0.21), respectively (with increasing age). At 24-month follow-up, similar incidences of AF recurrence were observed in the four subgroups. When the sample was arbitrarily divided into the three age groups, a higher rate of recurrence was observed in older patients with regard to long-term follow-up (freedom from AF recurrence was 71.8% and 40.9%, respectively, at 12 and 24-month follow-up). In the univariate and multivariate analysis, age did not result in a significant predictor of AF recurrence during follow-up; however, a trend toward higher AF recurrences rates in patients ≥67 years was observed., Conclusion: The data demonstrated a high degree of safety during CBA across all patient ages. Procedural performance and complications were similar between different ages; AF recurrences seem to be more frequent in patients over 74 years., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2021 Luigi Sciarra et al.)

Aims: Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is mainly reserved for patients with drug-refractory or drug-intolerant symptomatic atrial fibrillation. We evaluated a large cohort of patients treated in a real-world setting and examined the safety and efficacy profile of CBA when applied as a first-line treatment for atrial fibrillation., Methods: In total, 249 patients (23% women; 56 ± 13 years; mean left atrial diameter 41 ± 7 mm; 73.5% paroxysmal atrial fibrillation; and 26.5% persistent atrial fibrillation) underwent an index PVI by CBA. Data were collected prospectively in the framework of the 1STOP ClinicalService project, involving 26 Italian cardiology centers., Results: Median procedure and fluoroscopy times were 90.0 and 21.0 min, respectively. Acute procedural success was 99.8%. Acute/periprocedural complications were observed in seven patients (2.8%), including: four transient diaphragmatic paralyses, one pericardial effusion (not requiring any intervention), one transient ischemic attack, and one minor vascular complication. The Kaplan--Meier freedom from atrial fibrillation recurrence was 86.3% at 12 months and 76% at 24 months. Seventeen patients (6.8%) had a repeat catheter ablation procedure during the follow-up period. At last follow-up, 10% of patients were on an anticoagulation therapy, whereas 6.8% were on an antiarrhythmic drug., Conclusion: In our multicenter real-world experience, PVI by CBA in a first-line atrial fibrillation patient population was well tolerated, effective, and promising. CBA with a PVI strategy can be used to treat patients with paroxysmal and persistent atrial fibrillation with good acute procedural success, short procedure times, and acceptable safety., Clinical Trial Registration: clinicaltrials.gov (NCT01007474)., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background: Pulmonary veins isolation (PVI) by cryoballoon (CB) ablation is marginally represented in clinical studies in obese patients. The aim of this analysis was to evaluate the safety and efficacy of CB-PVI in a large cohort of overweight and obese patients from the 1STOP project., Methods: From 2012 to 2018, 2048 patients with atrial fibrillation (AF) (70% male, 59 ± 11 years; 75% paroxysmal AF) underwent index CB-PVI. The patient data were separated into three cohorts for statistical evaluation, including: normal weight (body mass index [BMI] < 25 kg/m 2 ), overweight (BMI = 25-30 kg/m 2 ), and obese patients (BMI > 30 kg/m 2 )., Results: Out of 2048 patients, 693 (34%) patients had a BMI < 25 and were deemed as normal. There were 944 (46%) patients categorized as overweight (BMI = 25-30) and 411 (20%) as obese (BMI > 30). Overweight or obese patients were more often in persistent AF, had more frequently hypertension and diabetes, had higher CHA 2 DS 2 -VASc score, and had a number of failed antiarrhythmic drug (AAD). Periprocedural complication rates were similar among the three cohorts. The 12-month freedom from AF recurrence was 76.4% in the normal BMI group as compared to 79.2% in the overweight and 73.5% in the obese group (p = .35). However, 48% of overweight patients were on AAD treatment during the follow-up. By multivariate analysis, BMI was not a predictor for AF recurrence following the index CB-PVI., Conclusion: CB-PVI in obese patients is a safe procedure. Increased BMI (either moderate or severe) does not seem to be associated with a worse outcome or to a different rate of AAD discontinuation at 12 months., (© 2020 Wiley Periodicals LLC.)

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.)

Objective: To estimate the prevalence of unknown atrial fibrillation (AF) in the elderly population of the Veneto Region, Italy., Methods: 1820 patients aged ≥ 65 years with no history of AF and not anticoagulated were enrolled in primary-care settings. They underwent an opportunistic electrocardiogram screening with a handheld device (MyDiagnostick) designed to specifically detect AF. The electrocardiogram recordings were reviewed by the researchers, who confirmed the presence of AF., Results: The device detected an arrhythmia in 143 patients, which was confirmed as AF in 101/143 (70.6%), with an overall prevalence of AF of 5.5% (101/1820). Prevalence of unknown AF resulted in 3.6% in patients aged 65-74 years, and 7.5% in patients age 75 or older, and increased according to CHA 2 DS 2 -VASc score: 3.5% in patients with a score of 1 or 2, 5.6% in patients with a score of 3, 7.0% in patients with a score of 4, and 7.2% in patients with a score ≥ 5. The detection rate was significantly higher in patients with mild symptoms compared to asymptomatic counterparts (24.1% vs. 4.0%, P < 0.0001). At multivariate analysis, congestive heart failure and age ≥ 75 years-old were independent predictors for screen-detected AF., Conclusions: An opportunistic screening with handheld device revealed an unexpectedly high prevalence of unknown AF in elderly patients with mild symptoms. Prevalence increased with age and CHA 2 DS 2 -VASc score., (Copyright and License information: Journal of Geriatric Cardiology 2020.)

Background: 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., Method: 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., Results: 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 (CHA 2 DS 2 VASc ≥2: 63.4% vs 40.2%; p < 0.001), had a higher body mass index (27.7 ± 3.9 vs 26.4 ± 3.9 kg/m 2 ; p < 0.001), had a larger atrial diameter (43.8 ± 7.0 vs 40.2 ± 5.8 mm; p < 0.001), and had a lower LV ejection fraction (57.2 ± 7.7% vs 60.7 ± 6.0%; p < 0.001). At the time of ablation, 73% of patients were on class Ic or III anti-arrhythmic drugs. Procedure time (106.9 ± 41.5 vs 112.1 ± 46.8 min; p = 0.248), fluoroscopic time (28.7 ± 14.7 vs 28.6 ± 15.2 min; p = 0.819), and complication rate (3.9% vs 4.8%; p = 0.525) were not different between the SHD and non-SHD cohorts. However, the acute success rate (98.9% vs 97.7%; p = 0.016) was higher in patients with SHD. After a follow-up of 13.4 ± 12.8 months, freedom from symptomatic recurrence was 78.0% for SHD and 78.4% for non-SHD (p = 0.895). Recurrence rate was not related to either left atrial size or LVEF. In the SHD cohort, Class Ic or III anti-arrhythmic drugs treatment decreased from 70.7% of patients before ablation to 28.7% of patients after CB-PVI (p = 0.001)., Conclusions: CB-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., (Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand. Published by Elsevier B.V. All rights reserved.)

Background: Which technique is better for repeat ablation in patients with atrial fibrillation (AF) remains unclear. The aim of the study was to compare long-term efficacy of repeat ablation using the alternative technique for the first redo ablation procedure: (a) cryoballoon (CB) re-ablation after a failed index pulmonary vein isolation (PVI) with radiofrequency (RF) ablation, RF-then-CB group or (b) RF repeat ablation following a failed CB ablation, CB-then-RF group., Methods: Within the 1STOP Italian Project, consecutive patients undergoing repeat ablation with a different technique from the index procedure were included., Results: We studied 474 patients, 349 in RF-then-CB and 125 in CB-then-RF group. Less women (21% vs 30%; P = .041), more persistent AF (33% vs 22%; P = .015), longer duration of AF (60 vs 31 months; P < .001), and more hypertension (50% vs 36%; P = .007) were observed in the RF-then-CB cohort as compared with the CB-then-RF group. The number of reconnected PVs was 3.7 ± 0.7 and 1.4 + 1.3 in RF-then-CB and CB-then-RF group, respectively (P < .001). During the follow-up, significantly less AF recurrence occurred in the CB-then-RF group (22% vs 8%, HR = 0.46; 95% CI: 0.24-0.92; P = .025). Cohort designation was the only independent predictor of AF recurrence., Conclusion: Alternation of energy source for repeat ablation was safe and effective, regardless the energy used first. However, patients initially treated with CB PVI undergoing repeat ablation with RF current had less AF recurrence at long-term follow-up as compared with those originally treated by RF ablation receiving a CB repeat ablation., (© 2020 Wiley Periodicals LLC.)

Introduction: Four generations of the cryoballoon (CB) catheter were retrospectively evaluated in a real-world examination of patients with atrial fibrillation (AF)., Methods and Results: Four hundred eighty patients (27% female and 60 ± 10 years) suffering from AF, underwent pulmonary vein (PV) ablation with one-of-four generations of the CB catheter. The total cohort was divided into four groups of patients: 120 with first-generation (CB-1); 120 with second-generation (CB-2); 120 with third-generation (CB-3); and 120 with fourth-generation (CB-4). Equal group sizes were achieved by examining the last 120 patients treated in each cohort, attempting to minimize the effect of a learning curve between the generations of CB catheter. Baseline clinical and patient characteristics were similar between the four cohorts, excepting age and the number of tested antiarrhythmic drugs. Procedure, fluoroscopy, and left atrial dwell times were significantly lower in the CB-4 cohort compared to previous generations of the CB catheters, while the acute procedural success rate was comparable across all catheter groups (>99%). Total acute procedural complications were low (2.5%), and acute complications were comparable within the CB-2, CB-3, and CB-4 groups (0.8% reported in each cohort). The rate of time-to-isolation (TTI) visualization increased with later generations of the CB catheters., Conclusions: The novel CB-4 achieved significantly faster procedural ablation times in comparison to the previous generations, while still maintaining a low rate of acute complications. Also, the rate of TTI visualization was observed to be higher with the CB-4 catheter. Further long-term evaluation is necessary, including an assessment of AF recurrence and PV reconnection(s)., (© 2019 Wiley Periodicals, Inc.)

Background: Radiofrequency (RF) catheter ablation is one of the most common strategies for the current management of cavotricuspid isthmus (CTI)-dependent atrial flutter (AFL). The interindividual anatomic variability can influence the duration and outcome of ablation procedure., Objective: The purpose of this study was to establish complication rates in patients undergoing RF catheter ablation for CTI-dependent AFL, assess the role of CTI morphology in procedural success, and determine the anatomic variability of CTI ex vivo., Methods: RF catheter ablation for CTI-dependent AFL was performed in 337 consecutive patients. Angiographically determined CTI morphology was classified as either simple or complex due to pouchlike recesses. Macroscopic and histologic examination of the CTI was performed in 104 heart specimens from consecutive autopsies., Results: Complex CTI anatomy was present in 10.9% of AFL patients. RF application time to achieve bidirectional isthmus block was longer in patients showing pouchlike recesses than in those without (10.7 vs 8.3 min; P= .025). Acute procedure failure or major complications occurred in 3 cases, all with complex CTI anatomy. A pouchlike recess of the CTI was present in 9.6% of autopsy hearts. Histomorphometric analysis of the CTI atrial wall demonstrated that the central level was the thinnest in the 3 sectors and the paraseptal level was the thickest., Conclusion: Although RF catheter ablation is a safe and effective procedure for AFL treatment, CTI anatomic complexity can affect ablation parameters and outcome. Standard definition of CTI morphologic variants is recommended. Preprocedural assessment of CTI anatomy might lead to personalized ablation preventing potential difficulties and complications., (Copyright © 2019 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Purpose: Pulmonary vein isolation (PVI) using cryoablation (PVI-C) is a widespread therapy for treating symptomatic, recurrent atrial fibrillation (AF). The impacts of sex on efficacy and safety of PVI-C in a real-world clinical practice is lacking. In a multicenter prospective project, we evaluated whether clinical characteristics, procedure parameters, procedural complications, long-term AF recurrence rates, and/or AF-related symptoms differed according to sex in patients treated with PVI-C., Methods: Data from the study population were collected in the framework of the 1STOP ClinicalService® project, involving 47 Italian cardiology centers. Multivariable statistical analyses were conducted to determine if any baseline clinical characteristics impacted the efficacy of PVI-C., Results: From April 2012, 2125 patients (27% female, 59 ± 11 years, 73% paroxysmal AF, and mean left atrial diameter = 42 ± 8 mm) underwent PVI-C. According to baseline characteristics, women were more likely to be older, with higher clinical risk scores (e.g., CHA 2 DS 2 -VASc), and a higher number of tested antiarrhythmic drugs before the index PVI-C procedure. Male and female cohorts showed comparable procedure time (mean = 107.7 ± 46.8 min) and a similar incidence of periprocedural complications (4.5% overall), even after adjustment for baseline characteristics (P = 0.880). The multivariable analyses demonstrated that the strongest predictor of AF recurrences was sex (0.74; 95% CI 0.58-0.93; P = 0.011). After propensity score adjustment, the hazard ratio from a multivariable model, which included age and AF type (persistent) as covariates, was 0.76 (0.60-0.97) (P = 0.025)., Conclusions: According to the 1STOP project, in a real-world setting, PVI-C was relatively safe regardless of the patient's sex; however, when considering efficacy of the procedure, female patients had a lower long-term efficacy in comparison to males., Clinical Trial Registration: NCT01007474.

Background: Pulmonary vein isolation by cryoablation (PVI-C) is a standard therapy for the treatment of atrial fibrillation (AF); however, PVI-C can become a challenging procedure due to the anatomy of the left atrium and pulmonary veins (PVs). Importantly, the utility of imaging before the procedure is still unknown regarding the long-term clinical outcomes following PVI-C. The aim of the analysis is to evaluate the impact of imaging before PVI-C on procedural data and AF recurrence., Methods: Patients with paroxysmal AF underwent an index PVI-C. Data were collected prospectively in the framework of 1STOP ClinicalService® project. Patients were divided into two groups according to the utilization of pre-procedural imaging of PV anatomy (via CT or MRI) or the non-usage of pre-procedural imaging., Results: Out of 912 patients, 461 (50.5%) were evaluated with CT or MRI before the PVI-C and denoted as the imaging group. Accordingly, 451 (49.5%) patients had no pre-procedural imaging and were categorized as the no imaging group. Patient baseline characteristics were comparable between the two cohorts, but the ablation centers that comprised the imaging group had fewer PVI-C cases per year than the no imaging group (p < 0.001). The procedure, fluoroscopy, and left atrial dwell times were significantly shorter in the no imaging cohort (p < 0.001). The rates of complications were significantly greater in the imaging group compared to the no imaging group (6.9% vs. 2.7%; p = 0.003); this difference was attributed to differences in transient diaphragmatic paralysis. The 12-month freedom from AF was 76.2% in the imaging group and 80.0% in the no imaging group (p = 0.390)., Conclusions: In our analysis, PVI-C was effective regardless of the availability of imaging data on PV anatomy.

Background: Pulmonary vein isolation (PVI) is an accepted strategy for paroxysmal atrial fibrillation (PAF) and persistent AF (PerAF) ablation. Limited data are available on outcomes of cryoballoon (CB) PVI in patients with structural heart disease (SHD). The purpose is to assess the clinical efficacy of a single CB-PVI procedure in patients with PAF or PerAF who also have SHD., Methods: From April 2012, 460 AF patients with concomitant SHD underwent CB-PVI and were followed prospectively in the framework of the 1STOP ClinicalService ® project. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated. Out of 460 subjects, 282 patients (61%) had PAF and 178 (39%) PerAF., Results: SHD patients were predominantly male (80.9%), old (62.8±8.9 years), with preserved functional capacity (New York Heart Association class >1: 39.4%), high cardioembolic risk (CHA 2 DS 2 VASc score ≥2: 69.3%), and conserved left ventricular ejection fraction (56.5±8% LVEF). Both subjects with PAF and PerAF had similar baseline clinical characteristics except for left atrial diameter (43.8±7 vs. 45.7±7mm) and area (22.9±5.2 vs. 25.1±4.4cm 2 ), respectively. Procedure time and fluoroscopic time as well as the rate of procedural complications were not different between subjects with PAF and PerAF. After a mean follow-up of 12 months, antiarrhythmic drug therapy had dropped from 71.7% before ablation to 33.6% post-ablation (p<0.001) and the freedom from symptomatic AF recurrence was 78% for PAF and 77% for PerAF (p=0.793). Furthermore, atrial arrhythmia recurrence rate was not related to SHD., Conclusions: In a large multicenter, real-world cohort, CB-PVI was used to treat patients with PAF and PerAF who also had SHD. The arrhythmia recurrence after a single procedure was not related to either the degree of cardiac structural remodeling or the type of AF, and the rate of AF recurrence was lower than previously reported in patients with SHD in other cohort series using focal radiofrequency catheter ablation., Clinical Trial Registration: clinicaltrials.gov (NCT01007474)., (Copyright © 2019 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Background: Real-time visualization of the electrical activity of the pulmonary veins (PV) is not always possible in the setting of atrial fibrillation (AF) cryoballoon ablation. We investigated the relation between the effective documentation of time to PV isolation and the clinical outcome in a cohort of patients with paroxysmal AF who underwent cryoballoon ablation., Methods: One thousand forty two consecutive patients were enrolled. An inner lumen mapping catheter was typically used to visualize real-time electrical activity inside the PVs., Results: Time to PV isolation was documented in all targeted PVs in 391 patients (Group 1), in 651 patients it was not possible to record PV potentials and assess time to PV isolation in at least one PV (Group 2). In Group 1 a longer procedure duration and ablation time were observed, while a longer fluoroscopy time was observed in Group 2. After a mean follow-up of 14 ± 11 months, 209/1042 (20%) patients had an atrial arrhythmia recurrence (20.2% in Group 1, 19.9% in Group 2, p = 0.25). Complications occurred in 54/1042 (5.2%) patients without any difference among the two study groups., Conclusion: In our retrospective analysis, in about two thirds of patients undergoing cryoballoon ablation it was not possible to acutely assess time to PV isolation in all PVs. However, one-year freedom from clinically symptomatic atrial tachyarrhythmia was similar to that of patients in which time to PV isolation was documented in all targeted veins., Clinical Trial Registration: clinicaltrials.gov (NCT01007474)., (Copyright © 2018. Published by Elsevier B.V.)

Background: The aim of this research was to evaluate whether the procedural data, the incidence of complications, and the long-term freedom from atrial fibrillation (AF) recurrences are influenced by center experience in a paroxysmal AF (PAF) population performing a first-time pulmonary vein isolation (PVI) by cryoballoon ablation (CBA)., Methods: A total of 860 patients underwent PVI by CBA. Center experience groups were predefined according to the quartiles of the distribution regarding the amount of performed procedures: 3.1%, 10.6%, 22.7% and 63.6% of patients were respectively followed in each group from 1st (less experienced) to 4th (more experienced) quartile of experience., Results: In the entire population, median procedure and fluoroscopy time were 105 and 25 min, respectively. The median procedure time significantly decreased from 130 to 90 min (P < 0.001) as the center's experience increased. In 47 (5.5%) patients, a peri-procedural complication occurred. As the experience of centers increased, the acute intraprocedural PVI success rate increased (from 94.3% to 98.9%, P = 0.007), whereas there was a tendency towards a decreased incidence of peri-procedure complications (from 7.4% to 4.6%, P = 0.998). The mean 1-year freedom from AF recurrence probability was 78.3%, and the 18-month mean was 68.9% with no difference among the groups with different levels of experience., Conclusion: CBA is a safe and effective treatment for patients with PAF. Peri-procedural complications and procedural times were low in all the analyzed sub-groups, showing a decreasing trend in function of center expertise. The long-term freedom from AF recurrence was not influenced by the level of experience. (clinicaltrials.gov: NCT01007474)., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Aims: Cryoablation is an indicated therapy for the treatment of recurrent atrial fibrillation through pulmonary vein isolation; however, the optimal time between first diagnosis of atrial fibrillation and cryoablation is still unknown. We aimed to assess the clinical efficacy and safety of early versus later treatment of patients with paroxysmal atrial fibrillation by cryoablation., Methods: Five hundred and ten patients underwent atrial fibrillation cryoablation and were prospectively followed for at least 6 months in 43 Italian cardiology centers. The population was divided into two groups according to the time since the first diagnosis of atrial fibrillation until the index cryoablation procedure. An early-treatment group had an elapsed time of 15 months or less from atrial fibrillation diagnosis until cryoablation, and the late-treatment group had an elapsed time of greater than 15 months. During the evaluation, clinical efficacy was defined as atrial fibrillation recurrence outside a landmark 90-day blanking period, and safety was defined as the reporting of all procedure-related complications., Results: In the total cohort, cryoablation was performed after a median of 36 months from the point of the patient diagnosis with drug refractory symptomatic recurrent atrial fibrillation. The early-treatment group was composed of 130 (25%) patients, whereas the late-treatment group had 380 (75%) patients. Both cohorts had similar baseline clinical characteristics. Of 510 patients, 22 had a complication related to the procedure with no difference between the two groups. Multivariable analysis showed that the risk of atrial fibrillation recurrence was significantly higher in the late-treatment group (hazard ratio: 1.77; 95% confidence interval 1.00-3.13) CONCLUSION: In our multicenter observational examination, cryoablation was well tolerated and effective in the treatment of patients with drug refractory symptomatic paroxysmal atrial fibrillation. Reducing the time between diagnosis and ablation brought about a treatment that had a lower risk of atrial fibrillation recurrence with no change in safety.(Italian ClinicalService Project: NCT01007474).

Background: Pulmonary vein isolation (PVI) is a cornerstone ablation strategy in the management of patients with atrial fibrillation (AF). Consensus guidelines and statements recommend PVI during the index catheter ablation procedure in patients with paroxysmal and persistent AF., Objective: The objective of this analysis was to evaluate patients with persistent and long-standing persistent AF who were treated with the cryoballoon ablation catheter by PVI technique., Methods: Consecutive patients with drug-refractory symptomatic persistent and long-standing persistent AF who underwent cryoballoon catheter ablation by a PVI-only procedure were prospectively included in this single-arm multicenter evaluation. Data on procedural characteristics, safety, and long-term freedom from AF recurrence were analyzed., Results: Four hundred eighty-six subjects (mean age 60.8 ± 9.3 years; 389 (80%) men; 434 (89.3%) with persistent AF; 52 (10.7%) with long-standing persistent AF; left atrial diameter 44.6 ± 6.2 mm) underwent cryoballoon ablation in 35 Italian centers. The mean procedure time (skin-to-skin) was 109.9 ± 52.9 minutes, and the mean fluoroscopy time was 29.6 ± 14.5 minutes. Periprocedural complications were observed in 21 subjects (4.3%), and the acute PVI success rate was 97.6% across all patients. Using a 90-day blanking period, the single procedure Kaplan-Meier estimates of AF event-free survival were 63.9% at 12 months and 51.5% at 18 months., Conclusion: In this multicenter evaluation of cryoballoon ablation, the PVI procedure was safe, effective, and efficient with regard to the treatment of patients with persistent and long-standing persistent AF. The reasonable mid-term success rates agree with current clinical studies that establish PVI as a cornerstone index ablation strategy., (Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Brugada syndrome (BrS) is an arrhythmogenic disease reported to be one among the leading causes of cardiac death in subjects under the age of 40 years. In these patients, episodes of lethal arrhythmias may be induced by several factors or situations, and for this reason, management during anesthesia and surgery must provide some precautions and drugs restrictions. To date, it is difficult to formulate guidelines for anesthetic management of patients with BrS because of the absence of prospective studies, and there is not a definite recommendation for neither general nor regional anesthesia, and there are no large studies in merit. For this reason, in the anesthesia management of patients with BrS, the decision of using each drug must be made after careful consideration and always in controlled conditions, avoiding other factors that are known to have the potential to induce arrhythmias and with a close cooperation between anesthetists and cardiologists, which is essential before and after surgery. In conclusion, given the absence of large studies in literature, we want to focus on some general rules, which resulted from case series and clinical practice, to be followed during the perioperative and anesthetic management of patients with BrS., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Catheter ablation (CA) is recommended for patients with drug refractory symptomatic atrial fibrillation (AF). "One Shot" catheters have been introduced to simplify CA and cryoballoon ablation (CBA) is spreading rapidly. Few real-world data are available on standard clinical practice, mainly from single-center experience. We aimed to evaluate clinical settings, demographics, and acute procedural outcomes in a large cohort of patients treated with CBA., Methods: A total of 903 patients (73% male, mean age 59 ± 11) underwent pulmonary vein CBA. Correlations between the patient's inclusion time and clinical characteristics, procedure duration, acute success rate, and intraprocedural complications were evaluated., Results: Seventy-seven percent of patients were affected by paroxysmal AF and 23% by persistent AF. Overall, acute success rate was 97.9% and periprocedural complications were observed in 35 (3.9%) patients, 13 (1.4%) of which were classified as major complications. With respect to the patient's inclusion time analysis, an increase in treatment of persistent AF was observed, a significant decrease in CBA times (procedure, ablation, and fluoroscopy: 136.0 ± 46.5 minutes, 28.8 ± 19.6 minutes, and 34.3 ± 15.4 minutes, respectively) was observed, with comparable acute success rate and intraprocedural complications over time. The rate of major complications was extremely low (1.4%); no death, atrioesophageal fistula, stroke, or other major periinterventional or late complications occurred., Conclusion: This series represents the largest experience of CBA in the treatment of AF that also describes the adoption curve of this relatively recent technology. CBA showed an excellent safety profile when performed in a large real-world clinical setting, with satisfactory acute success rate and, on average, short procedural times., Clinical Trial Registration: clinicaltrials.gov (NCT01007474)., (© 2016 Wiley Periodicals, Inc.)

Background: Device follow-up is mandatory in the care of patients with a pacemaker. However, in most cases, device checks appear to be mere technical, time-consuming procedures. The aim of this research is to evaluate whether remote follow-up can replace in-clinic device checks by assessing clinical outcomes for pacemaker patients followed only via remote follow-up., Methods and Results: Consecutive pacemaker patients followed with remote monitoring were prospectively included by 6 Italian cardiology centers in an observational investigation. The workflow for remote monitoring included an initial assessment by nursing staff and, when necessary, by a responsible physician for medical decisions. No in-person visits were scheduled after the start of remote monitoring. One-thousand and two-hundred and fifty one patients (30% female, 75±11years old) were followed for a median observation period of 15months. Out of 4965 remote transmissions, 1882 (38%) had at least one clinically relevant event to be investigated further, but, only after 137 transmissions (2.8%), the patients were contacted for an in-clinic visit or hospitalization. Sixty-nine patients died and 124 were hospitalized for various reasons. Atrial fibrillation episodes were the most common clinical events discovered by remote transmissions, occurring in 1339 (26%) transmissions and 471 (38%) patients., Conclusions: Our experience shows that remote monitoring in a pacemaker population can safely replace in-clinic follow-up, avoiding unnecessary in-hospital device follow-up., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Purpose: An optimal active-can lead configuration during implantable cardioverter defibrillator (ICD) placement is important to obtain an adequate defibrillation safety margin. The purpose of this multicenter study was to evaluate the rate of the first shock success at defibrillation testing according to the type of lead implant (single vs. dual coil) and shock polarity (cathodal and anodal) in a large series of consecutive patients who received transvenous ICDs., Methods: This was a multicenter study enrolling 469 consecutive patients. Single- versus dual-coil leads and cathodal versus anodal polarity were evaluated at defibrillation testing. In all cases, the value of the energy for the first shock was set to 20 J less than the maximum energy deliverable from the device., Results: A total of 469 patients underwent defibrillation testing: 158 (34 %) had dual-coil and 311 (66 %) had single-coil lead systems configuration, 254 (54 %) received anodal shock and 215 (46 %) received cathodal shock. In 35 (7.4 %) patients, the shock was unsuccessful. No significant differences in the outcome of defibrillation testing using single- versus dual-coil lead were observed but the multivariate analysis showed an increased risk of shock failure using cathodal shock polarity (OR 2.37, 95 % CI 1.12-5.03)., Conclusions: Both single- and dual-coil transvenous ICD lead systems were associated with high rates of successful ICD implantation, and we found no significant differences in ventricular arrhythmias interruption between the two ICD lead systems configuration. Instead, anodal defibrillation was more likely to be successful than cathodal defibrillation.

Background: Cardiac perforation of the right ventricle (RV) is a rare but potentially life-threatening complication of both pacemaker (PM) and implantable cardioverter defibrillator (ICD) implant. Appropriate management is still uncertain. We assessed the incidence of subacute (24 hours-1 month) or delayed (>1 month) cardiac perforation by RV lead and the results of percutaneous lead extraction., Method: The study population included all patients diagnosed with subacute or delayed RV-lead perforation during the period 2007-2013. The incidence of perforation according to device type and fixation mechanism was calculated. The outcome of the percutaneous approach, consisting of lead extraction by simple traction, was assessed., Results: Cardiac perforation was diagnosed in 14 (eight females, mean age 71 [range 47-83] years) patients out of 3,815 who received an RV-lead implant (0.4%). The overall incidence of RV-lead perforation was similar between ICD (0.3%) and PM (0.4%) implants (P = 1.0) and between active (0.5%) and passive (0.3%) fixation leads (P = 0.3). All perforating leads were originally placed at the RV apex. Five patients were asymptomatic, but all presented altered lead electrical parameters. Surgical removal of the lead was performed in one patient while in the remaining the leads were successfully extracted by direct manual traction in the absence of any complications. In all patients, new active fixation leads were positioned in the RV septum and the follow-up (42 ± 27 months) was uneventful., Conclusions: RV perforation is a rare complication of both PM and ICD implants, regardless of the lead fixation mechanism. In most patients, percutaneous lead extraction is a safe and effective management approach., (©2014 Wiley Periodicals, Inc.)

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, 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 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., (© 2014 Wiley Periodicals, Inc.)

Background: The aim of this study was to investigate the efficacy of catheter ablation in the treatment of persistent atrial fibrillation (AF) and the predictors of arrhythmia recurrence., Methods: Absence of atrial tachyarrhythmia (AT) recurrence during a mid-term follow-up was correlated with several clinical and procedural characteristics in a population of 82 patients aged 20-70 years who had experienced at least one documented relapse of persistent AF during a single trial of antiarrhythmic drug therapy. Electrophysiological success of ablation was declared when all identified PVs were isolated (confirmation of entry and exit block). Patients were followed for a maximum of 24 months after the blanking period with outpatient visits, ECG recordings, 24-hour Holter monitoring, and weekly transtelephonic monitoring for 30s., Results: Electrophysiological success was documented in 38/82 (46.3%) patients. During a mean follow-up of 24.7 ± 4.2 months, 69/82 (84.1%) patients presented at least one episode of AT after the 2 month blanking period. According to univariate and multivariate logistic regression analyses, only an electrophysiologically successful ablation significantly correlated with the absence of documented AT relapse (OR 5.32, 95% CL 1.02-27.72; p=.0472)., Conclusions: Mid-term outcome of a single procedure of catheter ablation without the adjunction of antiarrhythmic drug therapy is poor in patients with persistent AF. Documented PV isolation is useful to increase the success rate of circumferential PV ablation even in persistent AF patients., (Copyright © 2013. Published by Elsevier Ireland Ltd.)

We report the case of a 27-year-old man who received a single chamber implantable cardioverter defibrillator with a St Jude Medical Riata double coil passive lead for secondary prevention of sudden cardiac death due to idiopathic ventricular fibrillation. Subsequently, he was readmitted for lead extraction because of device infection. Fluoroscopy showed externalization of the conductors proximally to the distal coil in the absence of any signs of electrical lead failure. Successful lead extraction was achieved using a laser sheath without any complications after unsuccessful mechanical sheath because of the tenacious fibrotic adherences proximal to the distal coil and extrusion of the conductors that hindered the advancement of the sheath over the lead. Our report highlights that Riata ICD leads are prone to externalization of the conductor wires, which may render an indicated lead extraction procedure of these leads more challenging. A laser powered sheath may facilitate the procedure, especially in the presence of extensive adhesions and fibrosis.

Objective: The performances of implantable cardioverter defibrillators and leads are important issues for healthcare providers and patients. In 2007 Sprint Fidelis leads were found to be associated with an increased failure rate and so the purpose of the study was to evaluate long-term mortality and clinical outcomes in patients implanted with Sprint Fidelis leads compared with Sprint Quattro leads., Design, Setting, Patients: 508 patients with Sprint Fidelis leads and 468 with Sprint Quattro leads were prospectively followed in 12 Italian cardiology centres., Main Outcome Measures: Information on hospitalisations and other clinical events were collected during scheduled and unscheduled hospital visits. Deaths were identified from medical records or via phone contacts with patients' family members or through the National Office of Vital Statistics., Results: Over a mean follow-up of 27±18 months 141 deaths occurred in the overall population. No death was observed in patients with diagnosed failing lead. Kaplan-Meier patient survival differed between the two lead groups (80±2% in Fidelis leads vs 70±4% in the Sprint Quattro leads at 4 years, p=0.002). Multivariate analyses showed that mortality was neither associated with lead type nor with diagnosed failed lead. The annual rate of lead failure was 1.8% patient-year for Fidelis leads and 0.2% for the Sprint Quattro leads., Conclusions: In our multicentre research, the clinical outcomes of patients with Fidelis leads differed from those of patients with Sprint Quattro leads. Nevertheless, neither mortality nor the combined endpoint of mortality and heart failure hospitalisations was associated with the lead type. http://clinicaltrials.gov/ct2/show/NCT01007474.

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 < 0.01), less advanced NYHA functional class (III-IV: 73% vs 100%, P < 0.01), higher LVEF (26% vs 21%, P < 0.01), higher SBP (122 vs 112 mmHg, P < 0.01), and less diabetes (27% vs 41%, P < 0.01). This status was reflected in lower mortality (11.5% vs 26%) and a lower incidence of appropriate ICD shocks (12.1% vs 19.3%). AF history was an independent predictor of the combination of all-cause mortality and cardiac-cause hospitalization (HR: 3.31; P < 0.001). Recurrent or new atrial arrhythmias were independently associated with the development of ventricular arrhythmias (HR: 3.4; P < 0.001)., Conclusions: This population appears clinically less compromised and had a lower incidence of adverse clinical outcomes than those of reference trials. However, we recorded a substantial burden of atrial arrhythmias, which was independently associated with a higher incidence of ventricular arrhythmias., (© 2012 Wiley Periodicals, Inc.)

Background: The role of pacing sites and atrial electrophysiology on the progression of atrial fibrillation (AF) to the permanent form in patients with sinus node dysfunction (SND) has never been investigated. The aim of the study was to investigate the relationship between atrial electrophysiology and the efficacy of atrial pacing at the low interatrial septum (IAS) or at the right atrial appendage (RAA) to prevent persistent/permanent AF in patients with SND., Methods and Results: The Electrophysiology-Guided Pacing Site Selection (EPASS) Study was a prospective, controlled, randomized study. Atrial refractoriness, basal and incremental conduction times from the RAA to the coronary sinus ostium were measured before implantation, and the difference (ΔCTos) was calculated. Patients with ΔCTos ≥ 50 ms (study group) and those with ΔCTos <50 ms (control group) were randomly assigned to RAA or IAS with algorithms for continuous atrial stimulation "on." The primary end point was time to development of permanent or persistent AF within a 2-year follow-up in the study group, IAS versus RAA. Data were analyzed by intention to treat. One hundred two patients (77 ± 7 years, 44 mol/L) were enrolled, 69 (68%) in the study group and 33 (32%) in the control group. Of these, 97 ended the study, respectively, randomly assigned: 29 IAS versus 36 RAA and 18 IAS versus 14 RAA. After a mean follow-up of 15 ± 7 (median, 17) months, 11 (16.6%) patients in the study group met the primary end point: 2 IAS versus 9 RAA (log rank=3.93, P=0.047)., Conclusions: In patients with SND and intra-atrial conduction delay, low IAS pacing was superior to RAA pacing in preventing progression to persistent or permanent AF., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00239226.

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.

Objectives: Evaluation of left ventricular (LV) dyssynchrony in patients undergoing short-term right ventricular apical (RVA) pacing and correlation with baseline echocardiographic and clinical characteristics., Background: RVA pacing causes abnormal ventricular depolarization that may lead to mechanical LV dyssynchrony. The relationships between pacing-induced LV dyssynchrony and baseline echocardiographic and clinical variables have not been fully clarified., Methods: Tissue Doppler echocardiography was performed in 153 patients before and after RVA pacing. LV dyssynchrony was measured by the time between the shortest and longest electromechanical delays in the five basal LV segments (intra-LV). The prevalence and degree of LV dyssynchrony after RVA pacing was evaluated in three groups: baseline LV ejection fraction (LVEF) <35%, 35-55%, and >or=55%. The intrapatient effect of RVA pacing was determined as the percent increase in intra-LV value (Deltaintra-LV%). The pacing-induced intra-LV was correlated with baseline variables., Results: The prevalence and degree of LV dyssynchrony after RVA pacing was significantly higher in patients with lower LVEF (P < 0.001). DeltaIntra-LV% was inversely correlated with baseline intra-LV and LVEF (B =-2.6, B =-4.2, P < 0.001). Baseline intra-LV and LV end-systolic volume correlated positively with intra-LV after RVA pacing (B = 0.49, B = 0.6, P < 0.001), whereas LVEF showed an inverse correlation., Conclusions: The degree of LV dyssynchrony induced by RVA is variable. Patients with higher baseline LV dyssynchrony, more dilated LV, and more depressed LVEF showed a higher degree of LV dyssynchrony during pacing. These findings may assume importance in predicting the risk of heart failure in pacemaker patients.

Background: Electrical fusion between left ventricular pacing and spontaneous right ventricular activation is considered the key to resynchronisation in sinus rhythm patients treated with single-site left ventricular pacing., Aim: Use of QRS morphology to optimize device programming in patients with heart failure (HF), sinus rhythm (SR), left bundle branch block (LBBB), treated with single-site left ventricular pacing., Methods and Results: We defined the "fusion band" (FB) as the range of AV intervals within which surface ECG showed an intermediate morphology between the native LBBB and the fully paced right bundle branch block patterns.Twenty-four patients were enrolled. Echo-derived parameters were collected in the FB and compared with the basal LBBB condition. Velocity time integral and ejection time did not improve significantly. Diastolic filling time, ejection fraction and myocardial performance index showed a statistically significant improvement in the FB. Interventricular delay and mitral regurgitation progressively and significantly decreased as AV delay shortened in the FB. The tissue Doppler asynchrony index (Ts-SD-12-ejection) showed a non significant decreasing trend in the FB. The indications provided by the tested parameters were mostly concordant in that part of the FB corresponding to the shortest AV intervals., Conclusion: Using ECG criteria based on the FB may constitute an attractive option for a safe, simple and rapid optimization of resynchronization therapy in patients with HF, SR and LBBB.

Objectives: To evaluate the prevalence of severe right atrial conduction delay in patients with sinus node dysfunction (SND) and atrial fibrillation (AF) and the effects of pacing in the right atrial appendage (RAA) and in the inter-atrial septum (IAS)., Methods: Forty-two patients (15 male, 72 +/- 7 years) underwent electrophysiologic study to measure the difference between the conduction time from RAA to coronary sinus ostium during stimulation at 600 ms and after extrastimulus (DeltaCTos). Patients were classified as group A if DeltaCTos > 60 ms and group B if < 60 ms. Each Group was randomized to RAA/IAS pacing and algorithms ON/OFF., Results: Fifteen patients (36%, group A) had DeltaCTos = 76 +/- 11 ms and 27 patients (64%, group B) had DeltaCTos = 36 +/- 20 ms. Twenty-two patients were paced at the RAA and 20 at the IAS. During the study, no AF recurrences were reported in 11 of 42 (26%) patients, independently of RAA or IAS pacing. Patients from group A and RAA pacing had 0.79 +/- 0.81 episodes of AF/day during DDD, which increased to 1.52 +/- 1.41 episodes of AF/day during DDDR + Alg (P = 0.046). Those with IAS pacing had 0.5 +/- 0.24 episodes of AF/day during DDD, which decreased to 0.06 +/- 0.08 episodes of AF/day during DDDR + Alg (P = 0.06). In group B, no differences were reported between pacing sites and pacing modes., Conclusions: Severe right atrial conduction delay is present in one-third of patients with SND and AF: continuous pacing at the IAS is superior to RAA for AF recurrences. In patients without severe conduction delay, no differences between pacing site or mode were observed.

Aims: This multicentre prospective study evaluated the ability of electroanatomic mapping (EAM) using a specific parameter setting to identify clearly the mid-diastolically activated isthmus (MDAI) and guide ablation of macro-re-entrant atrial tachycardia (MAT)., Methods and Results: Consecutive patients with MAT, different from typical isthmus-dependent atrial flutter, were enrolled. EAM was performed using a specific setting of the window of interest, calculated to identify the MDAI and guide ablation of this area. Sixty-five patients exhibiting 81 MATs (mean cycle length 308 +/- 68 ms) were considered. Thirty-two (49.2%) had previous heart surgery. In 79 of 81 morphologies (97.5%), EAM reconstructed 95.9 +/- 4.3% of the tachycardia circuit and identified the MDAI; 23 of the 79 morphologies (29.1%) were double-loop re-entry. Mapping of two morphologies was incomplete due to MAT termination after catheter bumping. In 73 of 79 mapped morphologies (92.4%), abolition of the MAT was obtained by 13.2 +/- 12.4 applications. During the 14 +/- 4 month follow-up, MAT recurred in 4 of the successfully treated patients (6.8%)., Conclusion: EAM using a specific parameter setting proved highly effective at identifying the MDAI in MAT, even in patients with previous surgery and multiple re-entrant loops. Ablation of the MDAI yielded acute arrhythmia suppression with low rate of recurrence during follow-up.

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.

Objective: A detailed definition of pulmonary vein (PV) anatomy is of great importance in patients undergoing radiofrequency catheter ablation for atrial fibrillation. In fact, it is known that variations in the number and anatomy of the PV ostia are more frequent than thought. The aim of this study was to assess the usefulness of transoesophageal echocardiography (TOE) in defining the exact PV anatomy by comparing it with magnetic resonance angiography (MRA), which is proven to be very accurate., Methods: Forty-five consecutive patients (39 male, 6 female, mean age 50 + or - 6 years) affected by drug-refractory atrial fibrillation underwent radiofrequency catheter ablation. They were all studied with MRA and then with TOE in order to exclude intra-atrial thrombi and to assess PV anatomy., Results: TOE visualised the superior PVs in 100% of cases and the right and left inferior PVs in 98% and 94% of cases, respectively. Only 19 patients (42%) showed typical PV anatomy, with two left and two right distinct PV ostia. In 14 patients (31%), one or two intermediate right PVs and in 12 patients (27%) a common left trunk were detected. The concordance with MRA was high (95%)., Conclusions: TOE is accurate in assessing PV anatomy and in showing anatomic variations in the PV ostia compared with MRA. Anomalous pulmonary venous drainage is more frequent than expected. TOE can provide functional Doppler information, thus being particularly useful in the follow-up after radiofrequency catheter ablation.

Introduction: The aim of this study was to compare the outcome of anatomical pulmonary vein (PV) radiofrequency (RF) ablation with that of an integrated approach (anatomical with electrophysiological confirmation of PV disconnection)., Methods: Sixty consecutive patients affected by drug-refractory paroxysmal (39), persistent (13), and permanent (8) atrial fibrillation (AF) were assigned to an anatomical (group A: 30 patients; 25 male, 5 female, mean age: 55 +/- 7 years) or integrated approach (group B: 30 patients; 26 male, 4 female, mean age: 52 +/- 9 years). In all cases, RF ablation was performed by means of the Carto system in order to anatomically create circumferential lines around PVs. In group B, the persistence of PV potentials was then assessed with a multipolar circular catheter. If PV potentials persisted, RF pulses targeting the electrophysiological breakthroughs were delivered to disconnect PVs., Results: Total procedure duration, fluoroscopy time, and RF delivery time were similar in both groups: 227 +/- 43, 50 +/- 23, and 43 +/- 16 minutes (group A); 232 +/- 32, 55 +/- 15, and 42 +/- 10 minutes (group B), respectively (ns). One asymptomatic PV stenosis and one pericardial effusion occurred in group A and B, respectively. After 15.4 +/- 7.4 months, 17 (57%) group A patients and 25 (83%) group B patients were in stable sinus rhythm (P = 0.02) (RR 1.78; 95% CI: 1.7-2.9)., Conclusions: PV ablation by means of an integrated anatomical and electrophysiological approach seems more effective than a purely anatomical RF ablation approach. Electrophysiological confirmation of PV disconnection could be a useful marker of successful RF treatment of AF.

Background: Ostial radiofrequency catheter ablation (RFCA) of pulmonary veins (PVs) is a promising invasive approach for the non-pharmacologic treatment of atrial fibrillation, but PV stenosis has been reported as a possible complication of this intervention. The aim of this study was to assess PV anatomy and stenosis (i.e. number and progression) by means of transesophageal echocardiography (TEE) during the follow-up of patients undergoing RFCA., Methods: Twenty-three consecutive patients with refractory and highly symptomatic atrial fibrillation underwent ostial radiofrequency isolation of arrhythmogenic triggers/foci, localized into the PVs, by an electroanatomic approach (CARTO system) or circular mapping with a multipolar catheter (LASSO) placed under radioscopic guidance. All patients were investigated using TEE and magnetic resonance angiography before radiofrequency application to evaluate PV anatomy. TEE examination was repeated after 2 months of follow-up and, in the presence of a stenosis, 1 year later., Results: TEE allowed to identify 100% of the left and right superior PVs, 96% of right inferior PVs, and 74% of the left inferior PVs. Anatomic variants were detected at TEE in 33% of patients against 37% at magnetic resonance angiography (95% of concordance). After ostial RFCA, TEE disclosed a significant reduction in the mean diameters of the left superior PV (14.1 +/- 3.2 vs 12.0 +/- 2.7 mm, p < 0.01), left inferior PV (11.2 +/- 2.3 vs 9.8 +/- 2.2 mm, p = 0.05) and right superior PV (14.2 +/- 2.6 vs 12.9 +/- 2.7 mm, p < 0.05), and an increase in the mean peak velocities of the left superior PV (69.8 +/- 14.8 vs 91 +/- 42.4 cm/s, p < 0.05) and left inferior PV (59.2 +/- 18.1 vs 79.3 +/- 40.5 cm/s, p < 0.05). From a total of 88 PVs treated, 7 (7.9%) showed a higher significant stenosis in patients treated using the LASSO than the CARTO system (31.3 vs 2.8% respectively, p < 0.01). After 1-year follow-up there was no progression of PV stenosis., Conclusions: TEE was successful to evaluate PV anatomy and stenosis of patients undergoing ostial RFCA for atrial fibrillation. This complication is not rare and seems to be strictly related to the method of ablation, in particular when circular mapping and disconnection of triggers/foci was carried out by only a circular multipolar catheter without an electroanatomic approach.

Introduction: Slow pathway (SP) ablation of AV nodal reentrant tachycardia (AVNRT) can be complicated by second- to third-degree AV block. We assessed the usefulness of pace mapping of Koch's triangle in preventing this complication., Methods and Results: Nine hundred nine consecutive patients undergoing radiofrequency ablation of AVNRT were analyzed. Group 1 (n=487) underwent conventional slow pathway ablation. Group 2 (n=422) underwent ablation guided by pace mapping of Koch's triangle, which located the anterogradely conducting fast pathway (AFP) based on the shortest St-H interval obtained by stimulating the anteroseptal, midseptal, and posteroseptal aspects of Koch's triangle. In group 2, AFP was anteroseptal in 384 (91%), midseptal in 33 (7.8%), and posteroseptal or absent in 5 (1.2%). In 32 of 33 patients with midseptal AFP, slow pathway ablation was performed strictly in the posteroseptal area. In 4 of 5 patients with posteroseptal or no AFP, retrograde fast pathway was ablated. Two patients refused ablation. Persistent second- to third-degree AV block was induced in 7 (1.4%) of 487 group 1 patients versus 0 (0%) of 422 group 2 patients (P=0.038). Ablation was successful in all patients in whom ablation was performed., Conclusion: Pace mapping of Koch's triangle identifies patients in whom the AFP is absent or is abnormally close to the slow pathway. In these cases, guiding ablation helps to avoid AV block.

The aim of this prospective study was to compare the long-term follow-up after transisthmic ablation of patients with preablation lone atrial flutter, coexistent AF, and drug induced atrial flutter to determine if postablation AF followed a different clinical course and displayed different predictors in these groups. The study evaluated 357 patients who underwent transisthmic ablation for typical atrial flutter. These were divided into four groups according to their preablation history. Group A included patients with typical atrial flutter and without preablation AF (n=120, 33.6%). Group B included patients with preablation AF and spontaneous atrial flutter (n=132, 37.0%). Group C patients had preablation AF and atrial flutter induced by treatment with IC drugs (propafenone or flecainide) (n=63, 17.6%) Group D included patients with preablation AF and atrial flutter induced by treatment with amiodarone (n=42, 11.8%). During a mean follow-up of 15.2 double dagger 10.6 months (range 6-55 months) AF occurred more frequently in groups B (56.1%) and C (57.1%) patients than in groups A (20.8%, P <0.0001) and D (31.0%, P <0.0001) patients. The results of multivariate analysis revealed that different clinical and echocardiographical variables were correlated with postablation AF occurrence in the different groups. Patients with atrial flutter induced by amiodarone have a significantly lower risk of postablation AF than patients with spontaneous atrial flutter and AF, and those with atrial flutter induced by IC drugs. Different clinical and echocardiographical variables predict postablation AF occurrence in different subgroups of patients.

Objectives: To evaluate the time to onset and the predictors of atrial fibrillation (AF) during long term follow up of patients with typical atrial flutter (AFL) treated with transisthmic ablation., Design: Prospective multicentre study., Methods and Results: 383 patients (75.4% men, mean (SD) age 61.7 (11.1) years) who underwent transisthmic ablation for typical AFL were investigated. In 239 patients (62.4%) AF was present before ablation. Ablation proved successful in 367 patients (95.8%). During a mean (SD) follow up of 20.5 (12.4) months, 41.5% of patients reported AF. The cumulative probability of postablation AF increased continuously as time passed: it was 22% at six months, 36% at one year, 50% at two years, 58% at three years, and 63% at four years., Conclusions: AF occurred in a large proportion of patients after transisthmic catheter ablation of typical AFL. The occurrence of AF was progressive during follow up. Preablation AF, age < 65 years, and left atrial size > 50 mm are associated with postablation AF occurrence.

Background: Arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D) is a condition associated with the risk of sudden death (SD)., Methods and Results: We conducted a multicenter study of the impact of the implantable cardioverter-defibrillator (ICD) for prevention of SD in 132 patients (93 males and 39 females, age 40+/-15 years) with ARVC/D. Implant indications were a history of cardiac arrest in 13 patients (10%), sustained ventricular tachycardia in 82 (62%), syncope in 21 (16%), and other in 16 (12%). During a mean follow-up of 39+/-25 months, 64 patients (48%) had appropriate ICD interventions, 21 (16%) had inappropriate interventions, and 19 (14%) had ICD-related complications. Fifty-three (83%) of the 64 patients with appropriate interventions received antiarrhythmic drug therapy at the time of first ICD discharge. Programmed ventricular stimulation was of limited value in identifying patients at risk of tachyarrhythmias during the follow-up (positive predictive value 49%, negative predictive value 54%). Four patients (3%) died, and 32 (24%) experienced ventricular fibrillation/flutter that in all likelihood would have been fatal in the absence of the device. At 36 months, the actual patient survival rate was 96% compared with the ventricular fibrillation/flutter-free survival rate of 72% (P<0.001). Patients who received implants because of ventricular tachycardia without hemodynamic compromise had a significantly lower incidence of ventricular fibrillation/flutter (log rank=0.01). History of cardiac arrest or ventricular tachycardia with hemodynamic compromise, younger age, and left ventricular involvement were independent predictors of ventricular fibrillation/flutter., Conclusions: In patients with ARVC/D, ICD therapy provided life-saving protection by effectively terminating life-threatening ventricular arrhythmias. Patients who were prone to ventricular fibrillation/flutter could be identified on the basis of clinical presentation, irrespective of programmed ventricular stimulation outcome.

Background: Radiofrequency ablation of either the fast or the slow pathway in atrioventricular nodal reentrant tachycardia (AVNRT) can be complicated by transient or permanent atrioventricular (AV) block. Little is known about the possibility of AV block occurring during the first weeks after the procedure and nothing about the risk of AV block during the long-term follow-up., Methods: To clarify these latter points, from February 1990 to December 2000 we enrolled 510 consecutive patients (56 males, 454 females, mean age 55 +/- 16 years) with AVNRT. The target of ablation was the fast pathway in 29 patients (group A) and the slow pathway in 474 (group B), while in 7 (group C) the slow pathway was targeted after unsuccessful fast pathway ablation. Follow-up was available for 488/510 (95.6%). The length of follow-up was 8.2 +/- 2.4 years in group A, 3.4 +/- 2.4 years in group B (83 group B patients had a follow-up > 6 years: 7.3 +/- 0.8 years), and 7.3 +/- 2.4 years in group C., Results: The success rates were 93, 99 and 100% in the three groups respectively. Intraprocedural II-III degree AV block occurred in 6/29 patients (20%) of group A, in 11/474 patients (2.3%) of group B and in 3/7 patients (42%) of group C. In all patients of groups A and C, the II-III degree AV block was transient. In contrast, in 6/474 patients of group B (1.2%, 2 II degree and 4 III degree AV block) the block still persisted at the end of the procedure. Within 7 days of the procedure, a late persistent II-III degree AV block developed in 1/29 patients (3.4%, 1 III degree) of group A, in 1/474 patients (0.2%, 1 II degree) of group B and in 0/7 patients of group C. In 1 out of 6 patients of group B who developed an intraprocedural persistent AV block, 1:1 conduction resumed within the first week. A definitive pacemaker was implanted for permanent III degree AV block in 1/29 patients of group A (3.4%), in 4/474 patients (0.8%) of group B and in 0/7 patients of group C. In the remaining 2/474 group B patients with permanent II degree AV block, a pacemaker was not implanted. During follow-up, no patient presented with a II-III degree AV block related to the ablation. In group B, 2 patients received a pacemaker implant for reasons unrelated to the ablation (1 sick sinus syndrome, 1 progressive intraventricular conduction disease)., Conclusions: The risk of permanent AV block in patients who undergo fast or slow pathway ablation is low and limited to the procedure or to the days immediately after the procedure, and there is no risk of II-III degree AV block during long-term follow-up.

Aims: Permanent atrial fibrillation develops in many patients after ablation and pacing therapy. We compared a strategy that initially allowed patients to remain in atrial fibrillation with a strategy that initially attempted to restore and maintain sinus rhythm., Methods and Results: In this multicentre randomized controlled trial, 68 patients affected by severely symptomatic paroxysmal atrial fibrillation were assigned, after successful atrioventricular junction ablation and pacing treatment, to antiarrhythmic drug therapy with amiodarone, propafenone, flecainide or sotalol and were compared with 69 patients assigned, after successful AV junction ablation and pacing treatment, to no antiarrhythmic drug therapy. The patients were followed-up for 12 to 24 months (mean 16+/-4). The drug arm patients had a 57% reduction in the risk of developing permanent atrial fibrillation (21% vs 37%, P=0.02). Evaluation after 12 months revealed similar quality of life scores and echocardiographic parameters in the two groups, but the drug arm patients had more episodes of heart failure and hospitalizations (P=0.05). The outcome was similar between the 40 patients who developed permanent atrial fibrillation and the 97 who did not., Conclusion: Conventional antiarrhythmic therapy reduces the risk of development of permanent atrial fibrillation after ablation and pacing therapy. The present data do not support the concept that the development of permanent atrial fibrillation is related to an adverse outcome when a perfect control of heart rate is obtained by ablation and pacing., (Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.)