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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.

Background Pulmonary vein isolation by cryoablation (PVI-C) is a standard therapy for the treatment of patients with symptomatic atrial fibrillation (AF). AF symptoms are highly subjective; however, they are important outcomes for the patient. The aim is to describe the use and impact of a web-based App to collect AF-related symptoms in a population of patients who underwent PVI-C in seven Italian centers. Methods A patient App to collect AF-related symptoms and general health status was proposed to all patients who underwent an index PVI-C. Patients were divided into two groups according to the utilization of the App or the non-usage. Results Out of 865 patients, 353 (41%) subjects composed the App group, and 512 (59%) composed the No-App group. Baseline characteristics were comparable between the two cohorts except for age, sex, type of AF, and body mass index. During a mean follow-up of 7.9±13.8 months, AF recurrence was found in 57/865 (7%) subjects with an annual rate of 7.36% (95% CI:5.67-9.55%) in the No-App versus 10.99% (95% CI:9.67-12.48%) in the App group, p=0.007. In total, 14,458 diaries were sent by the 353 subjects in the App group and 77.1% reported a good health status and no symptoms. In only 518 diaries (3.6%), the patients reported a bad health status, and bad health status was an independent parameter of AF recurrence during follow-up. Conclusions The use of a web App to record AF-related symptoms was feasible and effective. Additionally, a bad health status reporting in the App was associated with AF recurrence during follow-up.

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.

Background Coronary ostial lesions are a rare entity and isolated coronary ostial stenosis is even less frequent. Diffuse coronary artery atherosclerosis is the main cause for the non-isolated stenosis, based on old post-mortem series and histological analysis of tissue removed during atherectomies. Case presentation A 49-year-old woman suffering from mild non-familial hypercholesterolemia reported to her family physician repeated episodes of chest pain related to exercise. During a cardiological outpatient evaluation, 12 lead electrocardiogram (ECG) and echocardiography turned out normal. During a stress test she had recurrent chest pain coupled with ECG ischemic changes (diffuse ST segment elevation). She was immediately referred to the emergency department where the ECG was back to normal and the troponin dosage within normal range. Coronary angiography was performed: non-selective cannulation revealed some irregularities of the aortic wall profile at the level of the right coronary ostium, with inability to visualize the right coronary artery. The selective cannulation of the left main coronary artery (LMCA), left anterior descending (LAD) and left circumflex branches showed a critical ostial stenosis at the origin of the LMCA without any other relevant lumen restriction, in a left-dominant pattern of coronary circulation. A suspicion of LAD dissection was raised when a laminar flux was observed at its origin. At the end of the procedure, the patient suddenly collapsed. The recorded rhythm was initially bradycardia, evolving to episodes of ventricular tachycardia for which multiple shocks were applied. Despite the resuscitation efforts, the patient never recovered. Autopsy was performed at the local hospital. At gross analysis, a non-uniform pale-tan thickening at the level of the sino-tubular junction was evident with involvement of both the right and left coronary ostia. Histological examination allowed to ascribe the thickening to recurrent thrombosis, without any underlying inflammatory process at the level of the aortic wall and with only minimal atherosclerotic plaques. No coronary artery dissection nor significant stenosis was present in all the coronary tree. Regarding the ventricular myocardium, one focus of replacement-type fibrosis was identified at subendocardial level in the infero-septal wall coupled with a small spot of loose connective tissue rich in hemosiderin-laden macrophages in the same region, consistent with an area of subacute ischemic damage. Conclusion Several series reported a higher frequency of isolated coronary ostial stenosis in women versus men. In fact, female sex along with hypertriglyceridemia have been recognized as independent risk factors for ostial lesions. The case herein reported highlights the diagnostic relevance of the autopsy investigation together with clinicopathological correlation, particularly in cases where the definite diagnosis can't be achieved in vivo.

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

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.

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.

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.

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).

Background Remote control/monitoring (RC/M) of cardiac implantable electronic devices (CIEDs) is still underutilized, with a significant heterogeneity of use across and within countries. Not all models are equivalent in terms of effectiveness and efficiency. Purpose This cost comparative study aimed to analyse different models of following patients with CIEDs in three districts (four implanting facilities) merged into the same administrative area, to assess the impact of RC/M on expenditure, and to propose a common practice with the objectives of standardisation of approach, optimisation of efficiency, and future capillary implementation of RC/M. Methods The workload related to CIED-patient follow-ups was assessed in four public hospitals reflecting three different models with different proportions of patients followed by RC/M and different modus operandi. All CIED-patients in charge were scrutinized at 31/08/2019. The workload analysis was based on one-year data, collected retrospectively. Costs were calculated in terms of nursing and physician hours and based on public tariffs. Five variables, identified as drivers of costs, were tested by the simulation model. The main outcome was a total expenditure and cost per patient followed by RC/M compared to the standard care (SC) (in-office only). Results A total of 6830 patients with CIEDs were followed, 34.8% by RC/M (five platforms, 19.7% high voltage devices). An additional 25.8% had monitorable devices. The proportion of RC/M-patients across centres was 63.3%, 60.6%, 51% and 2.65%. RC/M resulted more costly than SC in all hospitals. Modelling demonstrated the overall cost in the year 2018 to be €228,075. No single factor optimisation tested separately (number of transmissions, nursing time for each transmission revision, doctor time for transmission processing, nursing time for phone calls, time for single enrolment) was able to reduce the cost per patient below the cost of SC. Providing monitoring to all compatible patients increased the costs of total care to €248,785. After the optimisation of other factors, the additional benefit of extending RC/M to compatible devices was achieved, with the final result of a total expenditure of €128,181 and of €15.97 per RC/M-patient per year vs. €27.93 per SC-patient, below the reimbursement tariff of monitoring recently approved in Veneto (€25.55 per patient/year). Conclusion Real-world data from an unselected population confirmed the huge inconsistency in managing patients with CIEDs. RC/M was associated with a significant specific workload. RC/M may be cost-saving compared to the standard in-office follow-up; however, organisation needs to be optimised. Improvement can be achieved by implementing new standards for RC/M procedures using Lean Management tools. A common platform might be of help. Centralisation could represent a further step to ensure high quality service and to save money at the same time. Funding Acknowledgement Type of funding source: None

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] 30 kg/m2 ). Results Out of 2048 patients, 693 (34%) patients had a BMI 30). Overweight or obese patients were more often in persistent AF, had more frequently hypertension and diabetes, had higher CHA2 DS2 -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.

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.

Background Ablation technique targeting high-amplitude signals (maximum voltage guided - MVG -) on the cavotricuspid isthmus (CTI) has emerged as viable alternative option compared to standard anatomical approach (ST) for the creation of bidirectional conduction block (BDB) across the isthmus but limited data are available to date. Purpose To evaluate the effectiveness of acute and long-term outcome of CTI ablation through MVG technique for AFL compared to standard linear (SL) lesion ablation. Methods Atrial Flutter Ablation in a Real World Population (LEONARDO) is a prospective, multicenter cohort study aimed at providing an estimate of acute to long-term outcome in a large population of patients (pts) indicated for AFL ablation. Recurrence of AFL were retrieved at 12-month follow-up. Complete BDB was defined by agreement with the presence of widely split double potentials (DP) along the ablation line and assessment of the atrial activation sequence (AAS). For MVG technique the ablation catheter was positioned at the site of maximum local electrogram voltage. Results Two-hundred fifteen consecutive pts were included (mean age 68 years, 73% male). A median of 4 [2–6] ablation lesions were required. Median follow up was 359 [192–443] days. Complete BDB was achieved in 175 (81.4%) pts (9 pts had DP only criterion, 30 pts had AAS only criterion whereas in 1 pt we failed to reach a BDB). In the 106 pts with complete data at 1-year follow-up, 10 (9.4%) had a recurrence of AFL. 171 pts (79%) underwent a SL ablation whereas 44 pts (21%) were treated by MVG approach. The median number of lesions/pt was significantly lower in the group of pts targeted with MVG compared to the SL approach (3 [2–4] vs 4 [2–8], p Conclusion Ablation of a targeted site through MGV approach seems to be safe and effective as standard anatomical ablation technique. This strategy may avoid unnecessary ablation of the entire anatomic isthmus. Acknowledgement/Funding None

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).

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.

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. 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. 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., CHA2DS2-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). 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. NCT01007474

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)

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 (CHA2DS2VASc 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 ± 7 mm) and area (22.9 ± 5.2 vs. 25.1 ± 4.4 cm2), 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 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 ).

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. 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. 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

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.

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.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.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).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.

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.

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.

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

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.

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.

Edizione di alcuni capitli del volgarizzamento trecentesco toscano della Leggenda aurea di Iacopo da Varazze

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

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)

Pacemaker (PM) and implantable cardiac defibrillator (ICD) malfunction is a serious and frequent finding in clinical setting. Depending on baseline rhythm and the type of malfunction, symptoms with different severity can occur, from no symptoms to syncope and sudden death due to asystole or ventricular fibrillation. Unfortunately, symptoms, such as asthenia, dizziness, dyspnea, and palpitations, are often vague, and this can lead to a dangerous delay in cardiac implantable electronic device (CIED) malfunction detection. An ECG recording and careful device and lead evaluation by means of telemetry are necessary for the diagnosis. A great help to early detection of CIED malfunctions is coming from remote control, allowing therapeutic interventions within 24 h since the malfunction occurs in most cases.