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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.

The Respiratory Disturbance Index (RDI) computed by an implantable cardioverter defibrillator (ICD) algorithm accurately identifies severe sleep apnea (SA). In the present analysis, we tested the hypothesis that RDI could also predict atrial fibrillation (AF) burden.Patients with ejection fraction ≤35% implanted with an ICD were enrolled and followed up for 24 months. One month after implantation, patients underwent a polysomnographic study. The weekly mean RDI value was considered, as calculated during the entire follow-up period and over a 1-week period preceding the sleep study. The endpoints were as follows: daily AF burden of ≥5 min, ≥6 h, ≥23 h.Here, 164 patients had usable RDI values during the entire follow-up period. Severe SA (RDI ≥ 30 episodes/h) was diagnosed in 92 (56%) patients at the time of the sleep study. During follow-up, AF burden ≥ 5 min/day was documented in 70 (43%), ≥6 h/day in 48 (29%), and ≥23 h/day in 33 (20%) patients. Device-detected RDI ≥ 30 episodes/h at the time of the polygraphy, as well as the polygraphy-measured apnea hypopnea index ≥ 30 episodes/h, were not associated with the occurrence of the endpoints, using a Cox regression model. However, using a time-dependent model, continuously measured weekly mean RDI ≥ 30 episodes/h was independently associated with AF burden ≥ 5 min/day (hazard ratio [HR]: 2.13, 95% confidence interval [CI]: 1.24-3.65, p = .006), ≥6 h/day (HR: 2.75, 95% CI: 1.37-5.49, p = .004), and ≥23 h/day (HR: 2.26, 95% CI: 1.05-4.86, p = .037).In heart failure patients, ICD-diagnosed severe SA on follow-up data review identifies patients who are from two- to three-fold more likely to experience an AF episode, according to various thresholds of daily AF burden.

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.

The implantable cardioverter defibrillator(ICD) has revolutionized the management of patients with hypertrophic cardiomyopathy (HCM) at risk of sudden cardiac death (SCD). However, the identification of ideal candidates remains challenging. We aimed to describe the long-term impact of the ICD for primary prevention in patients with HCM based on stringent (high SCD risk) vs lenient indications (need for pacing/personal choice).Data from two Italian HCM Cardiomyopathy Units were retrospectively analyzed. Only patients1 follow-up visits were divided into two groups according to ICD candidacy:stringent (high SCD risk) and lenient (need for pacing, patients' choice, physician advice despite lack of high SCD risk). Major cardiac events (composite of appropriate shock/intervention and SCD) was the primary endpoint. A safety endpoint was defined as a composite of inappropriate shocks and device-related complications.Of 2009 patients, 252(12.5%) received an ICD, including 27(1.3%) in secondary prevention and 225(11.2%) in primary prevention (age at implantation 49 ± 16 years; men 65.3%). Among those in primary prevention, 167(74.2%) had stringent, while 58(25.8%) had lenient indications. At 5 ± 4 years, only stringent ICD patients experienced major cardiac events (2.84%/year, 5-year cumulative incidence: 8.1%, 95%CI [3.5-14.1%]). ICD-related complications were similar across stringent and lenient subgroups. However, patients implanted60 years had a significantly higher risk of adverse events.One third of ICD recipients with HCM in primary prevention received a lenient implantation and had no appropriate intervention. ICD implantation due to systematic upgrade in patients requiring pacing and increased risk perception may offer little advantage and increase complication rates.

Aims In subcutaneous implantable cardioverter defibrillator (S-ICD) recipients, the UNTOUCHED study demonstrated a very low inappropriate shock rate on programming a conditional zone between 200 and 250 bpm and a shock zone for arrhythmias >250 bpm. The extent to which this programming approach is adopted in clinical practice is still unknown, as is its impact on the rates of inappropriate and appropriate therapies. Methods and results We assessed ICD programming on implantation and during follow-up in a cohort of 1468 consecutive S-ICD recipients in 56 Italian centres. We also measured the occurrence of inappropriate and appropriate shocks during follow-up. On implantation, the median programmed conditional zone cut-off was set to 200 bpm (IQR: 200–220) and the shock zone cut-off was 230 bpm (IQR: 210–250). During follow-up, the conditional zone cut-off rate was not significantly changed, while the shock zone cut-off was changed in 622 (42%) patients and the median value increased to 250 bpm (IQR: 230–250) (P < 0.001). UNTOUCHED-like programming of detection cut-offs was adopted in 426 (29%) patients immediately after device implantation, and in 714 (49%, P < 0.001) at the last follow-up. UNTOUCHED-like programming was independently associated with fewer inappropriate shocks (hazard ratio 0.50, 95%CI 0.25–0.98, P = 0.044), and had no impact on appropriate and ineffective shocks. Conclusions In recent years, S-ICD implanting centres have increasingly programmed high arrhythmia detection cut-off rates, at the time of implantation in the case of new S-ICD recipients, and during follow-up in the case of pre-existing implants. This has contributed significantly to reducing the incidence of inappropriate shocks in clinical practice. Rordorf: Programming of the S-ICD Clinical Trial Registration URL: http://clinicaltrials.gov/Identifier: NCT02275637

In patients with unexplained syncope, bifascicular block (BFB) is considered associated with syncope due to either heart block or sinus arrest. Immediate or delayed pacemaker (PM) implantation after ECG documentation of syncopal recurrence by means of implantable cardiac monitors (ICM) is still debated. We aimed to assess the incidence of recurrent syncope and guideline-based PM implantation in patients with syncope and BFB implanted with ICM.Consecutive patients with syncope and BFB followed at two tertiary care syncope units and implanted with ICM from 2012 to 2020 were retrospectively reviewed. Only patients with ≥2 clinical visits and ≥ 18 years of age were included. Incidence of a Class I indication for PM implantation was the primary outcome.Of 635 syncope patients implanted with an ICM, 55 (8.7%) had a BFB and were included. Median age at implantation was 75 [interquartile range, IQR:64-81] years, and 28(49.1%) were women. At 26 [IQR:12-41] months follow-up, 20 (36.3%,16.3%/year) patients experienced syncope: in 6(10.9%) patients syncope was classified 'arrhythmic' with a higher prevalence in older individuals (p = 0.048). PM implantation (N = 14,25.5%) was more frequent in patients ≥75 years (p = 0.024). At survival analysis, patients ≥75 years were at highest risk of arrhythmic syncope and guideline directed PM implantation (Hazard Ratio: 4.5, 95% Confidence Intervals 1.5-13.3).Most older patients with syncope who received an ICM did not have events during follow-up. One-in-three experienced syncope, and an even smaller number had an arrhythmic syncope with indication for PM implantation. Older age was strongly associated with PM implantation.

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) 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.