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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., (© 2023. The Author(s).)

Introduction: Recently, a new cryoballoon (CB) technology (POLARx; Boston Scientific) has come onto the market. Preliminary data have shown that its acute safety and efficacy are similar to those of the first-generation CB. The aim of this study was to assess the medium-term outcome of pulmonary vein isolation (PVI) with the POLARxTM CB in a large multicenter registry., Methods: We prospectively collected data on 125 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent PVI by means of a novel CB system. Two cases of transient phrenic nerve palsy occurred, with full recovery in the 48h post procedure; no major procedure-related adverse events were reported. During the 90-day blanking period, 4 (3.2%) patients experienced an early recurrence. After the blanking period, over a mean follow-up of 411 ± 62 days, 19 patients (15.2%) suffered an AF/atrial tachycardia (AT) recurrence. The 1-year freedom from AF/AT recurrence was 86.4% (n = 17): 10 (8%) patients had an AF recurrence, 6 (4.8%) had an AT occurrence and 1 (0.8%) suffered both events. Patients with AF/AT recurrences had both a shorter deflation time and total deflation time. Moreover, CB ablations with measured TTI < 90 s and TTI < 60 s were more frequent in patients without AF/AT recurrence (88.5% and 77.4%, respectively) than in those who experienced at least one AF/AT recurrence (67.5% and 55.0%, p = .001 and p = .005, respectively)., Conclusion: The novel POLARx cryo-balloon system is safe and effective for PV isolation, displaying a 1-year freedom from atrial arrhythmia recurrence of 86.4%, which is in line to that reported with AFA-Pro CB or RF ablation., Clinical Trial Registration: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. Registration date: January 4, 2019., (© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Background: In heart failure (HF) patients, atrial fibrillation (AF) is associated with a worse prognosis. Implantable cardioverter-defibrillator (ICD) diagnostics allow continuous monitoring of AF and are equipped with algorithms for HF monitoring., Objective: We evaluated the association between the values of the multisensor HF HeartLogic index and the incidence of AF, and assessed the performance of the index in detecting follow-up periods of significantly increased AF risk., Methods: The HeartLogic feature was activated in 568 ICD patients. Median follow-up was 25 months [25th-75th percentile (15-35)]. The HeartLogic algorithm calculates a daily HF index and identifies periods of IN-alert state on the basis of a configurable threshold. The endpoints were daily AF burden ≥5 minutes, ≥6 hours, and ≥23 hours., Results: The HeartLogic index crossed the threshold value 1200 times. AF burden ≥5 minutes/day was documented in 183 patients (32%), ≥6 hours/day in 118 patients (21%), and ≥23 hours/day in 89 patients (16%). The weekly time of IN-alert state was independently associated with AF burden ≥5 minutes/day (hazard ratio [HR] 1.95; 95% confidence interval [CI] 1.22-3.13; P = .005), ≥6 hours/day (HR 2.66; 95% CI 1.60-4.44; P <.001), and ≥23 hours/day (HR 3.32; 95% CI 1.83-6.02; P <.001), after correction for baseline confounders. Comparison of the episode rates in the IN-alert state with those in the OUT-of-alert state yielded HR ranging from 1.57 to 3.11 for AF burden from ≥5 minutes to ≥23 hours., Conclusions: The HeartLogic alert state was independently associated with AF occurrence. The intervals of time defined by the algorithm as periods of increased risk of HF allow risk stratification of AF according to various thresholds of daily burden., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

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

Purpose: Ablation index (AI) is a radiofrequency lesion quality marker. The AI value that allows effective and safe pulmonary vein isolation (PVI) is still debated. We evaluated the incidence of acute and late PV reconnection (PVR) with different AI settings and its predictors., Methods: The Ablation Index Registry is a multicenter study that included patients with paroxysmal/persistent atrial fibrillation (AF) who underwent first-time ablation. Each operator performed the ablation using his preferred ablation catheter (ThermoCool® SmartTouch or Surround Flow) and AI setting (380 posterior-500 anterior and 330 posterior-450 anterior). We divided the study population into two groups according to the AI setting used: group 1 (330-450) and group 2 (380-500). Incidence of acute PVR was validated within 30 min after PVI, whereas the incidence of late PVR was evaluated at repeat procedure., Results: Overall, 490 patients were divided into groups 1 (258) and 2 (232). There was no significant difference in the procedural time, fluoroscopy time, and rate of the first-pass PVI between the two study groups. Acute PVR was observed in 5.6% PVs. The rate of acute PVR was slightly higher in group 2 (64/943, 6.8%, PVs) than in group 1 (48/1045, 4.6% PVs, p = 0.04). Thirty patients (6%) underwent a repeat procedure and late PVR was observed in 57/116 (49%) PVs (number of reconnected PV per patient of 1.9 ± 1.6). A similar rate of late PVR was found in the two study groups. No predictors of acute and late PVR were found., Conclusion: Ablation with a lower range of AI is highly effective and is not associated with a higher rate of acute and late PVR. No predictors of PV reconnection were found., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)

Aim: To evaluate the current interpretation of the lower doses of direct oral anticoagulants (DOAC) dabigatran, apixaban, edoxaban and rivaroxaban in nonvalvular atrial fibrillation., Methods: A questionnaire of 14 statements to which the possible answers were fully agree/partially agree/partially disagree/fully disagree or yes/no was prepared within the board of the Italian Atherosclerosis, Thrombosis and Vascular Biology Study Group and forwarded to individual Italian physicians., Results: A total of 620 complete questionnaires were received from nearly all the Italian regions and physicians of various medical specialists, either enabled or not for the prescription of DOAC. A wide agreement was found as regards the pharmacological, as well as clinical consequences of the administration of the lower dose of factor-Xa inhibitors both in patients with and without clinical and/or laboratory criteria requiring dose reduction. Wide agreement was also found as regards the presence of moderate kidney insufficiency in selecting the dose of DOAC. Instead, more debated were issues regarding the proportionality between dabigatran dose and plasma concentration and selection of dabigatran dose, as well as the role of measuring drug plasma concentration and/or determine the anticoagulant activity of factor-Xa inhibitors when used at the lower dose., Conclusion: The interpretation of the lower doses of DOAC in current Italian clinical practice appears largely correct and shared. Because of the persistence of some residual uncertainties, essentially regarding dabigatran, however, continuous educational effort still appears warranted., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background: An early, comprehensive rhythm-control therapy is needed in order to treat atrial fibrillation (AF) effectively and to improve ablation outcomes., Methods: A total of 153 consecutive patients from the CHARISMA registry undergoing AF ablation at eight centers were included. Patients with de novo PVI were classified as having undergone early treatment (ET) if the procedure was performed within 6 months after the first AF episode, and as having undergone delayed treatment (DT) if ablation was performed over 6 months after the first AF episode., Results: One-hundred fifty-three patients were enrolled (69.9% male, 59 ± 10 years, 61.4% paroxysmal AF, 38.6% persistent AF). The time from the first AF episode to the ablation procedure was 1034 ± 1483 days. The ET group comprised 36 patients (25.3%), the DT group 60 (39.2%) and Redo cases were 57 (37.3%). During a mean follow-up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/AT recurrence. More DT patients than ET patients suffered recurrences (15.7% vs. 2.2%, p = 0.0452) and the time to AT/AF recurrence was shorter in the group of patients who received an ablation treatment after 6 months (HR = 6.19, 95% CI: 1.7 to 21.9; p = 0.0474). On multivariate Cox analysis, only hypertension (HR = 4.86, 95% CI: 1.6 to 14.98, p = 0.0062) was independently associated with recurrences. Beyond the hypertension risk factor, ET was associated with a low risk of recurrence; recurrence rate ranged from 0% (ET patients without hypertension) to 25.0% (DT patients with hypertension)., Conclusions: An early rhythm-control ablation therapy in the absence of common risk factors was associated with the lowest rate of recurrences., (© 2021 Wiley Periodicals LLC.)

Purpose: To evaluate how the integration of intracardiac echocardiography (ICE) and ultrasound-guided femoral venipuncture (USGVC) may affect the safety of catheter ablation (CA) of atrial fibrillation (AF)., Methods: From a single center 374 patients with AF underwent 3D electroanatomic mapping-guided CA with or without the integration of ICE and USGVC. The primary endpoints were periprocedural complications, fluoroscopy time, and procedure time between the two groups., Results: The median age of patients was 60 years. Sixteen patients had major complications (4.3%); 10 of these (2.7%) had major vascular complications. Thirty-seven patients had minor complications (9.9%) that did not require intervention. There were fewer major complications in the CA with the aid of ICE and USGVC than in the conventional approach (1% vs 7%, p = 0.004). The combined approach required less fluoroscopy time than the conventional procedure (median with ICE + USGVC 14 min (interquartile range (IQR) 8-21) vs median without ICE + USGVC 22 min (IQR 17-32)), p < 0.001, and less radiofrequency time (median with ICE + USGVC 1686 s (IQR 1367-1998) vs median time without ICE + USGVC: 1792 s (IQR 1390-2400)), p = 0.012. After adjustment for confounding factors, only the use of ICE + USGVC (hazard ratio: 0.139; p = 0.05) was a significantly protective factor against major complications., Conclusion: The use of ICE and USGVC in CA of AF is associated with significantly fewer major complications and lower fluoroscopy and radiofrequency time, so these aids increased the safety of the procedure., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose of Review: Catheter ablation of atrial fibrillation in heart failure seems to be the way to improve the quality of life, life expectance, and prognosis. In this review, we outline the growing role of this therapy and which patients can benefit from it., Recent Findings: While previous studies comparing rate control and rhythm control had not demonstrated the superiority of rhythm control in the prognosis of patients with atrial fibrillation and heart failure, recent findings seem to demonstrate that catheter ablation of atrial fibrillation reduces mortality and hospitalization for heart failure and improves the quality of life, when compared to medical therapy alone. An early rhythm-control strategy in atrial fibrillation may reduce cardiovascular death, stroke, hospitalization for HF, or acute coronary syndrome. Catheter ablation in heart failure is an effective and safe solution to obtain a rhythm control and, therefore, to improve outcomes. A better selection of the patients could help to avoid futile procedures and to identify patients requiring a closer follow-up, to redo procedures, or the addition of antiarrhythmic drugs.

Background: Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have recently emerged as a viable real-time indicator of tissue characteristics and durability of the lesions created. We report the outcomes of acute and long-term clinical evaluation of the new DirectSense algorithm in AF ablation., Methods: Consecutive patients undergoing AF ablation were included in the CHARISMA registry. RF delivery was guided by the DirectSense algorithm, which records the magnitude and time-course of the impedance drop. The ablation endpoint was pulmonary vein isolation (PVI), as assessed by the entrance and exit block., Results: 3556 point-by-point first-pass RF applications of >10 s duration were analyzed in 153 patients (mean age=59 ± 10 years, 70% men, 61% paroxysmal AF, 39% persistent AF). The mean baseline LI was 105 ± 15 Ω before ablation and 92 ± 12 Ω after ablation (p < .0001). Both absolute drops in LI and the time to LI drop (LI drop/τ) were greater at successful ablation sites (n = 3122, 88%) than at ineffective ablation sites (n = 434, 12%) (14 ± 8 Ω vs 6 ± 4 Ω, p < .0001 for LI; 0.73 [0.41-1.25] Ω/s vs. 0.35[0.22-0.59 Ω/s, p < .0001 for LI drop/τ). No major complications occurred during or after the procedures. All PVs had been successfully isolated. During a mean follow-up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/atrial tachycardia recurrence after the 90-day blanking period., Conclusion: The magnitude and time-course of the LI drop during RF delivery were associated with effective lesion formation. This ablation strategy for PVI guided by LI technology proved safe and effective and resulted in a very low rate of AF recurrence over 1-year follow-up., (© 2021 Wiley Periodicals LLC.)

Purpose: Catheter ablation (CA) for atrial fibrillation (AF) in heart failure (HF) patients is associated with a lower rate of cardiac events compared with medical therapy. This study deals with the clinical, echocardiographic, and prognostic outcomes in these patients. Prognostic scores, as MAGGIC (Meta-analysis Global Group in Chronic Heart Failure) score, may help to predict the outcomes., Methods: From a single center, 47 patients with AF, HF, and left ventricular ejection fraction (LVEF) < 50% underwent CA. The primary endpoints were NYHA functional class, LVEF, and MAGGIC score., Results: The median age of patients was 59 years; 49% had paroxysmal AF. At 12 months, a significant improvement of NYHA class (median before II [interquartile range (IQR) II-III] vs median after I [IQR I-II]) and of LVEF (median before 44% [IQR 37-47] vs median after 55% [IQR49-57]) was observed (p value < 0.001). The MAGGIC 1-year and 3-year probability of death was estimated before (mean score 13 [IQR 11-17]) and at 12-month (mean score 11 [IQR 8-13]), showing a significant decrease in the probability of death (p value <0.001). At 12-month, a lower LVEF was associated with more HF hospitalizations (p value 0.035). Coronary artery disease (CAD) (HR 5, p value 0.035) and MAGGIC score (HR 1.2, p value 0.030) were predictors of HF hospitalization., Conclusions: CA for AF in HF patients was associated with a significant improvement of NYHA functional class and LVEF and a higher life expectation. CAD history, LVEF < 40%, and MAGGIC score before ablation were predictors of HF hospitalization.

Background: Ablation index (AI) is a new lesion quality marker that has been demonstrated to allow a high single-procedure arrhythmia-free survival in single-center studies. This prospective, multi-center study was designed to evaluate the reproducibility of pulmonary vein (PV) isolation guided by the AI., Methods: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV isolation and were divided in four study groups according to operator's preference in choosing the ablation catheter (a contact force (ST) or contact force surround flow (STSF) catheter) and the AI setting (330-450 or 380-500 at anterior wall or posterior wall, respectively)., Results: At 12 months a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs 83.3%; P = .039). There was no difference in the rate of AF recurrence among the four study groups (4.5% in group ST330-450, 12.2% in group ST 380-500, 14.9% in group STSF330-450, 9.4% in group STSF380-500; P = .083). Recurrence was also similar between patients treated with a ST (8%) or STSF catheter (12.1%; P = .2), and within patients targeting an AI settings of 330 to 450 (10.9%) or 380 to 500 (10.3%; P = .64). In patients with paroxysmal AF, there was no difference (P = .12) in the 1-year freedom from AF recurrence among 14 operators that performed ≥10 ablation procedure., Conclusions: An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of 1-year freedom from AF recurrence, irrespective of the ablation catheters, AI settings, and operator., (© 2020 Wiley Periodicals LLC.)

Background: Continuous monitoring by implantable loop recorder (ILR) can provide information relevant to rhythm control and oral anticoagulation (OAC) after atrial fibrillation (AF) ablation, but there is little agreement on patients' selection and appropriate management strategy., Methods: An expert panel (EP) made up of eight Italian electrophysiologists with expertise in AF ablation, gathered to define an algorithm to guide continuous rhythm monitoring in AF patients who have undergone ablation. The process included a review of the current literature and two EP face-to-face meetings. Between the two meetings, an on-line survey was sent to 50 Italian electrophysiologists practicing AF ablation. Agreement level was considered reached when ≥70% of respondents agreed or were neutral., Results: Two algorithms were developed to define patients for whom the ILR would be suggested support for (OAC) therapy discontinuation and rhythm management after AF ablation. Thirty-three out of 50 physicians responded to on-line survey (66% response rate). Together with EP members the responders accounted for electrophysiology centers performing about 50% of total yearly Italian AF ablation procedures. Agreement level was reached at the first survey round on all the questions, so the algorithms were not further modified and re-tested., Conclusions: EP developed two algorithms for ECG monitoring to guide OAC therapy discontinuation and rhythm management after AF ablation. These suggestions, validated by wide feedback and consensus of physicians performing AF ablations, might support the decision on the choice and the use of ECG monitoring techniques, based on specific patient characteristics., Competing Interests: Declaration of competing interest The EP panel was sponsored by Medtronic Italy., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Atrial fibrillation (AF) ablation outcome is still operator dependent. Ablation Index (AI) is a new lesion quality marker that has been demonstrated to allow acute durable pulmonary vein (PV) isolation followed by a high single-procedure arrhythmia-free survival. This prospective, multicenter study was designed to evaluate the reproducibility of acute PV isolation guided by the AI., Methods: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV encircling and were divided in four study groups according to operator preference in choosing the ablation catheter (a contact force [ST] or contact force surround flow [STSF] catheter) and the AI setting (330 at posterior and 450 at anterior wall or 380 at posterior and 500 at anterior wall). Radiofrequency was delivered targeting interlesion distance ≤6 mm., Results: The rate of first-pass PV isolation (ST330 90 ± 16%, ST380 87 ± 19%, STSF330 90 ± 17%, STSF380 91 ± 15%, P = .585) was similar among the four study groups, whereas procedure (ST330 129 ± 44 minutes, ST380 144 ± 44 minutes, STSF330 120 ± 72 minutes, STSF380 125 ± 73 minutes, P < .001) and fluoroscopy time (ST330 542 ± 285 seconds, ST380 540 ± 416 seconds, STSF330 257 ± 356 seconds, STSF380 379 ± 454 seconds, P < 0.001) significantly differed. The difference in the rate of first-pass isolation was not statistical different (P = .06) among the 12 operators that performed at least 15 procedures., Conclusions: An ablation protocol respecting strict criteria for contiguity and quality lesion results in high and comparable rate of acute PV isolation among operator performing ablation with different catheters, AI settings, procedure, and fluoroscopy times., (© 2019 Wiley Periodicals, Inc.)

Although it is well recognized that warfarin dramatically reduces the risk for ischemic stroke, its use for stroke prevention in patients with atrial fibrillation is often inadequate. Even among patients with other known risk factors for stroke (e.g., high blood pressure) and no contraindications to warfarin, warfarin therapy is prescribed in less than 60% of cases. In addition, safety and efficacy of warfarin therapy depend on adequate anticoagulation effect, but time in therapeutic range is 63%. Notably, major bleeding and intracranial hemorrhage represent a feared, though infrequent, complication. Aspirin monotherapy for stroke prevention in patients with atrial fibrillation should be discouraged, as it does not provide adequate protection against stroke and is associated with a significant increase in bleeding complications. New oral anticoagulants have a favorable risk-benefit profile, resulting in significant reductions in stroke, intracranial hemorrhage and mortality, with similar rates of major bleeding compared to warfarin but increased risk for gastrointestinal bleeding. The present review describes the new oral anticoagulants dabigatran, rivaroxaban, apixaban and edoxaban with a focus on the results from major randomized clinical trials and meta-analyses. It also provides practical suggestions for their use in daily clinical practice, introducing a dedicated, novel application for smartphones and tablets.

Background: In patients with atrial fibrillation (AF) undergoing radiofrequency (RF) electrical disconnection of multiple pulmonary veins (PVs), the incidence of late conduction recurrences has not been systematically determined., Methods and Results: Using a prospectively designed, multistep approach, we aimed at assessing the correlation between acute achievement and chronic maintenance of electrical conduction block across RF lesions disconnecting the distal tract of the PV in 43 patients (52.3+/-8.2 years) with AF. Forty-one left superior (LS), 42 right superior (RS), 25 left inferior (LI), and 9 right inferior (RI) PVs were targeted during 108 EP procedures (2.6+/-0.5 per patient). Seventeen patients underwent 2 procedures, 23 patients underwent 3 procedures, and 3 patients underwent 4 procedures. During the first attempt, electrical disconnection was achieved in 112 PVs (95.7%). During a next procedure (time interval, 4.6+/-1.9 months), conduction recurrence was observed in 32 of 39 LSPVs (82.1%), 29 of 40 RSPVs (72.5%), 20 of 24 LIPVs (83.3%), and 7 of 9 RIPV (77.8%). After reablation at gap sites, a later procedure (time interval, 5.1+/-2.4 months) revealed a second recurrence in 13 of 22 LSPVs (59.1%) and 14 of 19 RSPVs (73.7%)., Conclusions: Conduction recurrence across disconnecting RF lesions can be observed in approximately 80% of cases 4 months after ablation. After reablation, similar recurrence rates are observed 5 months later. This high rate of late conduction recurrence may contribute significantly to AF recurrence in patients undergoing catheter ablation aiming at disconnection of multiple PVs.