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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.

Transseptal puncture is a fundamental learning step for a young electrophysiologist. New technologies have been developed to reduce the complexity of the procedure and improve safety. One of them is AcQCross™️Qx. Our aim is to discuss our procedural approach with this new technology, during cryoballoon pulmonary vein isolation.

Background Several studies have evaluated the role of QRS duration (QRSd) or QRS narrowing as predictor of response to cardiac resynchronization therapy (CRT) in order to reduce non-responders. However, their results have been conflicting. In our study we analyzed retrospectively a cohort of patients from three centers to better correlate the association between the relative change in QRS narrowing index (QI) and clinical outcome and prognosis in patients who underwent CRT implantation. Methods We included 398 patients in whom a CRT device was implanted in accordance with current guidelines in our three centres. Baseline clinical variables, echocardiographic parameters and pharmacological therapies were included. QRS duration before and after CRT implantation and QI [(pre implant QRS duration - QRS duration during CRT)/pre implant QRS duration × 100] were measured. Results Respect to echocardiographic follow up at 6 months, a significant improvement in all parameters (EF, LVEDV, LVESV) was observed. In 68% of patients, LVESV decreased by 10% or more. QI was significantly related to reverse remodelling (r = + 0.22; 95% CI: 0.11 to 0.32, p = 0.001). The cut-off value of QI that predicted best LV reverse remodelling after 6 months of CRT was 12.25% (sensitivity 65,49%, specificity 75%, area under the curve 0.7, p = 0.001). Regarding clinical outcomes at 12 mounths, a statistically significant difference was found between patients with a QI ≤ 12.25%, and those with a QI > 12.25%, in terms of NYHA class worsening (p 0,04). Another statistically significant difference was found analyzing the relation between QI and the causes of deaths, the mean of the QI of patients who died from cardiovascular causes was lower than patients who died of other causes. (p 0,0179). Conclusions Therefore decrease in QRSd after CRT initiation was related to greater echocardiographic reverse remodelling and better outcome from death or cardiovascular hospitalization. Even if larger studies are needed, QI seems to be an easy-to- measure variable that could be used or evaluated to predict CRT response.

The risk of complications has been shown to be lower with subcutaneous implantable defibrillator (S-ICD) than with conventional ICDs. Given the low frequency of complications, experience of how to manage them is limited. In this paper, we describe generator- and lead-related complications recorded in a series of S-ICD patients, and we propose our conservative approach to managing them.The study cohort consisted of S-ICD patients who were referred to our institution owing to generator- or lead-related complications requiring surgical intervention. With our "shift and cover" approach, the system component involved is moved from its original position to an alternative, more protected location. In the case of the generator, this involves moving it to an intermuscular pocket. In the case of infections at the parasternal scar, the electrode sleeve is moved away from its original location, stitched, and then covered with the muscular fascia.Fourteen S-ICD patients were referred to our institution owing to system-related complications. Complications involved the generator in 7 cases (deep pocket infections with erosion, extrusion, or pain), the lead in 5 cases (parasternal infections at the xyphoid incision site), and both the generator and the lead in 2 cases. Complications were managed without completely removing the device and resolved in a single surgical session with no intraoperative complications. During defibrillation testing, the first shock at 65 J was effective in all patients. The shock impedance after revision was significantly lower than that measured during first implantation (59 ± 10 Ohm versus 86 ± 24 Ohm, P = 0.013). In all cases, the cosmetic result was satisfactory. No complications or recurrent infections were reported at the 12-month follow-up visit.The proposed conservative approach was successful in managing S-ICD complications. The revision procedure allowed to optimize the system configuration in terms of the defibrillation vector, resulting in lower shock impedance values and better device positioning.

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

Permanent pacemaker implantation (PPI) represents a rare complication after cardiac surgery, with no uniform agreement on timing and no information on follow-up. A multi-center retrospective study was designed to assess pacemaker dependency (PMD) and long-term mortality after cardiac surgery procedures. Between 2004 and 2016, PPI-patients from 18 centers were followed. Time-to-event data were evaluated with semiparametric regression Cox models and semiparametric Fine and Gray model for competing risk framework. Of 859 (0.90%) PPI-patients, 30% were pacemaker independent (PMI) at 6 months. PMD showed higher mortality compared with PMI (10-year survival 80.1% +/- 2.6% and 92.2% +2.4%, respectively, log-rank p-value < 0.001) with an unadjusted hazard ratio for death of 0.36 (95% CI 0.20 to 0.65, p< 0.001 favoring PMI) and an adjusted hazard ratio of 0.19 (95% CI 0.08 to 0.45, p< 0.001 with PMD as reference). Crude cumulative incidence function of restored PMI rhythm at follow-up at 6 months, 1 year and 12 years were 30.5% (95% CI 27.3% to 33.7%), 33.7% (95% CI 30.4% to 36.9%) and 37.2% (95% CI 33.8% to 40.6%) respectively. PMI was favored by preoperative sinus rhythm with normal conduction (SR) (HR 2.37, 95% CI 1.65 to 3.40, p< 0.001), whereas coronary artery bypass grafting and aortic valve replacement were independently associated with PMD (HR 0.63, 95% CI 0.45 to 0.88, p = 0.006 and HR 0.807, 95% CI 0.65 to 0.99, p = 0.047 respectively). Time-to-implantation was not associated with increased rate of PMI. Although 30% of PPI-patients are PMI after 6 months, PMD is associated with higher mortality at long term. (C) 2020 The Author(s). Published by Elsevier Inc.

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

Aims Ablation index (AI) is a marker of lesion quality during catheter ablation that incorporates contact force, time, and power in a weighted formula. This index was originally developed for pulmonary vein isolation as well as other left atrial procedures. The aim of our study is to evaluate the feasibility and efficacy of the AI for the ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical atrial flutter (AFL). Methods and results This prospective multicentre non-randomized study enrolled 412 consecutive patients with typical AFL undergoing AI-guided cavotricuspid isthmus ablation. The procedure was performed targeting an AI of 500 and an inter-lesion distance measurement of ≤6 mm. The primary endpoints were CTI ‘first-pass’ block and persistent block after a 20-min waiting time. Secondary endpoints included procedural and radiofrequency duration and fluoroscopic time. A total of 412 consecutive patients were enrolled in 31 centres (mean age 64.9 ± 9.8; 72.1% males and 27.7% with structural heart disease). The CTI bidirectional ‘first-pass’ block was reached in 355 patients (88.3%), whereas CTI block at the end of the waiting time was achieved in 405 patients (98.3%). Mean procedural, radiofrequency, and fluoroscopic time were 56.5 ± 28.1, 7.8 ± 4.8, and 1.9 ± 4.8 min, respectively. There were no major procedural complications. There was no significant inter-operator variability in the ability to achieve any of the primary endpoints. Conclusion AI-guided ablation with an inter-lesion distance ≤6 mm represents an effective, safe, and highly reproducible strategy to achieve bidirectional block in the treatment of typical AFL.

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). 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. 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

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. From a single center, 47 patients with AF, HF, and left ventricular ejection fraction (LVEF)

Novel implantable defibrillators (ICDs) allow first (S1) and third (S3) heart sounds to be measured by means of an embedded accelerometer. ICD-measured S1 and S3 have been shown to significantly correlate with hemodynamic changes in acute animal models. The HeartLogic algorithm (Boston Scientific) measures and combines multiple parameters, including S3 and S1, into a single index to predict impending heart failure decompensation. We evaluated the echocardiographic correlates of ICD-measured S1 and S3 in patients with ICD and cardiac resynchronization therapy ICD.The HeartLogic feature was activated in 104 patients. During in-office visits, patients underwent echocardiographic evaluation, and parameters of systolic and diastolic function were correlated with S3 and S1 amplitude measured on the same day as the visit.S3 amplitude inversely correlated with deceleration time of the E-wave (r = -0.32; 95% CI -0.46 - -0.17; P 0.001), and S1 amplitude significantly correlated with left ventricular ejection fraction (r = 0.17; 95% CI 0.03-0.30; P = 0.021). S3 0.9 mG detected a restrictive filling pattern with 85% (95% CI 72%-93%) sensitivity and 82% (95% CI 75%-88%) specificity, while S1 1.5 mG detected ejection fraction35% with 28% (95% CI 19%-40%) sensitivity and 88% (95% CI 80%-93%) specificity.ICD-measured heart sound parameters are significantly correlated with echocardiographic indexes of systolic and diastolic function. This confirms their utility for remote patient monitoring when used as single sensors and their potential relevance when considered in combination with other physiological ICD sensors that evaluate various aspects of heart failure physiology.

A 78 year-old patient with postischaemic dilated cardiomyopathy and severely reduced ejection fraction was implanted with a Boston Scientific RESONATE X4 CRT-D and followed by LATITUDE remote monitoring platform. From the end of January to the end of March 2021 he was hospitalized for COVID19 pneumonia followed by two episodes of acute heart decompensation with bilateral pleural effusion. We remotely followed the patient and identified a typical Heart Logic sensor pattern linked to the COVID19 pneumonia, different from the one linked to the heart failure (HF). We eventually made a literature review on the topic.

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.

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.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.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.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.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.

The risk of microbial air contamination in a dental setting, especially during aerosol-generating dental procedures (AGDPs), has long been recognized, becoming even more relevant during the COVID-19 pandemic. However, individual pathogens were rarely studied, and microbial loads were measured heterogeneously, often using low-sensitivity methods. Therefore, the present study aimed to assess microbial air contamination in the dental environment, identify the microorganisms involved, and determine their count by active air sampling at the beginning (T0), during (T1), and at the end (T2) of ultrasonic scaling in systemically and periodontally healthy subjects. Air microbial contamination was detected at T0 in all samples, regardless of whether the sample was collected from patients treated first or later; predominantly Gram-positive bacteria, including Staphylococcus and Bacillus spp. and a minority of fungi, were identified. The number of bacterial colonies at T1 was higher, although the species found were similar to that found during the T0 sampling, whereby Gram-positive bacteria, mainly Streptococcus spp., were identified. Air samples collected at T2 showed a decrease in bacterial load compared to the previous sampling. Further research should investigate the levels and patterns of the microbial contamination of air, people, and the environment in dental settings via ultrasonic scaling and other AGDPs and identify the microorganisms involved to perform the procedure- and patient-related risk assessment and provide appropriate recommendations for aerosol infection control.

Coronavirus disease 2019 (COVID-19) has shown high morbidity and mortality and the relationship between pulmonary embolism (PE) and COVID-19 is well established in the literature.We describe the characteristics of a cohort of COVID-19 patients (EP-COV) hospitalized at our Centre with PE, investigating how COVID-19 may have influenced their outcomes, as compared to patients without COVID-19 hospitalized for PE in the same months of 2020 (EP-2020) and 2019 (EP-2019).EP-COV patients (n=25) were younger (60.5 ± 8.5 vs 71.4 ± 14.5 vs 70.9 ± 11.8 years, p=0.003), more frequently male (76% vs 48% vs 35%, p=0.016), with a lower history of neoplasia (12% vs 47% vs 40%, p=0.028) and more clinically severe (SOFA score 3.4 ± 1.4 vs 2.2 ± 1.4 vs 1 ± 1.1, p0.001 and PaO2/FiO2 ratio 223.8 ± 75.5 vs 306.5 ± 49.3 vs 311.8 ± 107.5) than EP-2020 (n=17) and EP-2019 patients (n=20). D-dimer and C-reactive protein were higher in EP-COV (p=0.038 e p0.001, respectively). The rate of concomitant deep vein thrombosis associated with PE did not differ significantly between the three groups. EP-COV patients developed PE more frequently during in-hospital stay than non-COVID-19 patients (p = 0.016). The mortality rate was higher in EP-COV than in EP-2020 and EP-2019 patients (36% vs 0% vs 5%, p=0.019).In our study, the risk factors for PE in COVID-19 patients seem to differ from the traditional risk factors for venous thromboembolism; EP-COV patients are clinically more severe and display a higher mortality rate than EP-2020 and EP-2019 patients.

Background An early, comprehensive rhythm-control therapy is needed in order to treat atrial fibrillation (AF) effectively and to improve ablation outcomes. Methods 153 consecutive patients from the CHARISMA registry undergoing AF ablation at 8 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. Clinical trial registration Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. This article is protected by copyright. All rights reserved.

About one-third of patients receiving cardiac resynchronization therapy (CRT) are not responders, due to either patient selection or technical issues. Left ventricular quadripolar passive fixation leads (QPL) and bipolar active fixation (BAF) leads have been designed to ensure a targeted left ventricular stimulation area, minimizing lead dislodgments and phrenic nerve stimulation (PNS). The aim was to compare real-world safety and efficacy of BAF (Attain Stability, Medtronic Plc.) and QPL (Attain Performa, Medtronic Plc.).We performed a retrospective analysis examining procedural and follow-up data of 261 BAF and 124 QPL (programmed to single-site left ventricular pacing), included in the ClinicalService project from 16 Italian hospitals.At median follow-up of 12 months, no difference in left ventricular pacing threshold was recorded between BAF and QPL (1.3 ± 0.9 V @0.4 ms vs. 1.3 ± 1.0 V @0.4 ms; P = 0.749). Total left ventricular lead dislodgement rate was 1.43/100 patient-years in BAF vs. 2.9/100 patient-years in QPL (P = 0.583). However, no dislodgements occurred among BAF after hospital discharge. Events requiring repeated surgery or permanently turning CRT off occurred in 0.8% of BAF, as compared with 4.0% of QPL (P = 0.025). There was no difference between groups in the echo CRT responders' rate (70% of BAF and 66% of QPL; P = 0.589) or in the annual rate of heart failure hospitalization (P = 0.513).BAF resulted in noninferior clinical outcome and CRT responders' rate in comparison to QPL. Moreover, BAF ensured more precise and stable placement in cardiac veins, with comparable electrical performance and less than 1% patients with unsolved PNS.

Aims In the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients study, a novel algorithm for heart failure (HF) monitoring was implemented. The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter defibrillator (ICD)‐based sensors and has proved to be a sensitive and timely predictor of impending HF decompensation. The remote monitoring of HF patients by means of HeartLogic has never been described in clinical practice. We report post‐implantation data collected from sensors, the combined index, and their association with clinical events during follow‐up in a group of patients who received a HeartLogic‐enabled device in clinical practice. Methods and results Patients with ICD and cardiac resynchronization therapy ICD were remotely monitored. In December 2017, the HeartLogic feature was activated on the remote monitoring platform, and multiple ICD‐based sensor data collected since device implantation were made available: HeartLogic index, heart rate, heart sounds, thoracic impedance, respiration, and activity. Their association with clinical events was retrospectively analysed. Data from 58 patients were analysed. During a mean follow‐up of 5 ± 3 months, the HeartLogic index crossed the threshold value (set by default to 16) 24 times (over 24 person‐years, 0.99 alerts/patient‐year) in 16 patients. HeartLogic alerts preceded five HF hospitalizations and five unplanned in‐office visits for HF. Symptoms or signs of HF were also reported at the time of five scheduled visits. The median early warning time and the time spent in alert were longer in the case of hospitalizations than in the case of minor events of clinical deterioration of HF. HeartLogic contributing sensors detected changes in heart sound amplitude (increased third sound and decreased first sound) in all cases of alerts. Patients with HeartLogic alerts during the observation period had higher New York Heart Association class (P = 0.025) and lower ejection fraction (P = 0.016) at the time of activation. Conclusions Our retrospective analysis indicates that the HeartLogic algorithm might be useful to detect gradual worsening of HF and to stratify risk of HF decompensation.

Funding Acknowledgements Type of funding sources: None. Background Limited data exist on factors associated with radiation exposure during ablation procedures when a high definition mapping technology is used. Purpose To report factors associated with radiation exposure and data on feasibility and safety of a minimal fluoroscopic approach using the Rhythmia mapping system in supraventricular tachycardia (SVT) ablation procedures. Methods Consecutive patients indicated for arrhythmia ablation were enrolled in the CHARISMA study at 12 centers. We included in this analysis consecutive right-side procedures performed through a minimal fluoroscopy approach with the Rhythmia mapping system were analyzed. A 3D geometry of chambers of interest was reconstructed on the basis of the electroanatomic information taken from the mapping system. Fluoroscopy was used only if deemed necessary. The effective dose (ED) was calculated using accepted formula. For our purpose high dose exposure was defined as an ED greater than the median value of ED of the population exposed to radiation. Results This analysis included 325 patients (mean age = 56 ± 17 years, 57% male) undergoing SVT procedures (152 AVNRT, 116 AFL, 41 AP and 16 AT). During the study, 27481 seconds of fluoroscopy was used (84.6 ± 224 seconds per procedure), resulting in a mean equivalent ED of 1.1 ± 3.7 mSv per patient. The mean reconstructed RA volume was 99 ± 54 ml in a mean mapping time of 12.2 ± 7 min. The mean number of radiofrequency ablations (RFC) to terminate each arrhythmia was 9.4 ± 9 (mean RFC delivery time equal to 6.7 ± 6 min). 192 procedures (59.1%) were completed without any use of fluoroscopy; during the remaining 133 procedures (39.9%), 206.6 ± 313.4 seconds of fluoroscopy was used (median ED = 1.2 mSv). In a minority of the cases (n = 25, 7.7%) the fluoroscopy time was higher than 5 minutes (median ED = 6.5 mSv), whereas radiologic exposure time greater than 1 minute occurred in ninety cases (27.7%, median ED = 2.1 mSv). On multivariate logistic analysis adjusted for baseline confounders the RFC application time (OR = 1.0014, 95%CI: 1.0007 to 1.0022; p = 0.0001) was independently associated to an ED greater than 1.2 mSv, whereas female gender had an inverse association (0.54, 0.29 to 0.98; p = 0.0435). Acute success was reached in 97.8% of the cases. During a mean of 290.7 ± 169.6 days follow-up, no major adverse events related to the procedure were reported. Overall, the recurrence rate of the primary arrhythmia during follow-up was 2.5%. Conclusions In our experience, arrhythmias ablation through minimal fluoroscopy approach with the use of a novel ablation technology is safe, feasible, and effective in common right atrial arrhythmias. High-dose exposure occurred in a very limited number of cases, without any reduction of the safety and acute and long-term effectiveness profile.

Funding Acknowledgements Type of funding sources: None. Background An early and comprehensive rhythm-control therapy emerges as a need to treat AF in an effective way and to improve the ablation outcomes, in terms of arrhythmia-free survival. Purpose We aimed to investigate the importance of timing of ablation in preventing AF recurrences. Methods 153 consecutive patients (pts) undergoing AF ablation from the CHARISMA registry at 8 Italian centres were included. Ablations were guided by a novel radiofrequency ablation catheter with local impedance (LI)-sensing capability through a dedicated algorithm (DirectSense, Boston Scientific). Pts were grouped as early treated (ET) if the procedure was performed within 1 year after the first AF episode and as delayed treated (DT) if admitted for ablation after more than 1 year. The ablation endpoint was PVI as assessed by entrance and exit block. Post-ablation follow-up was scheduled at 3, 6 and 12 months. AF and atrial tachycardia (AT) recurrences were considered as long-term endpoint. Results Of the 153 pts enrolled (69.9% male, 59 ± 10 years, 61.4% paroxysmal AF, 38.6% persistent AF), 123 (80.4%) met Class I indications, 23 (15%) Class IIa indications and 7 (4.6%) Class IIb indications according to current ESC AF guidelines. The mean time to ablation procedure from the first AF episode was 1034 ± 1483 days. Eighty pts (52.3%) were included in ET group, whereas 73 pts (47.7%) in DT group. No differences were found between AF type in terms of ablation strategy (53.3% of the cases -52 out 94- were classified as ET for paroxysmal AF vs 47.5% of the cases -28 out 59- were ET for persistent AF, p = 0.4346). At the end of the procedures, all PVs had been successfully isolated in all study pts. During a mean follow-up of 366 ± 130 days, 18 pts (11.8%) suffered an AF/AT recurrence after the 90-day blanking period. Recurrences occurred mostly in the DT group compared to the ET one (13 out 73 -17.8%- vs 5 out 80 -6.3%-, p = 0.042) and the time to AT/AF recurrence was longer in the ET group (HR = 0.2876, 95%CI: 0.1029 to 0.8038; p = 0.0181). On multivariate logistic analysis adjusted for baseline confounders, only hypertension (HR = 4.66, 95%CI: 1.5 to 14.48, p = 0.0081) was independently associated with recurrences. An early rhythm-control therapy was associated with a low risk of recurrences beyond the hypertension risk factor, ranging from 2% (no hypertension and an ET ablation therapy) to 30.3% (with hypertension and a DT procedure) (Figure 1). Conclusion A LI-guided ablation strategy for PVI proved to be safe and effective and resulted in a very high recurrence-free rate. An early rhythm-control therapy in the absence of common risk factors was associated with the lowest rate of recurrences. Abstract Figure. AT/AF Recurrence

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.

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. 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: More and more heart failure (HF) patients aged ≥ 75 years undergo cardiac resynchronization therapy (CRT) device implantation, however the data regarding the outcomes and their predictors are scant. We investigated the mid- to long-term outcomes and their predictors in CRT patients aged ≥ 75 years. Methods: Patients in the Cardiac Resynchronization Therapy Modular (CRT MORE) Registry were divided into three age-groups: &lt, 65 (group A), 65–74 (group B) and ≥75 years (group C). Mortality, hospitalization, and composite event rate were evaluated at 1 year and during long-term follow-up. Results: Patients (n = 934) were distributed as follows: group A 242, group B 347, group C 345. On 12-month follow-up examination, 63% of patients ≥ 75 years displayed a positive clinical response. Mortality was significantly higher in patients ≥ 75 years than in the other two groups, although the rate of hospitalizations for HF worsening was similar to that of patients aged 65–74 (7 vs. 9.5%, respectively, p = 0.15). Independent predictors of death and of negative clinical response were age &gt, 80 years, chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD). Over long-term follow-up (1020 days (IQR 680-1362)) mortality was higher in patients ≥ 75 years than in the other two groups. Hospitalization and composite event rates were similar in patients ≥ 75 years and those aged 65–74 (9 vs. 11.8%, p = 0.26, and 26.7 vs. 20.5%, p = 0.06). Conclusion: Positive clinical response and hospitalization rates do not differ between CRT recipients ≥ 75 years and those aged 65–74. However, age &gt, 80 years, COPD and CKD are predictors of worse outcomes.

Background No data exist on the ability of the novel Rhythmia 3-D mapping system to minimize fluoroscopy exposure during transcatheter ablation of arrhythmias. We report data on the feasibility and safety of a minimal fluoroscopic approach using this system in supraventricular tachycardia (SVT) procedures. Methods Consecutive patients were enrolled in the CHARISMA registry at 12 centers. All right-sided procedures performed with the Rhythmia mapping system were analyzed. The acquired electroanatomic information was used to reconstruct 3-D cardiac geometry; fluoroscopic confirmation was used whenever deemed necessary. Results Three hundred twenty-five patients (mean age = 56 ± 17 years, 57% male) were included: 152 atrioventricular nodal reentrant tachycardia, 116 atrial flutter, 41 and 16 right-sided accessory pathway and atrial tachycardia, respectively. Overall, 27 481 s of fluoroscopy were used (84.6 ± 224 s per procedure, equivalent effective dose = 1.1 ± 3.7 mSv per patient). One hundred ninety-two procedures (59.1%) were completed without the use of fluoroscopy (zero fluoroscopy, ZF). In multivariate analysis, the presence of a fellow in training (OR = 0.15, 95% CI: 0.05-0.46; p = .0008), radiofrequency application (0.99, 0.99-1.00; p = .0002), and mapping times (0.99, 0.99-1.00; p = .042) were all inversely associated with ZF approach. Acute procedural success was achieved in 97.8% of the cases (98.4 vs. 97% in the ZF vs. non-ZF group; p = .4503). During a mean of 290.7 ± 169.6 days follow-up, no major adverse events were reported, and recurrence of the primary arrhythmia was 2.5% (2.1 vs. 3% in the ZF vs. non-ZF group; p = .7206). Conclusions The Rhythmia mapping system permits transcatheter ablation of right-sided SVT with minimal fluoroscopy exposure. Even more, in most cases, the system enables a ZF approach, without affecting safety and efficacy.

Purpose A novel multiparametric algorithm based on implantable cardioverter defibrillator (ICD) sensors has been recently developed. The HeartLogic index combines multiple parameters, i.e. heart sounds, intrathoracic impedance, respiration pattern, night heart rate, and patient activity, in a single index. In the validation study, the HeartLogic alert condition was shown to identify patients during periods of significantly increased risk of heart failure (HF) events. We sought to evaluate the risk stratification ability of the algorithm in a group of patients who received the system in clinical practice. Methods The HeartLogic feature was activated in 257 ICD and cardiac resynchronization therapy ICD patients (186 male, 70±11 years, left ventricular ejection fraction 30±8%) at 11 centers. The median follow-up duration was 14 months [25–75 percentile: 7–19]. The HeartLogic algorithm automatically calculates a daily HF index and identifies periods in or out of an alert state relative to a configurable threshold (in this analysis set to 16). Results Patients experienced 40 HF hospitalizations requiring at least 1 overnight stay (0.14/patient-year) during the observation period (285 patient-years). The HeartLogic index crossed the threshold value 191 times in 105 patients. The time in the alert state was 27 patient-years, i.e. 9.5% of the total observation period. HF hospitalization rate while in alert was 0.96/patient-year and 0.05/patient-year while out of alert. The occurrence of ≥1 index crossing during follow-up was associated with the risk of HF hospitalization (odds ratio: 4.70, CI 95%: 1.79–12.4, p=0.002), independently from other baseline clinical variables. Conclusions Our analysis of data collected in clinical practice confirms that the multiparametric ICD algorithm is an independent predictor of higher risk of HF. In particular, it allows dynamic identification of time-intervals when patients are at significantly increased risk of worsening HF. This potentially helps better triage resources to a more vulnerable patient population. Funding Acknowledgement Type of funding source: None

Background Electrophysiological studies and ablation procedures expose both physicians and patients to a large amount of radiation. Most of 3-D mapping systems provide improved tracking of catheters, possibly allowing relevant reductions in radiation exposure. No data exists on the ability of the Rhythmia mapping system to minimize fluoroscopy time and dose. Purpose To report preliminary data on feasibility and safety of a minimal fluoroscopic approach using the Rhythmia mapping system in supraventricular tachycardia (SVT) procedures. Methods Consecutive patients indicated for arrhythmia ablation were enrolled in the CHARISMA study at 12 centers. For our purpose consecutive right-side procedures performed through a minimal fluoroscopy approach with the Rhythmia mapping system were analyzed. A 3D geometry of chambers of interest was reconstructed on the basis of the electroanatomic information taken from the mapping system. Fluoroscopy was used only if deemed necessary. Results This analysis included 266 patients (mean age = 57±17 years, 57% male) undergoing SVT procedures (120 AVNRT, 91 AFL, 32 AP, 11 AT and 12 other right atrial procedures). In all cases, diagnostic EP and ablation catheters were positioned using a low fluoroscopic electroanatomic guided approach. The mean fluoroscopy time needed for each procedure was 55±128 s. The median reconstructed RA volume was 92 [63–131] ml in a median mapping time of 11 [7–17] min. The median number of radiofrequency ablations to terminate each arrhythmia was 6 [3–12] (total RF delivery time of 291 [180–505] s). Sixty-five percent of the procedures (n=174) were completed with less than 10 s of fluoroscopy. Low fluoroscopy approach with less than 10 s (minimal fluoroscopy approach) was most frequently obtained in case of AVNRT (91, 76%) compared to other arrhythmias' ablation (83, 57%, p=0.001) Achievement of a minimal fluoroscopic approach was not affected by operator's experience (65% vs 66%, p=1.00, respectively within physician with more or less of 10 years of active practice), whereas it was affected by presence of a fellow in training during the procedure (72% without fellow vs 26% with fellow, p Conclusions In our preliminary experience, arrhythmias' ablation through minimal fluoroscopy approach with the use of a novel ablation technology seems to be safe, feasible, and effective in common right atrial arrhythmias. Use of fluoroscopy can be dramatically reduced in most cases, without any reduction of the safety and acute effectiveness profile. Funding Acknowledgement Type of funding source: None

Severe acute respiratory syndrome coronavirus 2 may affect the cardiovascular system and cause acute cardiac injury. Other authors described cases of myocarditis with reduced systolic function and/or a life-threatening presentation. We describe the clinical course of an unusual presentation with isolated reversible high degree atrioventricular block in a patient with COVID-19. In this case, a "wait and see approach" avoided an unnecessary permanent pacemaker implantation.

Funding Acknowledgements NO FUNDING Background Electrophysiological studies and ablation procedures expose both physicians and patients to a significant amount of radiation. Nowadays, most of 3-D mapping systems allow for improved tracking of catheters with possible reduction in radiation exposure. No data exists on the ability to minimize fluoroscopy time and dose while using the Rhythmia mapping system. Purpose To report preliminary data on feasibility and safety of a low fluoroscopic approach using the Rhythmia mapping system in SVT procedures. Methods The CHARISMA study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for arrhythmia were enrolled. For our purpose consecutive right-side procedures performed through a low fluoroscopy approach with the Rhythmia mapping system were analyzed. The mapping system was used to create the 3D geometry of chambers of interest and anatomic reference points and to visualize the catheters from the beginning to the end of the procedure. Fluoroscopy was used only if deemed necessary. Results 204 unselected consecutive cases of SVT from 11 centers were included in the study (mean age = 55 ± 18 years, 53% male, 85 AVNRT, 75 AFL, 28 AP, 9 AT and 7 other right atrial procedures). In all the cases, diagnostic EP and ablation catheters were positioned using only the low fluoroscopic guided mapping approach. During the study, a total of 7157 s of fluoroscopy was needed in 204 patients (51 ± 137 s per procedure). One hundred fourty-one procedures (69%) were completed with less than 10 seconds of fluoroscopy, whereas in 169 (83%) of the cases the fluoroscopy time was lower than 60 seconds. Low fluoroscopy approach with less than 10 seconds was less frequently obtained in case of AFL (46, 61.3%) compared to AVNRT ablation (65, 76.5%, p = 0.041) whereas no differences were found comparing with AP (21, 75%, p = 0.248). The median reconstructed RA volume was 94[65-133] ml in a median mapping time of 11 [6-16] min. The median number of radiofrequency ablations to terminate each arrhythmia was 5 [3-12] (total RF delivery time of 293 [180-505] sec). A 100% rate of acute success was observed in our case series. No complications occurred. Conclusions In our preliminary experience, arrhythmias ablation through low fluoroscopy approach and the use of a novel ablation technology seems to be safe, feasible, and effective in common right atrial arrhythmias. Use of fluoroscopy can be nearly avoided in most cases, without any reduction of the safety and effectiveness profile.

Funding Acknowledgements No Funding OnBehalf RHYTHM DETECT study group Background A two-incision technique, in association with inter-muscular positioning of the subcutaneous defibrillator (S-ICD), is now the most frequently adopted implantation approach in Europe. Ultrasound-guided serratus anterior plane block (SAPB) has been proposed in order to provide anesthesia/analgesia during S-ICD implantation. Objective We performed a case-control analysis in which a standardized SAPB approach was compared with the typical local anesthesia and sedation approach. Methods 91 consecutive patients underwent implantation of an S-ICD with the SAPB approach for anesthesia/analgesia at 10 centers. The control group consisted of 55 consecutive patients who underwent S-ICD implantation with standard local approach. Results The mean procedure duration was 59 ± 15min in the SAPB group and 76 ± 23min in the control group (p Conclusions SAPB is feasible and effective in providing anesthesia/analgesia during S-ICD implantation. The procedures were successfully accomplished and no complications occurred in either group. However, SAPB was associated with lower pain levels, enabling the need for sedation to be reduced and more patients to remain awake. Moreover, it resulted in shorter procedure durations.

Background Catheter ablation (CA) for atrial fibrillation (AF) in heart failure (HF) patients is associated with a lower rate of cardiac events compared to medical therapy. Purpose This study deals with the clinical, echocardiographic and prognostic outcomes in these patients. Methods From a single center 47 patients with AF, HF and left ventricular ejection fraction (LVEF) (Meta-Analysis Global Group in Chronic Heart Failure) Risk score before the procedure and after 12 months. Results The median age of patients was 59 years; 49% had paroxysmal AF. At 12-month 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 0.000). 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 0.000). At 12-month patients with reduced LVEF before the ablation had more HF hospitalizations than HF mid-range patients (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. Conclusion 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 score before ablation were predictors of HF hospitalization at 12-month follow-up.

Background The HeartLogic algorithm measures and combines multiple parameters, i.e. heart sounds, intrathoracic impedance, respiration pattern, night heart rate, and patient activity, in a single index. The associated alert has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation, and the HeartLogic alert condition was shown to identify patients during periods of significantly increased risk of HF events. Purpose To report the results of a multicenter experience of remote HF management with HeartLogic algorithm and appraise the value of an alert-based follow-up strategy. Methods The HeartLogic feature was activated in 104 patients (76 male, 71 ± 10 years, left ventricular ejection fraction 29 ± 7%). All patients were followed according to a standardized protocol that included remote data reviews and patient phone contacts every month and at the time of HeartLogic alerts. In-office visits were performed every 6 months or when deemed necessary. Results During a median follow-up of 13[11-18] months, centers performed remote follow-up at the time of 1284 scheduled monthly transmissions (10.5 per pt-year) and 100 HeartLogic alerts (0.82 alerts/pt-year). The mean delay from alert to the next monthly remote data review was 14 ± 8 days. Overall, the patient time in the alert state (i.e. HeartLogic index above the threshold) was 14% of the total observation period. HF events requiring active clinical actions were detected at the time of 11 (0.9%) monthly remote data reviews and at 43 (43%, p Conclusions HeartLogic alerts are frequently associated with relevant actionable HF events. Events are detected earlier and the volume of alert-driven remote follow-ups is limited when compared with a monthly remote follow-up scheme. The probability of detecting common signs and symptoms of HF at regular remote or in-office assessment is extremely low when the patient is out of HeartLogic alert state. These results support the adoption of an alert-based follow-up strategy.

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.

Background The HeartLogic algorithm measures data from multiple implantable cardioverter‐defibrillator‐based sensors and combines them into a single index. The associated alert has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. Hypothesis We describe a multicenter experience of remote HF management by means of HeartLogic and appraise the value of an alert‐based follow‐up strategy. Methods The alert was activated in 104 patients. All patients were followed up according to a standardized protocol that included remote data reviews and patient phone contacts every month and at the time of alerts. In‐office examinations were performed every 6 months or when deemed necessary. Results During a median follow‐up of 13 (10–16) months, the overall number of HF hospitalizations was 16 (rate 0.15 hospitalizations/patient‐year) and 100 alerts were reported in 53 patients. Sixty alerts were judged clinically meaningful, and were associated with multiple HF‐related conditions. In 48 of the 60 alerts, the clinician was not previously aware of the condition. Of these 48 alerts, 43 triggered clinical actions. The rate of alerts judged nonclinically meaningful was 0.37/patient‐year, and the rate of hospitalizations not associated with an alert was 0.05/patient‐year. Centers performed remote follow‐up assessments of 1113 scheduled monthly transmissions (10.3/patient‐year) and 100 alerts (0.93/patient‐year). Monthly remote data review allowed to detect 11 (1%) HF events requiring clinical actions (vs 43% actionable alerts, P

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.

Background Professional guidelines are based on the best available evidence. However, patients treated in clinical practice may differ from those included in reference trials. Objective The aim of this study was to evaluate the effects of cardiac resynchronization therapy (CRT) in a large population of patients implanted with a CRT device stratified in accordance with the 2016 European heart failure (HF) guidelines. Methods We collected data on 930 consecutive patients from the Cardiac Resynchronization Therapy MOdular REgistry. The primary end point was a composite of death and HF hospitalization. Results Five hundred sixty-three (60.5%) patients met class I indications, 145 (15.6%) class IIa, 108 (11.6%) class IIb, and 114 (12.3%) class III. After a median follow-up of 1001 days, 120 (14.7%) patients who had an indication to CRT had died and 71 (8.7%) had been hospitalized for HF. The time to the end point was longer in patients with a class I indication (hazard ratio 0.55; 95% confidence interval 0.39–0.76; P = .0001). After 12 months, left ventricular (LV) end-systolic volume had decreased by ≥15% in 61.5% (320/520) of patients whereas in 57.5% (389/676) of patients the absolute LV ejection fraction improvement was ≥5%. Adherence to class I was also associated with an absolute LV ejection fraction increase of >5% (P = .0142) and an LV end-systolic volume decrease of ≥15% (P = .0055). Conclusion In our population, ∼60% of patients underwent implantation according to the 2016 European HF guidelines class I indication. Adherence to class I was associated with a lower death and HF hospitalization rates and better LV reverse remodeling.

Background Arial fibrillation (AF) ablation outcome is still operator dependent. Ablation Index (AI) is a new lesion quality marker that has demonstrated to allow acute durable pulmonary vein (PV) isolation followed by a high single-procedure arrhythmia-free survival. Aim This prospective, multi-centre study was designed to evaluate the reproducibility of 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 380–500). Radiofrequency energy was delivered targeting interlesion distance ≤ 6 mm. Results At 12 months’ follow-up a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs. 83.3%, P = 0.039). There was no difference in the rate of atrial arrhythmias 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 = 0.083). At 12 months’ follow-up, the rate of atrial arrhythmias recurrence was also similar between patients treated with a ST catheter (8%) and STSF catheter (12.1%, P = 0.2), between patients treated with an AI settings of 330–450 (10.9%) and an AI of 380–500 (10.3%, P = 0.64), and among the several operators (P = 0.84 and P = 0.75 respectively in patients with paroxysmal and persistent AF) ( Fig. 1 ). Conclusions An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of one-year freedom from AF recurrence, both in patients with paroxysmal and persistent AF, irrespective of the ablation catheters, AI settings, and operator.

Background: A two-incision technique, in association with inter-muscular positioning of the subcutaneous defibrillator (S-ICD), is now the most frequently adopted implantation approach in Europe. Ultrasound-guided serratus anterior plane block (SAPB) has been proposed to provide anesthesia/analgesia during S-ICD implantation. Objective: We performed a case-control analysis in which a standardized SAPB approach was compared with the typical local anesthesia and sedation approach. Methods: Ninety-one consecutive patients underwent implantation of an S-ICD with the SAPB approach for anesthesia/analgesia at 10 centers. The control group consisted of 55 consecutive patients who underwent S-ICD implantation with a standard local approach. Results: The mean procedure duration was 59 ± 15 minutes in the SAPB group and 76 ± 23 minutes in the control group (P

Background The benefit of cardiac resynchronization therapy (CRT) in patients (pts) with chronic kidney disease (CKD) remains controversial despite frequent use. Pts with impaired renal function have systematically been excluded from randomized clinical trials and therefore specific recommendations for the use of CRT in these pts are still lacking. Purpose Study objectives were to assess long-term outcomes and clinical/echocardiographic response in a large population of patients with moderate-to-severe impaired renal function implanted with a CRT device in accordance with the current standard of care. Methods We prospectively analyzed clinical, instrumental data and survival of pts with CKD who received a CRT device in the CRT-MORE registry from 2011 to 2014. Adverse events for the analysis of clinical outcome comprised death from any cause and nonfatal HF events requiring hospitalization after CRT implantation. LV reverse remodeling and Clinical Response (CR) were also evaluated at 12-month follow-up. Patients were stratified according to current definition of CKD stage: low-moderate CKD with a GFR = 45–59 mL/min (stage 3A); moderate CKD with a GFR = 30–44 mL/min (stage 3B) and severe CKD with a GFR = 15–29 mL/min (stage 4). Results Of the 922 consecutive patients enrolled in the registry, 416 (45%) pts had a moderate-to-severe impaired renal function (43% Stage 3A, 43% Stage 3B and 14% Stage 4). The mean follow-up was 935±506 days. By the end of the study, 85 pts had died and 47 pts had been hospitalized for HF. The combined end-point of death or HF hospitalization was reached by 121 (29%) pts. After 12 months the absolute LVEF improvement was greater than 10% in 37% of pts and 58% of pts displayed a positive clinical response. The percentage of pts who died was higher in the group of pts with severe CKD (32.8% vs 18.4%; p=0.012, compared to the group of pts with moderate CKD). On the contrary the percentage of pts who had at least one HF hospitalization was lower in the group with more severe CKD (2% vs 13%; p=0.011). According to CKD stage both LV remodeling (LVEF improvement ranging from 43.7% - 3A - to 30.8% - 4) and CR (positive response ranging from 63.9% - 3A - to 50% - 4) were higher in low-moderate stage and decreased with CKD severity. At multivariate Cox regression analysis adjusted for baseline confounders, CKD class at implantation [HR=1.5; 95% CI: 1.06–2.14; p=0.0219], chronic obstructive pulmonary disease [HR=1.89; 1.18–3.01; p=0.0077], persistent/permanent AF [HR=1.86; 1.15–3.01; p=0.0115] and male gender [HR=1.92; 1.07–3.46; p=0.0301] remained associated with death. Conclusions Among CKD patients in the CRT-MORE registry, severity of renal dysfunction at the time of CRT implantation was associated with worse prognosis, lower clinical response and LV reverse remodeling. Acknowledgement/Funding None

Background The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter-defibrillator (ICD)-based sensors and has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. Objective To describe a preliminary experience of remote HF management of patients who received a HeartLogic-enabled ICD or cardiac resynchronization therapy ICD (CRT-D) in clinical practice. Methods The HeartLogic feature was activated in 101 patients (74 male, 71±10 years, ejection fraction 30±7%). From implantation to activation (blinded phase), the HeartLogic index trend was not available, thus no clinical actions were taken in response to it. After activation (active phase), remote data reviews and patient phone contacts were performed monthly and at the time of HeartLogic alerts (when the index crossed the nominal alert threshold value of 16), to assess the patient decompensation status. In-office visits were performed when deemed necessary. Results During the blinded phase, the HeartLogic index crossed the threshold value 24 times (over 24 person-years, 0.99 alerts/pt-year) in 16 patients. HeartLogic alerts preceded all hospitalizations and unplanned in-office visits for HF (sensitivity: 100%, median early warning: 38 days for hospitalizations, 12 days for HF visits). No clinical events were detected during or within 30 days of recovery of 10 HeartLogic alerts (unexplained alert rate: 0.41 per patient-year). Thus, the positive predictive value was 58% (14/24). During the active phase, 44 HeartLogic alerts were reported (over 46 person-years, 0.95 alerts/pt-year) in 30 patients. 26 (59%) HeartLogic alerts were judged clinically meaningful (i.e. associated with worsening of HF and/or influenced the clinician's decision to make changes to the subject's management). Conclusions In this first description of the use of HeartLogic in clinical practice, the algorithm demonstrated its ability to detect gradual worsening of HF. The results of the blinded phase of our experience favorably compare with those reported in the validation study. In the active phase, the HeartLogic index provided clinically meaningful information for the remote management of HF patients.

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

Objectives The aim of the study was to confirm the value of the VALID‐cardiac resynchronization therapy (CRT) risk score in predicting outcome and to assess its association with clinical response (CR) in an unselected real‐world CRT population. Methods and Results The present analysis comprised all consecutive CRT patients (pts) enrolled in the CRT‐MORE registry from 2011 to 2013. Pts were stratified into five groups (quintiles 1‐5) according to the VALID‐CRT risk predictor index applied to the CRT‐MORE population. In the analysis of clinical outcome, adverse events comprised death from any cause and non‐fatal heart failure (HF) events requiring hospitalization. CR at 12‐month follow‐up was also assessed. We enrolled 905 pts. During a median follow‐up of 1005 [627‐1361] days, 134 patients died, and 79 had at least one HF hospitalization. At 12 months, 69% of pts displayed an improvement in their CR. The mean VALID‐CRT risk score derived from the CRT‐MOdular Registry (MORE) population was 0.317, ranging from −0.419 in Q1 to 2.59 in Q5. The risk‐stratification algorithm was able to predict total mortality after CRT (survival ranging from 93%‐Q1 to 77%‐Q5; hazards ratio [HR] = 1.42, 95% confidence interval [CI]: 1.25‐1.61, P

Background Several studies have investigated the association between native QRS duration (QRSd) or QRS narrowing and response to biventricular pacing. However, their results have been conflicting. The aim of our study was to determine the association between the relative change in QRS narrowing index (QI) and clinical outcome and prognosis in patients who undergo cardiac resynchronization therapy (CRT) implantation. Methods and results We included 311 patients in whom a CRT device was implanted in accordance with current guidelines for CRT. On implantation, the native QRS, the QRSd and the QI during CRT were measured. After 6months, 220 (71%) patients showed a 10% reduction in LVESV. The median [25th–75th] QI was 14.3% [7.2–21.4] and was significantly related to reverse remodeling (r=+0.22; 95%CI: 0.11–0.32, p=0.0001). The cut-off value of QI that best predicted LV reverse remodeling after 6months of CRT was 12.5% (sensitivity=63.6%, specificity=57.1%, area under the curve=0.633, p=0.0002). The time to the event death or cardiovascular hospitalization was significantly longer among patients with QI>12.5% (log-rank test, p=0.0155), with a hazard ratio (HR) of 0.3 [95%CI: 0.11–0.78]. In the multivariate regression model adjusted for baseline parameters, a 10% increment in QI (HR=0.61[0.44–0.83], p=0.002) remained significantly associated with CRT response. Conclusions Patients with a larger decrease in QRSd after CRT initiation showed greater echocardiographic reverse remodeling and better outcome from death or cardiovascular hospitalization. QI is an easy-to-measure variable that could be used to predict CRT response at the time of pacing site selection or pacing configuration programming.