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The prevalence and impact of pulmonary embolism (PE) in patients with lead-related infective endocarditis undergoing transvenous lead extraction (TLE) are unknown.Twenty-five consecutive patients with vegetations ≥10 mm at transoesophageal echocardiography were prospectively studied. Contrast-enhanced chest computed tomography (CT) was performed before (pre-TLE) and after (post-TLE) the lead extraction procedure.Pre-TLE CT identified 18 patients (72%) with subclinical PE. The size of vegetations in patients with PE did not differ significantly from those without (median 20.0 mm [interquartile range: 13.0-30.0] vs. 14.0 mm [6.0-18.0], p = 0.116). Complete TLE success was achieved in all patients with 3 (2-3) leads extracted per procedure. There were no postprocedure complications related to the presence of PE and no differences in terms of fluoroscopy time and need for advanced tools. In the group of positive pre-TLE CT, post-TLE scan confirmed the presence of silent PE in 14 patients (78%). There were no patients with new PE formation. Large vegetations (≥20 mm) tended to increase the risk of post-TLE subclinical PE (odds ratio 5.99 [95% confidence interval (CI): 0.93-38.6], p = 0.059). During a median 19.4 months follow-up, no re-infection of the implanted system was reported. Survival rates in patients with and without post-TLE PE were similar (hazard ratio: 1.11 [95% CI: 0.18-6.67], p = 0.909).Subclinical PE detected by CT was common in patients undergoing TLE with lead-related infective endocarditis and vegetations but was not associated with the complexity of the procedure or adverse outcomes. TLE procedure seems safe and feasible even in patients with large vegetations.

Introduction Implantable cardioverter defibrillators (ICDs) provide daily values of thoracic impedance (TI) that are inversely correlated with fluid accumulation in the lungs. Since sustained ventricular arrhythmias (SVA) are known to have a short-term relationship with heart failure exacerbations, our objective was to assess TI trends temporally related to SVA episodes. Methods This study analyzed data daily transmitted from patients with ICD or cardiac resynchronization therapy defibrillator (CRT-D) of the nationwide Home Monitoring Expert Alliance network. Device-detected SVAs were adjudicated for appropriateness. Patients were randomly split into a derivation and validation cohort. To identify the most significant TI trend (TI-index), several numerical TI transformations were tested in a cross-sectional analysis of the derivation cohort modelling the odds of first SVA with univariate logistic regressions. In the same cohort, the threshold of the selected transformation was identified to maximize the projected specificity. The relative risk of SVA for TI-index above threshold was estimated in the validation cohort by applying Cox proportional hazard models stratified by individual patients to 60-day duration windows. Analyses were performed separately in the ICD and CRT-D groups. Results The study cohort included 2,384 patients with 69 years of age (interquartile range: 60, 77); 19% were women, 42% had coronary artery disease, and 43% had a CRT-D. After a median follow-up of 2.0 (1.0, 3.4) years, there were 3,298 appropriate SVA episodes in 727 patients (30%). The derived IT-index consisted of the percentage of 6-day intervals of the rolling average of TI values showing monotone decrease in the last 82 days. The increase in the risk of SVA was 3% (p In the validation cohort, the TI-Index was associated with a 42% increased risk of SVA episodes in the ICD group (hazard ratio [HR] 1.42, 95% confidence interval [CI] 1.05-1.92, p=0.023). The TI-index exceeded the 60% threshold before the episode in 38% of the detected episodes. The association was not significant in the CRT-D group (HR 0.96, 95% CI 0.62-1.47, p=0.84). Conclusions In our analysis of remote monitoring data, a specific monotonic decreasing trend of TI was temporally associated with SVA in patients with ICD. Careful monitoring of TI can identify a period of susceptibility to ventricular arrhythmias that deserves more intensive attention.

Reliable post-approval surveillance of implantable cardioverter-defibrillator (ICD) lead performance remains a challenge. In the past, two ICD leads were recalled due to a high frequency of failures. In this meta-analysis, we sought to provide a combined estimate of failure-free rate for ICD leads by reconstructing individual patient data from published Kaplan-Meier (KM) curves and to investigate whether estimates could be influenced by the characteristics of the study.Observational studies assessing failure-free estimates of transvenous ICD leads with KM method, were identified through a systematic search up to November 2021.Forty-four studies were eligible that included 41,870 (63.1%) non-recalled leads and 24,493 (36.9%) recalled leads. The 8-year cumulative failure-free rate was 94.1% (CI, 93.6% - 94.6%) for contemporary non-recalled leads and 81.2% (80.3% - 82.0%) for recalled leads (hazard ratio [HR], 3.15 [2.85-3.47], p 0.001). Failure-free rate was lower in single-center studies in both the non-recalled (HR, 0.28 [0.15-0.51], p 0.001) and recalled (HR, 0.54 [0.33-0.88], p = 0.014) group compared with multicenter studies. Similarly, estimates were significantly lower in small (i.e. extracted KM curve with312 leads) versus large studies (HR non-recalled group, 0.54 [CI, 0.33-0.89], p = 0.015; HR recalled group, 0.62 [CI, 0.43-0.89], p = 0.009).In this meta-analysis including66,000 leads, we provide pooled survival curves that may play a role in generating evidence-based standards for assessing clinically acceptable failure rates for ICD leads. Lead performance was underestimated with single-center and small-sized studies; multicenter studies remain the main tool to reliably conduct post-market surveillance of ICD leads.

Aims Implantable cardiac monitors (ICMs) can generate false-positive (FP) alerts. Although these devices have an extended programmability, there are no recommendations on their optimization to reduce not-relevant activations. We tested a strategic programming optimization guide based on the type of FP and investigated the safety and feasibility of the nurse-led insertion of ICMs with a long-sensing vector. Methods and results Consecutive patients implanted by trained nurses with long-sensing vector ICM were enrolled in a 1-month observational stage (Phase A). Patients who had ≥10 FP episodes underwent ICM reprogramming based on the predefined guide and were followed for an additional month (Phase B). A total of 78 patients had successful ICM insertion by nurses with a mean R wave amplitude of 0.96 ± 0.43 mV and an 86% P wave visibility. Only one patient reported a significant device-related issue, and nurse-delivered ICM was generally well accepted by the patients. During Phase A, 11 patients (14%) generated most of FP (3,627/3,849; 94%) and underwent ICM reprogramming. In the following month (Phase B), five patients (45%) were free from FP and six (55%) transmitted 57 FP alerts (98% reduction compared with Phase A). The median number of FP per patient was significantly reduced after reprogramming [195 (interquartile range, 50–311) vs. one (0–10), P = 0.0002]. Conclusion A strategic reprogramming of ICM in those patients with a high FP alert burden reduces the volume of erroneous activations with potential benefits for the remote monitoring service. No concerns were raised regarding nurse-led insertion of ICMs with a long-sensing vector.

Background Permanent cardiac pacing is the therapy of choice for treating severe and/or symptomatic bradyarrhythmia. During the COVID-19 outbreak, it has been reported a decrease in the incidence of acute coronary syndrome, but few data are available about pacemaker implantation rates. This study aimed to analyse patients referred to our centre with permanent cardiac pacing indication during the COVID-19 outbreak. Methods We compared the number, the characteristics and the outcomes of patients who underwent urgent pacemaker implantation between March and April 2019 (Group I) with those performed in the corresponding 2020 period (Group II). Results A total of 27 patients (Group I) were implanted in March-April 2019 and 34 patients (Group II) in the corresponding 2020 period. In both groups, about half of the patients received a dual-chamber pacemaker. No significant differences in baseline patients' characteristics were observed. The most frequent indication was advanced atrio-ventricular block with a prevalence of 78% and 62% in Group I and II, respectively. The rate of procedural complications, the in-hospital and 1-month mortality were also similar between the two groups. Conclusions In our regional referral center, we observed a routine activity in terms of urgent pacemaker implantations for the treatment of symptomatic bradyarrhythmia during the COVID-19 outbreak.

A 51-year-old man with Brugada syndrome (BrS) electrocardiogram (ECG) type I pattern underwent implantable cardiac monitor (ICM) insertion. After pre-insertion potential mapping, we could observe the patient-specific repolarization abnormalities on the subcutaneous ECG provided by the ICM. A few weeks later, we received remotely a device recording with a higher ST-segment elevation and a longer duration of the interval between the onset of the coved elevation and its termination at the isoelectric line. Our observation supports the conceptual premise that ICM could add information on quantifying the amount of time with abnormal ECG patterns rather than only for the diagnosis of cardiac arrhythmias.

Background: Optimal timing for catheter ablation of ventricular tachycardia is an important unresolved issue. There are no randomized trials evaluating the benefit of ablation after the first implantable cardioverter defibrillator (ICD) shock. Methods: We conducted a 2-phase, prospective, multicenter, randomized clinical trial. Patients with ischemic or nonischemic dilated cardiomyopathy and primary or secondary prevention indication for ICD were enrolled in an initial observational phase until first appropriate shock (phase A). After reconsenting, patients were randomly assigned 1:1 in phase B to immediate ablation (within 2 months from shock delivery) or continuation of standard therapy. The primary end point was a composite of death from any cause or hospitalization for worsening heart failure. Amiodarone intake was not allowed except for documented atrial tachyarrhythmias. On July 23, 2021, phase B of the trial was interrupted as a result of the first interim analysis on the basis of the Bayesian adaptive design. Results: Of the 517 patients enrolled in phase A, 154 (30%) had ventricular tachycardia, 56 (11%) received an appropriate shock over a median follow-up of 2.4 years (interquartile range, 1.4–4.4), and 47 of 56 (84%) agreed to participate in phase B. After 24.2 (8.5–24.4) months, the primary end point occurred in 1 of 23 (4%) patients in the ablation group and 10 of 24 (42%) patients in the control group (hazard ratio, 0.11 [95% CI, 0.01–0.85]; P =0.034). The results met the prespecified termination criterion of >99% Bayesian posterior probability of superiority of treatment over standard therapy. No deaths were observed in the ablation group versus 8 deaths (33%) in the control group ( P =0.004); there was 1 worsening heart failure hospitalization in the ablation group (4%) versus 4 in the control group (17%; P =0.159). ICD shocks were less frequent in the ablation group (9%) than in the control group (42%; P =0.039). Conclusions: Ventricular tachycardia ablation after first appropriate shock was associated with a reduced risk of the combined death or worsening heart failure hospitalization end point, lower mortality, and fewer ICD shocks. These findings provide support for considering ventricular tachycardia ablation after the first ICD shock. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01547208.

This review addresses tilt-testing methodology by searching the literature which reports timing of asystole and loss of consciousness (LOC). Despite the Italian protocol being the most widely adopted, its stipulations are not always followed to the letter of the European Society of Cardiology guidelines. The discrepancies permit reassessment of the incidence of asystole when tilt-down is early, impending syncope, compared with late, established LOC. Asystole is uncommon with early tilt down and diminishes with increasing age. However, if LOC is established as test-end, asystole is more common, and it is age-independent. Thus, the implications are that asystole is commonly under-diagnosed by early tilt-down. The prevalence of asystolic responses observed using the Italian protocol with a rigorous tilt down time is numerically close to that observed during spontaneous attacks by electrocardiogram loop recorder. Recently, tilt-testing has been questioned as to its validity but, in selection of pacemaker therapy in older highly symptomatic vasovagal syncope patients, the occurrence of asystole has been shown to be an effective guide for treatment. The use of head-up tilt test as an indication for cardiac pacing therapy requires pursuing the test until complete LOC. This review offers explanations for the findings and their applicability to practice. A novel interpretation is offered to explain why pacing induced earlier may combat vasodepression by raising the heart rate when sufficient blood remains in the heart.

We hypothesized that an accurate assessment of preoperative venography could be useful in predicting transvenous lead extraction (TLE) difficulty.A dedicated preoperative venogram was performed in consecutive patients with cardiac implantable electronic device who underwent TLE. The level of stenosis was classified as without significant stenosis, moderate, severe, and occlusion. The presence of extensive lead-venous wall adherence (≥50 mm) was also assessed. A total of 105 patients (median age: 71 years; 72% male) with a median of 2 (1-2) leads to extract were enrolled. Preoperative venography showed moderate to severe stenosis in 31 (30%), complete occlusion in 15 (14%), and extensive lead-venous wall adherence in 50 (48%) patients. Complete TLE success was achieved in 103 (98%) patients. A total of 55 (52%) were advanced extractions as they required a powered mechanical and/or laser sheath. They were more prevalent in the group with extensive lead-venous wall adherence (72% vs. 34%, p .001), while no differences were found between patients with and without venous occlusion. In multivariate analysis, the presence of adherence was a predictor of advanced extraction (odds ratio: 2.89 [1.14-7.32], p = .025). The fluoroscopy time was also significantly longer (14.0 [8.2-18.7] vs. 5.1 [2.1-10.0] min, p .001). The rate of complications did not differ based on the presence of venous lesions.Although procedural success and complication rates were similar, patients with extensive lead-venous wall adherence required a longer fluoroscopy time and were three times more likely to need advanced extraction tools. Conversely, the presence of total venous occlusion had no impact on the procedure complexity.

Causes of sex differences in incidence of sustained ventricular arrhythmias (SVAs) are poorly understood.This study aims to investigate sex-specific risk of SVAs and device therapies by balancing sex groups in relation to several baseline characteristics with the propensity score (PS).We used a large remote monitoring dataset from implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Study endpoints were time to the first appropriate SVA, time to the first device therapy for SVA, and time to the first ICD shock. Results were compared between females and a PS-matched male subgroup.In a cohort of 2,532 patients with an ICD or CRT-D (median age, 70 years), 488 patients (19.3%) were women. After selecting 488 men PS-matched for 19 variables relative to baseline demographics, implant indications, principal comorbidities, and concomitant therapy, yet the SVA rate at the 2.1-year median follow-up was significantly lower in women than in man (adjusted HR: 0.65; 95% CI: 0.51-0.81; P 0.001). Women also showed a reduced risk of any device therapy (HR: 0.59; 95% CI: 0.45-0.76; P 0.001) and shocks (HR: 0.66; 95% CI: 0.47-0.94; P = 0.021). Differences in sex-specific SVA risk profile were not confirmed in CRT-D patients (HR: 0.78; 95% CI: 0.55-1.09; P = 0.14) nor in those with an ejection fraction 30% (HR: 0.80; 95% CI: 0.52-1.23; P = 0.31).After matching demographics, indications, principal comorbidities, and concomitant therapy, women still exhibited a lower SVA risk profile than men, except in the subgroups of CRT-D or/and ejection fraction 30%.

Background Laser balloon ablation is a promising option for performing pulmonary vein isolation (PVI) which is the cornerstone of invasive atrial fibrillation (AF) treatment. Purpose We aimed to investigate the acute efficacy and safety of the novel third-generation of the laser balloon system in an initial multicenter experience. Methods First and consecutive patients who underwent PVI with LB3 for drug-resistant paroxysmal or persistent AF at 7 Italian sites were included in this analysis. Study endpoints were acute procedural efficacy, defined as successful isolation of all identified PVs without radiofrequency touch-up, total and fluoroscopy times, and periprocedural complications. Results Our population included 86 patients (81% males, mean age 60.6±9.5 years) who underwent a procedure of PVI using LB3 between June 2020 and March 2021. Most patients had paroxysmal AF (74%) and were in sinus rhythm at the beginning of the procedure. The mean procedure time was 138±60 min; fluoroscopy time was 22±17 min and the mean ablation time was 44±40 min. Of the 313 targeted PVs, 311 (99.4%) could be isolated with first-pass LB3 application, while 2 (0.6%) required radiofrequency touchup. At the end of the procedure, all patients were in sinus rhythm and 26 (32%) received electrical cardioversion to achieve stable sinus rhythm. The total rate of major compilations was 1.2% (1/82 patients): one pericardial tamponade requiring epicardial puncture. No surgical intervention was necessary, and the patient recovered without any sequalae. There were no vascular access complications or phrenic nervy palsy. Three pinhole balloon raptures (3.5%) were observed during energy applications that required replacement of the whole system but had no effect on patient safety. Conclusions In a first multicenter experience, the LB3 system for PVI was safe with excellent acute efficacy. Funding Acknowledgement Type of funding sources: None.

Background Automatic diagnosis of implantable cardioverter defibrillator (ICD) requires confirmation through analysis of electrograms (EGM) recordings by an electrophysiologist (EP) specialist. Purpose To investigate whether the atrial sensing capability in single-chamber ICD improves reliability in episodes assessment. Methods The THINGS registry enrolled 526 consecutive patients without atrial pacing indication who underwent single-lead ICD implantation. Of them, 343 patients received a conventional single-chamber ICD (ICD VR) and 183 a single-lead ICD with atrial sensing capability (ICD DX, BIOTRONIK). Device-detected ventricular episodes were independently classified by two experienced electrophysiologists as ventricular (VT) or supraventricular tachycardia (SVT) by analyzing the EGMs. In case of disagreement, a third experienced EP specialist, blinded to previous assessment, was consulted. The inter-rate reliability was evaluated using the Cohen's kappa (k) coefficient in the ICD VR and ICD DX group. Results A total 441 (383 in the ICD VR and 58 in the ICD DX group) device-detected events were analyzed. Using ventricular EGM alone for ICD VR patients, the proportion of observed agreement between the 1st and 2nd adjudicator was 86.4% consisting of 268 (70.0%) episodes confirmed as VT and 63 (16.4%) classified as SVT. The k coefficient was 0.61 and no agreement was reached for 52 (13.6%) tracings. For them, the third assessment had low agreement with both previous EP evaluations (the k coefficients 1st/3th and 2nd/3th EP specialist were 0.03 and −0.05, respectively). In ICD DX group, with available atrial EGM, the proportion of observed agreement in the first stage improved to 93.0%: 44 (75.8%) episodes were adjudicated as VT and 10 (17.2%) as SVT with a k=0.79. Only 4 (7.0%) recordings had a discordant classification. For them, the 2nd and 3rd EP specialist had perfect agreement (k=1). Conclusions Atrial sensing capability improves EP specialist assessment of ICD episodes allowing dual EGMs analysis. Misinterpretation of ICD recordings may thus be less common in ICD DX than in conventional single-chamber ICD VR and may improve clinical decisions. Funding Acknowledgement Type of funding sources: None.

Background The rapid mode feature implemented in the latest version of the laser balloon system (LB3, HeartLight, X3, Cardiofocus) offers an automated continuous 360° lesion for pulmonary vein isolation (PVI). However, data on its clinical applicability and the potential reduction of procedural times are not yet available. Purpose To explore the use of the rapid mode and its association with PV total and fluoroscopy times in our initial experience with LB3. Methods This analysis included consecutive patients who underwent PVI procedure with LB3. We attempted to perform a complete circular ablation line using the rapid mode at 13 W, but if needed to achieve successful isolation, rapid mode was interrupted and manual mode (5.5–8.5 W) applications were used. The percentage of rapid mode use on the 360° lesion was measured for each PV. Total and fluoroscopy times to complete PVI were also collected. Results A total of 110 PVs were identified in 27 LB3 procedures and successfully isolated with a mean procedural time of 85±31 min. Sixty (55%) PVs were treated by using rapid mode for more than 50% (180°) lesion and 13 (12%) of them had a pure rapid mode ablation (without necessity of manual mode applications). Right inferior PV had the highest use of rapid mode (median value 70%). The main reasons for manual applications were poor PV occlusion, imperfect ostium visualization and presence of blood. PVs with >50% rapid mode use were treated in a significantly shorter time (21.2±13.7 vs 26.8±12.4, p=0.043). Fluoroscopy time did not differ significantly (4.7±4.2 vs 5.4±4.9, p=0.48). Three pinhole balloon ruptures were observed during rapid mode energy application in the second, third and twenty-fifth procedure. No other complications occurred. Conclusions Few PVs could be isolated using pure rapid mode; however, its applicability for more than 50% lesion was observed more frequently and significantly reduced the time to isolation. Funding Acknowledgement Type of funding sources: None. Time to isolation using Rapid Mode

Background Electric isolation of the pulmonary veins (PVs) can successfully treat patients with atrial fibrillation (AF). Isolation of pulmonary veins can be achieved by several methods: radiofrequency, cryoballoon or laser balloon ablation (LBA). The main procedural challenge with either method is to achieve a continuous circumferential lesion at the left atrium-PVs junction, with the persistence of functional gaps. Purpose A novel endoscopic ablation system equipped with a precise motor control system (MCS) has been evaluated. The balloon is used with an endoscope to directly visualize and ablate tissue at the left atrial-PVs junction with laser energy. This system enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician. The MCS is intended to reduce procedure time and to ensure continuity of ablation lesions. The feasibility of the motorized ablation in terms of extent of applicability along each PV-left atrium junction and time of use of the manual point-by-point mode has been investigated. Methods 27 consecutive patients (male 70.3%, age 61.2±8.7 years) with paroxysmal or persistent AF who underwent LBA were enrolled in our institution. Exclusion criteria were any contraindication for the procedure including the presence of intracavitary thrombosis and contraindications to general anesthesia or deep sedation. After transseptal puncture, the balloon-based endoscopic ablation system was advanced to each PV ostium, and laser energy were projected onto the target. Results A total of 110 PVs were treated with LBA; in 9 patients there was a redundant right intermediate pulmonary vein; in 4 patients there was a right common ostium and in 2 a left common ostium. MCS was used for 82 PVs (74.5%): in particular, MCS was used continuously between 180° and 325° degrees (50 to 90% of PV circumference) for 35 PVs (31.8%) and between 326° and 359° degrees (91 to 99% of PV circumference) for 25 veins (22.7%). In 13 PVs (12%) MCS was used for the entire circumference. During 8508 (19.6%) seconds out of a total of 43.368 seconds, laser energy delivery occurred in the rapid mode by MCS. No clinical complications, either local or systemic (stroke or TIA, pericardial effusion, pericardial tamponade, pulmonary vein stenosis, esophageal injury, temporary or permanent phrenic nerve palsy), were observed neither during the use of MSC nor during the use of manual point-by-point mode. Of note, a pinhole rupture of the balloon occurred in 3 cases of our series, during the use of MCS, without harm to the patient and requiring only replacement of the LBA. Conclusions In our case series, laser balloon ablation with the help of motor control system appears safe and feasible in most cases for large portions of pulmonary vein circumference, providing considerable time sparing (74.5% of total ablation extent in 19.6% of total ablation time). Funding Acknowledgement Type of funding sources: None.

This study evaluated the temporal association between atrial high-rate episodes (AHREs) and sustained ventricular arrhythmias (VAs) in a remotely monitored cohort with implantable cardioverter-defibrillators (ICD) with and/or without cardiac resynchronization therapy with a defibrillator (CRT-D).Clinical relevance of AHREs in terms of VA rate and survival has not been outlined yet.This study analyzed data of patients with ICDs and CRT-Ds from the nationwide Home Monitoring Expert Alliance network. The cohort included 2,435 patients with a median follow-up of 25 months (interquartile range: 13 to 42 months) and age 70 years (range 61 to 77 years); 19.7% were women, 51.4% had coronary artery disease, and 45.2% had a CRT-D. There were 3,410 appropriate VA episodes; 498 (14.6%) were preceded by AHREs within 48 h; in 85.5% of this group, AHREs were still ongoing at episode onset.In a longitudinal analysis, the odds ratios (ORs) of experiencing any VA in a 30-day interval with AHREs versus intervals without AHREs were 2.35 (95% confidence interval [CI]: 1.86 to 2.97; p 0.001) for ventricular tachycardia (VT), 3.06 (95% CI: 2.35 to 3.99; p 0.001) for fast VT, 1.84 (95% CI: 1.36 to 2.48; p 0.001) for self-extinguishing ventricular fibrillation (VF), and 2.31 (95% CI: 1.17 to 4.57; p = 0.01) for VF. ORs decreased with increasing AHRE burden. Patients with AHREs 48 h before VAs were more likely to experience VA recurrences (adjusted hazard ratio [HR]: 1.78; 95% CI: 1.41 to 2.24; p 0.001) and had higher overall mortality (HR: 2.67; 95% CI: 1.68 to 4.23; p 0.001).AHREs were not uncommon 48 h before VAs, which tended to be distributed around intervals with AHREs. Temporal connection between AHREs and VAs was a marker of increased risk of VA recurrence and a poorer prognosis.

This case describes the feasibility of permanent His bundle pacing (HBP) with a standard bipolar lead positioned through cephalic access without a dedicated delivery sheath. The use of a stylet pre-shaped on an echocardiographic reference allowed a successful procedure without specific technical difficulties. This "simplified" approach may provide some advantages with respect to the only commercially available system.

The aim of this study was to investigate the reliability of a novel electrocardiographic (ECG) marker in predicting ventricular arrhythmia (VA) inducibility in individuals with drug-induced Brugada syndrome (BrS) type I pattern. Consecutive patients with drug-induced type I BrS pattern underwent programmed ventricular stimulation (PVS) and, according to their response, were divided into 2 groups. Clinical characteristics and 12-lead ECG intervals before and after ajmaline infusion were compared between the 2 groups. A novel ECG marker named dST-Tiso interval consisting in the interval between the onset of the coved ST-segment elevation and its termination at the isoelectric line was also evaluated. Our cohort included 76 individuals (median age 44 years, 75% male). Twenty-five (32.9%) had VA inducibility requiring defibrillation. As compared with not inducible subjects, those with VA inducibility were more frequently male (92% vs 65%, p = 0.013), had longer PQ interval (basal: 172 vs 152 ms, p = 0.033; after ajmaline: 216 vs 200 ms, p = 0.040), higher J peak (0.6 vs 0.5 mV, p = 0.006) and longer dST-Tiso (360 vs 240 ms, p < 0.001). The dST-Tiso showed a C-statistics of 0.90 (95% confidence interval: 0.82 to 0.99) and an adjusted odds ratio for VA of 1.03 (1.01 to 1.04, p < 0.001). A dST-Tiso interval >300 ms yielded a sensitivity of 92.0%, a specificity of 90.2%, positive and negative predictive values of 82.1% and 95.8%. In conclusion, the dST-Tiso interval is a powerful predictor of VA inducibility in drug-induced BrS type I pattern. External validation is needed, but this marker might be useful in the clinical counseling process of these individuals before invasive PVS.

Funding Acknowledgements Type of funding sources: None. Background In Italy, a strict lockdown was imposed from 8 March 2020 to stop the spread of the Coronavirus Disease 2019 (COVID-19). Purpose To explore the effect of this lockdown on data transmitted by remote monitoring (RM) of implantable cardioverter and cardiac resynchronization therapy defibrillators (ICDs/CRT-Ds). Methods RM daily transmissions from ICDs and CRT-Ds were analyzed and compared in two consecutive 1-month frames pre- and post-lockdown: Period I (7 February–7 March 2020) and Period II (8 March–7 April 2020). Results The study cohort included 180 patients (81.1% male, 63.3% ICDs and 36.7% CRT-Ds) with a median age of 70 (interquartile range 62-78) years. The median value of physical activity provided by accelerometric sensors showed a significant reduction between Period I and II (13.1% [8.2-18.1%] versus 9.4% [6.3-13.8%], p Conclusions In cardiac patients, the lockdown imposed to contain COVID-19 outbreak significantly reduced the amount of physical activity and the mean heart rate. These side effects of in-home confinement quarantine should be taken in consideration for frail patients. Abstract Figure. Activity and mean heart rate trends

Funding Acknowledgements Type of funding sources: None. Background Electric isolation of the pulmonary veins (PVs) can successfully treat patients with atrial fibrillation (AF). Isolation of pulmonary veins can be achieved by several methods: radiofrequency, cryoballoon or laser balloon ablation (LBA). The main procedural challenge with either method is to achieve a continuous circumferential lesion at the left atrium-PVs junction, with the persistence of functional gaps. Purpose A novel endoscopic ablation system equipped with a precise motor control system (MCS) has been evaluated. The balloon is used with an endoscope to directly visualize and ablate tissue at the left atrial-PVs junction with laser energy. This system enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician. The MCS is intended to reduce procedure time and to ensure continuity of ablation lesions. The feasibility of the motorized ablation in terms of extent of applicability along each PV-left atrium junction and time of use of the manual point-by-point mode has been investigated. Methods sixteen consecutive patients (male 68.7%, age 60.9 ± 7.8 years) with paroxysmal or persistent AF who underwent LBA were enrolled in our institution. Exclusion criteria were any contraindication for the procedure including the presence of intracavitary thrombosis and contraindications to general anesthesia or deep sedation. After transseptal puncture, the balloon-based endoscopic ablation system was advanced to each PV ostium, and laser energy were projected onto the target. Results A total of 62 PVs were treated with LBA; in 3 patients there was a redundant right intermediate pulmonary vein; in 4 patients there was a right common ostium and in one a left common ostium. MCS was used for 41 PVs (66.1%): in particular, MCS was used continuously between 180° and 325° degrees (50 to 90% of PV circumference) for 22 PVs (35.5%) and between 326° and 359° degrees (91 to 99% of PV circumference) for 16 veins (25.8%). In 3 PVs (4.8%) MCS was used for the entire circumference. During 5.659 (23.6%) seconds out of a total of 23.986 seconds, laser energy delivery occurred in the rapid mode by MCS. No clinical complications, either local or systemic (stroke or TIA, pericardial effusion, pericardial tamponade, pulmonary vein stenosis, esophageal injury, temporary or permanent phrenic nerve palsy), were observed neither during the use of MSC nor during the use of manual point-by-point mode. Of note, a pinhole rupture of the balloon occurred in the first 2 cases of our series, during the use of MCS, without harm to the patient and requiring only replacement of the LBA. Conclusions In our case series, laser balloon ablation with the help of motor control system appears safe and feasible in most cases for large portions of pulmonary vein circumference, providing considerable time sparing (66.1% of total ablation extent in 23.6% of total ablation time).

Purpose Predictors of difficulty and complications of transvenous lead extraction (TLE) have been investigated in several studies; however, little is known about the venous anatomical characteristics that can have an impact on procedural outcomes. Among them, the persistent left superior vena cava (PLSVC) is a common anomaly often discovered incidentally during cardiac device implantation and could raise concerns if TLE is indicated. We report technical considerations and outcomes of TLE for two patients with leads implanted via PLSVC. Methods and results Two cardiac implantable electronic device recipients with isolated PLSVC required TLE due to infective endocarditis in one case and lead failure in the other. In the first case, TLE procedure was performed in a hybrid operating room with minimally invasive video-assisted thoracoscopic monitoring due to the high procedural risk. Two active fixation 20-year-old pacing leads were removed with a relatively short fluoroscopy time. In the second case, we successfully extracted a single-coil active fixation lead without the need of a locking stylet or advanced extraction tools. There were no procedural complications or adverse events at 1-year follow-up. Conclusion TLE procedures for two patients with isolated PLSVC were successfully completed with less difficulty and tools than expected based on the characteristics of the targeted leads. If indicated, TLE in the presence of a PLSVC should be considered in experienced centers.

Purpose The purpose of this study was to assess the available mortality risk stratification models for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) patients. Methods We conducted a review of mortality risk stratification models and tested their ability to improve prediction of 1-year survival after implant in a database of patients who received a remotely controlled ICD/CRT-D device during routine care and included in the independent Home Monitoring Expert Alliance registry. Results We identified ten predicting models published in peer-reviewed journals between 2000 and 2021 (Parkash, PACE, MADIT, aCCI, CHA2DS2-VASc quartiles, CIDS, FADES, Sjoblom, AAACC, and MADIT-ICD non-arrhythmic mortality score) that could be tested in our database as based on common demographic, clinical, echocardiographic, electrocardiographic, and laboratory variables. Our cohort included 1,911 patients with left ventricular dysfunction (median age 71, 18.3% female) from sites not using any risk stratification score for systematic patient screening. Patients received an ICD (53.8%) or CRT-D (46.2%) between 2011 and 2017, after standard physician evaluation. There were 56 deaths within 1-year post-implant, with an all-cause mortality rate of 2.9% (95% confidence interval [CI], 2.3-3.8%). Four predicting models (Parkash, MADIT, AAACC, and MADIT-ICD non-arrhythmic mortality score) were significantly associated with increased risk of 1-year mortality with hazard ratios ranging from 3.75 (CI, 1.31-10.7) to 6.53 (CI 1.52-28.0, p ≤ 0.014 for all four). Positive predictive values of 1-year mortality were below 25% for all models. Conclusion In our analysis, the models we tested conferred modest incremental predicting power to ordinary screening methods.

It is unknown whether some of the clinical parameters transmitted by remote monitoring (RM) of cardiac implanted devices could show recurrent patterns caused by COVID-19 infection. Our aim was to describe RM daily temporal trends for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) recipients during COVID-19 infection. A 65-year-old woman with a CRT-D had a sudden increase of approximately 15 bpm and 10 bpm in nocturnal and mean heart rate, respectively, 11 days before hospitalization for COVID-19 pneumonia. At the same time physical activity decreased progressively and continuously. A 78-year-old woman with an ICD showed significant changes in RM trends starting from the COVID-19-related symptoms: strong decrease in physical activity, progressive increase in mean and nocturnal heart rate, irregular trend of heart rate variability, and rapid drop in thoracic impedance. Two months later, on hospitalization, computed tomography showed a “crazy-paving” pattern of the lungs, which is a clinical picture of COVID-19 pneumonia with concomitant pleural effusion. Learning objective Patients with complications related to the COVID-19 infection appeared to show variations in the remote monitoring (RM) temporal trends of clinical variables daily transmitted from implanted cardiac devices. These changes may not be specific to COVID-19, but owing to the severity of the pandemic, the use of RM to capture patient's condition makes intuitive sense for early diagnosis, intervention, and additional follow-up in this high-risk population.

INTRODUCTION Factors influencing malignant arrhythmia onset are not fully understood. We explored the circadian periodicity of ventricular arrhythmias (VAs) in patients with implantable cardioverter and cardiac resynchronization defibrillators (ICD/CRT-D). METHODS Time, morphology (monomorphic/polymorphic), and mode of termination (anti-tachycardia pacing [ATP] or shock) of VAs stored in a database of remote monitoring data were adjudicated. Episodes were grouped in six 4-h timeslots from 00:00 to 24:00. Circadian distributions and adjusted marginal odds ratios (ORs), with 95% confidence interval (CI), were analyzed using mixed-effect models and logit generalized estimating equations, respectively, to account for within-subject correlation of multiple episodes. RESULTS Among 1303 VA episodes from 446 patients (63% ICD and 37% CRT-D), 120 (9%) self-extinguished, and 842 (65%) were terminated by ATP, 343 (26%) by shock. VAs clustered from 08:00 to 16:00 with 44% of episodes, as compared with 22% from 00:00 to 08:00 (p

Background Undiagnosed sinus or atrioventricular node dysfunction may bias estimation of the real efficacy of cardiac pacing in preventing vasovagal reflex syncope. We assessed this hypothesis in the BIOSync CLS trial which showed that dual-chamber pacing with closed loop stimulation (CLS) remarkably reduced recurrences of syncope. Methods and results In the study patients aged 40 years or older with ≥2 episodes of loss of consciousness in the last year and an asystolic response to Tilt-Table test were randomized to pacing ON (DDD-CLS mode) or pacing OFF (ODO mode). We utilized the available pacemaker diagnostic data in a total of 103 patients (52 pacing ON, 51 pacing OFF) to generate cumulative distribution charts for heart rate (HR) and percentage of pacing. At 12 months, we did not find evidence of suspected sinus or atrioventricular node dysfunction. Beats were similarly distributed between groups (p = 0.96), with an average HR of 76 ± 8 bpm (pacing ON) versus 77 ± 7 bpm (pacing OFF). In the active group, the median percentage of atrial and ventricular pacing was 47% and 0%, respectively. Intolerance to high pacing rates was reported in only one patient (1.6%) and was easily resolved by reprogramming the maximum CLS pacing rate. Conclusions We did not find evidence of suspected sinus or atrioventricular node dysfunction in the BIOSync CLS patients. The benefit of pacing should be ascribed to pacing prevention of pure vasovagal episodes. CLS algorithm modulated pacing rates over a wide frequency range, consistently competing with sinus node.

Aim The benefit of cardiac pacing in patients with severe recurrent reflex syncope and asystole induced by tilt testing has not been established. The usefulness of tilt-table test to select candidates for cardiac pacing is controversial. Methods and results We randomly assigned patients aged 40 years or older who had at least two episodes of unpredictable severe reflex syncope during the last year and a tilt-induced syncope with an asystolic pause longer than 3 s, to receive either an active (pacing ON; 63 patients) or an inactive (pacing OFF; 64 patients) dual-chamber pacemaker with closed loop stimulation (CLS). The primary endpoint was the time to first recurrence of syncope. Patients and independent outcome assessors were blinded to the assigned treatment. After a median follow-up of 11.2 months, syncope occurred in significantly fewer patients in the pacing group than in the control group [10 (16%) vs. 34 (53%); hazard ratio, 0.23; P = 0.00005]. The estimated syncope recurrence rate at 1 year was 19% (pacing) and 53% (control) and at 2 years, 22% (pacing) and 68% (control). A combined endpoint of syncope or presyncope occurred in significantly fewer patients in the pacing group [23 (37%) vs. 40 (63%); hazard ratio, 0.44; P = 0.002]. Minor device-related adverse events were reported in five patients (4%). Conclusion In patients aged 40 years or older, affected by severe recurrent reflex syncope and tilt-induced asystole, dual-chamber pacemaker with CLS is highly effective in reducing the recurrences of syncope. Our findings support the inclusion of tilt testing as a useful method to select candidates for cardiac pacing. Study registration ClinicalTrials.gov identifier NCT02324920, Eudamed number CIV-05-013546.

Introduction Histological studies reported that the His bundle (HB) is partitioned into narrow cords by collagen running in its long axis, providing the anatomical setting necessary for its longitudinal dissociation. Further confirmations came from the demonstration that direct HB pacing normalizes the QRS axis and duration in subjects with proximal HB lesions causing bundle branch block. However, there is no evidence of the possibility of selective HB partitions pacing destined to the composition of branches and fascicles. Methods and results We describe a case of intra-Hisian left bundle branch block in which permanent distal HB pacing corrects left ventricular delay and produces different QRS morphology at different voltage outputs, as an expression of different selective HB compartments recruitment. Conclusion This case would strengthen the limited data in the literature about HB longitudinal dissociation.

Aims There are conflicting data on the benefit of cardiac resynchronization therapy (CRT) in heart failure (HF) patients with permanent atrial fibrillation (AF). We aimed to compare patient outcomes according to the presence or absence of permanent AF at device implantation. Methods and results We retrospectively analysed remote monitoring data from 1141 CRT defibrillators. Propensity score with inverse‐probability weighting method was used to balance AF and sinus rhythm (SR) groups. Analysis endpoints included total mortality, appropriate defibrillation shocks, and CRT percentage. There were 229 patients (20.1%) in the AF group and 912 patients (79.9%) in the SR group. Compared with SR patients, AF patients were older (median age, 77 vs. 72 years, P

Aims We developed and validated an algorithm for prediction of heart failure (HF) hospitalizations using remote monitoring (RM) data transmitted by implanted defibrillators. Methods and results The SELENE HF study enrolled 918 patients (median age 69 years, 81% men, median ejection fraction 30%) with cardiac resynchronization therapy (44%), dual-chamber (38%), or single-chamber defibrillators with atrial diagnostics (18%). To develop a predictive algorithm, temporal trends of diurnal and nocturnal heart rates, ventricular extrasystoles, atrial tachyarrhythmia burden, heart rate variability, physical activity, and thoracic impedance obtained by daily automatic RM were combined with a baseline risk-stratifier (Seattle HF Model) into one index. The primary endpoint was the first post-implant adjudicated HF hospitalization. After a median follow-up of 22.5 months since enrolment, patients were randomly allocated to the algorithm derivation group (n = 457; 31 endpoints) or algorithm validation group (n = 461; 29 endpoints). In the derivation group, the index showed a C-statistics of 0.89 [95% confidence interval (CI): 0.83–0.95] with 2.73 odds ratio (CI 1.98–3.78) for first HF hospitalization per unitary increase of index value (P Conclusion With the developed algorithm, two-thirds of first post-implant HF hospitalizations could be predicted timely with only 0.7 false alerts per patient-year.

Background Cardiac implantable electronic device (CIED) recipients could have an unfavorable prognosis if infected with the novel coronavirus (COVID‐19). We aimed to analyze the data daily transmitted by the Home Monitoring (HM) system (BIOTRONIK, Berlin, Germany) of CIEDs during the infection. Methods We identified CIED patients followed with the HM who experienced COVID‐19 clinical manifestations. The daily trends of the following HM variables were analyzed: mean heart rate (HR), physical activity, thoracic impedance (TI), ventricular and atrial arrhythmic burden. Results The study cohort included 10 CIED patients (median age 90 [84‐92] years, male 90%) with acute respiratory syndrome. The HR showed an increase of a value ranging from 10 to 30 bpm well in advance of the severe clinical manifestations. The physical activity was generally low during the entire infection course. The TI decreased in patients presented with pulmonary edema, but increased significantly (8 to 25 Ω) in most COVID‐19 patients (8 out of 10) suggesting an association with pulmonary fibrosis. Arrhythmic complications were also found in half of the patients. Conclusion The trends of HR and TI in CIEDs recipients infected by the COVID‐19 often showed early recurrent patterns before adverse clinical manifestations., We analyzed longitudinal trends daily transmitted by the Home Monitoring system of CIED patients with confirmed COVID‐19 infection. The heart rate showed the most recurrent pattern with a significant increase well in advance of severe clinical manifestations. As expected, the thoracic impedance decreased in patients presented with pulmonary edema, but increased significantly in most COVID‐19 patients suggesting an association with pulmonary fibrosis. Arrhythmic complications were also found in half of the patients. Continuous Home Monitoring data should be further investigated for early warning of infection as patients with underlying cardiovascular diseases are at high risk of adverse outcomes.