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Introduction: Antitachycardia pacing (ATP) is one of the therapies provided by an implantable cardioverter defibrillator (ICD) for the treatment of ventricular arrhythmias (VA). Successful ATP leads to avoidance of shock, that is related to an increase in mortality and morbidity. Methods and Results: A total of 63 documents have been obtained by using the key term “Antitachycardia pacing” in PubMed, focusing on optimal ATP and ICD programing to reduce inappropriate or avoidable therapies, predictive factors of ATP efficacy and latest technologies and devices still in experimentation. Conclusions: Antitachycardia pacing confirms to be a good therapeutic tool to interrupt ventricular arrhythmias. An optimal ICD programming could lead to the reduction of inappropriate or avoidable ATP therapies. Furthermore, a better knowledge in predictive factors of ATP efficacy not only could better orient physicians on the device to implant, but also could allow for a better arrhythmic risk stratification.

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.

Background The VOYAGER PAD and COMPASS trials established the benefit of dual pathway inhibition (DPI) with aspirin and low dose rivaroxaban for eligible patients with peripheral artery disease (PAD) undergoing revascularisation and for those with PAD or chronic coronary syndromes (CCS), respectively. However, in-hospital implementation of DPI remains slow in clinical practice, also due to eligibility uncertainties. Purpose To assess the eligibility to DPI among contemporary patients hospitalised in cardiology and vascular surgery units, and to evaluate clinical outcomes of patients presenting with revascularised PAD according to their eligibility to the DPI strategy. Methods We analysed data from patients with revascularised PAD included in the prospective institutional RAPID (RivAroxaban for PerIpheral artery Disease) and applied the VOYAGER PAD criteria to identify patients eligible to DPI and the frequency and distribution of exclusion criteria. Clinical outcomes were compared between patients eligible and not eligible to DPI. The primary efficacy outcome was the composite of cardiovascular death, acute limb ischemia, or unplanned limb revascularization, while the primary safety outcome was major bleeding according to the Bleeding Academic Research Consortium definition (i.e., type 3 or 5). Secondary outcomes included the individual components of the primary efficacy outcome, all-cause death, clinically relevant bleeding and minor bleeding. Finally, to explore the residual potential for DPI applicability in clinical practice, COMPASS criteria were also applied to a contemporary CCS cohort from the institutional registry enrolling coronary artery disease patients undergoing invasive management, and the frequency and characteristics of DPI eligibility between PAD and CCS were compared. Results From May 2021 to August 2022, 122 patients (mean age 70.9±10.1 years, 74.6% male) were included in the RAPID registry. Based on VOYAGER PAD eligibility criteria, 62 patients (50.8%) were eligible to DPI. Main reasons for exclusion were oral anticoagulation (13.1%), prior stroke or transient ischemic attack (11.5%), high bleeding risk (46.7%), or concurrent indications for dual antiplatelet therapy (0.8%). In the CCS registry, 1,389 patients were enrolled in the same period (mean age 70.3±10.5 years, 75.6% male). CCS patients who were eligible to DPI were 276 (19.9%). Main reasons for exclusion were concurrent need for dual antiplatelet therapy (27.1%), high bleeding risk (44.8%), need for oral anticoagulation (21.4%), severe heart failure (9.9%), absence of CAD or PAD (35.3%), and end-stage renal disease (2.6%). To provide updated follow-up information, clinical outcomes will be made available for presentation on December 2022. Conclusions Approximately one patient out of two with revascularised PAD and only one fifth of patients with CCS undergoing invasive management were eligible to DPI. According to these results, unlike candidates to the VOYAGER PAD strategy, candidates to the COMPASS strategy are more likely to be identified in an outpatient than hospital setting.

A significant problem for patients undergoing oral anticoagulation therapy is gastrointestinal bleeding (GIB), a problem that has become increasingly urgent following the introduction of direct oral anticoagulants (DOACs). Furthermore, in recent years a greater focus has been placed on the quality of life (QOL) of patients on long-term oral anticoagulant therapy, which necessitates changes in lifestyle, as well as posing an increased risk of bleeding without producing objective symptomatic relief. Here, we examine current evidence linked to GIB associated with oral anticoagulants, with a focus on randomized control trials, meta-analyses, and postmarketing observational studies. Rivaroxaban and dabigatran (especially the 150-mg bis-in-die dose) appeared to be linked to an increased risk of GIB. The risk of GIB was also greater when edoxaban was used, although this was dependent on the dose. Apixaban did not pose a higher risk of GIB in comparison with warfarin. We provided a summary of current knowledge regarding GIB risk factors for individual anticoagulants, prevention strategies that lower the risk of GIB and management of DOAC therapy after a GIB episode.

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 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.

Management of recent-onset (

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.

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.

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. The variation between rest and peak stress end-systolic pressure-volume relation (ΔESPVR) is an index of myocardial contractility, easily obtained during routine stress echocardiography and never tested during dipyridamole stress-cardiac magnetic resonance (CMR). We assessed the ΔESPVR index in patients with known/suspected coronary artery disease (CAD) who underwent dipyridamole stress-CMR.Methods. One-hundred consecutive patients (24 females, 63.76±10.17 years) were considered. ESPVR index was evaluated at rest and stress from raw measurement of systolic arterial pressure and end-systolic volume by biplane Simpson’s method. Results. The ΔESPVR index showed a good inter-operator reproducibility. Mean ΔESPVR index was 0.48±1.45 mmHg/mL/m2. ΔESPVR index was significantly lower in males than in females. ΔESPVR index was not correlated to rest left ventricular end-diastolic volume index or ejection fraction. Forty-six of 85 patients had myocardial fibrosis detected by the late gadolinium enhancement technique and they showed significantly lower ΔESPVR values. An abnormal stress CMR was found in 25 patients and they showed significantly lower ΔESPVR values. During a mean follow-up of 56.34±30.04 months, 24 cardiovascular events occurred. At receiver-operating characteristic curve analysis, a ΔESPVRConclusions. The noninvasive assessment of the ΔESPVR index during a dipyridamole stress-CMR exam is feasible and reproducible. The ΔESPVR index was independent from rest LV dimensions and function and can be used for a comparative assessment of patients with different diseases. ΔESPVR by CMR can be a useful and simple marker for additional prognostic stratification.

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.

Graphical abstract, Background COVID-19 pandemic impacted on heart failure patients’ lifestyle and quality of life, affecting both physical activity levels and state of health. Methods Demographic data and device records were extracted for patients with heart failure in the 16 weeks at the turn of lockdown during pandemic. To explore the variability across the lockdown period, a week-to-week analysis was performed. Patients were interviewed to investigate physical activity and psychological insights. The primary endpoint was the variation in physical activity at the turn of lockdown. Results At our facility, 2225 patients implanted with a cardiac device were screened and data were collected for 211 patients fulfilling the inclusion criteria. Patients’ physical activity significantly decreased in the lockdown period compared with the control period (active time per day 8.0% vs. 10.8%; relative reduction [RRR] 25.9%; p

Background Current medication adherence telemonitoring systems have several limitations prompting the need for simpler, low-cost and widely applicable tools. To meet these needs, we propose a novel method consisting in sending a digital feedback of medication intake by just reading a pre-defined Quick Response (QR) code attached on the pills box. Methods To assess the potential clinical applicability of the proposed QR code-based task, its feasibility was tested among elderly with heart diseases. The primary endpoint was the learning success defined as a correct execution of all QR code-based digital task steps within 10 min. Study outcomes were compared between patients 65–75 years old (younger cohort) and those aged >75 years (older cohort) admitted to the Cardiology ward of a tertiary center. Results A total of 262 patients were included: 128 (48.9%) were younger and 134 (51.1%) older. Despite a baseline low smartphone use in the overall population (41.2%), patients learning success of the digital task was as high as 75.6%, with lower rates among older vs. younger (67.9% vs. 83.6%, p = 0.005). After adjustment no significant independent association between age and success in learning the QR code-based task was found. Differently, increasing age was a negative independent predictor of smartphone use. The learning time was overall small, but longer in the older group (126 ± 100 vs. 100 ± 60 s, p = 0.03). Conclusions The QR code-based digital task was highly feasible for elderly with heart diseases suggesting its potential large-scale clinical application and encouraging the investigation of QR code-based systems for medication adherence telemonitoring.

Funding Acknowledgements This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Background/Introduction: Parameters routinely measured during cardiac devices implantation also depend on bioelectrical properties of the myocardial tissue. Purpose To explore the potential association of electrical parameters with clinical outcomes in implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) recipients. Methods In the framework of the Home Monitoring Expert Alliance, baseline electrical parameters for all implanted leads were compared by occurrence of all-cause mortality, adjudicated ventricular arrhythmia (VA) and atrial high rate episode lasting ≥7 days (7day-AHRE). Results In a cohort of 2,976 patients (58.1% ICD) with a median follow-up of 25 months, events rates were 3.1/100 patient-years for all-cause mortality, 18.1/100 patient-years for VA and 8.9/100 patient-years for 7day-AHRE. At univariate analysis baseline shock impedance was consistently lower in groups with events than in those without, with a 40 Ohm cut-off better identifying patients at high risk, but at multivariable analysis the adjusted-hazard ratios (HRs) lost statistical significance for any endpoint. Baseline atrial sensing amplitude during sinus rhythm was lower in patients with 7-day AHRE as compared to those without (2.40 [IQ: 1.62-3.71] Vs 3.50 [IQ: 2.35-4.66] mV, p 1.5 mV versus those with values ≤1.5 mV was 0.44 (95% CI:0.27-0.72), p = 0.001. Conclusion Despite in patients with events a lower baseline shock impedance was observed at univariate analysis, the association lost statistical significance at multivariable analysis. Conversely, low sinus rhythm atrial sensing (≤1.5 mV) measured with standard transvenous leads could identify subjects at high risk of long-lasting atrial arrhythmia. Abstract Figure. AHRE occurrence by atrial sensing

INTRODUCTION Atrial tachycardia/fibrillation (AT/AF) episodes are common in implantable cardioverter-defibrillator (ICD) recipients and can be undetected by standard single-chamber devices. This study aims to explore whether a single-lead ICD with an atrial dipole (ICD DX; BIOTRONIK SE & Co, Berlin, Germany) could improve the AT/AF diagnosis and management as compared to standard ICD (ICD VR). METHODS AND RESULTS We selected patients without AT/AF history from the THINGS registry which included consecutive patients implanted with ICD for standard indications. The ICD VR and the ICD DX groups included 236 (62.8%) and 140 (37.2%) patients, respectively, and had no significant differences in baseline characteristics. During a median follow-up of 27 months, there were 7 AT/AF diagnoses in the ICD VR and 18 in the ICD DX group. The 2-year incidence of AT/AF diagnosis was 3.6% (95% confidence interval [CI]: 1.6%-9.6%) for the ICD VR and 11.4% (95% CI: 6.8%-18.9%) for the ICD DX group (adjusted hazard ratio [HR]: 3.85 [95% CI: 1.58-9.41]; P = .003). Initiation of oral anticoagulation (OAC) due to AT/AF diagnosis was reported in 15 patients. The 2-year incidence of OAC onset was 3.6% (95% CI: 1.6%-7.8%) for the ICD VR and 6.3% (95% CI: 3.0%-12.7%) for ICD DX group (adjusted HR: 1.99 [95% CI: 0.72-5.56]; P = .184). CONCLUSION We observed that atrial sensing capability in single-chamber ICD patients without evidence of atrial arrhythmias at implant is associated with a greater likelihood of detecting AT/AF episodes. The management of these diagnosed arrhythmias often led to clinical interventions, mainly represented by initiation of OAC therapy.

Background Parameters measured during implantable cardioverter defibrillator (ICD) implant also depend on bioelectrical properties of the myocardium. We aimed to explore their potential association with clinical outcomes in patients with single/dual‐chamber ICD and cardiac resynchronization therapy defibrillator (CRT‐D). Methods In the framework of the Home Monitoring Expert Alliance, baseline electrical parameters for all implanted leads were compared by the occurrence of all‐cause mortality, adjudicated ventricular arrhythmia (VA), and atrial high‐rate episode lasting ≥24 hours (24 h AHRE). Results In a cohort of 2976 patients (58.1% ICD) with a median follow‐up of 25 months, event rates were 3.1/100 patient‐years for all‐cause mortality, 18.1/100 patient‐years for VA, and 9.3/100 patient‐years for 24 h AHRE. At univariate analysis, baseline shock impedance was consistently lower in groups with events than without, with a 40 Ω cutoff that better identified high‐risk patients. However, at multivariable analysis, the adjusted‐hazard ratios (HRs) lost statistical significance for any endpoint. Baseline atrial sensing amplitude during sinus rhythm was lower in patients with 24 h AHRE than in those without (2.45 [IQR: 1.65‐3.85] vs 3.51 [IQR: 2.37‐4.67] mV, P 1.5 mV vs those with values ≤1.5 mV was 0.52 (95% CI: 0.33‐0.83), P = .006. Conclusions Although lower baseline shock impedance was observed in patients with events, the association lost statistical significance at multivariable analysis. Conversely, low sinus rhythm atrial sensing (≤1.5 mV) measured with standard transvenous leads could identify subjects at high risk of atrial arrhythmia., Some of the electrical parameters routinely measured at ICD/CRT‐D implant differed according to long‐term clinical outcome. Shock impedance values were lower in patients who experienced death and both atrial and ventricular arrhythmias during follow‐up. Subjects with atrial signal amplitude below 1.5 mV showed a significant higher risk of atrial arrhythmias as compared to those with >1.5 mV, potentially revealing the presence of a more impaired atrial tissue.

Background CHA2DS2-VASc is a validated score for predicting stroke in patients with atrial fibrillation (AF). Objective The purpose of this study was to assess whether the CHA2DS2-VASc score can predict new-onset AF in a cohort of patients with a cardiac implantable electronic device (CIED) followed with remote monitoring. Methods Using the database of the Home Monitoring Expert Alliance project, we selected 2410 patients with no documented AF who had received a CIED with diagnostics on atrial high rate episodes (AHREs). The primary endpoint was time to first day with cumulative AHRE burden ≥15 minutes, 5 hours, 24 hours, and ≥7 consecutive days. Results During a median duration of 24.1(11.5–42.9) months, the incidence of AHRE increased with increasing CHA2DS2-VASc. At 6 years, occurrence of ≥15-minute AHRE was 80.2% (CHA2DS2-VASc ≤1) vs 93.7% (CHA2DS2-VASc ≥5), whereas ≥5-hour AHRE incidence was 68.4% (CHA2DS2-VASc ≤1) vs 92.5% (CHA2DS2-VASc ≥5). Occurrence of ≥24-hour and ≥7-day AHREs also increased with increasing CHA2DS2-VASc: 9.1% and 3.9% (CHA2DS2-VASc ≤1) vs 40.4% and 28.7% (CHA2DS2-VASc ≥5), respectively. Adjusted hazard ratio for unitary CHA2DS2-VASc increase ranged from 1.09 (confidence interval 1.04–1.14; P

Objectives This study deals with clinical and echocardiographic outcomes in cardiac resynchronization therapy (CRT) nonresponders patients undergoing Mitraclip procedure. Background Functional mitral regurgitation (FMR) occurs in approximately one-third of heart failure (HF) patients. Resynchronization therapy may correct FMR in patients with HF; however, significant FMR persists in 20-25% of CRT patients. Methods All patients included were previously treated with CRT for at least 6 months and remained classified as New York Heart Association (NYHA) functional class III or IV despite optimal medical therapy; the echocardiographic assessment showed lack of decrease of the left ventricular end-systolic volume (LVESV) of at least 10% and residual moderate-to-severe or severe FMR. Clinical and echocardiographic follow-up was scheduled at 1, 3, 6, and 12 months after Mitraclip implantation, and every 6 months thereafter. Results Thirty patients fulfilled inclusion criteria. Before Mitraclip implantation NYHA class was III in 83% and IV in 17% of patients; after CRT no patient experienced an improvement in FMR. There was a significant improvement in NYHA class from baseline to 6 months, which remained sustained at 12 and 24 months. The degree of FMR significantly improved from baseline to 6 months and from 6 to 12 months. There was left ventricle remodeling with significant reduction of LVESV and an increase of left ventricle ejection fraction at 6 and 12 months, while the opposite trend was noted between 12 and 24 months CONCLUSION: Treatment of moderate to severe FMR in CRT nonresponder is feasible, safe, and reasonably effective in reducing cardiac symptoms.

Objectives This study sought to compare the Intrinsic Rhythm Support (IRSplus) and Ventricular Pace Suppress (VpS) in terms of right ventricular pacing percentage (VP %), mean atrioventricular interval (MAVI), atrial fibrillation, and cardiac volumes. Background Modern pacemakers are provided with algorithms for reducing unnecessary ventricular pacing. These may be classified as: periodic search for intrinsic atrioventricular (AV) conduction prolonging the AV delay accordingly; or DDD-ADI mode switch. The IRSplus and VpS algorithms belong to the former and latter classes, respectively. Methods Patients with sick sinus dysfunction without evidence of II/III degree AV block were 1:1 randomized to 6-month periods of either IRSplus or VpS, and then crossed over. Subsequent follow-ups were at the 12th month after randomization for device data retrieving, and at the 18th month with the same device programming for echocardiographic assessment. Results A total of 230 patients (62% males, median age 75 years [interquartile range: 69 to 79 years]) were enrolled. At a linear mixed-model analysis with order of treatment and investigational sites as nested random effects, differences in VP% and MAVI reached statistical significance: VP% was 1% (0% to 11%) during IRSplus and 3% (0% to 26%) during VpS (p = 0.029); MAVI was 225 ms (198 to 253 ms) during IRSplus and 214 ms (188 to 240 ms) during VpS (p = 0.014). No differences were observed in atrial fibrillation burden and incidence, ejection fraction, and cardiac volumes. Conclusions Both IRSplus and VpS algorithms ensured VP% ≤3% in most patients with sinus node dysfunction and preserved AV conduction. The IRSplus was slightly more efficient in reducing VP% at the expense of a small MAVI increase, with statistical but clinically insignificant differences. (Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study; NCT01528657 )

Background: GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic t...

Aims The aims of this study were to determine the appropriateness of permanent pacemaker implantation (PPI) after TAVI through an analysis of PM dependency at follow-up, and to assess long-term outcomes of patients undergoing PPI after TAVI. Methods and results From June 2007 to February 2018, 1,116 consecutive patients without prior PM underwent TAVI in our institution. We assessed the incidence and predictors of PM dependency of patients who underwent PPI within 30 days, and also the six-year outcomes among patients who did not undergo PPI at 30 days. At 30 days, PPI was reported in 145 patients (13.0%). Rates of PM dependency were 35.7%, 35.8% and 33.3% at 1, 6 and 12 months, respectively. Analysing PPI timing, implantation on day 1 was found to be a predictor of PM dependency at six months (OR 20.7 [95% CI: 3.4-126.7]; p=0.001) and 12 months (OR 7.5 [95% CI: 1.4-40.2]; p=0.019). An interaction between PM dependency and the presence of baseline right bundle branch block (RBBB) at six months (pinteraction=0.024) and 12 months (pinteraction=0.028) was reported when PPI was performed on the same day as TAVI. At six years, patients who received a PM at 30 days showed a higher all-cause death rate (KM estimate 41.7% vs 57%; plog-rank=0.034). Conclusions Among patients receiving PPI after TAVI, PM dependency rates were about 33-36% at one year. Patients with a baseline RBBB undergoing PPI at day 0 or at day 1 when severe CDs persisted for 24 hours after TAVI, irrespective of baseline CDs, had a higher chance of being PM-dependent at follow-ups. Finally, PPI after TAVI was associated with increased six-year mortality.

Aims The present study sought to determine predictors for success and outcomes of patients who underwent cardiac implantable electronic devices (CIED) extraction indicated for systemic or local CIED related infection in particular where complete lead removal could not be achieved. Methods and results ESC-EORP ELECTRa (European Lead Extraction ConTRolled Registry) is a European prospective lead extraction registry. Out of the total cohort, 1865/3510 (52.5%) patients underwent removal due to CIED related infection. Predictors and outcomes of failure were analysed. Complete removal was achieved in 1743 (93.5%) patients, partial (4 cm of lead left) in 32 (1.8%) patients. Removal success was unrelated to type of CIED infection (pocket or systemic). Predictors for failure were older leads and older patients [odds ratio (OR) 1.14 (1.08–1.19), P Conclusion A total of 6.5% of infected CIED patients failed attempted extraction. Only were >4 cm of lead remained resulted in higher procedural complications and mortality rates.

Background: The occurrence of sustained ventricular arrhythmias (SVA) may be influenced by environmental factors. We aimed to investigate annual periodic trends of SVA from the intracardiac electrograms (IEGMs) stored in the implantable defibrillators (ICDs) or cardiac resynchronization therapy (CRT-D) recipients.Methods: Data from the Home Monitoring Expert Alliance project, a pooled repository of remote monitoring transmissions were analyzed. All IEGMs stored were independently adjudicated by three cardiac electrophysiologists. Periodicity of SVA was evaluated with Generalized Estimating Equations (GEE) models, including periodic terms depending on months in a year.Results: A total of 2936 ICD/CRT-D patients (median age 70 years, 79.6% male) were followed for a median period of 25[13-44] months. Most prevalent structural heart diseases were ischemic (50.8%) and idiopathic dilated (30.6%) cardiomyopathies. Overall, 942 (32.1%) patients experienced a total of 4824 SVA. At GEE analysis, we found a significant periodic component (p=0.048) when considering both shocked and non-shocked episodes. SVA less frequently occurred in Junes and Julies (3.7 x 1000 patient-month). No evidence of significant periodicity was collected in the subgroup of ischemic patients.Conclusions: In thisRM-based cohort of ICD/ CRT-T patients, we observed an annual periodicity of SVA occurrence, with a lower incidence in summer months. (c) 2018 Elsevier B.V. All rights reserved.

Background The role of atrial rate‐responsive (RR) pacing in cardiac resynchronization therapy (CRT) is unclear due to the favorable effect of rate lowering in systolic heart failure. Atrial high rate episodes (AHREs) in CRT recipients are particularly worrisome since they cause loss of CRT, beyond representing a stroke risk factor. Hypothesis The presence of an association between RR and the incidence of AHREs. Methods Daily remote transmissions from 836 CRT recipients were analyzed. AHREs were classified by duration: ≥15 minutes, ≥5 hours, and ≥ 24 hours. Variables possibly associated to AHREs were included in time‐dependent proportional‐hazard models, averaging over 30‐day periods and adjusting for main baseline variables. Results After a median follow‐up of 23.9 (12.2‐36.0) months, 507 (60.6%) patients experienced at least one 15‐minute AHRE. RR function was programmed in 166 (19.8%) patients and was associated with an increased AHRE occurrence rate with hazard ratio (HR) ranging from 1.45 to 1.78 for the 3 cutoffs of episode duration. The negative effect of RR function was not observed in the subset of patients with low mean heart rate ( 68 bpm is attained.

Introduction Clinical trials did not provide conclusive evidence concerning the benefit of prophylactic implantable cardioverter-defibrillators (ICDs) in patients with severe nonischemic cardiomyopathy (NICM). We aimed to compare incidence of appropriate sustained ventricular arrhythmia (SVA) and device therapy in ischemic cardiomyopathy (ICM) vs NICM ICD and/or cardiac resynchronization therapy (CRT-D) patients. Methods and results We analyzed remote-monitoring data from devices of the Home Monitoring Expert Alliance network. SVA recordings were adjudicated by three independent electrophysiologists. Our cohort included 1,946 patients who received either an ICD (55%) or a CRT-D (45%) for primary prevention of sudden cardiac death. Median (interquartile range) age was 70 (62-77) years, 81% were male, and 52% were in the ICM group. Patients were remotely monitored for a maximum follow-up of 5 years. The 5-year product-limit estimate of SVA incidence in patients with an ICD was 47.3% (95% confidence interval [CI], 41.0%-53.9%) in the ICM group and 44.7% (36.9%-53.3%) in the NICM group. In patients with a CRT-D, SVA incidence was 45.7% (37.3%-55.0%) in ICM patients and 49.2% (40.4%-58.7%) in NICM patients. The adjusted hazard ratio for SVA in the ICM vs NICM group was 0.96 (95% CI: 0.70-1.30, P = .77) in ICD patients and 0.85 (95% CI: 0.61-1.18, P = .34) in CRT-D patients. SVAs triggered appropriate device therapies with similar incidence in all groups. Conclusion In a large cohort of remotely monitored ICD and CRT-D recipients, SVA incidence did not significantly differ in ICM and NICM patients.

METHODS We performed a nationwide survey on the current practice of ventricular tachycardia catheter ablation in Italy during the year 2016. RESULTS Among 145 operators participating in the survey, 58 (40.0%) did not perform any ventricular tachycardia ablation in 2016. Among those performing ventricular tachycardia ablation, 9 operators (6.2%) performed only right ventricular endocardial catheter ablation, 52 (35.9%) performed endocardial catheter ablation both in the right and left ventricle (LV) and 26 (17.9%) performed both endocardial and epicardial LV catheter ablations. Seventy operators (89.7%) among the 78 performing LV and epicardial ablations treated patients with ischemic cardiomyopathy; ablations in the setting of other causes were less frequently performed. The following were considered as minimum requirements for ventricular tachycardia ablation: presence of a three-dimensional mapping system (120 operators, 82.8%), ICU in the hospital (118 operators, 81.4%), operator's training in high volume centers (93 operators, 64.1%). Twenty-eight operators (19.3%) performed catheter ablation in patients with electrical storm only after hemodynamic stabilization, 41 operators (28.3%) also during the acute phase and 9 operators (6.2%) never performed catheter ablation in electrical storm patients; the remaining 67 operators did not perform ventricular tachycardia ablation at all, or performed ablations only in the right ventricle. CONCLUSION The present survey provides a snapshot of the current invasive treatment of ventricular tachycardia by catheter ablation. The procedure, especially in the setting of ischemic cardiomyopathy, is performed nationwide. Complex cases, including those with electrical storm, should be managed within a preestablished integrated network of regional referral centers able to transfer patients as soon as possible.

CHAThe purpose of this study was to assess whether the CHAUsing the database of the Home Monitoring Expert Alliance project, we selected 2410 patients with no documented AF who had received a CIED with diagnostics on atrial high rate episodes (AHREs). The primary endpoint was time to first day with cumulative AHRE burden ≥15 minutes, 5 hours, 24 hours, and ≥7 consecutive days.During a median duration of 24.1(11.5-42.9) months, the incidence of AHRE increased with increasing CHAIn a CIED population with no previous diagnosis of clinical AF, AHRE incidence increased with increasing CHA

Introduction The main objective of research in pacemaker therapy has been to provide the best physiologic way to pace the heart. Despite the good results provided by right ventricular pacing minimization and by biventricular pacing in specific subsets of heart failure patients, these options present many limitations for standard pacemaker recipients. In these patients, pacing the right ventricle at alternative sites could result in a lower degree of left intraventricular dyssynchrony. Despite the lack of strong evidence and the difficulty in placing and accurately classifying the final lead position, pacing at alternative right ventricular sites seems to have become a standard procedure at many implanting centers. Material and methods The RIGHT PACE study is a multi-center, prospective, single-blind, double-arm, intervention-control trial comparing right ventricular pacing from the apex and from the septal site in terms of left intraventricular dyssynchrony. A total of 408 patients with indications for cardiac pacing but without indications for ICD and/or CRT will be enrolled. Investigators will be divided on the basis of their prior experience of selective site pacing lead implantation and patients will be treated according to the clinical practice of the centers. After device implantation, they will be followed up for 24 months through evaluation of clinical, echocardiographic and safety/system-performance variables. Discussion This study might provide important information about the impact of the right ventricular pacing on the left ventricular dyssynchrony, and about acute and chronic responses to selective site pacing, as adopted in current clinical practice. This trial is registered at ClinicalTrials.gov (ID: NCT01647490 ). Trial registration Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of apical and alternative position. ClinicalTrials.gov : NCT01647490 .

The Transvalvular Impedance (TVI) is derived between atrial and ventricular pacing electrodes. A sharp TVI increase in systole is an ejection marker, allowing the hemodynamic surveillance of ventricular stimulation effectiveness in pacemaker patients. At routine follow-up checks, the ventricular threshold test was managed by the stimulator with the supervision of a physician, who monitored the surface ECG. When the energy scan resulted in capture loss, the TVI system must detect the failure and increase the output voltage. A TVI signal suitable to this purpose was present in 85% of the tested patients. A total of 230 capture failures, induced in 115 patients in both supine and sitting upright positions, were all promptly recognized by real-time TVI analysis (100% sensitivity). The procedure was never interrupted by the physician, as the automatic energy regulation ensured full patient’s safety. The pulse energy was then set at 4 times the threshold to test the alarm specificity during daily activity (sitting, standing up, and walking). The median prevalence of false alarms was 0.336%. The study shows that TVI-based ejection assessment is a valuable approach to the verification of pacing reliability and the autoregulation of ventricular stimulation energy.