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AimsWe describe a novel, practical, and inexpensive method to add video recording during tilt table testing (TTT): Open-Access-Video-TTT.Methods and resultsThe Open-Access-Video-TTT set-up uses a personal computer (PC) to capture screen video data from a non-invasive-beat-to-beat (NIBTB) haemodynamic blood pressure (BP) device, combined with video recording of a patient, using Open Broadcaster Software (OBS®). The new Open-Access-Video-TTT set up was tested with both the Finometer (model Finapres Nova®, Medical Systems, the Netherlands) and the Task Force® Touch Cardio monitor (CNSystems, Austria). For this, the Finapres Nova® was enabled in ‘remote’ mode and Real Video Network Computing (RealVNC®) was installed on the PC/laptop. The Task Force® has a DisplayPort (DP) port, for which a DP/ high-definition multimedia interface (HDMI) cable and a video capture card is used to merge the signals to the PC/laptop. With this method the combined images are stored as a new video signal. TTT can be performed with any routine protocol.ConclusionsOpen Access-Video-TTT worked well for both the Finapres NOVA® and the Task Force Monitor ®. This novel method can be used easily by all physicians who wish to add video recording during TTT who do not have access to an electroencephalogram machine.

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.

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.

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%.

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.

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.

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.

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.

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

Aims A validated risk stratification schema for transvenous lead extraction (TLE) could improve the management of these procedures. We aimed to derive and validate a scoring system to efficiently predict the need for advanced tools to achieve TLE success. Methods and results Between November 2013 and March 2018, 1960 leads were extracted in 973 consecutive TLE procedures in two national referral sites using a stepwise approach. A procedure was defined as advanced extraction if required the use of powered sheaths and/or snares. The study population was a posteriori 1:1 randomized in derivation and validation cohorts. In the derivation cohort, presence of more than two targeted leads (odds ratio [OR] 1.76, P = 0.049), 3-year-old (OR 3.04, P = 0.001), 5-year-old (OR 3.48, P Conclusion In this study, we developed and tested a simple point-based scoring system able to efficiently identify patients at low and high risk of needing advanced tools during TLE procedures.

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 Cavotricuspid isthmus (CTI) radiofrequency (RF) catheter ablation is the standard treatment for patients suffering from CTI‐dependent atrial flutter (AFL). The aim of this study was to compare the use in clinical practice of 8‐mm gold‐tip catheter (8mmRFC) and open‐irrigated gold‐tip catheter (irrRFC) for RF typical AFL ablation. Methods Patients with typical AFL were treated with 8mmRFC or irrRFC catheters according to investigator preferences. The primary endpoint was the cumulative radiofrequency time (CRFT). Fluoroscopy time, acute and 6‐month success rates were secondary endpoints. Results After excluding 3 patients with left AFL, 157 of the enrolled patients (median age 71.8 [interquartile range, 64.1‐76.2], 76% men, 91% in NYHA class ≤II, 65% with no structural heart disease) were analyzed: 74 (47%) subjects were treated with the 8mmRFC and 83 (53%) with the irrRFC. The median CRFT was 3 [2‐6] minutes in the 8mmRFC group and 5 [3‐7] minutes in the irrRFC group (P = .183). There were no significant differences in ablation success rates, intraprocedural CTI reconnections, audible steam pops, and procedural times. In the 8mmRFC group, a significantly lower fluoroscopy time was observed as compared to the irrRFC group (8 [5‐12] vs 15 [10‐20] minutes, P

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

INTRODUCTION A lead extraction difficulty (LED) score was proposed to predict the difficult transvenous lead extraction (TLE) procedures, defined by means of the fluoroscopy time. The aim of this study was to validate the estimation model based on the LED index above 10 on an independent data set of TLE cases. METHODS Consecutive patients undergoing TLE between January 2014 and January 2016 were included in this analysis. The fluoroscopy time related to the leads removal was dichotomized as above or below its 90th percentile (PCTL). RESULTS In total, 446 permanent leads were removed during 233 TLE procedures. Complete procedural success was achieved in 232 (99.1%) patients. The LED index resulted >10 in 83(35.6%) procedures. Among these cases, 20 had fluoroscopy time above the 90th PCTL (23.3 minutes) and were classified as true positive. Over the 150 procedures with LED score

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/Introduction The lack of a validated method to efficiently combine information provided by Remote Monitoring (RM) of implantable defibrillators (ICD) and patient clinical profile has limited the use of RM in the prevention of worsening heart failure episodes. Purpose Our objective was to develop and validate an index combining RM temporal trends and a baseline risk score for predicting the first HF hospitalization after device implantation. Methods We prospectively enrolled 918 patients (81% male, median age 69, interquartile interval [QI], 61/76; Seattle Heart Failure Score [SHFS], 0.17, QI, −0.40/0.75) with indication to ICD (56%), or ICD with cardiac resynchronization therapy (44%). The Home Monitoring (HM) system was activated in all patients after implant to collect several technical and HF-related variables daily. Investigators were blinded to HM reports, and only received automatic alerts for critical technical issues. The primary endpoint was the first adjudicated HF hospitalization. The cohort was a posteriori 1:1 randomized in derivation and validation groups stratified by device type and primary endpoint occurrence. The SHFS was used for baseline risk assessment. Results During a median follow-up of 23 months (QI, 14/36), 62 first HF hospitalizations were adjudicated. In the derivation group, the index was constructed by combining the SHFS and temporal trends of 24-hour and rest mean heart rates, ventricular ectopic beat frequency, arrhythmic atrial burden, heart rate variability, physical exercise, and thoracic impedance. Variable selection was based on an automatic stepwise procedure, after applying appropriate transformations in variable-specific time frames to maximize the area under the receiver operating characteristics curve (AUC). The resulting index was associated to an AUC of 0.88 and an Odds Ratio of 2.72 (confidence interval [CI] 1.97–3.75, p Conclusion HM temporal trends of selected variables and the SHFS may be combined to timely and efficiently predict the first HF hospitalization after implant, with less than 1 expected per-patient false alert per year. Acknowledgement/Funding BIOTRONIK SE & Co. KG, Berlin, Germany

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.

Background This survey aimed to describe the organizational workflow of cardiac implantable electronic devices (CIEDs) remote monitoring (RM) service in ordinary practice. Methods A questionnaire was designed for our purpose and completed by 49 sites participating to the Italian Home Monitoring Expert Alliance. Results A dedicated organizational model for RM was set up for 86% of centers. The median RM team consisted of 2 (Interquartile range [IQR]: 1-3) physicians and 1 (IQR: 0-2) nurse. RM service was available in working hours and the median percentage of patients included was 100% (IQR: 10%-100%) for implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) recipients and 5% (IQR:0%-30%) for pacemakers. In-office follow-up was performed every 12 and 6 months for pacemaker and ICD/CRT recipients, respectively. More than 90% of sites used to activate all technical alerts, with a prompt reaction in case of an out-of-range parameter. The threshold for atrial fibrillation (AF) daily burden notification in most cases ranged from 2.4 to 7.2 hours. All ventricular arrhythmias alerts were usually switched on: an inappropriate therapy or more than one appropriate episode triggered an urgent in-hospital visit. Concerning heart failure, low CRT percentage pacing alert was always used, while the other available notifications were less frequently switched on. Conclusions This survey showed that RM service was usually set up with a primary nursing model including on average two responsible physicians and one nurse and mainly offered to ICD/CRT patients. Technical, AF and ventricular arrhythmia alerts triggered prompt reactions, while heart failure related indexes were generally less applied.

Heart failure is a leading cause of hospitalization and a significant medical burden in our society. Implantable medical devices are nowadays established therapies in heart failure patients that not only provide cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillators (ICDs) therapy but are also able to continuously and remotely monitor diagnostic information of various physiologic parameters. The value of combining individual diagnostic variables to predict worsening of heart failure is still largely unclear but could eventually become a valuable tool towards a better heart failure management.SELENE HF (Selection of potential predictors of worsening Heart Failure) is an observational, multicentre study designed to prospectively collect follow-up and home monitoring data trends from a population of individuals with ICDs with or without resynchronization therapy (CRT-D), to document heart failure hospitalizations and deaths and to correlate these events with Home Monitoring data in order to identify the combination with the greatest sensitivity and specificity in predicting heart failure events.The purpose of this study is to describe the design of the study focusing on the Heart Failure Predicting model and statistical approach that will be used to analyse the data.The results of the SELENE HF study could help to select and define potential predictors of worsening heart failure in patients with remotely monitored ICD or CRT-D devices.ClinicalTrials.gov Identifier NCT01836510.

BACKGROUND: The rate of device replacement in pacemaker recipients has not been investigated in detail. HYPOTHESIS: Current pacemakers with automatic management of atrial and ventricular pacing output provide sufficient longevity to minimize replacement rate. METHODS: We considered a cohort of 542 pacemaker patients (age 78 ± 9 years, 60% male, 71% de‐novo implants) and combined 1‐month projected device longevity with survival data and late complication rate in a 3‐state Markov model tested in several Monte Carlo computer simulations. Predetermined subgroups were: age < or ≥ 70; gender; primary indication to cardiac pacing. RESULTS: At the 1‐month follow‐up the reported projected device longevity was 153 ± 45 months. With these values the proportion of patients expected to undergo a device replacement due to battery depletion was higher in patients aged

Purpose: Benefit of cardiac pacing in patients with vasovagal syncope (VVS) and cardioinhibitory response to head-up tilt test (HUTT) is still debated. We aimed at retrospectively assessing the long-term effect of cardiac pacing in a cohort routinely followed in our institutions.Methods and results: From a cohort of 1502 patients who performed HUTT between 2008 and 2014, 181 (12%) patients had VASIS 2A (40) or 2B (141) response (median age 43 [interquartile range, 25-56] years, 59% male). Fifty patients (28%) received a dual-chamber pacemaker and 131 (72%) received training on physical maneuvers and medical therapy. The so-called 'Closed Loop Stimulation' (CLS) function was activated for at least 18 months in the pacing group. The 5-year recurrence rate of syncope of paced patients was compared with non-paced patients and with a subgroup of 18 propensity-score matched patients selected among non-paced patients. The 5-year Kaplan-Meier syncope free-rate was 81% (CI, 67%-90%) in the pacing group, 57% (47%-67%; p = 0.004) in the unmatched control group, 53% (27%-74%; p = 0.005) in the 18 propensity-matched patients. The hazard ratio of pacing versus non-pacing was 0.34 (CI, 0.18-0.70) when comparing with the whole non-pacing control group, and 0.25 (CI, 0.09-0.65) including only the propensity-score matched subgroup. No deaths were observed during the follow-up.Conclusions: In the selected VVS population with HUTT-induced cardioinhibitory response, pacemaker therapy with CLS function was associated to 66% relative and 24% absolute risk reduction of 5-year syncopal recurrence rate. Benefit was confirmed after controlling variables affecting propensity for pacemaker therapy. (c) 2018 Elsevier B.V. All rights reserved.

Aims The Really ProMRI study evaluates magnetic resonance imaging (MRI) access for patients with cardiac implantable electronic devices (CIEDs) as well as the performance of magnetic resonance (MR)-conditional leads when undergoing MRI. Methods and results Patients either with an MR-conditional pacemaker or implantable defibrillator (ICD) system or with at least a component (device or one or more leads) from an MR-conditional system, were asked to fill in a questionnaire when they were referred to a MR scan. The rate of prescription, denial, or execution of MR examinations was evaluated in a 1-year follow-up visit. In total, 555 patients [median age (interquartile range) 72.2 (62.2-78.6); 72% male] were enrolled, 49% (270) with a pacemaker, 51% (285) with an ICD system. Five-hundred and ten patients completed the follow-up period. A total of 37 MRI referrals were reported in 35 patients, with a consequent event rate of 7.0/100 patient-years (CI, 4.9-9.7). Fourteen were denied, while 23 [66%; (CI, 48-81%)] were performed. The number of patients with MR referrals was not statistically different between pacemaker and ICD groups (21 vs. 14; P = 0.178). The rate of scans performed was higher in the pacemaker subjects (19/23 vs. 4/14, P = 0.003), while it was similar between patients with or without a complete MR-conditional system (19/30 vs. 4/7, P = 0.606). Conclusion In this study, we reported a 7.0/100 patient-year's event rate of MR prescriptions in CIED patients. Many examinations were denied, despite MR-conditional systems, especially in ICD patients. Regulatory and cultural changes are needed to allow wider access to MR imaging in CIED patients with MR-conditional systems.

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

Aims The characteristics of electrocardiographic (ECG) patterns in the general population of adolescents are insufficiently defined. The purpose of this study is to report ECG patterns and their association with anthropometric characteristics. Methods and results Twenty-four thousand and sixty-two students of Roman schools, aged 12–19, were screened with ECG and physical examinations. Electrocardiographic abnormalities were classified as either minor/non-clinically relevant or major, and anthropometric measures were evaluated per age class. Obesity prevalence was 20.9%, with a higher rate in younger students (P

Whereas cardiac pacing has a very limited role overall in patients with vasovagal syncope (VVS), there are three reasons which support pacing efficacy in tilt-induced asystolic VVS. These are: (1) contrary to mixed and vasodepressor forms, an asystolic tilt response is specific, i.e., diagnostic, of VVS and is unlikely to occur in control patients without history of syncope and in patients with cardiac syncope; (2) contrary to mixed and vasodepressor forms, an asystolic tilt response predicts a similar asystolic event during prolonged ECG monitoring with a positive predictive value of 86%; (3) the available evidence from trials supports the efficacy of dual-chamber pacing with a low recurrence rate of syncope after pacing ranging from 6% up to 23% during 3 years of follow-up. The latter results should be confirmed by an ongoing double-blind randomized controlled trial before cardiac pacing becomes an established indication. It is commonly believed that the most frequent cause of recurrence of syncope in patients treated with a pacemaker is an associated hypotensive reflex. In these cases additional measures should be used to counteract hypotension. Recognizing prodromal symptoms, avoiding triggers, and performing counterpressure maneuvers are the well-known first steps. There are two additional useful measures when these fail: stopping/reducing hypotensive drugs and (in selected cases) adding fludrocortisone.