Performance of a multi-sensor implantable defibrillator algorithm for heart failure monitoring in the presence of atrial fibrillation.

AIMS: The HeartLogic Index combines data from multiple implantable cardioverter defibrillators (ICDs) sensors and has been shown to accurately stratify patients at risk of heart failure (HF) events. We evaluated and compared the performance of this algorithm during sinus rhythm and during long-lasting atrial fibrillation (AF). METHODS AND RESULTS: HeartLogic was activated in 568 ICD patients from 26 centres. We found periods of ≥30 consecutive days with an atrial high-rate episode (AHRE) burden <1 h/day and periods with an AHRE burden ≥20 h/day. We then identified patients who met both criteria during the follow-up (AHRE group, n = 53), to allow pairwise comparison of periods. For control purposes, we identified patients with an AHRE burden <1 h throughout their follow-up and implemented 2:1 propensity score matching vs. the AHRE group (matched non-AHRE group, n = 106). In the AHRE group, the rate of alerts was 1.2 [95% confidence interval (CI): 1.0-1.5]/patient-year during periods with an AHRE burden <1 h/day and 2.0 (95% CI: 1.5-2.6)/patient-year during periods with an AHRE-burden ≥20 h/day (P = 0.004). The rate of HF hospitalizations was 0.34 (95% CI: 0.15-0.69)/patient-year during IN-alert periods and 0.06 (95% CI: 0.02-0.14)/patient-year during OUT-of-alert periods (P < 0.001). The IN/OUT-of-alert state incidence rate ratio of HF hospitalizations was 8.59 (95% CI: 1.67-55.31) during periods with an AHRE burden <1 h/day and 2.70 (95% CI: 1.01-28.33) during periods with an AHRE burden ≥20 h/day. In the matched non-AHRE group, the rate of HF hospitalizations was 0.29 (95% CI: 0.12-0.60)/patient-year during IN-alert periods and 0.04 (95% CI: 0.02-0.08)/patient-year during OUT-of-alert periods (P < 0.001). The incidence rate ratio was 7.11 (95% CI: 2.19-22.44). CONCLUSION: Patients received more alerts during periods of AF. The ability of the algorithm to identify increased risk of HF events was confirmed during AF, despite a lower IN/OUT-of-alert incidence rate ratio in comparison with non-AF periods and non-AF patients. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/Identifier: NCT02275637.

Performance of a multisensor implantable defibrillator algorithm for heart failure monitoring related to co-morbidities.

AIMS: The HeartLogic algorithm combines multiple implantable defibrillator (ICD) sensor data and has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation in cardiac resynchronization therapy (CRT-D) patients. We evaluated the performance of this algorithm in non-CRT ICD patients and in the presence of co-morbidities. METHODS AND RESULTS: The HeartLogic feature was activated in 568 ICD patients (410 with CRT-D) from 26 centres. The median follow-up was 26 months [25th-75th percentile: 16-37]. During follow-up, 97 hospitalizations were reported (53 cardiovascular) and 55 patients died. We recorded 1200 HeartLogic alerts in 370 patients. Overall, the time IN the alert state was 13% of the total observation period. The rate of cardiovascular hospitalizations or death was 0.48/patient-year (95% CI: 0.37-0.60) with the HeartLogic IN the alert state and 0.04/patient-year (95% CI: 0.03-0.05) OUT of the alert state, with an incidence rate ratio of 13.35 (95% CI: 8.83-20.51, P < 0.001). Among patient characteristics, atrial fibrillation (AF) on implantation (HR: 1.62, 95% CI: 1.27-2.07, P < 0.001) and chronic kidney disease (CKD) (HR: 1.53, 95% CI: 1.21-1.93, P < 0.001) independently predicted alerts. HeartLogic alerts were not associated with CRT-D versus ICD implantation (HR: 1.03, 95% CI: 0.82-1.30, P = 0.775). Comparisons of the clinical event rates in the IN alert state with those in the OUT of alert state yielded incidence rate ratios ranging from 9.72 to 14.54 (all P < 0.001) in all groups of patients stratified by: CRT-D/ICD, AF/non-AF, and CKD/non-CKD. After multivariate correction, the occurrence of alerts was associated with cardiovascular hospitalization or death (HR: 1.92, 95% CI: 1.05-3.51, P = 0.036). CONCLUSIONS: The burden of HeartLogic alerts was similar between CRT-D and ICD patients, while patients with AF and CKD seemed more exposed to alerts. Nonetheless, the ability of the HeartLogic algorithm to identify periods of significantly increased risk of clinical events was confirmed, regardless of the type of device and the presence of AF or CKD.

Prognostic significance of remotely monitored nocturnal heart rate in heart failure patients with reduced ejection fraction.

BACKGROUND: Elevated resting heart rate is a risk factor for cardiovascular events. OBJECTIVE: The purpose of this study was to investigate the clinical significance of nocturnal heart rate (nHR) and 24-hour mean heart rate (24h-HR) obtained by continuous remote monitoring (RM) of implantable devices. METHODS: We analyzed daily-sampled trends of nHR, 24h-HR, and physical activity in patients on ß-blocker therapy for chronic heart failure and with implantable cardioverter-defibrillators or cardiac resynchronization therapy defibrillators (CRT-Ds). Patients were grouped by average nHR and 24h-HR quartile during follow-up to estimate the respective incidence of nonarrhythmic death and device-treated ventricular tachycardia/fibrillation (VT/VF). RESULTS: The study cohort included 1330 patients (median age 69 years [interquartile range 61-77 years]; 41% [n = 550] with CRT-D; median follow-up 25 months [interquartile range 13-42 months]). Compared with patients in the lowest nHR quartile (≤57 beats/min) group, patients in the highest quartile group (>65 beats/min) had an increased risk of nonarrhythmic death (adjusted hazard ratio [AHR] 2.25; 95% confidence interval [CI] 1.13-4.50; P = .021) and VT/VF (AHR 1.98; 95% CI 1.40-2.79; P < .001) and were characterized by the lowest level of physical activity (P ≤ .0004 vs every other nHR quartiles). The highest 24h-HR quartile group (>75 beats/min) showed an increased risk of VT/VF (AHR 2.13; 95% CI 1.52-2.99; P < .001) and a weaker though significant association with nonarrhythmic mortality (AHR 1.80; 95% CI 1.00-3.22; P = .05) as compared with the lowest 24h-HR quartile group (≤65 beats/min). CONCLUSION: In remotely monitored patients with implantable cardioverter-defibrillator/CRT-D on ß-blocker therapy for heart failure, elevated heart rates (nHR >65 beats/min and 24h-HR >75 beats/min) were associated with increased mortality and VT/VF risk. nHR showed a stronger association than 24h-HR with worst prognosis and lowest physical activity.

Combination of an implantable defibrillator multi-sensor heart failure index and an apnea index for the prediction of atrial high-rate events.

AIMS: Patients with atrial fibrillation frequently experience sleep disorder breathing, and both conditions are highly prevalent in presence of heart failure (HF). We explored the association between the combination of an HF and a sleep apnoea (SA) index and the incidence of atrial high-rate events (AHRE) in patients with implantable defibrillators (ICDs). METHODS AND RESULTS: Data were prospectively collected from 411 consecutive HF patients with ICD. The IN-alert HF state was measured by the multi-sensor HeartLogic Index (>16), and the ICD-measured Respiratory Disturbance Index (RDI) was computed to identify severe SA. The endpoints were as follows: daily AHRE burden of ≥5 min, ≥6 h, and ≥23 h. During a median follow-up of 26 months, the time IN-alert HF state was 13% of the total observation period. The RDI value was ≥30 episodes/h (severe SA) during 58% of the observation period. An AHRE burden of ≥5 min/day was documented in 139 (34%) patients, ≥6 h/day in 89 (22%) patients, and ≥23 h/day in 68 (17%) patients. The IN-alert HF state was independently associated with AHRE regardless of the daily burden threshold: hazard ratios from 2.17 for ≥5 min/day to 3.43 for ≥23 h/day (P < 0.01). An RDI ≥ 30 episodes/h was associated only with AHRE burden ≥5 min/day [hazard ratio 1.55 (95% confidence interval: 1.11-2.16), P = 0.001]. The combination of IN-alert HF state and RDI ≥ 30 episodes/h accounted for only 6% of the follow-up period and was associated with high rates of AHRE occurrence (from 28 events/100 patient-years for AHRE burden ≥5 min/day to 22 events/100 patient-years for AHRE burden ≥23 h/day). CONCLUSIONS: In HF patients, the occurrence of AHRE is independently associated with the ICD-measured IN-alert HF state and RDI ≥ 30 episodes/h. The coexistence of these two conditions occurs rarely but is associated with a very high rate of AHRE occurrence. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/Identifier: NCT02275637.

Implantable defibrillator-detected heart failure status predicts ventricular tachyarrhythmias.

INTRODUCTION: The prediction of ventricular tachyarrhythmias among patients with implantable cardioverter defibrillators is difficult with available clinical tools. We sought to assess whether in patients with heart failure (HF) and reduced ejection fraction with defibrillators, physiological sensor-based HF status, as summarized by the HeartLogic index, could predict appropriate device therapies. METHODS: Five hundred and sixty-eight consecutive HF patients with defibrillators (n = 158, 28%) or cardiac resynchronization therapy-defibrillators (n = 410, 72%) were included in this prospective observational multicenter analysis. The association of both HeartLogic index and its physiological components with defibrillator shocks and overall appropriate therapies was assessed in regression and time-dependent Cox models. RESULTS: Over a follow-up of 25 (15-35) months, 122 (21%) patients received an appropriate device therapy (shock, n = 74, 13%), while the HeartLogic index crossed the threshold value (alert, HeartLogic ≥ 16) 1200 times (0.71 alerts/patient-year) in 370 (65%) subjects. The occurrence of ≥1 HeartLogic alert was significantly associated with both appropriate shocks (Hazard ratios [HR]: 2.44, 95% confidence interval [CI]: 1.49-3.97, p = .003), and any appropriate defibrillator therapies. In multivariable time-dependent Cox models, weekly IN-alert state was the strongest predictor of appropriate defibrillator shocks (HR: 2.94, 95% CI: 1.73-5.01, p < .001) and overall therapies. Compared with stable patients, patients with appropriate shocks had significantly higher values of HeartLogic index, third heart sound amplitude, and resting heart rate 30-60 days before device therapy. CONCLUSION: The HeartLogic index is an independent dynamic predictor of appropriate defibrillator therapies. The combined index and its individual physiological components change before the arrhythmic event occurs.

Predicting all-cause mortality by means of a multisensor implantable defibrillator algorithm for heart failure monitoring.

BACKGROUND: The HeartLogic algorithm (Boston Scientific) has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. OBJECTIVE: The purpose of this study was to determine whether remotely monitored data from this algorithm could be used to identify patients at high risk for mortality. METHODS: The algorithm combines implantable cardioverter-defibrillator (ICD)-measured accelerometer-based heart sounds, intrathoracic impedance, respiration rate, ratio of respiration rate to tidal volume, night heart rate, and patient activity into a single index. An alert is issued when the index crosses a programmable threshold. The feature was activated in 568 ICD patients from 26 centers. RESULTS: During median follow-up of 26 months [25th-75th percentile 16-37], 1200 alerts were recorded in 370 patients (65%). Overall, the time IN-alert state was 13% of the total observation period (151/1159 years) and 20% of the follow-up period of the 370 patients with alerts. During follow-up, 55 patients died (46 in the group with alerts). The rate of death was 0.25 per patient-year (95% confidence interval [CI] 0.17-0.34) IN-alert state and 0.02 per patient-year (95% CI 0.01-0.03) OUT of the alert state, with an incidence rate ratio of 13.72 (95% CI 7.62-25.60; P <.001). After multivariate correction for baseline confounders (age, ischemic cardiomyopathy, kidney disease, atrial fibrillation), the IN-alert state remained significantly associated with the occurrence of death (hazard ratio 9.18; 95% CI 5.27-15.99; P <.001). CONCLUSION: The HeartLogic algorithm provides an index that can be used to identify patients at higher risk for all-cause mortality. The index state identifies periods of significantly increased risk of death.

Implantable defibrillator-detected heart failure status predicts atrial fibrillation occurrence.

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

Reduction of admissions for urgent and elective pacemaker implant during the COVID-19 outbreak in Northern Italy.

AIMS: The coronavirus disease-19 (COVID-19) outbreak has been recently associated with lower hospitalization rates for acute coronary syndromes. Aim of the study was to investigate whether a similar behaviour is observed in admissions for urgent pacemaker implant. METHODS: This retrospective study included 1315 patients from 18 hospitals in Northern Italy with a high number of COVID-19 cases. Hospitalization rates for urgent pacemaker implant were compared between the following periods: 20 February to 20 April 2020 (case period); from 1 January to 19 February 2020 (intra-year control period); from 20 February to 20 April 2019 (inter-year control period). RESULTS: The incidence rate of urgent implants was 5.0/day in the case period, 6.0/day in the intra-year control period and 5.8/day in the inter-year control period. Incidence rate in the case period was significantly lower than both the intra-year [incidence rate ratio (IRR): 0.81, 95% CI 0.67-0.99, P = 0.040] and inter-year control periods (IRR: 0.79, 95% CI 0.66-0.95, P = 0.012); this reduction was highest after the national lockdown (IRR 0.68, 95% CI 0.52-0.91, P = 0.009). The prevalence of residents in rural areas undergoing urgent pacemaker implant was lower in the case period (36%) than in both the intra-year (47%, P = 0.03) and inter-year control periods (51%, P = 0.002). Elective pacemaker implants also decreased in the case period, with the incidence rate here being 3.5/day vs. 6.4/day in the intra-year (-45%) and 6.9/day in the inter-year period (-49%). CONCLUSION: Despite severe clinical patterns, the COVID-19 outbreak has negatively affected the population presentation to Emergency Departments for bradyarrhythmias requiring urgent pacemaker implant in Northern Italy. This mainly occurred after the national lockdown and concerned patients living in rural areas.

Factors affecting signal quality in implantable cardiac monitors with long sensing vector.

PURPOSE: Electrical artefacts are frequent in implantable cardiac monitors (ICMs). We analyzed the subcutaneous electrogram (sECG) provided by an ICM with a long sensing vector and factors potentially affecting its quality. METHODS: Consecutive ICM recipients underwent a follow-up where demographics, body mass index (BMI), implant location, and surface ECG were collected. The sECG was then analyzed in terms of R-wave amplitude and P-wave visibility. RESULTS: A total of 84 patients (43% female, median age 68 [58-76] years) were enrolled at 3 sites. ICMs were positioned with intermediate inclination (n = 44, 52%), parallel (n = 35, 43%), or perpendicular (n = 5, 6%) to the sternum. The median R-wave amplitude was 1.10 (0.72-1.48) mV with P waves readily visible in 69.2% (95% confidence interval, CI: 57.8%-79.2%), partially visible in 23.1% [95% CI: 14.3%-34.0%], and never visible in 7.7% [95% CI: 2.9%-16.0%] of patients. Men had higher R-wave amplitudes compared to women (1.40 [0.96-1.80] mV vs 1.00 [0.60-1.20] mV, P = .001), while obese people tended to have lower values (0.80 [0.62-1.28] mV vs 1.10 [0.90-1.50] mV, P = .074). The P-wave visibility reached 86.2% [95% CI: 68.3%-96.1%] in patients with high-voltage P waves (≥0.2 mV) at surface ECG. The sECG quality was not affected by implant site. CONCLUSION: In ordinary clinical practice, ICMs with long sensing vector provided median R-wave amplitude above 1 mV and reliable P-wave visibility of nearly 70%, regardless of the position of the device. Women and obese patients showed lower but still very good signal quality.

Prevalence and predictors of atrial fibrillation in patients with embolic stroke of undetermined source: a real-life single-center retrospective study.

INTRODUCTION: Up to one-third of ischemic strokes remained cryptogenic despite extensive investigations. Atrial fibrillation may be detected in a significant proportion of patients with embolic stroke of undetermined source, particularly after the introduction of implantable loop recorder in clinical practice. METHODS: We retrospectively included all the consecutive patients with embolic stroke of undetermined source referred to our units in the period November 2013 to December 2018 and in which an implantable loop recorder was positioned within 6 months from stroke event. Prevalence and predictors of atrial fibrillation were investigated. RESULTS: One hundred thirty-eight patients with embolic stroke of undetermined source fulfilling inclusion criteria were identified. The crude prevalence of atrial fibrillation at the end of observation period was of 45.7%. Incidence rates at 6, 12, 18, 24, and 36 months resulted, respectively, 31.8% (95% CI, 30.4-46.7), 38.0% (95% CI, 30.4-46.9), 42.6% (95% CI, 34.5-51.6), 46.6% (95% CI, 38.2-55.8), and 50.4% (95% CI, 41.6-59.9). On multivariate analysis, only excessive supraventricular electric activity and left atrial enlargement resulted to be significant predictors of atrial fibrillation (p = 0.037 and p < 0.0001, respectively). CONCLUSIONS: Atrial fibrillation may be detected in a relevant proportion (up to 50%) of patients with embolic stroke of undetermined source if a careful and extensive diagnostic work-up is employed. Excessive supraventricular electric activity and left atrial enlargement are significant predictors of the occurrence of atrial fibrillation in these patients.

Clinical Discussions in Antithrombotic Therapy Management in Patients With Atrial Fibrillation: A Delphi Consensus Panel.

BACKGROUND: In recent years, direct-acting oral anticoagulants (DOACs) have entered clinical practice for stroke prevention in non-valvular atrial fibrillation or prevention and treatment of venous thromboembolism. However, remaining uncertainty regarding DOAC use in some clinical scenarios commonly encountered in the real world has not been fully explored in clinical trials. METHODS: We report on use of a Delphi consensus process on DOAC use in non-valvular atrial fibrillation patients. The consensus process dealt with 9 main topics: (i) DOACs vs vitamin K antagonists in atrial fibrillation (AF) patients; (ii) therapeutic options for patients with stable total time in range treated with vitamin K antagonists; (iii) therapeutic options for patients aged > 85 years; (iv) therapeutic management of hyperfiltering patients; (v) pharmacologic interactions; (vi) therapeutic options in the long-term treatment (prevention) of patients with AF and acute coronary syndrome after the triple therapy; (vii) low doses of DOACs in AF patients; (viii) ischemic stroke in patients inappropriately treated with low doses of DOACs; (ix) management of patients taking DOACs with left atrial appendage thrombosis. RESULTS: A total of 101 physicians (cardiologists, internists, geriatricians, and hematologists) from Italy expressed their level of agreement on each statement by using a 5-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = somewhat agree; 4 = agree; 5 = strongly agree). Votes 1-2 were considered to be disagreement; votes 3-5 were considered to be agreement. Agreement among the respondents of ≥ 66% for each statement was considered consensus. A brief discussion of the results for each topic is also reported. CONCLUSIONS: In clinical practice, there is still uncertainty on DOAC use, especially in elderly, fragile, comorbid, and hyperfiltering patients.

CONTEXTE: Depuis quelques années, les cliniciens prescrivent des anticoagulants oraux directs (AOD) pour prévenir les accidents vasculaires cérébraux (AVC) chez les patients présentant une fibrillation auriculaire (FA) non valvulaire ou pour prévenir et traiter les thromboembolies veineuses. Cependant, les doutes que suscite encore l'emploi des AOD dans certains contextes courants de la pratique clinique n'ont pas encore été bien explorés dans le cadre des études cliniques. MÉTHODOLOGIE: Nous avons utilisé la méthode de Delphes, une démarche visant à dégager un consensus, afin d'évaluer le recours aux AOD chez des patients présentant une FA non valvulaire. L'étude comprenait 9 thèmes principaux : i) utilisation des AOD et des antagonistes de la vitamine K chez les patients présentant une FA; ii) options thérapeutiques pour les patients traités par un antagoniste de la vitamine K dont l'état se maintient depuis un certain temps dans une plage de valeurs normales; iii) options thérapeutiques pour les patients âgés de plus de 85 ans; iv) prise en charge thérapeutique des patients souffrant d'hyperfiltration; v) interactions pharmacologiques; vi) options thérapeutiques pour le traitement prolongé (préventif) des patients présentant une FA et un syndrome coronarien aigu après une trithérapie; vii) utilisation des AOD à faible dose chez les patients présentant une FA; viii) AVC ischémique chez les patients traités de façon inappropriée par un AOD à faible dose; ix) prise en charge des patients prenant un AOD qui présentent une thrombose de l'appendice auriculaire gauche. RÉSULTATS: Au total, 101 médecins (cardiologues, internistes, gériatres et hématologues) italiens ont exprimé leur degré d'accord avec chacun des énoncés proposés sur une échelle de Likert à 5 points (1 = tout à fait en désaccord; 2 = en désaccord; 3 = moyennement d'accord; 4 = d'accord; 5 = tout à fait d'accord). Une note de 1 ou 2 a été considérée comme un désaccord et une note de 3, 4 ou 5, comme un accord. On considérait qu'il y avait un consensus si 66 % ou plus des répondants étaient d'accord avec l'énoncé. Nous présentons également brièvement les résultats obtenus pour chacun des thèmes. CONCLUSIONS: Dans la pratique clinique, l'emploi des AOD soulève encore des doutes, en particulier chez les patients âgés, fragiles ou présentant des affections concomitantes ou une hyperfiltration.

Eligibility of cardiac resynchronization therapy patients for subcutaneous implantable cardioverter defibrillators.

BACKGROUND: Before subcutaneous implantable cardioverter defibrillator (S-ICD) implantation, the adequacy of sensing is required to be verified through surface ECG screening. Our objective was to determine whether S-ICD can be considered as a supplementary therapy in patients who are receiving biventricular (BIV) pacing. METHODS: We evaluated 48 patients with BIV devices to determine S-ICD candidacy during BIV, left ventricular (LV), right ventricular (RV) pacing, and intrinsic conduction (left bundle branch block-LBBB) by using an automated screening tool. Eligibility was defined by the presence of at least one appropriate vector in the supine and standing positions. RESULTS: Eligibility was verified during BIV pacing in 34 (71%) patients. In patients screened-out, QRS duration was longer (p = 0.035) and ischemic cardiomyopathy was more frequent (p = 0.027). LV-only pacing was associated with a lower passing rate (46%) (p < 0.001 versus BIV). The LBBB QRS morphology during inhibited ventricular pacing was acceptable in 51% of patients. The QRS generated by RV pacing was acceptable in 25% of patients. In patients who passed the screening test during BIV, the QRS was not acceptable in 76% during RV pacing (i.e., accidental loss of LV capture). The concomitant adequacy during inhibited ventricular pacing (i.e., possible intrinsic conduction) was not assessed in 40% of patients. CONCLUSIONS: S-ICD may be a supplemental therapy in the majority of CRT patients. Standard BIV pacing should be preferred to the LV-only pacing mode, as it is more frequently associated with adequacy of S-ICD sensing. Spontaneous LBBB and RV-paced QRS morphologies are frequently inadequate. Therefore, in patients selected for concomitant S-ICD and CRT implantation, accidental loss of LV capture or possible intrinsic conduction must be prevented.

Percutaneous Left Atrial Appendage Closure with WATCHMAN™ device: peri-procedural and mid-term outcomes from the TRAPS Registry.

PURPOSE: The WATCHMAN device for Left Atrial Appendage Occlusion (LAAO) has proven to be an effective alternative to oral anticoagulation (OAC) in patients with atrial fibrillation (AF), and has now been adopted in clinical practice. In the present study, we analyzed the safety and efficacy profile of the LAAO procedure at mid-term follow-up. METHODS: The TRAPS Registry is an observational, multicenter registry involving four Italian centers. Consecutive patients who had undergone LAAO with WATCHMAN device were enrolled. Clinical, demographic, and procedural data were collected at the time of implantation, and follow-up data were collected to assess the clinical outcome. RESULTS: A total of 151 patients were included in the Registry from May 2012 to October 2015. Implantation of the device was successful in 150/151 patients, with no or minimal (< 5 mm) leakage as assessed by peri-procedural transesophageal echo. In the remaining patient, early device embolization was reported, with no sequelae. Overall, intra-procedural events were reported in 5 (3.3%) patients. During a median follow-up of 16 months (25th and 75th percentile, 10-25), 5 patients died of any cause. The annual rate of all-cause stroke was 2.2% (95% CI, 0.7-5.1), the rate of transient ischemic attack was 1.3% (95% CI, 0.3-3.8), and that of major bleeding 0.4% (95% CI, 0.01-2.4). CONCLUSIONS: LAAO for stroke prevention was safely and effectively achieved by implantation of the WATCHMAN device in patients with non-valvular AF. Moreover, regardless of the risk profile of the population, we observed low rates of death and thromboembolic and bleeding events over a median follow-up of 16 months. These findings were obtained in an unselected group of consecutive patients who were variably eligible for chronic OAC therapy.

Economic impact of remote monitoring after implantable defibrillators implantation in heart failure patients: an analysis from the EFFECT study.

AIMS: Heart failure (HF) patients with implantable cardioverter-defibrillators (ICD) require admissions for disease management and out-patient visits for disease management and assessment of device performance. These admissions place a significant burden on the National Health Service. Remote monitoring (RM) is an effective alternative to frequent hospital visits. The EFFECT study was a multicentre observational investigation aiming to evaluate the clinical effectiveness of RM compared with in-office visits standard management (SM). The present analysis is an economic evaluation of the results of the EFFECT trial. METHODS AND RESULTS: The present analysis considered the direct consumption of healthcare resources over 12-month follow-up. Standard tariffs were applied to hospitalizations, in-office visits and remote device interrogations. Economic comparisons were also carried out by means of propensity score (PS) analysis to take into account the lack of randomization in the study design. The analysis involved 858 patients with ICD or CRT-D. Of these, 401 (47%) were followed up via an SM approach, while 457 (53%) were assigned to RM. The rate of hospitalizations was 0.27/year in the SM group and 0.16/year in the RM group (risk reduction =0.59; P = 0.0004). In the non-adjusted analysis, the annual cost for each patient was €817 in the SM group and €604 in the RM group (P = 0.014). Propensity score analysis, in which 292 RM patients were matched with 292 SM patients, confirmed the results of the non-adjusted analysis (€872 in the SM group vs. €757 in the RM group; P < 0.0001). CONCLUSION: There is a reduction in direct healthcare costs of RM for HF patients with ICDs, particularly CRT-D, compared with standard monitoring. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/Identifier, NCT01723865.

Twelve-year follow-up of catheter ablation for atrial fibrillation: A prospective, multicenter, randomized study.

BACKGROUND: Randomized and controlled studies have reported the effect of catheter ablation (CA) for atrial fibrillation (AF) over a follow-up of 12-24 months. OBJECTIVE: We report on the effect of CA plus antiarrhythmic drugs in comparison with antiarrhythmic drugs alone on the maintenance of sinus rhythm over 12-year follow-up. METHODS: We extended the follow-up duration of the 137 patients who were enrolled in the Catheter Ablation for the Cure of Atrial Fibrillation Study between February 1, 2002, and June 30, 2003, and randomized to antiarrhythmic drugs (control group) or antiarrhythmic drugs plus CA (ablation group). The primary end point was time to first symptomatic or asymptomatic recurrence of atrial arrhythmia lasting >30 seconds during follow-up. RESULTS: During follow-up, 19 of 68 (27.9%; 95% confidence interval [CI] 18.7%-39.6%) ablation group patients and 3 of 69 (4.3%; 95% CI 1.49%-12.0%) control group patients did not experience any relapse of atrial tachyarrhythmia (P < .001). The Kaplan-Meier analysis performed to determine the probability of survival free from atrial arrhythmias showed a statistical difference in favor of the ablation group (log-rank, P < .001). The effect of CA was consistent in both patients with paroxysmal AF and those with persistent AF. In the multivariate Cox regression analysis, belonging to the control group (hazard ratio 2.95; 95% CI 1.896-4.726; P < .001) and longer time since first AF episode (hazard ratio 1.004; 95% CI 1.002-1.084; P = .041) were predictors of atrial tachyarrhythmia recurrence. CONCLUSION: In patients with paroxysmal and persistent AF, CA significantly increased time to first recurrence of atrial arrhythmias during 12-year follow-up.

Association between remote implantable cardioverter defibrillator monitoring and beta-blocker utilization: An analysis from the EFFECT study.

INTRODUCTION: A substantial number of heart failure patients undergoing implantation of implantable cardioverter defibrillators (ICDs) fail to receive beta-blockers, or receive them at a suboptimal dose. Remote monitoring (RM) is becoming the standard means of following up recipients of ICDs. However, the impact of this shift toward remote ICD follow-up on the quality of drug therapy management in current clinical practice is unknown. The present analysis was aimed at investigating the impact of RM on the dose of beta-blockers achieved, and its association with clinical outcome at 12 months. METHODS: Altogether 987 consecutive patients were enrolled and followed up for at least 12 months in 25 Italian centres. RM was adopted by 499 patients. RESULTS: The number of patients receiving beta-blockers at any dose decreased after 12 months (from 403 (81%) to 370 (74%) for the remote arm and from 389 (80%) to 342 (70%) for the standard arm, both p < 0.02). Nonetheless, the number of patients on beta-blockers at the effective dose increased in both arms (from 60 (12%) to 82 (16%) for remote and from 63 (13%) to 98 (20%) for standard arms respectively, both p < 0.05). At multivariate analysis, RM was not associated with an effective dose of beta-blockers at the follow-up evaluation. However, the adoption of RM (p = 0.003) and the achievement of the effective dose of beta-blockers (p = 0.006) were independently and positively associated with an improved outcome. DISCUSSION: In a 'real-world' setting, we did not find an association between RM and the achieved dose of beta-blockers. However, we reported outcome benefits in achieving the effective dose of beta-blockers during follow-up and in adopting RM.

Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study.

AIMS: Internet-based remote interrogation systems have been shown to reduce emergency department and in-office visits in patients with implantable cardioverter defibrillators (ICDs), resulting in increased efficiency for healthcare providers. Nonetheless, studies sized to demonstrate the impact of remote monitoring on patients' outcome have been lacking. METHODS AND RESULTS: The EFFECT study was a multicentre clinical trial aimed at measuring and comparing the outcome of ICD patients conventionally followed-up by means of in-clinic visits (Standard arm) or by remote monitoring (Remote arm) in the clinical practice of 25 Italian centres. From 2011 to 2013, 987 consecutive patients were enrolled and followed up for at least 12 months. The primary endpoint was the rate of death and cardiovascular hospitalizations. Remote monitoring was adopted by 499 patients. Patients in the Standard and Remote arms did not differ significantly in terms of baseline clinical characteristics, except for a more frequent use of ICD with cardiac resynchronization therapy (CRT-D) in the Remote arm (48 vs. 36%, P < 0.001). One-year rates of the primary combined endpoint were 0.27 events/year for patients in the Standard arm and were 0.15 events/year for those in the Remote arm (incident rate ratio, 0.55; 95% CI, 0.41-0.73; P < 0.001). The endpoint rates in the Standard and Remote arms were 0.27 and 0.08 events/year, respectively, among CRT-D recipients (P < 0.001), and 0.28 vs. 0.21 among ICD patients (P = 0.094). The rates of in-office visits were 1.9 per year in the Standard arm and 1.7 per year in the Remote arm. CONCLUSION: Compared with the standard follow-up through in-office visits, remote monitoring is associated with reduced death and cardiovascular hospitalizations in patients with ICD in clinical practice. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/ Identifier: NCT01723865.

Symptomatic and asymptomatic long-term recurrences following transcatheter atrial fibrillation ablation.

BACKGROUND: Atrial fibrillation (AF) relapses, following transcatheter AF ablation, are frequently reported based on patients' symptoms, scheduled electrocardiograms (ECGs), or 24-hour Holter recordings. The aim of this study is to determine the incidence of asymptomatic and symptomatic AF recurrences, using continuous subcutaneous ECG monitoring, in the long-term follow-up of patients with paroxysmal or persistent AF undergoing transcatheter ablation. METHODS AND RESULTS: In total 113 consecutive patients symptomatic for paroxysmal or persistent AF were enrolled. All patients underwent pulmonary vein isolation plus left linear lesions. The insertable cardiac monitor (ICM), subcutaneously implanted during the ablation procedure, recorded the amount of AF per day (daily burden) and per last follow-up period (total AF burden). Based on symptoms and on scheduled 12-lead ECG performed during follow-up, 40 patients (35.4%) suffered AF recurrences. By means of ICM data, however, arrhythmia relapses were recorded within 75 patients (66.3%), of whom 35 (46.7%) were asymptomatic. Patients suffering symptomatic AF recurrences resulted, at univariate analysis, older (66.6 ± 8.4 years vs 61.6 ± 10.7 years) and suffering greater AF burden (88.8 ± 26.9% vs 8.0 ± 8.0%). CONCLUSIONS: AF ablation outcome based on patients' symptoms and/or scheduled ECGs underestimated relapses, as up to half of the patients, during a long-term follow-up, suffer asymptomatic recurrences.

Remote monitoring for implantable defibrillators: a nationwide survey in Italy.

BACKGROUND: Remote monitoring (RM) permits home interrogation of implantable cardioverter defibrillator (ICD) and provides an alternative option to frequent in-person visits. OBJECTIVE: The Italia-RM survey aimed to investigate the current practice of ICD follow-up in Italy and to evaluate the adoption and routine use of RM. METHODS: An ad hoc questionnaire on RM adoption and resource use during in-clinic and remote follow-up sessions was completed in 206 Italian implanting centers. RESULTS: The frequency of routine in-clinic ICD visits was 2 per year in 158/206 (76.7%) centers, 3 per year in 37/206 (18.0%) centers, and 4 per year in 10/206 (4.9%) centers. Follow-up examinations were performed by a cardiologist in 203/206 (98.5%) centers, and by more than one health care worker in 184/206 (89.3%) centers. There were 137/206 (66.5%) responding centers that had already adopted an RM system, the proportion of ICD patients remotely monitored being 15% for single- and dual-chamber ICD and 20% for cardiac resynchronization therapy ICD. Remote ICD interrogations were scheduled every 3 months, and were performed by a cardiologist in 124/137 (90.5%) centers. After the adoption of RM, the mean time between in-clinic visits increased from 5 (SD 1) to 8 (SD 3) months (P<.001). CONCLUSIONS: In current clinical practice, in-clinic ICD follow-up visits consume a large amount of health care resources. The results of this survey show that RM has only partially been adopted in Italy and, although many centers have begun to implement RM in their clinical practice, the majority of their patients continue to be routinely followed-up by means of in-clinic visits.