Closed loop stimulation reduces the incidence of atrial high-rate episodes compared with conventional rate-adaptive pacing in patients with sinus node dysfunctions.

AIMS: Subclinical atrial fibrillation (AF) is associated with increased risk of progression to clinical AF, stroke, and cardiovascular death. We hypothesized that in pacemaker patients requiring dual-chamber rate-adaptive (DDDR) pacing, closed loop stimulation (CLS) integrated into the circulatory control system through intra-cardiac impedance monitoring would reduce the occurrence of atrial high-rate episodes (AHREs) compared with conventional DDDR pacing. METHODS AND RESULTS: Patients with sinus node dysfunctions (SNDs) and an implanted pacemaker or defibrillator were randomly allocated to dual-chamber CLS (n = 612) or accelerometer-based DDDR pacing (n = 598) and followed for 3 years. The primary endpoint was time to the composite endpoint of the first AHRE lasting ≥6 min, stroke, or transient ischaemic attack (TIA). All AHREs were independently adjudicated using intra-cardiac electrograms. The incidence of the primary endpoint was lower in the CLS arm (50.6%) than in the DDDR arm (55.7%), primarily due to the reduction in AHREs lasting between 6 h and 7 days. Unadjusted site-stratified hazard ratio (HR) for CLS vs. DDDR was 0.84 [95% confidence interval (CI), 0.72-0.99; P = 0.035]. After adjusting for CHA2DS2-VASc score, the HR remained 0.84 (95% CI, 0.71-0.99; P = 0.033). In subgroup analyses of AHRE incidence, the incremental benefit of CLS was greatest in patients without atrioventricular block (HR, 0.77; P = 0.008) and in patients without AF history (HR, 0.73; P = 0.009). The contribution of stroke/TIA to the primary endpoint (1.3%) was low and not statistically different between study arms. CONCLUSION: Dual-chamber CLS in patients with SND is associated with a significantly lower AHRE incidence than conventional DDDR pacing.

Temporal association between drops in thoracic impedance and malignant ventricular arrhythmia: A longitudinal analysis of remote monitoring trends.

INTRODUCTION: Thoracic impedance (TI) drops measured by implantable cardioverter-defibrillators (ICDs) have been reported to correlate with ventricular tachycardia/fibrillation (VT/VF). The aim of our study was to assess the temporal association of decreasing TI trends with VT/VF episodes through a longitudinal analysis of daily remote monitoring data from ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds). METHODS AND RESULTS: Retrospective data from 2384 patients were randomized 1:1 into a derivation or validation cohort. The TI decrease rate was defined as the percentage of rolling weeks with a continuously decreasing TI trend. The derivation cohort was used to determine a TI decrease rate threshold for a ≥99% specificity of arrhythmia prediction. The associated risk of VT/VF episodes was estimated in the validation cohort by dividing the available follow-up into 60-day assessment intervals. Analyses were performed separately for 1354 ICD and 1030 CRT-D patients. During a median follow-up of 2.0 years, 727 patients (30.4%) experienced 3298 confirmed VT/VF episodes. In the ICD group, a TI decrease rate of >60% was associated with a higher risk of VT/VF episode in a 60-day assessment interval (stratified hazard ratio, 1.42; 95% confidence interval (CI), 1.05-1.92; p = .023). The TI decrease preceded (40.8%) or followed (59.2%) the VT/VF episodes. In the CRT-D group, no association between TI decrease and VT/VF episodes was observed (p = .84). CONCLUSION: In our longitudinal analysis, TI decrease was associated with VT/VF episodes only in ICD patients. Preventive interventions may be difficult since episodes can occur before or after TI decrease.

Combining home monitoring temporal trends from implanted defibrillators and baseline patient risk profile to predict heart failure hospitalizations: results from the SELENE HF study.

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 < 0.001). In the validation group, sensitivity of predicting primary endpoint was 65.5% (CI 45.7-82.1%), median alerting time 42 days (interquartile range 21-89), and false (or unexplained) alert rate 0.69 (CI 0.64-0.74) [or 0.63 (CI 0.58-0.68)] per patient-year. Without the baseline risk-stratifier, the sensitivity remained 65.5% and the false/unexplained alert rates increased by ≈10% to 0.76/0.71 per patient-year. 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.

Circadian periodicity affects the type of ventricular arrhythmias and efficacy of implantable defibrillator therapies.

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 < .001) and 34% from 16:00 to 24:00 (p = .005). Episodes were more likely to be polymorphic at night with an adjusted marginal OR of 1.66 (CI, 1.15-2.40; p = .007) at 00:00-04:00 versus other timeslots. Episodes were less likely to be terminated by ATP in the 00:00-04:00 (success-to-failure ratio, 0.67; CI, 0.46-0.98; p = .039) and 08:00-12:00 (0.70; CI, 0.51-0.96; p = .02) timeslots, and most likely to be terminated by ATP between 12:00 and 16:00 (success-to-failure ratio 1.42; CI, 1.06-1.91; p = .02). CONCLUSION: VAs did not distribute uniformly over the 24 h, with a majority of episodes occurring from 08:00 to 16:00. Nocturnal episodes were more likely to be polymorphic. The efficacy of ATP depended on the time of delivery.

The role of atrial sensing for new-onset atrial arrhythmias diagnosis and management in single-chamber implantable cardioverter-defibrillator recipients: Results from the THINGS registry.

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.

Timing of cardioversion in atrial fibrillation: the sooner the better?

Management of recent-onset (<36 h) atrial fibrillation (AF) in the emergency room is highly variable, particularly concerning the type and timing of cardioversion, and the logistics of the treatment pathway. In clinical practice, it is fairly common for patients with recent-onset AF an attempt at re-establishing sinus rhythm, either with electric or pharmacologic cardioversion, as soon as feasible. Nonetheless, a 'wait-and-see' approach, and potentially delayed cardioversion, could represent a valid alternative to early cardioversion, considering that, often, in recent-onset AF, sinus rhythm is re-established spontaneously, thus repealing the need for active cardioversion, hence avoiding the possible risks of treatment. These concepts form the rationale for a recent multicentric randomized trial, Rate Control vs. Electrical Cardioversion Trial 7 - Acute Cardioversion vs. Wait and See (RACE 7 ACWAS), comparing the efficacy of delayed cardioversion, within 48 h from symptoms onset, in case of lack of spontaneous conversion, with early cardioversion in symptomatic patients with recent-onset AF. In patients presenting to the emergency department with recent-onset, symptomatic AF, a wait-and-see approach was non-inferior to early cardioversion in maintaining the sinus rhythm at 4 weeks. Nonetheless a system employing a delayed cardioversion strategy increases the costs of treatment, complicates the treatment pathway, and could represent a psychological burden for the patients. Accordingly, delayed cardioversion could not represent a practical choice for many hospitals with limited resources and without an adequate outpatient organization.

Long-term outcomes after prophylactic ICD and CRT-D implantation in nonischemic patients: Analysis from a nationwide database of daily remote-monitoring transmissions.

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.

Comparison of outcomes in infected cardiovascular implantable electronic devices between complete, partial, and failed lead removal: an ESC-EHRA-EORP ELECTRa (European Lead Extraction ConTrolled) registry.

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 88 (4.7%), and failed (>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 < 0.0001 and OR 2.68 (1.22-5.91), P = 0.0146, respectively]. In analysis by lead, predictors for failure were: pacemaker vs. defibrillator removal and failure to engage the locking stylet all the way to the tip [OR 0.20 (0.04-0.95), P = 0.03 and OR 0.32 (0.13-0.74), P = 0.008, respectively]. Significantly higher complication rates were noted in the failure group (40.6% vs. 15.9 for partial and 8.7% for success groups, P < 0.0001). Failure to remove a lead was a strong predictor for in hospital mortality [hazard ratio of 2.05 (1.01-4.16), P = 0.046]. 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.

Long-term clinical and echocardiographic outcomes of Mitraclip therapy in patients nonresponders to cardiac resynchronization.

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.

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.

Ventricular arrhythmias in aortic valve stenosis before and after transcatheter aortic valve implantation.

AIMS: Transcatheter aortic valve implantation (TAVI) is a therapeutic treatment for patients with severe aortic stenosis (AS) at high surgical risk. Although the procedure is associated with a reduction in total mortality, there are no data regarding changing in the incidence of premature ventricular contractions (PVCs) and ventricular arrhythmias (VAs) after TAVI. The aim of this study was to assess the incidence of VAs before and after TAVI. METHODS AND RESULTS: We enrolled 237 patients who underwent TAVI at our centre. Ninety-one patients were excluded for the following reasons: presence of prior permanent pacemaker (PPM) (n = 20), new PPM implant after TAVI (n = 48), death during the follow-up period (n = 16), and lost at follow-up (n = 7). Finally, 146 patients were included in our analysis. The presence of VAs was evaluated in all patients recording a 24 h Holter monitoring before the procedure and after 1 and 12 months. Ventricular arrhythmias were classified according to a modified Lown grading system. Before the procedure, isolates PVCs (grade 1-2 of Lown grading system) were present in 34.9% of patients (n = 51). Complex PVCs (grade 3-4a-4b of Lown grading system) were present in 48.6% of the population (multifocal PVCs in 32 patients, 21.9%; pairs in 25 patients, 17.1%; ventricular tachycardia in 14 patients, 9.6%). One month after the procedure, we observed statistically significant incidence decrease of arrhythmias of grade 3 (from 21.9 to 17.1%) and grade 4 (pairs from 17.1 to 12.3%; ventricular tachycardia from 9.6 to 4.8%). After 12 months, there was a further significant reduction in the frequency and severity of PVCs. In particular, 45.8% of patients had isolates PVCs (<30 in all given hours of monitoring in 45 patients, 30.8%; higher than 30 in any hour of monitoring in 22 patients, 15%) while the frequency of complex arrhythmias was reduced to 16.4% (multifocal PVCs in 13 patients, 9%; couplets 8 patients, 5.5% and ventricular tachycardia in 3 patients, 2.0%). The difference was statistically significant (P < 0.01). CONCLUSION: This study indicates that VAs are common in patients with AS. We observed a significant decrease in the incidence and severity of PVCs since the first month after TAVI. Furthermore, after 1 year follow-up there was a further and significant reduction in the frequency of complex PVCs. This may be related to the benefits determined by valve replacement on left ventricular function.

Device-detected atrial sensing amplitudes as a marker of increased risk for new onset and progression of atrial high-rate episodes.

BACKGROUND: Atrial high-rate episodes (AHREs) are frequent in patients with cardiac implantable electronic devices. A decrease in device-detected P-wave amplitude may be an indicator of periods of increased risk of AHRE. OBJECTIVE: The objective of this study was to assess the association between P-wave amplitude and AHRE incidence. METHODS: Remote monitoring data from 2579 patients with no history of atrial fibrillation (23% pacemakers and 77% implantable cardioverter-defibrillators, of which 40% provided cardiac resynchronization therapy) were used to calculate the mean P-wave amplitude during 1 month after implantation. The association with AHRE incidence according to 4 strata of daily burden duration (≥15 minutes, ≥6 hours, ≥24 hours, ≥7 days) was investigated by adjusting the hazard ratio with the CHA2DS2-VASc score. RESULTS: The adjusted hazard ratio for 1-mV lower mean P-wave amplitude during the first month increased from 1.10 (95% confidence interval [CI], 1.05-1.15; P < .001) to 1.18 (CI, 1.09-1.28; P < .001) with AHRE duration strata from ≥15 minutes to ≥7 days independent of the CHA2DS2-VASc score. Of 871 patients with AHREs, those with 1-month P-wave amplitude <2.45 mV had an adjusted hazard ratio of 1.51 (CI, 1.19-1.91; P = .001) for progression of AHREs from ≥15 minutes to ≥7 days compared with those with 1-month P-wave amplitude ≥2.45 mV. Device-detected P-wave amplitudes decreased linearly during the 1 year before the first AHRE by 7.3% (CI, 5.1%-9.5%; P < .001 vs patients without AHRE). CONCLUSION: Device-detected P-wave amplitudes <2.45 mV were associated with an increased risk of AHRE onset and progression to persistent forms of AHRE independent of the patient's risk profile.

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.

Selection of patient for cardiac resynchronization therapy: role of QT corrected dispersion.

AIMS: About 30 to 50% of patients undergoing cardiac resynchronization therapy (CRT) may not show clinical or echocardiographic improvement, despite fulfilling guidelines recommendations for CRT. For this reason, we need a more accurate method to assess CRT eligibility. The aims of this study were to verify, on a 12-month follow-up, the usefulness of QT corrected dispersion (QTcD) in a patient's selection for CRT. METHODS: We stratified 53 patients who underwent CRT, into two groups based on the estimation of QTcD, that is, QTcD > 60 ms and QTcD ≤ 60 ms. In all patients were performed New York Heart Association (NYHA) class determination, six-minute walking test, QtcD, and QRS measurements, and complete echocardiographic assessment at 1, 3, 6, and 12 months after implantation. RESULTS: At baseline, there were no significant differences in clinical, echocardiographic, and electrocardiographic parameters duration between two groups. At 12-month follow-up between the two groups, there were significant differences in NYHA (1.2 ± 0.4 vs 2 ± 0.6; P < 0.01), six-minute walking distance (422 ± 68 vs 364 ± 68; P < 0.01), left ventricular (LV) ejection fraction (34 ± 7% vs 28 ± 6%; P < 0.01), LV end-diastolic diameter (57 ± 7 vs 63 ± 8; P < 0.01), and LV intraventricular dyssynchrony (24 ± 14 vs 39 ± 23; P < 0.01). CONCLUSION: This study suggests that QTc dispersion in addition to QRS duration could improve the sensitivity of electrocardiogram in a patient's selection for CRT.

Pulsed Field Ablation to Treat Atrial Fibrillation: A Review of the Literature.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and catheter ablation, which can be used in symptomatic patients refractory to antiarrhythmic therapy. Pulmonary vein isolation (PVI) remains the cornerstone of any ablation procedure. A major limitation of current catheter ablation procedures is important to recognize because even when the PVI is performed in highly experienced centers, PVI reconnection was documented in about 20% of patients. Therefore, better technology is needed to improve ablation lesions. One of the novelties in recent years is pulsed filed ablation (PFA), a non-thermal energy that uses trains of high-voltage, very-short-duration pulses to kill the cells. The mechanism of action of this energy consists of creating pores in the myocardiocyte cell membrane in a highly selective and tissue-specific way; this leads to death of the target cells reducing the risk of damage to surrounding non-cardiac tissues. In particular during the animal studies, PVI and atrial lines were performed effectively without PV stenosis. Using PFA directly on coronary arteries, there was no luminal narrowing, there has been no evidence of incidental phrenic nerve injury, and finally, PFA has been shown not to injure esophageal tissue when directly applied to the esophagus or indirectly through ablation in the left atrium. The aim of this review is to report all published animal and clinical studies regarding this new technology to treat paroxysmal and persistent AF.

The "Defibrillation Testing, Why Not?" survey. Testing of subcutaneous and transvenous defibrillators in the Italian clinical practice.

BACKGROUND: Defibrillation testing (DT) can be omitted in patients undergoing transvenous implantable cardioverter-defibrillator (T-ICD) implantation, but it is still recommended for patients at risk for a high defibrillation threshold and for ICD generator changes. Moreover, DT is still recommended on implantation of subcutaneous ICD (S-ICD). The aim of the present survey was to analyze the current practice of DT during T-ICD and S-ICD implantations. METHODS: In March 2021, an ad hoc questionnaire on the current performance of DT and the standard practice adopted during testing was completed at 72 Italian centers implanting S-ICD and T-ICD. RESULTS: 48 (67%) operators reported never performing DT during de-novo T-ICD implantations, while no operators perform it systematically. The remaining respondents perform it for patients at risk for a high defibrillation threshold. DT is never performed at T-ICD generator change. At the time of de-novo S-ICD implantation, DT is never performed by 9 (13%) operators and performed systematically by 48 (66%). The remaining operators frequently omit DT in patients with more severe systolic dysfunction. DT is not performed at S-ICD generator change by 92% of operators. DT is conducted by delivering a first shock energy of 65 J by 60% of operators, while the remaining 40% test lower energy values. CONCLUSIONS: In current clinical practice, most operators omit DT at T-ICD implantation, even when still recommended in the guidelines. DT is also frequently omitted at S-ICD implantation, and a wide variability exists among operators in the procedures followed during DT.

Ventricular Arrhythmias and Implantable Cardioverter-Defibrillator Therapy in Women: A Propensity Score-Matched Analysis.

BACKGROUND: Causes of sex differences in incidence of sustained ventricular arrhythmias (SVAs) are poorly understood. OBJECTIVES: 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). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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%.

One-year mortality after implantable defibrillator implantation: do risk stratification models help improving clinical practice?

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.

Gastrointestinal Bleeding and Direct Oral Anticoagulants among Patients with Atrial Fibrillation: Risk, Prevention, Management, and Quality of Life.

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.

Remote monitoring for heart failure management during COVID-19 pandemic.

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 < 0.0001). A small decrease was noted for mean heart rate (70.1 vs. 71.7 beats per minute [bpm]; RRR 2.2%; p < 0.0001), while thoracic impedance slightly increased (82.2 vs. 82.7 ohm; RRR 0.6%; p = 0.001). Patients' physical activity decreased from week 7 to week 11 (10.9% vs. 6.9%; RRR 36.7%; P < 0.0001) with an increase between week 11 and week 16 (6.9% vs. 8.5%; RRR 18.8%; P < 0.0001). Patients' perceptions about physical activity showed a very low correlation with remote monitoring-assessed physical activity levels (r2 = 0.035, p = 0.039). CONCLUSIONS: Telemedicine and remote monitoring can explore the impact of COVID-19 pandemic on vital signs and physical activity levels of heart failure patients, playing a crucial role in the prediction of heart failure worsening during circumstances discouraging outpatient visits.