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Advanced heart failure, an end-stage disease characterized by high mortality and morbidity despite standard medical therapy, requires various therapeutic strategies like heart transplant and long-term mechanical circulatory support. Echocardiography is the main imaging technique to identify transitions to advanced stages of disease and guide risk stratification and therapeutic decision-making processes. Progressive development of advanced echocardiographic techniques allows more comprehensive assessment of the hemodynamic and structural profiles of patients with advanced heart failure, and its use in clinical practice continues to expand. This article provides an overview of basic and emerging echocardiographic tools to assess patients with advanced heart failure.

Background: Patients with advanced heart failure with reduced ejection fraction often cannot tolerate target doses of guideline-directed medical therapy due to symptomatic hypotension, renal dysfunction, and associated electrolyte abnormalities. While levosimendan can facilitate the titration of β-blockers in patients with advanced HFrEF, it is unclear whether ambulatory levosimendan infusions would offer the same benefit. In this prospective study, we investigate the effects of intermittent ambulatory levosimendan infusions on the uptitration of disease-modifying drugs. Methods: We enrolled 37 patients with advanced HFrEF who received repeated ambulatory infusions of levosimendan between January 2018 and January 2021. The demographic, clinical, and laboratory data were acquired 24 h before the first and the last ambulatory levosimendan infusion. Results: At the 1 year follow-up, the enrolled patients were on significantly higher doses of guideline-directed medical therapy, including bisoprolol (3.2 ± 2.8 mg vs. 5.9 ± 4.1 mg; p = 0.02), sacubitril/valsartan (41.67 ± 32.48 mg vs. 68.5 ± 35.72 mg; p = 0.01), and eplerenone (12.7 ± 8.5 mg vs. 22.8 ± 13.6 mg; p = 0.03). Furthermore, a substantial decrease in the furosemide dose was observed (123.2 ± 32.48 mg vs. 81.6 ± 19.47 mg; p < 0.0001). Conclusions: Levosimendan facilitates the optimization of disease-modifying heart failure medications in previously intolerant advanced HFrEF patients.

Introduction In patients with symptomatic permanent atrial fibrillation (PEAF) and narrow QRS, atrio-ventricular junction ablation (AVJA) plus cardiac resynchronization therapy (CRT) is superior to medical therapy in reducing heart failure (HF) hospitalization and all-cause mortality. To compare the mortality of a population of patients with HF, reduced EF (rEF), and PEAF treated with AVJA plus CRT with that of a contemporary cohort of patients in sinus rhythm (SR) with similar baseline characteristics. Methods and Results In this prospective, multicentre, observational study, all-cause mortality in a group of consecutive patients undergoing AVJA and implantable cardioverter-defibrillator (ICD) combined with CRT implantation for HFrEF, narrow QRS, and PEAF with uncontrolled ventricular rate was compared with that of a contemporary cohort of patients in SR undergoing ICD implantation (not combined with CRT) for HFrEF and narrow QRS. Individual 1:1 propensity matching of baseline characteristics was performed. A total of 824 patients were enrolled. Propensity matching yielded 107 matched pairs. After a median follow-up of 52 months, all-cause mortality was similar in patients treated with AVJA plus CRT and in the control group (p = .434). In AVJA plus CRT patients, mortality was significantly lower than in control group patients with a history of paroxysmal/persistent AF (n = 45, p = .020), and similar to that of patients without a history of AF (n = 62, p = .459). Conclusions After adjustment for patient characteristics, the long-term prognosis of patients with HFrEF, narrow QRS, and PEAF who underwent AVJA plus CRT was similar to that of a population of patients in SR with similar characteristics.

Background Few studies have examined the causes of syncope/collapse recurrences in patients with a previously implanted pacemaker for bradyarrhythmic syncope. Objective The purpose of this study was to assess the causes of syncope/collapse recurrences after pacemaker implantation for bradyarrhythmic syncope in a large patient population. Methods The SYNCOpal recurrences in patients treated with permanent PACing for bradyarrhythmic syncope (SYNCOPACED) registry was a prospective multicenter observational registry enrolling 1364 consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope. During follow-up, the time to the first syncope/collapse recurrence was recorded. Patients with syncope/collapse recurrences underwent a predefined diagnostic workup aimed at establishing the mechanism of syncope/collapse. Results During a median follow-up of 50 months, 213 patients (15.6%) reported at least 1 syncope/collapse recurrence. The risk of syncope/collapse recurrence was highest in patients who underwent implantation for cardioinhibitory vasovagal syncope (26.4%), followed by unexplained syncope and chronic bifascicular block (21.5%), cardioinhibitory carotid sinus syndrome (17.2%), atrial fibrillation needing pacing (15.5%), atrioventricular block (13.6%), and sinus node disease (12.5%) (P = .017). The most frequent cause of syncope/collapse recurrence was reflex syncope (27.7%), followed by orthostatic hypotension (26.3%), pacemaker or lead malfunction (5.6%), structural cardiac disease (5.2%), and atrial and ventricular tachyarrhythmias (4.7% and 3.8%, respectively). In 26.8% of cases, the mechanism of syncope/collapse remained unexplained. Conclusion In patients receiving a pacemaker for bradyarrhythmic syncope, reflex syncope and orthostatic hypotension are the most frequent mechanisms of syncope/collapse recurrence after implantation. Pacing system malfunction, structural cardiac diseases, and tachyarrhythmias are rare mechanisms. The mechanism remains unexplained in >25% of patients.

Aims To evaluate the risk of syncopal recurrences after pacemaker implantation in a population of patients with syncope of suspected bradyarrhythmic aetiology. Methods and results Prospective, multicentre, observational registry enrolling 1364 consecutive patients undergoing pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed). Before pacemaker implantation, all patients underwent a cardiac work-up in order to establish the bradyarrhythmic aetiology of syncope. According to the results of the diagnostic work-up, patients were divided into three groups: Group A, patients in whom a syncope-electrocardiogram (ECG) correlation was established (n = 329, 24.1%); Group B, those in whom clinically significant bradyarrhythmias were detected without a documented syncope-ECG correlation (n = 877, 64.3%); and Group C, those in whom bradyarrhythmias were not detected and the bradyarrhythmic origin of syncope remained presumptive (n = 158, 11.6%). During a median follow-up of 50 months, 213 patients (15.6%) reported at least one syncopal recurrence. Patients in Groups B and C showed a significantly higher risk of syncopal recurrences than those in Group A [hazard ratios (HRs): 1.60 and 2.66, respectively, P Conclusion In selecting patients with syncope of suspected bradyarrhythmic aetiology for pacemaker implantation, establishing a correlation between syncope and bradyarrhythmias maximizes the efficacy of pacing and reduces the risk of syncopal recurrences.

Introduction: We sought to determine prevalence and predictive accuracy of clinical markers (red flags, RF), known to be associated with specific systemic disease in a consecutive cohort of patients with hypertrophic cardiomyopathy (HCM). Methods: We studied 129 consecutive patients (23.7 ± 20.9 years, range 0–74 years; male/female 68%/32%). Pre-specified RF were categorized into five domains: family history; signs/symptoms; electrocardiography; imaging; and laboratory. Sensitivity (Se), specificity (Sp), negative predictive value (NPV), positive predictive value (PPV), and predictive accuracy of RF were analyzed in the genotyped population. Results: In the overall cohort of 129 patients, 169 RF were identified in 62 patients (48%). Prevalence of RF was higher in infants (78%) and in adults >55 years old (58%). Following targeted genetic and clinical evaluation, 94 patients (74%) had a definite diagnosis (sarcomeric HCM or specific causes of HCM). We observed 14 RF in 13 patients (21%) with sarcomeric gene disease, 129 RF in 34 patients (97%) with other specific causes of HCM, and 26 RF in 15 patients (45%) with idiopathic HCM (p < 0.0001). Non-sarcomeric causes of HCM were the most prevalent in ages 55yo. Se, Sp, PPV, NPV and PA of RF were 97%, 70%, 55%, 98% and 77%, respectively. Single and clinical combination of RF (clusters) had an high specificity, NPV and predictive accuracy for the specific etiologies (syndromes/metabolic/infiltrative disorders associated with HCM). Conclusions: An extensive diagnostic work up, focused on analysis of specific diagnostic RF in patients with unexplained LVH facilitates a clinical diagnosis in 74% of patients with HCM.

In patients with unexplained syncope and bifascicular block (BFB), syncope may be caused by intermittent atrioventricular (AV) block. When a correlation between syncope and bradyarrhythmia is not documented in these patients, 2 alternative management strategies can be adopted: (1) empiric pacemaker (PM) implantation or (2) long-term continuous electrocardiographic monitoring by implantable loop recorder (ILR).The purpose of this study was to compare the risk of syncope recurrence associated with empiric PM implantation or ILR monitoring.A prospective, multicenter, observational study enrolled consecutive patients with unexplained, recurrent, traumatic syncope and BFB who underwent ILR monitoring or empiric PM implantation. The risk and causes of syncope recurrence were assessed and compared between the 2 groups. Individual 1:1 propensity matching of baseline characteristics was performed.A total of 309 consecutive patients (age 77.2 ± 12.2 years; 60.8% male) were enrolled. Propensity matching yielded 89 matched pairs. After median follow-up of 33 months, empiric PM implantation was associated with a significantly lower risk of syncope recurrence than ILR monitoring (19.1 vs 46.1%; P.001). A total of 35 patients (39.3%) who underwent ILR monitoring developed bradyarrhythmias (68.6% paroxysmal AV block) requiring PM implantation during follow-up. Excluding bradyarrhythmic syncope, the most frequent causes of syncope recurrence in both study groups were reflex syncope and orthostatic hypotension.In patients with unexplained, recurrent, traumatic syncope and BFB, empiric PM implantation significantly reduced the risk of syncope recurrence in comparison with ILR monitoring. A high rate of patients who underwent ILR monitoring developed bradyarrhythmias requiring PM implantation.

Background The remote device management (RM) is recommended for patients with cardiac implantable electronic devices (CIEDs). RM underutilization is frequently driven by the lack of correct system activation. The MyLATITUDE Patient App (Boston Scientific) has been developed to encourage patient compliance with RM by providing information on communicator setup, troubleshooting, and connection status of the communicator. Methods At 14 centers, patients with CIEDs were invited to download and install the App on a mobile device. After 3 months, patients were asked to complete an ad hoc questionnaire to evaluate their experience. Results The App was proposed to 242 consecutive patients: 81 before RM activation, and 161 during follow-up. The App was successfully installed by 177 (73%) patients. The time required for activation of the communicator and the need for additional support were similar between patients who followed the indications provided by the App and those who underwent standard in-clinic training. During follow-up, notifications of lack of connection were received by 20 (11%) patients and missed transmission by 22 (12%). The median time from notification to resolution was 2 days. After 3 months, 175 (99%) communicators of the 177 patients who installed the App were in “Monitored” status versus 113 (94%) of 120 patients without the App installed (p=0.033). The use of the app made 84% of patients feel reassured. Conclusions The App was well accepted by CIED patients and offered support for communicator management and installation. Its use enabled patients to remain connected with greater continuity during follow-up.

No data on the add-on sacubitril/valsartan (S/V) therapy among cardiac resynchronization therapy with a defibrillator (CRT-D) nonresponder patients are currently available in literature. We conducted a prospective observational study including 190 CRT-D nonresponder patients with symptomatic heart failure with reduced ejection fraction despite the optimal medical therapy from at least 1 year. The primary endpoint was the rate of additional responders (left ventricular end-systolic volume reduction >15%) at 12 months from the introduction of S/V therapy. At the end of the 12 months follow-up, 37 patients (19.5%) were deemed as "additional responders" to the combination use of CRT + S/V therapy. The only clinical predictor of additional response was a lower left ventricular ejection fraction [OR 0.881 (0.815-0.953), P = 0.002] at baseline. At 12 months follow-up, there were significant improvements in heart failure (HF) symptoms and functional status [New York Heart Association 2 (2-3) vs. 1 (1-2), P < 0.001; physical activity duration/day: 10 (8-12) vs. 13 (10-18) hours, P < 0.001]. Compared with the 12 months preceding S/V introduction, there were significant reductions in the rate of HF rehospitalization (35.5% vs. 19.5%, P < 0.001), in atrial tachycardia/atrial fibrillation burden [6.0 (5.0-8.0) % vs. 0 (0-2.0) %, P < 0.001] and in the proportions of patients experiencing ventricular arrhythmias (21.6% vs. 6.3%; P < 0.001). Our results indicate that S/V add-on therapy in CRT-D nonresponder patients is associated with 19.5% of additional responders, a reduction in HF symptoms and rehospitalizations, AF burden, and ventricular arrhythmias.

The role of prognostic risk scores in predicting the competing risk of non-sudden death in heart failure patients with reduced ejection fraction (HFrEF) receiving an implantable cardioverter-defibrillator (ICD) is unclear. To this goal, we evaluated the accuracy and usefulness of the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) score. The present analysis included 1089 HFrEF ICD recipients enrolled in the OBSERVO-ICD registry (NCT02735811). During a median follow-up of 36 months (1st–3rd IQR 25–48 months), 193 patients (17.7%) experienced at least one appropriate ICD therapy, and 133 patients died (12.2%) without experiencing any ICD therapy. The frequency of patients receiving ICD therapies was stable around 17–19% across increasing tertiles of 3-year MAGGIC probability of death, whereas non-sudden mortality increased (6.4% to 9.8% to 20.8%, p < 0.0001). Accuracy of MAGGIC score was 0.60 (95% CI, 0.56–0.64) for the overall outcome, 0.53 (95% CI, 0.49–0.57) for ICD therapies and 0.65 (95% CI, 0.60–0.70) for non-sudden death. In patients with higher 3-year MAGGIC probability of death, the increase in the competing risk of non-sudden death during follow-up was greater than that of receiving an appropriate ICD therapy. Results were unaffected when analysis was limited to ICD shocks only. The MAGGIC risk score proved accurate and useful in predicting the competing risk of non-sudden death in HFrEF ICD recipients. Estimation of mortality risk should be taken into greater consideration at the time of ICD implantation.

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

BACKGROUND: Aim of our study was to assess the association between COVID-19 lockdown and cardiac pacing (CP) procedures rates in Campania Region, the third-most-populous region of Italy with about 5.8 million residents. METHODS: Data about type of CP procedures and unit admissions were obtained from 14 CP centers throughout Campania region from March 10th and May 4Th 2020 and compared with the same time frame in 2019. RESULTS: A remarkable reduction in both temporary (reduction rate: -62.5%), definitive pace maker (reduction rate: -30.2%), ICD (reduction rate: -48.3%) and CRT (reduction rate: -48.4%) implantation and in CRT replacement (reduction rate: -88.8%) procedures has been shown between the two observation periods among 951 hospitalized patients. Planned hospitalizations showed a reduction rate of 69.3%. Conversely, urgent intra-hospital admissions (increase rate +430%; P 

Background: Virtually all patients with heart failure with reduced ejection fraction have a reduction of myocardial mechano-energetic efficiency (MEE). Cardiac contractility modulation (CCM) is a novel therapy for the treatment of patients with HFrEF, in whom it improves the quality of life and functional capacity, reduces hospitalizations, and induces biventricular reverse remodeling. However, the effects of CCM on MEE and global longitudinal strain (GLS) are still unknown; therefore, this study aims to evaluate whether CCM therapy can improve the MEE of patients with HFrEF. Methods: We enrolled 25 patients with HFrEF who received an Optimizer Smart implant (the device that develops CCM therapy) between January 2018 and January 2021. Clinical and echocardiographic evaluations were performed in all patients 24 h before and six months after CCM therapy. Results: At six months, follow-up patients who underwent CCM therapy showed an increase of left ventricular ejection fraction (30.8 ± 7.1 vs. 36.1 ± 6.9%; p = 0.032) as well a rise of GLS 10.3 ± 2.7 vs. −12.9 ± 4.2; p = 0.018), of MEE (32.2 ± 10.1 vs. 38.6 ± 7.6 mL/s; p = 0.013) and of MEE index (18.4 ± 6.3 vs. 24.3 ± 6.7 mL/s/g; p = 0.022). Conclusions: CCM therapy increased left ventricular performance, improving left ventricular ejection fraction, GLS, as well as MEE and MEEi.

Introduction:Little is known about the clinical performance of single-chamber leadless pacemaker (LLPM) in patients without atrial fibrillation (AF) as pacing indication. The aim of this study was to describe the clinical characteristics of patients who underwent single chamber LLPM implantation at three tertiary referral centers and to compare the safety and effectiveness of the single-chamber LLPM among patients with or without AF.Materials and Methods:All the consecutive patients who underwent LLPM implantation at three referral centers were analyzed. The indications to LLPM in a real-world setting were described. The study population was divided into two groups according to AF as pacing indication. We assessed the procedure-related complications; moreover, we compared syncope, cardiac hospitalization, pacemaker syndrome, and all-cause death recurrence during the follow-up between patients with and without AF as pacing indication.Results:A total of 140 consecutive patients (mean age, 76.7 ± 11.24 years, men 64.3%) were included in the study. The indication to implantation of LLPM was permanent AF with slow ventricular response (n: 67; 47.8%), sinus node dysfunction (n: 25; 17.8%), third atrioventricular block (AVB) (n: 20; 14.2%), second-degree AVB (n: 18; 12.8%), and first degree AVB (n: 10; 7.1%). A total of 7 patients (5%) experienced perioperative complications with no differences between the AF vs. non-AF groups. During a mean follow-up of 606.5 ± 265.9 days, 10 patients (7.7%) died and 7 patients (5.4%) were reported for cardiac hospitalization; 5 patients (3.8%) experienced syncope; no patients showed pacemaker syndrome. No significant differences in the clinical events between the groups were shown. The Kaplan–Meier analysis for the combined endpoints did not show significant differences between the AF and non-AF groups [hazard ratio (HR): 0.94, 95% CI: 0.41–2.16; p = 0.88].Conclusion:Our real-world data suggest that LLPM may be considered a safe and reasonable treatment in patients without AF in need of pacing. Further studies are needed to confirm these preliminary results.

INTRODUCTION Implantable cardioverter-defibrillator (ICD) alarm systems are an important means of monitoring device functioning. The aim of this study was to compare the ability of patients with sense two types of device alert systems: an audible alert and a vibratory alarm. METHODS The ability to recognize the alarms was assessed in three alarm tests performed in a series of consecutive ICD patients enrolled during routine outpatient device follow-up. To avoid overestimating the rate of patients able to sense the alarm, the first test was performed without forewarning. Subsequently, the second test was performed after the patients had been forewarned. Finally, to assess the learning effect of a demonstration test, a third test was performed, again without forewarning. RESULTS A total of 528 patients (65.4 ± 14.4 years, 74.6% male) were enrolled: 347 (65.7%) with an audible alert-endowed device and 181 (34.3%) with a vibratory alarm-endowed device. When emitted without warning, the alarms were sensed by 72.4% of patients. When patients were forewarned, the probability of sensing the alarms rose to 92.5% (P

Background: Patients with advanced heart failure with reduced ejection fraction often cannot tolerate target doses of guideline-directed medical therapy due to symptomatic hypotension, renal dysfunction, and associated electrolyte abnormalities. While levosimendan can facilitate the titration of β-blockers in patients with advanced HFrEF, it is unclear whether ambulatory levosimendan infusions would offer the same benefit. In this prospective study, we investigate the effects of intermittent ambulatory levosimendan infusions on the uptitration of disease-modifying drugs. Methods: We enrolled 37 patients with advanced HFrEF who received repeated ambulatory infusions of levosimendan between January 2018 and January 2021. The demographic, clinical, and laboratory data were acquired 24 h before the first and the last ambulatory levosimendan infusion. Results: At the 1 year follow-up, the enrolled patients were on significantly higher doses of guideline-directed medical therapy, including bisoprolol (3.2 ± 2.8 mg vs. 5.9 ± 4.1 mg; p = 0.02), sacubitril/valsartan (41.67 ± 32.48 mg vs. 68.5 ± 35.72 mg; p = 0.01), and eplerenone (12.7 ± 8.5 mg vs. 22.8 ± 13.6 mg; p = 0.03). Furthermore, a substantial decrease in the furosemide dose was observed (123.2 ± 32.48 mg vs. 81.6 ± 19.47 mg; p < 0.0001). Conclusions: Levosimendan facilitates the optimization of disease-modifying heart failure medications in previously intolerant advanced HFrEF patients.

INTRODUCTION Comparison data on management of device-related complications and their impact on patient outcome and healthcare utilization between subcutaneous implantable cardioverter-defibrillator (S-ICD) and transvenous ICD (TV-ICD) are lacking. We designed this prospective, multicentre, observational registry to compare the rate, nature, and impact of long-term device-related complications requiring surgical revision on patient outcome and healthcare utilization between patients undergoing S-ICD or TV-ICD implantation. METHODS AND RESULTS A total of 1099 consecutive patients who underwent S-ICD or TV-ICD implantation were enrolled. Propensity matching for baseline characteristics yielded 169 matched pairs. Rate, nature, management, and impact on patient outcome of device-related complications were analyzed and compared between two groups. During a mean follow-up of 30 months, device-related complications requiring surgical revision were observed in 20 patients: 3 in S-ICD group (1.8%) and 17 in TV-ICD group (10.1%; p = .002). Compared with TV-ICD patients, S-ICD patients showed a significantly lower risk of lead-related complications (0% vs. 5.9%; p = .002) and a similar risk of pocket-related complications (0.6 vs. 2.4; p = .215) and device infection (0.6% vs. 1.2%; p = 1.000). Complications observed in S-ICD patients resulted in a significantly lower number of complications-related rehospitalizations (median 0 vs. 1; p = .013) and additional hospital treatment days (1.0 ± 1.0 vs. 6.5 ± 4.4 days; p = .048) compared with TV-ICD patients. CONCLUSIONS Compared with TV-ICD, S-ICD is associated with a lower risk of complications, mainly due to a lower risk of lead-related complications. The management of S-ICD complications requires fewer and shorter rehospitalizations.

Background Device replacement is the ideal time to reassess health care goals regarding continuing implantable cardioverter-defibrillator (ICD) therapy. Only few data are available on the decision making at this time. Objectives The goals of this study were to identify factors associated with poor prognosis at the time of ICD replacement and to develop a prognostic index able to stratify those patients at risk of dying early. Methods DEtect long-term COmplications after implantable cardioverter-DEfibrillator replacement (DECODE) was a prospective, single-arm, multicenter cohort study aimed at estimating long-term complications in a large population of patients who underwent ICD/cardiac resynchronization therapy – defibrillator replacement. Potential predictors of death were investigated, and all these factors were gathered into a survival score index (SUSCI). Results We included 983 consecutive patients (median age 71 years (63-78)); 750 (76%) were men, 537 (55%) had ischemic cardiomyopathy; 460 (47%) were implanted with cardiac resynchronization therapy – defibrillator. During a median follow-up period of 761 days (interquartile range 628–904 days), 114 patients (12%) died. In multivariate Cox regression analysis, New York Heart Association class III/IV, ischemic cardiomyopathy, body mass index Conclusion A simple score that includes a limited set of variables appears to be predictive of total mortality in an unselected real-world population undergoing ICD replacement. Evaluation of the patient’s profile may assist in predicting vulnerability and should prompt individualized options, especially for high-risk patients.

Aims Following coronavirus disease (COVID-19) outbreak, the Italian government adopted strict rules of lockdown and social distancing. The aim of our study was to assess the admission rate for cardiac implantable electronic devices (CIEDs) replacement procedures in Campania, the 3rd-most-populous region of Italy, during COVID-19 lockdown. Methods and results Data were sourced from 16 referral hospitals in Campania from 10 March to 4 May 2020 (lockdown period) and during the same period in 2019. We retrospectively evaluated consecutive patients hospitalized for CIEDs replacement procedures during the two observational periods. The number and type of CIEDs replacement procedures among patients followed by remote monitoring (RM), the admission rate, and the type of hospital admission between the two observational periods were compared. In total, 270 consecutive patients were hospitalized for CIEDs replacement procedures over the two observation periods. Overall CIEDs replacement procedures showed a reduction rate of 41.2% during COVID-19 lockdown. Patients were equally distributed for sex (P = 0.581), and both age [median 76 years (IQR: 68–83) vs. 79 years (IQR: 68–83); P = 0.497]. Cardiac implantable electronic devices replacement procedures in patients followed by RM significantly increased (IR: +211%; P Conclusions We showed a significant increase trend rate of replacement procedures among CIEDs patients followed by RM, suggesting the hypothesis of its increased use to closely monitoring and to optimize the hospital admission time during COVID-19 lockdown.

Sacubitril/valsartan has been associated with a positive reverse left ventricular remodelling in patients with heart failure with reduced ejection fraction (HFrEF). These patients may also benefit from an ICD implant. We aimed to assess EF improvement after 6 months of treatment with sacubitril/valsartan, evaluating when ICD as primary prevention was no longer indicated.Multicentre, observational, prospective study enrolling all consecutive patients with HFrEF and EF ≤ 35% with an ICD as primary prevention and starting treatment with sacubitril/valsartan (NCT03935087). Resynchronization therapy and patients experiencing appropriate ICD therapies before sacubitril/valsartan were excluded.Two-hundred-and-thirty patients were enrolled (73.9% males, mean age 64.3 ± 12.1 years) After 6 months of treatment, a reduction in left ventricular end-diastolic and end-systolic volumes was noted and LVEF increased from 28.3 ± 5.6% to 32.2 ± 6.5% (p 0.001). At 6 months, a non-ischemic aetiology of cardiomyopathy and a final dose of sacubitril/valsartan 24/26 mg twice daily were associated with a higher probability of an absolute increase of 5% in LVEF. A total of 5.3% of primary prevention patients still had an arrhythmic event in the first 6 months after treatment with sacubitril/valsartan started.Sacubitril/valsartan improves systolic function in HFrEF, mainly due to reverse left ventricular remodelling. Improvement in EF after 6 months of treatment could help prevent ICD implantation in nearly one out of four patients, with important clinical and economic implications. However, the risk of sudden cardiac death in this recovered HFrEF population has not been thoroughly studied, and the present data should be interpreted only as hypothesis-generating.

Funding Acknowledgements No funding OnBehalf RHYTHM DETECT Registry Background With subcutaneous implantable cardioverter–defibrillators (S-ICD), conversion test (CT) is still recommended at implantation. However, prior works found that adherence to this recommendation is declining in clinical practice. Purpose To describe current practice regarding CT at S-ICD implantation, and also measure in-hospital outcome of patients who underwent CT and mid-term outcome of patients without CT. Methods We analyzed 1652 consecutive patients (49 ± 15 years old, 80% male, 51% with ischemic or non-ischemic dilated cardiomyopathy, 45% with ejection fraction ≤35%) who underwent S-ICD implantation in 60 Italian centers from 2013 to 2019. Results CT data were missing in 27 patients. CT was performed in 1300 patients. Successful conversion with ≤65J was obtained in 97.4% of patients. Shock at 80J was not effective in 12 (0.9%) patients. In 10 of these patients the CT was successful after device repositioning, while in 2 patients it was decided to implant a transvenous ICD. Two (0.15%) episodes of electromechanical dissociation (1 fatal) were reported as consequence of CT. CT was not performed in 325 patients (for clinical reasons in 182 patients, for facility preference in 71, ventricular fibrillation not inducible in 72 patients). As compared to the CT group, these patients were older (51 ± 16 vs. 48 ± 15 years; p Conclusions This analysis showed that CT is frequently omitted in current clinical practice, especially in older patients with worse systolic function. Shocks at CT are very frequently effective and system revision after CT is rarely required. CT is also safe, although serious adverse events cannot be excluded. A strategy that omits CT did not appear to compromise the effectiveness of the S-ICD, but larger populations and longer follow-up are needed to confirm this finding.

Coronavirus disease 2019 (COVID-19) outbreak is a public health emergency of international concern due to a highly pathogenic human coronavirus (HCoV), actually named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Despite much emerging data about the epidemiological association between cardiovascular diseases and COVID-19, little is still known atrial fibrillation (AF) and its optimal management in this clinical contest. The aim of our review is to describe the pharmacological interactions between cardiovascular drugs more commonly used in AF management and experimental COVID-19 therapies, based on European (EU) and Unites States (US) summaries of product characteristics.

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.

Objectives: This study aimed to determine how CIED-related complications affect all-cause and cardiovascular mortality over a long-term follow-up. Background: Although complications related to implantable electronic device (CIED) implantation are steadily increasing in Europe, little is known about the impact of complications other than device infection on mortality. Methods: The POINTED (Impact on Patient Outcome and health care utilization of cardiac ImplaNTable Electronic Device complications) registry was a prospective, multicenter, observational study designed to collect data on complications in patients undergoing de novo CIED implantation (NCT03612635). All consecutive patients were enrolled in 6 high-volume centers between January 2010 and December 2012 and followed up for at least 3 years. A complication was defined as any CIED-related adverse event requiring surgical revision after implantation. Results: During follow-up (median 56.9 months), we observed 283 complications in 263 of 2811 consecutive patients (71 ± 14 years of age, 66.7% men). Early complications (≤30 days) were associated with significantly lower cumulative survival from cardiovascular death in comparison with late complications and with freedom from complications. On multivariate analysis, early complication, pneumothorax, and pocket hematoma were significantly associated with a higher risk of all-cause death, while device infection remained the only complication significantly associated with a higher risk of cardiovascular death. Conclusions: All CIED-related complications are associated with an increased risk of cardiovascular mortality, and early complications are associated with an increased risk of all-cause mortality. These data underline the importance of specific measures aimed at reducing CIED complications and improving their management.

Aims Knowledge of the long-term progression of rhythm disorders requiring pacemaker implantation could have significant implications for the choice of device and its management during follow-up. Accordingly, we conducted an observational study to analyse the long-term progression of rhythm disorders requiring pacemaker implantation. Methods This multicentre, observational study enrolled 1810 pacemaker patients (age 71.6W13.3 years, men 53.8%) consecutively evaluated during scheduled pacemaker follow-up visits. To evaluate the long-term progression of rhythm disorders, we analysed the patient's rhythm disorders at the time of device implantation and during follow-up. After pacemaker implantation, the rhythm disorders were reassessed and recorded at each scheduled pacemaker follow-up visit, and the spontaneous rhythm was analysed during pacemaker interrogation. Results During a median follow-up of 61.6 months, we observed a progression of the primary rhythm disorder in 295 patients (16.3%; worsening of the preexisting rhythm disorder in 7.7%; occurrence of a new rhythm disorder added to the preexisting one in 8.6%). Specifically, the cumulative per-year risks of developing the following disorders were: Atrioventricular block (AVB) in patients implanted for sinus node disease (SND), 0.3%; permanent atrial fibrillation in SND patients, 2.9%; SND in AVB patients, 0.7%; and persistent AVB in patients implanted for chronic bifascicular block 3.0%. Conclusion Our results revealed that rhythm disorders requiring pacemaker implantation show long-term progression in a significant number of cases. In many cases, the progression is substantial and may require a change in pacing mode.

Background Cardiac Implantable Electronic Device (CIED) surgery is threatened by serious complications both during the procedure and during follow-up. The factors associated to attenuated clinical benefit over long term follow-up are poorly understood. Purpose To evaluate type and extent of Adverse Events (AEs) and potential predictors of major AEs over 12 months after ICD/CRT-D replacement/upgrade in a contemporary Italian population. Methods Detect long-term complications after ICD replacement (DECODE) was a prospective, single-arm, multicenter cohort study aimed at estimating medium- to long-term complications in a large population of patients (pts) who underwent ICD/CRT-D replacement/upgrade from 2013 to 2015. The endpoint for this analysis is death from any cause, procedure-related infection, and surgical actions/hospitalizations necessary to treat the AEs. Results We included 983 consecutive pts (median age 71 years, 76% male, 55% ischemic, 47% CRT-D). During a mean follow-up duration of 353±49 days, 7% of the pts died. A total of 104 AEs occurred in 70 (7.1%) pts. 43 (4.4%) pts needed at least one surgical action to treat the AEs. A total of 23 (2.3%) pts had infective AEs (CIED related in 12 pts, due to other causes in 11). Mortality was unrelated to the occurrence of overall AEs, or of CIED-related AEs, or of surgical actions/hospitalizations needed to correct AEs. The endpoint was reached by 109 (11%) pts over 12-month follow-up (97 pts had a single event, and 12 pts had two events). The median time to the endpoint was 137 [50 - 254] days. On multivariate Cox regression analysis adjusted for baseline confounders, ischemic cardiomyopathy (HR = 1.86, 95% CI: 1.18 to 2.91; p=0.0076), hospitalization prior to the procedure (2.34, 1.35 to 4.05; 0.0025) and anticoagulation (1.91, 1.25 to 2.92; 0.0032) were associated with the endpoint during follow-up. Conclusion Evaluation of the patient's profile may assist in predicting vulnerability and should prompt reconsideration of the procedure by deferring at a more stable clinical status, and carefully individualized in the setting of upgrades and anticoagulation management Acknowledgement/Funding None

Clinical trials have shown the benefits of &beta, blockers therapy in patients with heart failure reduced ejection fraction. These benefits include improved survival and a reduced need for hospitalization. Cardiac resynchronization therapy has emerged as an essential device-based therapy for symptomatic patients with heart failure reduced ejection fraction despite optimal pharmacologic treatment. The extent to which &beta, blockers are being utilized in patients receiving cardiac resynchronization therapy is not well known. In this study, we evaluate the possibility of increasing &beta, blockers doses in an unselected cohort of heart failure reduced ejection patients after cardiac resynchronization therapy capable defibrillator system implantation and the correlation between &beta, blockers treatments and clinical outcome. Methods and results: Patients with heart failure reduced ejection fraction in &beta, blockers therapy that underwent cardiac resynchronization therapy capable defibrillator system implantation between July 2008, and December 2016 were enrolled in the study. The &beta, blockers dose was determined at the time of discharge and during follow-up. Cardiovascular mortality, hospitalization for worsening heart failure or arrhythmic storm and appropriate intervention of the device, were recorded. The study cohort included 480 patients, 289 patients (60.3%) had &beta, blockers doses equal to the dose before CRT (Group 1), 191 patients (39.7%) had higher &beta, blockers doses than those before the CRT implant (Group 2). Comparing the two groups, Group 2 have lower cardiovascular mortality, heart failure-related hospitalization, and arrhythmic events than Group 1. Conclusion: After initiating CRT, &beta, blockers could be safely up-titrated at higher doses with the reduction in mortality, heart failure-related hospitalization, and arrhythmic events.

Introduction Implantable cardioverter-defibrillator (ICD) alarm systems are an important means of monitoring device functioning. The aim of this study was to compare the ability of patients with sense two types of device alert systems: an audible alert and a vibratory alarm. Methods The ability to recognize the alarms was assessed in three alarm tests performed in a series of consecutive ICD patients enrolled during routine outpatient device follow-up. To avoid overestimating the rate of patients able to sense the alarm, the first test was performed without forewarning. Subsequently, the second test was performed after the patients had been forewarned. Finally, to assess the learning effect of a demonstration test, a third test was performed, again without forewarning. Results A total of 528 patients (65.4 ± 14.4 years, 74.6% male) were enrolled: 347 (65.7%) with an audible alert-endowed device and 181 (34.3%) with a vibratory alarm-endowed device. When emitted without warning, the alarms were sensed by 72.4% of patients. When patients were forewarned, the probability of sensing the alarms rose to 92.5% (P < 0.001). In both cases, the vibratory alarm was more likely to be sensed than the audible alert (77.3 vs. 67.7% in the first case; 96.1 vs. 87.9% in the second case; all P < 0.05). Conclusion ICD alarms emitted in an outpatient setting are sensed by a large proportion of patients, but not by all. Training patients by means of demonstration tests significantly increases the rate of patients who recognize the alarm. Vibratory alarm seems to be more effective than audible alert.

Background Electrical storm (ES) is defined as 3 or more episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) within 24 hours and is associated with increased cardiac and all-cause mortality. Objective The purpose of this study was to test whether aggressive implantable cardioverter-defibrillator (ICD) programming can be associated with ES. Methods The OBSERVational registry On long-term outcome of ICD patients (OBSERVO-ICD) is a multicenter, retrospective registry enrolling all consecutive patients undergoing ICD implantation from 2010 to 2012 in 5 Italian high-volume arrhythmia centers. Clinical history and risk factors were collected for all patients, as were ICD therapy-related variables such as detection zones and delays. The total number of arrhythmic episodes and therapies delivered by the ICD were collected through out-of-hospital visits and remote monitoring. Results The registry enrolled 1319 consecutive patients, of whom 62 (4.7%) experienced at least 1 ES during follow-up (median 39 months). Patients who experienced ES had a significantly lower VF detection zone ( P = .002), more frequently had antitachycardia pacing therapies programmed off during capacitor charge ( P = .001), and less frequently had an ICD set with delayed therapies for VT zones ( P = .042) and VF zone ( P = .036). Patients who experienced ES had a significantly higher incidence of death and heart failure–related death compared to patients with no ventricular arrhythmias and patients with unclustered VTs/VFs ( P = .025 and P Conclusion Patients with ES had a more aggressive ICD programming setup, including lower VF detection rates, shorter detection times, and no antitachycardia pacing therapies during capacitor charge. This kind of ICD programming potentially could increase the likelihood of ES and the related risk of death.

Background: right ventricle-pulmonary artery (RV-PA) coupling assessed by measuring the tricuspid anular plane systolic excursion (TAPSE)/pulmonary artery systolic pressure (PASP) ratio has been recently proposed as an early marker of right ventricular dysfunction in patients with heart failure with a reduced ejection fraction (HFrEF). Methods: As the effects of sacubitril/valsartan therapy on RV-PA coupling remain unknown, this study aimed to analyse the effect of this drug on TAPSE/PASP in patients with HFrEF. We retrospectively analysed all outpatients with HFrEF referred to our unit between October 2016 and July 2018. Results: At the 1-year follow-up, sacubitril/valsartan therapy was associated with a significant improvement in TAPSE (18.26 &plusmn, 3.7 vs. 19.6 &plusmn, 4.2 mm, p &lt, 0.01), PASP (38.3 &plusmn, 15.7 vs. 33.7 &plusmn, 13.6, p &lt, 0.05), and RV-PA coupling (0.57 &plusmn, 0.25 vs. 0.68 &plusmn, 0.30 p &lt, 0.01). These improvements persisted at the 2-year follow-up. In the multivariable analysis, the improvement in the RV-PA coupling was independent of the left ventricular remodelling. Conclusions: in patients with HFrEF, sacubitril/valsartan improved the RV-PA coupling, however, further trials are necessary to evaluate the role of sacubitril/valsartan in the treatment of right ventricle (RV) dysfunction either associated or not associated with left ventricular dysfunction.

Aim Ventricular tachycardia (VT)/ventricular fibrillation (VF) occurrence after cardiac resynchronization therapy-defibrillator (CRT-D) replacement is unknown; hence, there is no practical guideline to recommend either CRT-D or CRT-pacemaker at the time of device replacement. We observed the 1-year VT/VF occurrence after CRT-D replacement in a subanalysis of the Detect Long-term Complications after ICD Replacement (DECODE) registry. Methods and results A total of 332 consecutive patients who had undergone CRT-D replacement from 2013 to 2015 were enrolled in 36 Italian centres. The primary endpoint was the number of patients with any appropriate implantable cardioverter-defibrillator (ICD) interventions during 12-month follow-up. The secondary endpoint comprised death from any cause and appropriate ICD interventions. At replacement, 214 (64.5%) patients had a left ventricular ejection fraction ≤ 35% and 138 (41.6%) patients had a secondary prevention indication for ICD. Seventy (21.1%) patients had no longer indication to ICD therapy. During a median follow-up period of 406.5 (362-533) days, VT/VF requiring therapy delivery occurred in 57 (17%) patients, specifically in 7% of those who no longer had an ICD indication. On multivariate analysis, number of criteria for ICD replacement independently predicted appropriate ICD intervention during follow-up [hazard ratio (HR) = 1.62, 95% confidence interval (CI) 1.07-2.46; log-rank P = 0.02]. The combined endpoint of death from any cause or appropriate ICD therapy occurred in 76 (23%) patients. Only NYHA class remained associated with this combined endpoint (HR = 1.97, 95% CI 1.23-3.14; P = 0.005). Conclusions The DECODE registry showed the 'real-world' experience of CRT-D recipients approaching device replacement, in which 7% of patients who no longer had an indication for ICD therapy experienced appropriate ICD interventions.