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The subsequent waves of the COVID-19 pandemic in Italy had a major impact on cardiac care.A survey to evaluate the dynamic changes in arrhythmia care during the first five waves of COVID-19 in Italy (first: March-May 2020; second: October 2020-January 2021; third: February-May 2021; fourth: June-October 2021; fifth: November 2021-February 2022) was launched.A total of 127 physicians from arrhythmia centers (34% of Italian centers) took part in the survey. As compared to 2019, a reduction in 40% of elective pacemaker (PM), defibrillators (ICD), and cardiac resynchronization devices (CRT) implantations, with a 70% reduction for ablations, was reported during the first wave, with a progressive and gradual return to pre-pandemic volumes, generally during the third-fourth waves, slower for ablations. For emergency procedures (PM, ICD, CRT, and ablations), recovery from the initial 10% decline occurred in most cases during the second wave, with some variability. However, acute care for atrial fibrillation, electrical cardioversions, and evaluations for syncope showed a prolonged reduction of activity. The number of patients with devices which started remote monitoring increased by 40% during the first wave, but then the adoption of remote monitoring declined.The dramatic and profound derangement in arrhythmia management that characterized the first wave of the COVID-19 pandemic was followed by a progressive return to the volume of activities of the pre-pandemic periods, even if with different temporal dynamics and some heterogeneity. Remote monitoring was largely implemented during the first wave, but full implementation is needed.

Background— Celivarone is a new antiarrhythmic agent developed for the treatment of ventricular arrhythmias. This study investigated the efficacy and safety of celivarone in preventing implantable cardioverter-defibrillator (ICD) interventions or death. Methods and Results— Celivarone (50, 100, or 300 mg/d) was assessed compared with placebo in this randomized, double-blind, placebo-controlled, parallel-group study. Amiodarone (200 mg/d after loading dose of 600 mg/d for 10 days) was used as a calibrator. A total of 486 patients with a left ventricular ejection fraction ≤40% and at least 1 ICD intervention for ventricular tachycardia or ventricular fibrillation in the previous month or ICD implantation in the previous month for documented ventricular tachycardia/ventricular fibrillation were randomized. Median treatment duration was 9 months. The primary efficacy end point was occurrence of ventricular tachycardia/ventricular fibrillation–triggered ICD interventions (shocks or antitachycardia pacing) or sudden death. The proportion of patients experiencing an appropriate ICD intervention or sudden death was 61.5% in the placebo group; 67.0%, 58.8%, and 54.9% in the celivarone 50-, 100-, and 300-mg groups, respectively; and 45.3% in the amiodarone group. Hazard ratios versus placebo for the primary end point ranged from 0.860 for celivarone 300 mg to 1.199 for celivarone 50 mg. None of the comparisons versus placebo were statistically significant. Celivarone had an acceptable safety profile. Conclusions— Celivarone was not effective for the prevention of ICD interventions or sudden death. Clinical Trial Registration— http://www.clinicaltrials.gov . Unique identifier: NCT00993382.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and has been identified as an independent risk factor for stroke. Prevention of thromboembolic events has been based on oral anticoagulation (OAC) using Vitamin K antagonists (VKA). However, long-term OAC medication is limited by an increased bleeding risk and a low patient compliance. Relying on the observation that the majority of cardiac thrombi originate from the left atrial appendage (LAA) different devices aiming for LAA closure have been proposed. This review will discuss contemporary LAA closure devices with special emphasis on procedure related complications.

We assessed the influence of clinically significant mitral regurgitation (MR) on clinical-echocardiographic response and outcome in heart failure (HF) patients treated with a biventricular defibrillator (cardiac resynchronization therapy defibrillator [CRT-D]). METHODS AND RESULTS: A total of 659 HF patients underwent successful implantation of CRT-D and were enrolled in a multicenter prospective registry (median follow-up of 15 months). Following baseline echocardiographic evaluation, patients were stratified into two groups according to the severity of MR: 232 patients with more than mild MR (Group MR+: grade 2, 3, and 4 MR) versus 427 patients with mild (grade 1) or no functional MR (Group MR-). On 6- and 12-month echocardiographic evaluation, MR was seen to have improved in the vast majority of MR+ patients, while it remained unchanged in most MR- patients. On 12-month follow-up evaluation, a comparable response to CRT was observed in the two groups, in terms of the extent of left ventricular reverse remodeling and combined clinical and echocardiographic response. During long-term follow-up, event-free survival did not differ between MR+ and MR- patients, even when subpopulations of patients with ischemic heart disease and with dilated cardiomyopathy were analyzed separately. On multivariate analysis, the only independent predictor of death from any cause was the lack of β-blocker use. CONCLUSIONS: This observational analysis supports the use of CRT-D in HF patients with clinically significant MR; MR had no major influence on patient outcome.

Aims To analyse the effectiveness of cardiac resynchronization therapy (CRT) in patients with valvular heart disease (a subset not specifically investigated in randomized controlled trials) in comparison with ischaemic heart disease or dilated cardiomyopathy patients. Methods and results Patients enrolled in a national registry were evaluated during a median follow-up of 16 months after CRT implant. Patients with valvular heart disease treated with CRT ( n = 108) in comparison with ischaemic heart disease ( n = 737) and dilated cardiomyopathy ( n = 635) patients presented: (i) a higher prevalence of chronic atrial fibrillation, with atrioventricular node ablation performed in around half of the cases; (ii) a similar clinical and echocardiographic profile at baseline; (iii) a similar improvement of LVEF and a similar reduction in ventricular volumes at 6–12 months; (iv) a favourable clinical response at 12 months with an improvement of the clinical composite score similar to that occurring in patients with dilated cardiomyopathy and more pronounced than that observed in patients with ischaemic heart disease; (v) a long-term outcome, in term of freedom from death or heart transplantation, similar to patients affected by ischaemic heart disease and basically more severe than that of patients affected by dilated cardiomyopathy. Conclusion In ‘real world’ clinical practice, CRT appears to be effective also in patients with valvular heart disease. However, in this group of patients the outcome after CRT does not precisely overlap any of the two other groups of patients, for which much more data are currently available.

Background: Few data exist on the long-term changes and the prognostic value of heart rate variability (HRV) assessed by implanted devices in heart failure (HF) patients treated with resynchronization therapy (CRT). Aims: To analyze the long-term changes in the standard deviation of 5-minute median atrial–atrial sensed intervals (SDANN), and assess its role in predicting CRT efficacy and major cardiovascular events. Methods and results: We included 509 consecutive patients implanted with CRT devices. At 12-month follow-up, 44 patients had died and 86 patients had at least one HF hospitalisation. A significant increase in SDANN occurred after 4 weeks of CRT (from 69±22 ms to 82±27 ms, p

Objectives: This study evaluated the efficacy of conversion test performed at 40 J (defibrillation margin ≥40 J), and factors potentially associated with test failure were identified. Background: Current subcutaneous implantable cardioverter-defibrillator (S-ICD) devices deliver a maximum of 80 J. Functional defibrillation testing is recommended at S-ICD implantation, and it is usually conducted by delivering a shock energy of 65 J to ensure a safety defibrillation margin ≥15 J. Although high rates of successful conversion were reported at 65 J, limited data exist on the defibrillation margin extent. Methods: Ventricular fibrillation was induced and conversion test was performed by delivering a 40-J shock in 308 patients. Success was defined as termination of ventricular fibrillation by the first shock delivered in standard polarity. The S-ICD system positioning was evaluated with the PRAETORIAN score using bidirectional chest X-rays. Results: The generator was positioned in an intermuscular pocket in 301 patients (98%) and the lead was implanted by means of a 2-incision technique. The PRAETORIAN score was 50 (OR: 2.93; 95% CI: 1.26 to 6.83; p = 0.013) were independently associated with conversion failure. Conclusions: The authors showed a high rate of defibrillation success with 40-J shocks in S-ICD systems implanted by means of modern surgical techniques. The variables associated with shock failure were male gender, higher body mass index, and suboptimal device position according to the PRAETORIAN score.

Background Sleep apnea, as measured by polysomnography, is associated with adverse outcomes in heart failure. The DASAP-HF (Diagnosis and Treatment of Sleep Apnea in Patient With Heart Failure) study previously demonstrated that the respiratory disturbance index (RDI) computed by the ApneaScan algorithm (Boston Scientific) accurately identifies severe sleep apnea in implantable cardioverter-defibrillator (ICD) patients. Objective The purpose of the long-term study phase was to assess the incidence of clinical events after 24 months and investigate the association with RDI values. Methods Patients with left ventricular ejection fraction ≤35% implanted with an ICD were enrolled and followed-up for 24 months. The RDI calculated at 1 month after implantation was used to stratify patients (below or above 30 episodes/h). The endpoints were all-cause death and a combination of all-cause death or cardiovascular hospitalization. Results Of the 265 enrolled patients, 224 had usable RDI values. Severe sleep apnea (RDI ≥30 episodes/h) was diagnosed in 115 patients (51%). These patients were more frequently male (84% vs 72%; P = .030) and had higher creatinine levels. During median follow-up of 25 months, 19 patients (8%) died. Cardiovascular hospitalizations were reported in 19 patients (8%). The risk of all-cause death was higher in patients with RDI ≥30 episodes/h (hazard ratio [HR] 3.33; 95% confidence interval [CI] 1.35–8.21; P = .023), as well as the risk of all-cause death or cardiovascular hospitalization (HR 1.94; 95% CI 1.01–3.76; P = .048). At multivariate analysis, independent predictors of death were RDI ≥30 episodes/h (HR 4.02; 95% CI 1.16–13.97; P = .029) and creatinine levels (HR 2.36; 95% CI 1.26–4.42; P = .008). Conclusion In heart failure patients implanted with an ICD, higher RDI values are associated with death and cardiovascular hospitalizations. Device-detected severe sleep apnea independently predicts death.

Background: The subcutaneous implantable cardioverter defibrillator (S-ICD) is a relatively novel alternative to the transvenous ICD for the treatment of life-threatening ventricular arrhythmias, and is currently used in the clinical practice of several centers. The aim of this analysis was to describe current Italian practice regarding S-ICD implantation and its evolution over the years. Methods: We analyzed 607 consecutive patients (78% male, 48 ± 16 years) who underwent S-ICD implantation in 39 Italian centers from 2013 to 2017. Results: Structural cardiomyopathy was present in 78% of patients and 30% of patients received their device for secondary prevention. The proportion of patients with dilated cardiomyopathy and with left ventricular ejection fraction ≤35% increased from ≤2014 to 2017 (from 38% to 58%, from 33% to 53%, respectively; both p < 0.05). Almost all procedures (97%) were performed in electrophysiology laboratories. Over the last 4 years, the 2-incision implantation technique has been widely adopted, with sub- or inter-muscular positioning of the generator, under local anesthesia or deep sedation (≤2014 versus 2017: all p < 0.001). Defibrillation testing was performed in 81% of patients. Shock energy of ≤65 J was successful in 93.9% of patients and the overall cardioversion success rate at ≤80 J was 99.8%. Conclusions: Our analysis confirmed that the S-ICD continues to be preferentially used in specific patients (younger, less frequently with dilated cardiomyopathy and low ejection fraction.). Nonetheless, we noted a trend toward the wider use of S-ICD in patients with dilated cardiomyopathy and systolic dysfunction over the years. Novel approaches have been adopted while the acute efficacy of the system has remained stably high.

The medical device industry must implement accurate programs to monitor product performance once the product is released into the market. Product-experience reports provide a means for physicians who use medical devices to provide continuous feedback to manufacturers in order to monitor device performance. We examined product-experience reports sent from Italy over 4 years (2004-2007) related to a single manufacturer's family of permanent endocardial leads (Endotak Reliance, Boston Scientific, MA, USA) used with implantable cardioverter-defibrillators. Out of 15,772 implanted leads, physicians sent in 454 (2.87%) product-experience reports. Only 126 out of 454 (28%) leads were returned to the company; most of these (101 out of 126; 80%) were related to implant procedure. Laboratory analyses of returned leads rarely showed loss of integrity (0.01%). The practice of reporting product performance and returning the device to companies should be strongly encouraged in order to better identify potential issues affecting implantable devices.

Atrial fibrillation (AF) is a common problem in pacemaker patients. We conducted a prospective observational study in patients paced for bradycardia with associated paroxysmal or persistent AF, to determine whether P-wave duration may stratify patients at higher risk for AF recurrences and AF-related hospitalizations. The patients were evaluated for the prevalence, cause, and predictors of hospitalization.We studied 660 consecutive patients (50% male, 72 +/- 9 years) who received a dual-chamber pacemaker. Median value of baseline P-wave duration was equal to 100 ms (25%-75% quartile range equal to 80-120 ms). We used this cut-off to divide the patients into group A (Por = 100 ms), composed of 385 (58.3%) patients, and group B (P100 ms), composed of 275 (41.7%) patients.In a median follow-up of 19 months, 173 patients were hospitalized for all causes, 130 for cardiovascular causes, and 85 for AF-related hospitalizations. Multivariate logistic analysis showed that P-wave duration100 ms identified patients at higher risk (OR = 1.6, 95% confidence interval (1.1-2.8), P = 0.044) for AF-related hospitalizations. Patients in group B (P100 ms) more frequently suffered AF-related hospitalizations (16.4% vs 10.4%, P = 0.02) and underwent more frequent cardioversions (14.5% vs 9.1%, P = 0.029) compared with group A (Por = 100 ms).P-wave duration may define the risk of persistent AF requiring cardioversion or AF-related hospitalization in patients with a pacemaker for bradycardia with associated paroxysmal or persistent AF.

Several studies have tested non-pharmacological therapies for atrial tachyarrhythmias (ATs) by measuring the cumulative time (burden) the patient spends in arrhythmia. Contradictory results questioned either therapy efficacy or statistical power of the trials. We studied AT burden variability in patients paced for sinus node disease (SND) in order to interpret currently published data appropriately and to evaluate reliable sample sizes. METHODS AND RESULTS: One hundred and five patients with AT and SND received a dual chamber pacemaker with antitachyarrhythmia-pacing capability, and were followed for 13 months. Seventy-eight patients (74%) suffered AT recurrences. Device-gathered diagnostic measures were used to simulate results of randomized studies both with crossover and parallel design. The sample size required for statistically significant results was calculated as a function of the expected therapy-induced burden reduction. AT burden intra-patient variability was high: 43% of patients showed intrinsic fluctuations hiding any therapy-induced burden reduction lower than 30%. Demonstrating therapeutic breakthrough through a 6 month study would require 290 patients with crossover design and 5800 patients with parallel design. Doubling the study period requires 400 and 3000 patients, respectively. CONCLUSION: Patients with AT and paced for SND showed high intra-patient burden variability, which could possibly hide an AT burden reduction induced by a therapy. Previous studies involving non-pharmacological therapies utilizing AT burden endpoints could lack the power to reach statistical significance.