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Aims A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket. Methods and results We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17–0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30–0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50–1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction. Conclusion Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks. Clinical trial registration Clinical Trial Registration: ClinicalTrials.gov; NCT02275637.

Aims: Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness. Methods & results: Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis – based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276. Conclusion: WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well.

Aims In subcutaneous implantable cardioverter defibrillator (S-ICD) recipients, the UNTOUCHED study demonstrated a very low inappropriate shock rate on programming a conditional zone between 200 and 250 bpm and a shock zone for arrhythmias >250 bpm. The extent to which this programming approach is adopted in clinical practice is still unknown, as is its impact on the rates of inappropriate and appropriate therapies. Methods and results We assessed ICD programming on implantation and during follow-up in a cohort of 1468 consecutive S-ICD recipients in 56 Italian centres. We also measured the occurrence of inappropriate and appropriate shocks during follow-up. On implantation, the median programmed conditional zone cut-off was set to 200 bpm (IQR: 200–220) and the shock zone cut-off was 230 bpm (IQR: 210–250). During follow-up, the conditional zone cut-off rate was not significantly changed, while the shock zone cut-off was changed in 622 (42%) patients and the median value increased to 250 bpm (IQR: 230–250) (P < 0.001). UNTOUCHED-like programming of detection cut-offs was adopted in 426 (29%) patients immediately after device implantation, and in 714 (49%, P < 0.001) at the last follow-up. UNTOUCHED-like programming was independently associated with fewer inappropriate shocks (hazard ratio 0.50, 95%CI 0.25–0.98, P = 0.044), and had no impact on appropriate and ineffective shocks. Conclusions In recent years, S-ICD implanting centres have increasingly programmed high arrhythmia detection cut-off rates, at the time of implantation in the case of new S-ICD recipients, and during follow-up in the case of pre-existing implants. This has contributed significantly to reducing the incidence of inappropriate shocks in clinical practice. Rordorf: Programming of the S-ICD Clinical Trial Registration URL: http://clinicaltrials.gov/Identifier: NCT02275637

Aims To evaluate the effectiveness and safety of dronedarone compared with other commonly used antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrences. Methods and results An international observational cohort study in Germany, Spain, Italy, and the USA enrolling patients with AF receiving AAD therapy. Patients with New York Heart Association (NYHA) Class IV heart failure were excluded. Participants were followed for up to 18 months, regardless of discontinuation or subsequent AAD switches. Atrial fibrillation recurrence was captured by hospitalization, emergency room visit, or electrocardiogram-based documentation of AF. Confounding bias was controlled for in the analysis of AF recurrence using multivariate models of 19 variables for adjustment. A total of 1009 participants [mean age 67.2 (10.8) years, male to female ratio 1.3] were recruited from 170 centres, 693 (69%) of which were from across Europe and the remaining 316 (31%) from the USA. At the time of enrolment, participants were taking dronedarone (51%) or other AADs (49%) [flecainide or propafenone (42%), sotalol (11%), and amiodarone (47%)]. No significant differences in the risk of first confirmed AF recurrence with dronedarone vs. other AADs [crude hazard ratio (HR) 1.10 (95% confidence interval 0.85–1.42); adjusted HR 1.16 (0.87–1.55)] were found, irrespective of whether univariate or multivariate models were used. Reported safety events were in accordance with the known safety profile of dronedarone. Conclusion In this population of patients from either Europe or the USA receiving dronedarone or another AAD, the effectiveness of dronedarone was comparable to that observed for other AADs in preventing first AF recurrence.

Thromboembolism is the most serious complication of AF, and oral anticoagulation is the mainstay therapy. Current guidelines place all AF types together in terms of anticoagulation with the major determinants being associated comorbidities translated into risk marker. Among patients in large clinical trials, those with non-paroxysmal AF appear to be at higher risk of stroke than those with paroxysmal AF. Higher complexity of the AF pattern is also associated with higher risk of mortality. Moreover, continuous monitoring of AF through cardiac implantable devices provided us with the concept of ‘AF burden’. Usually, the larger the AF burden, the higher the risk of stroke; however, the relationship is not well characterised with respect to the threshold value above which the risk increases. The picture is more complex than it appears: AF and underlying disorders must act synergically respecting the magnitude of its own characteristics, which are the amount of time a patient stays in AF and the severity of associated comorbidities.

Although radiofrequency (RF) catheter ablation of cavo-tricuspid isthmus (CTI) is an established treatment for typical right atrial flutter (RAFL), it remains to be established whether local tissue impedance (LI) is able to predict effective CTI ablation and what LI drop values during ablation should be used to judge a lesion as effective. We aimed to investigate the ability of LI to predict ablation efficacy in patients with RAFL.RF delivery was guided by the DirectSense™ algorithm. Successful single RF application was defined according to a defragmentation of atrial potentials (DAP), reduction of voltage (RedV) by at least 80% or changes on unipolar electrogram (UPC). The ablation endpoint was the creation of bidirectional conduction block (BDB) across the isthmus.392 point-by-point RF applications were analyzed in 48 consecutive RAFL patients. The mean baseline LI was 105.4 ± 12Ω prior to ablation and 92.0 ± 11Ω after ablation (p 0.0001). According to validation criteria, absolute drops in impedance were larger at successful ablation sites than at ineffective ablation sites (DAP: 17.8 ± 6Ω vs. 8.7 ± 4Ω; RedV: 17.2 ± 6Ω vs. 7.8 ± 5Ω; UPC: 19.6 ± 6Ω vs. 10.1 ± 5Ω, all p 0.0001). LI drop values significantly increased according to the number of criteria satisfied (ranging from 7.5Ω to 19.9). BDB was obtained in all cases. No procedure-related adverse events were reported.A LI-guided approach to CTI ablation was safe and effective in treating RAFL. The magnitude of LI drop was associated with effective lesion formation and BDB and could be used as a marker of ablation efficacy.Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

Background. Cardiac resynchronization therapy (CRT) is a treatment for heart failure (HF) patients with prolonged QRS and impaired left ventricular (LV) systolic function. We aim to evaluate how the baseline PR interval is associated with outcomes (all-cause death or HF hospitalizations) and LV reverse remodeling (>15% relative reduction in LV end-systolic volume). Methods. Among 2224 patients with CRT defibrillators, 1718 (77.2%) had a device programmed at out-of-the-box settings (sensed AV delay: 100 ms and paced AV delay: 130 ms). Results. In this cohort of 1718 patients (78.7% men, mean age 66 years, 71.6% in NYHA class III/IV, LVEF = 27 ± 6%), echocardiographic assessment at 6-month follow-up showed that LV reverse remodeling was not constant as a function of the PR interval; in detail, it occurred in 56.4% of all patients but was more frequent (76.6%) in patients with a PR interval of 160 ms. In a median follow-up of 20 months, the endpoint of death or HF hospitalizations occurred in 304/1718 (17.7%) patients; in the multivariable regression analysis it was significantly less frequent when the PR interval was between 150 and 170 ms (hazard ratio = 0.79, 95% confidence interval (CI): 0.63–0.99, p = 0.046). The same PR range was associated with higher probability of CRT response (odds ratio = 2.51, 95% CI: 1.41–4.47, p = 0.002). Conclusions. In a large population of CRT patients, with fixed AV pacing delays, specific PR intervals are associated with significant benefits in terms of LV reverse remodeling and lower morbidity. These observational data suggest the importance of optimizing pacing programming as a function of the PR interval to maximize CRT response and patient outcome.

BACKGROUND The COVID-19 pandemic forced several European governments to impose severe lockdown measures. The reduction of physical activity during the lockdown could have been deleterious. OBJECTIVE The aim of this observational, retrospective study was to investigate the effect of the lockdown strategy on the physical activity burden and subsequent reassessment in a group of patients with heart failure who were followed by means of remote monitoring. METHODS We analyzed remote monitoring transmissions during the 3-month period immediately preceding the lockdown, 69 days of lockdown, and 3-month period after the first lockdown in a cohort of patients with heart failure from a general hospital in Lombardy, Italy. We compared variation of daily physical activity measured by cardiac implantable electrical devices with clinical variables collected in a hospital database. RESULTS We enrolled 41 patients with heart failure that sent 176 transmissions. Physical activity decreased during the lockdown period (mean 3.4, SD 1.9 vs mean 2.9, SD 1.8 hours/day; PP=.99). We found a significant correlation between physical activity reduction during and after the lockdown (R2=0.45, P CONCLUSIONS An excessive reduction of exercise in patients with heart failure decreased the tolerance to exercise, especially in patients with more comorbidities. Remote monitoring demonstrated exercise reduction, suggesting its potential utility to encourage patients to maintain their usual physical activity levels.

Non-vitamin K oral anticoagulants (NOACs) are the first choice for prophylaxis of cardioembolism in patients with non-valvular atrial fibrillation (AF) who are anticoagulant-naïve, as well as the preferable anticoagulation strategy in those who are on vitamin K antagonists (VKAs), but with a low time in therapeutic range (TTR). Nonetheless, there are many good reasons to consider switching from VKAs to NOACs also when TTR is >70%. From the pharmacological standpoint, anticoagulation with VKAs may remain erratic even in those patients who have high TTR values, owing to the mode of action of this drug class. Furthermore, experimental data suggest that, unlike VKAs, NOACs favorably modulate the effects of factor Xa and thrombin in the cardiovascular system through the protease-activated receptor family. Clinically, the most striking advantage provided by NOACs over VKAs, irrespective of the TTR, is the substantially lower risk of intracranial hemorrhage. NOACs have also been associated with less deterioration of renal function as compared with VKAs and may confer protection against cardiovascular events not strictly related to AF, especially the acute complications of peripheral artery disease. In this narrative review, we discuss the evidence according to which it is warranted to systematically substitute NOACs for VKAs for the prevention of AF-related stroke and systemic embolism.

Aims A prolonged PR interval is known to be associated with increased mortality and a higher risk of developing atrial fibrillation (AF). We tested the hypothesis that cardiac resynchronization therapy (CRT) is superior to conventional dual-chamber pacing with algorithms for right ventricular pacing avoidance (DDD-VPA) in preserving systolic and diastolic function and in preventing new-onset AF in patients with normal systolic function, indication for pacing and prolonged atrioventricular conduction (PR interval ≥220 ms). Methods and results We randomly assigned 82 patients with ejection fraction >35%, indication for pacing and PR interval ≥220 ms to CRT or to DDD-VPA. On 12-month follow-up examination, the study and control arms did not differ in terms of left ventricular end-systolic volume (44 ± 17 mL vs. 47 ± 16 mL, P = 0.511) or ejection fraction (55 ± 6% vs. 57 ± 8%, P = 0.291). The E to A mitral wave amplitude ratio was higher in the CRT arm (1.3 ± 1.3 vs. 0.8 ± 0.4, P = 0.046) and the E wave deceleration time was longer (262 ± 83 ms vs. 205 ± 51 ms, P = 0.027). Left atrial volume was smaller in the CRT arm (64 ± 17 mL vs. 84 ± 25 mL, P = 0.035). Moreover, the functional class was lower in CRT patients (1.4 ± 0.6 vs. 1.8 ± 0.5, P = 0.010). During follow-up, CRT was associated with a lower risk of new-onset AF [hazard ratio = 0.37 (0.13–0.98), P = 0.046]. Conclusion Cardiac resynchronization therapy proved superior to DDD-VPA in terms of better diastolic function, less left atrial enlargement and lower risk of new-onset AF, at 12 months. These data need to be confirmed in a larger trial with longer follow-up. Clinical trial registration URL: http://clinicaltrials.gov/ Identifier: NCT02150538

Aims Per standard of care, dual-chamber pacemakers are programmed in DDDR mode with fixed atrioventricular (AV) delay or with long AV delay to minimize ventricular pacing. We aimed to evaluate whether the PR interval may be a specific criterion of choice between standard DDDR, to preserve AV synchrony in long PR patients, and managed ventricular pacing (MVP), to avoid ventricular desynchronization imposed by right ventricle apical pacing, in short PR patients. Methods and results In the MINERVA trial, 1166 patients were randomized to Control DDDR, MVP, or atrial anti-tachycardia pacing plus MVP (DDDRP + MVP). We evaluated the interaction of PR interval with pacing mode by comparing the risk of atrial fibrillation (AF) longer than 7 consecutive days as a function of PR interval. Out of 906 patients with available data, the median PR interval was 180 ms. The PR interval was found to significantly (P = 0.012) interact with pacing mode for AF incidence: the risk of AF > 7 days was lower [hazard ratio (HR) 0.58, 95% confidence interval (95% CI) 0.34-0.99; P = 0.047] in patients with short PR (shorter than median PR) if programmed in MVP mode compared with DDDR mode and it was lower (HR 0.65, 95% CI 0.43-0.99; P = 0.049) in patients with long PR (equal to or longer than median PR) if programmed in DDDR mode compared with MVP. Conclusion Our data show that PR interval may be used as a selection criterion to identify the optimal physiological pacing mode. Persistent AF incidence was lower in short PR patients treated by right ventricular pacing minimization and in long PR patients treated by standard dual-chamber pacing.

Aims We developed and validated an algorithm for prediction of heart failure (HF) hospitalizations using remote monitoring (RM) data transmitted by implanted defibrillators. Methods and results The SELENE HF study enrolled 918 patients (median age 69 years, 81% men, median ejection fraction 30%) with cardiac resynchronization therapy (44%), dual-chamber (38%), or single-chamber defibrillators with atrial diagnostics (18%). To develop a predictive algorithm, temporal trends of diurnal and nocturnal heart rates, ventricular extrasystoles, atrial tachyarrhythmia burden, heart rate variability, physical activity, and thoracic impedance obtained by daily automatic RM were combined with a baseline risk-stratifier (Seattle HF Model) into one index. The primary endpoint was the first post-implant adjudicated HF hospitalization. After a median follow-up of 22.5 months since enrolment, patients were randomly allocated to the algorithm derivation group (n = 457; 31 endpoints) or algorithm validation group (n = 461; 29 endpoints). In the derivation group, the index showed a C-statistics of 0.89 [95% confidence interval (CI): 0.83–0.95] with 2.73 odds ratio (CI 1.98–3.78) for first HF hospitalization per unitary increase of index value (P Conclusion With the developed algorithm, two-thirds of first post-implant HF hospitalizations could be predicted timely with only 0.7 false alerts per patient-year.

Aims Patients with permanently increased risk of sudden cardiac death (SCD) can be protected by implantable cardioverter defibrillators (ICD). If an ICD must be removed due to infection, for example, immediate reimplantation might not be possible or indicated. The wearable cardioverter defibrillator (WCD) is an established, safe and effective solution to protect patients from SCD during this high‐risk bridging period. Very few economic evaluations on WCD use are currently available. Methods We conducted a systematic review to evaluate the available evidence of WCD in patients undergoing ICD explant/lead extraction. Additionally, a decision model was developed to compare use and costs of the WCD with standard therapy (in‐hospital stay). For this purpose, a cost‐minimization analysis was conducted, and complemented by a one‐way sensitivity analysis. Results In the base case scenario, the WCD was less expensive compared to standard therapy. The cost‐minimization analysis showed a cost reduction of €1782 per patient using the WCD. If costs of standard care were changed, cost savings associated with the WCD varied from €3500 to €0, assuming costs for standard care of €6800 to €3600. Conclusion After ICD explantation, patients can be safely and effectively protected from SCD after hospital discharge through WCD utilization. Furthermore, the use of a WCD for this patient group is cost saving when compared to standard therapy.

AIM: Adherence to guidelines was not homogeneous in Europe, according to the survey on cardiac resynchronization therapy conducted in 2008-2009. The aim of our study was to compare the results in the Italian and European cohorts of the Second European Cardiac Resynchronization Therapy Survey. METHODS: Patients' characteristics, procedural data and follow-up were collected. Italian records were compared with European countries. RESULTS: Italian hospitals enrolled 526 patients. The italian cohort was older (71.6 ± 9.5 vs. 68.4 ± 10.8; P II 47.2 vs. 59.6%; P

Clinical guidelines, while representing an objective reference to perform appropriate treatment choices, contain grey zones, where recommendations are not supported by solid evidence. In a conference held in Bergamo in October 2018, an attempt was made to highlight some of the main grey zones in Cardiology and, through a comparison between experts, to draw shared conclusions that can illuminate our clinical practice. This manuscript contains the statements of the symposium concerning the controversies regarding new oral anticoagulants (NOACs) and atrial fibrillation (AF). The manuscript represents the organization of the meeting, with an initial review of current guidelines on this topic, followed by an expert presentation of pros (white) and cons (black) related to the identified "gaps of evidence". For every issue is then reported the response derived from the votes of the experts and the public, the discussion and, finally, the highlights, which are intended as practical "take home messages" to be used in everyday clinical practice. The first topic concerns the indication for anticoagulant therapy in patients with subclinical AF revealed by implanted devices. The second issue examines the opportunity to use NOACs in oncological patients with AF. The third gap evaluates the necessity of anticoagulating patients with AF and CHA2DS2-VASc 1 or CHA2DS2-VASc 2 if women. The last "gap in evidence" concerns the preference of triple or double therapy in patients with AF and acute coronary syndrome/coronary stenting. The work has also been implemented with evidences deriving from important randomized studies published after the date of the Conference.

The frequency of premature atrial complexes (PACs) has been related with atrial fibrillation (AF) occurrence and adverse prognosis. Research objective was to evaluate whether temporal patterns of PACs are directly associated with AF onset in pacemaker patients with continuous monitoring of the atrial rhythm. Overall, 193 pacemaker patients (49% female, 72 ± 9 years old), enrolled in a national registry, were analyzed. Frequency of daily PACs was measured in a 14-day initial observation period, during which patients were in sinus rhythm. In the following period, temporal occurrence and frequency of daily PACs and eventual onset of AF were derived by pacemaker diagnostics. In the run-in period, median PACs frequency was 614 PACs/day (interquartile range 70–3056). Subsequently, in a median follow-up of 6 months, AF occurred in 109 patients, in particular in 37/96 (38.5%) patients with a PAC rate

Background Professional guidelines are based on the best available evidence. However, patients treated in clinical practice may differ from those included in reference trials. Objective The aim of this study was to evaluate the effects of cardiac resynchronization therapy (CRT) in a large population of patients implanted with a CRT device stratified in accordance with the 2016 European heart failure (HF) guidelines. Methods We collected data on 930 consecutive patients from the Cardiac Resynchronization Therapy MOdular REgistry. The primary end point was a composite of death and HF hospitalization. Results Five hundred sixty-three (60.5%) patients met class I indications, 145 (15.6%) class IIa, 108 (11.6%) class IIb, and 114 (12.3%) class III. After a median follow-up of 1001 days, 120 (14.7%) patients who had an indication to CRT had died and 71 (8.7%) had been hospitalized for HF. The time to the end point was longer in patients with a class I indication (hazard ratio 0.55; 95% confidence interval 0.39–0.76; P = .0001). After 12 months, left ventricular (LV) end-systolic volume had decreased by ≥15% in 61.5% (320/520) of patients whereas in 57.5% (389/676) of patients the absolute LV ejection fraction improvement was ≥5%. Adherence to class I was also associated with an absolute LV ejection fraction increase of >5% (P = .0142) and an LV end-systolic volume decrease of ≥15% (P = .0055). Conclusion In our population, ∼60% of patients underwent implantation according to the 2016 European HF guidelines class I indication. Adherence to class I was associated with a lower death and HF hospitalization rates and better LV reverse remodeling.

Background Atrial tachyarrhythmias (AT/AF) have been associated with an increased risk of mortality, morbidity and ischemic stroke. Up to now, single chamber ICD diagnostics was not able to detect AT/AF, therefore the incidence of new onset AT/AF in patients with single chamber ICD is not known. Objective To evaluate incidence and predictors of AT/AF occurrence in patients with dual-chamber ICD with no pacing indications and no history of AT/AF that strictly mimic single chamber ICD recipient. Methods & results Consecutive dual-chamber ICD patients were prospectively followed by 47 Italian cardiologic centers in an observational research. Clinical and device data were reviewed by expert cardiologists to assess AT/AF occurrence. Multivariate regression analysis evaluated the risk of new-onset AT/AF and its association with patients' baseline characteristics and with CHADS 2 score. 428 (13.4% female, 64years old) patients were followed for a median observation period of 31months. AT/AF episodes occurred in 160 (37.4%) patients when considering at least 5min duration, in 95 (22.2%) for AT/AF ≥6h, in 47 (11.0%) for AT/AF ≥1day, in 29 (6.8%) for AT/AF ≥7days. Patients with CHADS 2 ≥2, who comprised 36% of the whole population, showed higher incidence of AT/AF ≥6h compared with patients with CHADS 2 p =0.011). Conclusions Our observations in a population of dual-chamber ICD patients with no pacing indications and no history of AT/AF, who strictly mimic single–chamber ICD recipients, highlight that AT/AF episodes occurred in the 37.5% of the population and CHADS 2 score is predictive of new-onset AT/AF.

Atrial fibrillation is the most common sustained arrhythmia encountered in primary care practice and represents a significant burden on the health care system with a higher than expected hospitalization rate from the emergency department. The first goal of therapy is to assess the patient's symptoms and hemodynamic status. There are multiple acute management strategies for atrial fibrillation including heart rate control, immediate direct-current cardioversion, or pharmacologic cardioversion. Given the variety of approaches to acute atrial fibrillation, it is often difficult to consistently provide cost-effectiveness care. The likelihood of spontaneous conversion of acute atrial fibrillation to sinus rhythm is reported to be really high. Although active cardioversion of recent-onset atrial fibrillation is generally considered to be safe, the question arises of whether the strategy of immediate treatment for a condition that is likely to resolve spontaneously is acceptable for hemodynamically stable patients. Based on published data, non-managed acute treatment of atrial fibrillation appears to be cost-saving. The observation of a patient with recent-onset atrial fibrillation in a dedicated unit within the emergency department reduces the need for acute cardioversion in almost two-thirds of the patients, and reduces the median length of stay, without negatively affecting long-term outcome, thus reducing the related health care costs. However, to let these results broadly applicable, defined treatment algorithms and access to prompt follow-up are needed, which may not be practical in all settings.

Efficacy and safety of dronedarone was shown in the ATHENA trial for paroxysmal or persistent atrial fibrillation (AF) patients. Further trials revealed safety concerns in patients with heart failure and permanent AF. This review summarizes insights from recent real-world studies and meta-analyses, including reports on efficacy, with focus on liver safety, mortality risk in patients with paroxysmal/persistent AF, and interactions of dronedarone with direct oral anticoagulants. Reports of rapidly progressing liver failure in dronedarone-prescribed patients in 2011 led to regulatory cautions about potential liver toxicity. Recent real-world evidence suggests dronedarone liver safety profile is similar to other antiarrhythmics and liver toxicity could be equally common with many Class III antiarrhythmics. Dronedarone safety concerns (increased mortality in patients with permanent AF) were raised based on randomized controlled trials (RCT) (ANDROMEDA and PALLAS), but comedication with digoxin may have increased the mortality rates in PALLAS, considering the dronedarone–digoxin pharmacokinetic (PK) interaction. Real-world data on apixaban–dronedarone interactions and edoxaban RCT observations suggest no significant safety risks for these drug combinations. Median trough plasma concentrations of dabigatran 110 mg during concomitant use with dronedarone are at acceptable levels, while PK data on the rivaroxaban–dronedarone interaction are unavailable. In RCTs and real-world studies, dronedarone significantly reduces AF burden and cardiovascular hospitalizations, and demonstrates a low risk for proarrhythmia in patients with paroxysmal or persistent AF. The concerns on liver safety must be balanced against the significant reduction in hospitalizations in patients with non-permanent AF and low risk for proarrhythmias following dronedarone treatment.

Objectives The aim of the study was to confirm the value of the VALID‐cardiac resynchronization therapy (CRT) risk score in predicting outcome and to assess its association with clinical response (CR) in an unselected real‐world CRT population. Methods and Results The present analysis comprised all consecutive CRT patients (pts) enrolled in the CRT‐MORE registry from 2011 to 2013. Pts were stratified into five groups (quintiles 1‐5) according to the VALID‐CRT risk predictor index applied to the CRT‐MORE population. In the analysis of clinical outcome, adverse events comprised death from any cause and non‐fatal heart failure (HF) events requiring hospitalization. CR at 12‐month follow‐up was also assessed. We enrolled 905 pts. During a median follow‐up of 1005 [627‐1361] days, 134 patients died, and 79 had at least one HF hospitalization. At 12 months, 69% of pts displayed an improvement in their CR. The mean VALID‐CRT risk score derived from the CRT‐MOdular Registry (MORE) population was 0.317, ranging from −0.419 in Q1 to 2.59 in Q5. The risk‐stratification algorithm was able to predict total mortality after CRT (survival ranging from 93%‐Q1 to 77%‐Q5; hazards ratio [HR] = 1.42, 95% confidence interval [CI]: 1.25‐1.61, P

Background Because 20% to 40% of patients undergoing cardiac resynchronization therapy (CRT) do not respond to it, identification of potential factors predicting response is a relevant research topic. Hypothesis There is a possible association between right ventricular function and response to CRT. Methods We analyzed 227 patients from the Cardiac Resynchronization Therapy Modular Registry (CRT-MORE) who received CRT according to current guidelines from March to December 2013. Response to therapy was defined as a decrease of ≥15% in left ventricular end-systolic volume (LVESV) at 6 months. Results The tricuspid annular plane systolic excursion (TAPSE) value that best predicted improvement in LVESV (sensitivity 68%, specificity 54%) was 17 mm. Stratifying patients according to TAPSE, LVESV decreased ≥15% in 78% of patients with TAPSE >17 mm (vs 59% in patients with TAPSE ≤17 mm; P = 0.006). At multivariate analysis, TAPSE >17 mm was independently associated with LVESV improvement (odds ratio: 1.97, 95% confidence interval: 1.03-3.80, P 17 mm vs 55% in patients with TAPSE

Atrial fibrillation (AF) is a relevant cardiovascular condition that is more prevalent in the elderly patients aged over 65 years. AF, with abnormal rate and rhythm can cause symptoms directly or indirectly by exacerbating other frequently coexisting cardiac conditions such as valvular heart disease, hypertension, ischemic cardiomyopathy, dilated cardiomyopathy, and hypertrophic cardiomyopathy. Evidence suggests that aging-related cardiovascular changes predispose to the elderly to AF. Current therapeutic options such as antiarrhythmic drugs have not been extensively evaluated in the elderly population. Emerging pharmacological and non-pharmacological treatment options for the management of AF, such as dronedarone or catheter ablation, are of particular interest in the elderly. The present paper reviews the pathophysiology, diagnosis, and the management of AF in the elderly patient.

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.

Background:\ud \ud Cardiac resynchronisation therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure and is strongly recommended for such patients by guidelines. A European Society of Cardiology (ESC) CRT survey conducted in 2008–2009 showed considerable variation in guideline adherence and large individual, national and regional differences in patient selection, implantation practice and follow-up. Accordingly, two ESC associations, the European Heart Rhythm Association and the Heart Failure Association, designed a second prospective survey to describe contemporary clinical practice regarding CRT.\ud Methods and results:\ud \ud A survey of the clinical practice of CRT-P and CRT-D implantation was conducted from October 2015 to December 2016 in 42 ESC member countries. Implanting centres provided information about their hospital and CRT service and were asked to complete a web-based case report form collecting information on patient characteristics, investigations, implantation procedures and complications during the index hospitalisation. The 11 088 patients enrolled represented 11% of the total number of expected implantations in participating countries during the survey period; 32% of patients were aged ≥75 years, 28% of procedures were upgrades from a permanent pacemaker or implantable cardioverter-defibrillator and 30% were CRT-P rather than CRT-D. Most patients (88%) had a QRS duration ≥130 ms, 73% had left bundle branch block and 26% were in atrial fibrillation at the time of implantation. Large geographical variations in clinical practice were observed.\ud Conclusion:\ud \ud CRT Survey II provides a valuable source of information on contemporary clinical practice with respect to CRT implantation in a large sample of ESC member states. The survey permits assessment of guideline adherence and demonstrates variations in patient selection, management, implantation procedure and follow-up strategy.

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

BACKGROUND: Pacing in the right ventricle can cause a variety of detrimental effects, including atrial tachyarrhythmias (AT/AF).OBJECTIVE: To evaluate incidence and predictors of persistent AT/AF in patients with long term exposure to ventricular pacing.METHODS: In a multi-center international trial, 605 patients (75±11 years, 240 females), referred for replacement of an implanted pacemaker or cardioverter defibrillator (ICD), with history of high percentage (>40%) ventricular pacing, were randomly allocated to standard dual-chamber pacing or Managed Ventricular Pacing (MVP), a pacing modality which minimizes ventricular pacing. Main end point of this secondary analysis of the PreFER MVP randomized study was persistent AT/AF, defined as ≥7 consecutive days with AT/AF or AT/AF interrupted by atrial cardioversion or AT/AF present during 2 consecutive follow-up visits.RESULTS: Persistent AT/AF was observed in 71 patients (11.7%) after 2 years of follow-up. At multivariable Cox regression analysis, prior AT/AF (hazard ratio (HR)=2.85, 95% confidence intervals (CI)=1.20-6.22, p=0.017) and ventricular pacing percentage, estimated in the first 3 months, ≥10% (HR=3.24, CI=1.13-9.31, p=0.029) resulted as independent predictors for persistent AT/AF. MVP was associated with persistent AT/AF risk (HR=3.41, CI=1.10-10.6, p=0.024) in the subgroup of patients with a baseline long PR interval (PR>230 ms), but not in the whole population.CONCLUSION: In pacemaker and ICD replacement patients, high percentage of ventricular pacing is associated with higher risk of persistent AT/AF. The use of algorithms which minimize right ventricular pacing may benefit patients with normal spontaneous AV conduction but should be evaluated with caution in patients with long PR interval.CLINICAL TRIAL REGISTRATION: URL http://www.clinicaltrials.gov. Identifier: NCT00293241.

Atrial tachycardia (AT) and atrial fibrillation (AF) are common in pacemaker patients and are associated with bad prognoses.The purpose of this study was to evaluate atrial antitachycardia pacing impact on AT/AF-induced atrial remodeling, measured by early recurrence of AT/AF (ERAF) and by change in left atrial diameter (LAD), and to evaluate the impact of AT/AF duration on ERAF incidence.Pacemaker patients were randomized to dual-chamber pacing (Control DDDR: 385 patients), managed ventricular pacing (MVP: 398 patients), or atrial antitachycardia pacing plus MVP (DDDRP+MVP: 383 patients). LAD change, estimated by echocardiography, was considered significant if the relative difference between baseline and 24-month measurements was10%.At median follow-up of 34 months, ERAF incidence was significantly lower in the DDDRP+MVP arm for all AT/AF durations, in particular, ERAF followed AT/AF longer than 3 hours in 53% cases in Control DDDR, in 51% cases in MVP, and in 39% cases in DDDRP+MVP (P.001 vs other groups). ERAF incidence showed a U-shaped pattern when evaluated as a function of previous AT/AF duration, decreasing for durations from 5 minutes to 12 hours and increasing for longer durations. Among patients with significant LAD change, the proportion of patients with a reduction in LAD was 35% in Control DDDR, 37% in MVP, and 70% in DDDRP+MVP (P.05 vs other groups).Our data suggest that atrial electrical remodeling becomes important after about 12 hours of continuous arrhythmia. Compared to DDDR or MVP, DDDRP+MVP reduces ERAF and favors LAD reduction, suggesting that atrial antitachycardia pacing may reverse electrical and mechanical remodeling.

The introduction of non-vitamin K antagonist oral anticoagulants (NOACs) into clinical practice has revolutionized the prevention and the therapeutic approaches to thromboembolic events in patients with nonvalvular atrial fibrillation and represents with no doubts one of the most remarkable advances in the history of cardiovascular medicine over the last years. NOACs beyond a comparable efficacy with vitamin K antagonists allow to overcome the limitations of this last category of drugs owing to their less drug to drug interactions and a predictable anticoagulant effect that allows a fixed dose administration without the need for continuous monitoring. However, the penetration of NOACs into the Italian market is still lower than predicted with respect to their use in other European countries.The aim of this review is to critically analyze the reasons behind this attitude through the adoption of the nominal group technique, a methodology that permits to reach an official consensus.

Among atrial tachyarrhythmias (AT), atrial fibrillation (AF) is the most common sustained arrhythmia. Many patients with AT have no symptoms during brief or even extended periods of the arrhythmia, making detection in patients at risk for stroke challenging. Subclinical atrial tachyarrhythmia and asymptomatic or silent atrial tachyarrhythmia often precede the development of clinical AF. Clinical AF and subclinical atrial fibrillation (SCAF) are associated with an increased risk of thromboembolism. Indeed, in many cases, SCAF is discovered only after complications such as ischaemic stroke or congestive heart failure have occurred

Introduction The main objective of research in pacemaker therapy has been to provide the best physiologic way to pace the heart. Despite the good results provided by right ventricular pacing minimization and by biventricular pacing in specific subsets of heart failure patients, these options present many limitations for standard pacemaker recipients. In these patients, pacing the right ventricle at alternative sites could result in a lower degree of left intraventricular dyssynchrony. Despite the lack of strong evidence and the difficulty in placing and accurately classifying the final lead position, pacing at alternative right ventricular sites seems to have become a standard procedure at many implanting centers. Material and methods The RIGHT PACE study is a multi-center, prospective, single-blind, double-arm, intervention-control trial comparing right ventricular pacing from the apex and from the septal site in terms of left intraventricular dyssynchrony. A total of 408 patients with indications for cardiac pacing but without indications for ICD and/or CRT will be enrolled. Investigators will be divided on the basis of their prior experience of selective site pacing lead implantation and patients will be treated according to the clinical practice of the centers. After device implantation, they will be followed up for 24 months through evaluation of clinical, echocardiographic and safety/system-performance variables. Discussion This study might provide important information about the impact of the right ventricular pacing on the left ventricular dyssynchrony, and about acute and chronic responses to selective site pacing, as adopted in current clinical practice. This trial is registered at ClinicalTrials.gov (ID: NCT01647490 ). Trial registration Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of apical and alternative position. ClinicalTrials.gov : NCT01647490 .

Atrial fibrillation (AF) is the most frequent cardiac rhythm disorder and presents a considerable public health burden that is likely to increase in the next decades due to the ageing population. Current management strategies focus on the heart rate and rhythm control, thromboembolism prevention, and treatment of underlying diseases. The concept of quality of life (QoL) has gained significant importance in recent years as an outcome measure in AF studies evaluating therapeutic interventions and as a relevant component of a comprehensive treatment plan. Quality of life is impaired in the majority of patients with AF, and both rate and rhythm control strategies show significant improvement in QoL measures in highly symptomatic patients. This article reviews generic and specialized instruments for measuring QoL in the context of AF, discusses their applications and limitations to integration in clinical practice, and addresses the potential of early therapy for improving QoL outcomes. The development and validation of new QoL assessment tools will have a central role in the advancement of therapies and treatment guidelines for AF.

The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2014 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers.The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards.PM Registry: data about 24 680 PM implantations were collected (19 480 first implant and 5200 replacements). The number of collaborating centers was 208. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 45.3% of first PM implants, sick sinus syndrome in 23.1%, atrial fibrillation plus bradycardia in 11.7%, other in 19.9%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (22.7% of first implants). Use of single-chamber PMs was reported in 26.9% of first implants, of dual-chamber PMs in 63.6%, of PMs with cardiac resynchronization therapy (CRT) in 1.7%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 7.8%. ICD Registry: data about 17 116 ICD implantations were collected (11 274 first implants and 5842 replacements). The number of collaborating centers was 424. Median age of treated patients was 71 years (62 quartile I; 77 quartile III). Primary prevention indication was reported in 72.3% of first implants, secondary prevention in 27.7% (cardiac arrest in 10.1%). A single-chamber ICD was used in 32.2% of first implants, dual-chamber in 37.1% and biventricular in 30.7%.The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice.

CRT Patient Characteristics and Outcomes. Introduction: The characteristics and outcomes of patients who undergo cardiac resynchronization therapy (CRT) device implantation in current clinical practice may differ from those of reference trial populations. Study objectives were to assess 2-year outcomes in a population implanted with a CRT plus defibrillator device in accordance with the standard of care and to evaluate any independent association between clinical variables and outcome. Methods and Results: A total of 406 patients enrolled at 35 centers in Italy were followed up prospectively for 2 years. All patient management decisions were left to the treating physician's discretion, in accordance with clinical practice. ACTION-HF patients had a better baseline clinical status than patients enrolled in the COMPANION study: shorter HF history (1 vs 3.5 years, P

Objectives The purpose of this analysis was to evaluate the correlation between atrial tachycardia (AT) or atrial fibrillation (AF) and clinical outcomes in heart failure (HF) patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D). Background In HF patients, AT and AF have high prevalence and are associated with compromised hemodynamic function. Methods Forty-four Italian cardiological centers followed up 1,193 patients who received a CRT-D according to current guidelines for advanced HF, New York Heart Association functional class ≥II, left ventricular ejection fraction ≤35%, and QRS complex ≥120 ms. All patients were in sinus rhythm at implant. Results During a median follow-up period of 13 months, AT/AF >10 min occurred in 361 of 1,193 (30%) patients. The composite end point (deaths or HF hospitalizations) occurred in 174 of 1,193 (14.6%). Multivariate time-dependent Cox regression analyses showed that composite end point risk was higher among patients with device-detected AT/AF (hazard ratio [HR]: 2.16, p = 0.032), New York Heart Association functional class III or IV compared with II (HR: 2.09, p = 0.002), and absence of beta-blockers (HR: 1.36, p = 0.036). Furthermore, the composite end point risk was inversely associated with left ventricular ejection fraction (HR: 1.04, p = 0.045), increasing by a factor of 4% for each 1% decrease in left ventricular ejection fraction. Conclusions In HF patients with CRT-D, device-detected AT/AF is associated with a worse prognosis. Continuous device diagnostics monitoring and Web-based alerts may inform the physician of AT/AF occurrences and identify patients at risk of cardiac deterioration or patients with suboptimal rate or rhythm control. (Italian ClinicalService Project; NCT01007474 )

Background Pill-in-the-pocket treatment should be prescribed only if the administration of a loading oral dose of flecainide or propafenone has been proved safe in hospital, since major adverse effects have been reported in 5% of patients during in-hospital treatment. However, in emergency rooms, the oral administration of these drugs for the conversion of atrial fibrillation (AF) is very rarely used because it is time consuming. Objective To investigate whether tolerance to intravenous administration of flecainide or propafenone might predict the safety of pill-in-the-pocket treatment—the out-of-hospital self-administration of these drugs after the onset of palpitations—in patients with AF of recent onset. Methods One hundred and twenty-two patients with AF of recent onset who were successfully treated (conversion of AF within 2 h without major adverse effects) in hospital with intravenous flecainide or propafenone were discharged on pill-in-the-pocket treatment. Results During a mean follow-up of 11±4 months, 79 patients self-treated 213 arrhythmic episodes; treatment was successful in 201 episodes (94%). Major adverse events occurred in five patients (6%) and in four (5%) of these during the first oral treatment (one syncope, two presyncope, one sinus arrest). No patient reported symptoms attributable to bradyarrhythmia or hypotension during the self-treatment of arrhythmic recurrences when the first oral treatment was not accompanied by any major adverse effects. The study was prematurely terminated because of the high incidence of major adverse effects during the first out-of-hospital treatment. Conclusion The patient9s tolerance of intravenous administration of flecainide or propafenone does not seem to predict adverse effects during out-of-hospital self-administration of these drugs.

Atrial fibrillation (AF) is associated with impaired functional capacity and quality of life and significant morbidity and mortality. The current management approach fails to maintain stable sinus rhythm (SR) in the majority of patients. For many years, guidelines have recommended antiarrhythmic treatment of a first AF episode only if the AF is poorly tolerated, a position that has been reinforced by studies showing no mortality or morbidity advantage of rhythm control over rate control. During the last decade, research has shown mechanisms of self-perpetuation of AF based on electrophysiological and structural remodelling induced by AF itself. There is mounting evidence that 'lone' AF is because of a host of factors, some of which may be easily treatable, such as hypertension, sleep apnoea, and obesity, thus allowing secondary prevention at the time of the first episode of AF. According to these concepts, lack of early intervention could be one of the reasons for long-term failure of maintenance of SR. In this position paper, we propose testing the working hypothesis that if an SR maintenance strategy is selected, treatment of AF should commence at the first-detected episode and should be based on a double strategy of SR restoration and aggressive treatment of associated conditions that promote atrial remodelling.

Background: Most clinical trials that have tested pacing therapies to prevent and treat atrial tachyarrhythmias (AT) have chosen endpoints such as AT frequency or burden (defined as percentage of time a patient is in AT), but failed to show unequivocal evidence of a clinical impact. Aim: The aim of our multicenter prospective observational study was to measure the variability of AT burden and estimate its impact on study outcomes. Methods and Results: Two hundred and fifty patients indicated for permanent pacing and suffering from AT (age 71 ± 9 years; 47.2% male) received a dual-chamber pacemaker. AT burden was measured in two consecutive, 2-month observation periods; the Monte Carlo method was then applied to simulate findings of a crossover design study. We simulated several models of therapy impact, each model being characterized by the percentage of responder patients and the percentage reduction in AT burden. To show a significant impact of AT therapies in a sample of 250 patients in whom 100, 75, or 50% would be theoretical responders to therapies, AT burden reduction should be at least 27, 32, or 57%, respectively. Temporal fluctuations in AT burden were so high that about 60% of patients would falsely appear as responders or nonresponders in a crossover study, regardless of AT burden reduction. Conclusions: In patients paced for bradycardia and suffering from AT, high intrapatient variability in AT burden was measured. Various models of therapy impact showed that, in crossover trials of AT therapies, time-related fluctuations in AT burden negatively impact on sample sizes and impair the ability to identify patients as responders or nonresponders.

Accurate selection of patients with left bundle branch block (LBBB) may help increasing response to cardiac resynchronization therapy (CRT). There is no agreement on LBBB definition. The aim of the study was to investigate the prevalence of 'true-LBBB' according to Strauss in patients undergoing CRT.The study population included 414 consecutive patients (71.9% men; mean age 69.7 ± 9.6 years), who underwent CRT according to 2010 European Society of Cardiology (ESC) guidelines. Patients were classified into three groups: traditional LBBB according to American Heart Association, LBBB according to Strauss and intraventricular conduction delay (IVCD). Subsequently, they were re-classified into classes of recommendations, according to the current 2013 ESC Guidelines. Traditional LBBB was recorded in 229 patients (55%), an LBBB according to Strauss in 153 (37%) and an IVCD in 32 (8%). Patients with an LBBB according to Strauss showed a significantly more prolonged QRS duration (P 0.001), greater baseline end-systolic and end-diastolic volumes (P = 0.011 and P = 0.013, respectively) compared with those with IVCD. The prevalence of mid-QRS notching in at least two contiguous leads was 100% in LBBB according to Strauss; 24% in traditional LBBB and 21.9% in IVCD (P 0.001). At multivariate analysis, PR interval less than 200 ms and QRS of at least 150 ms were independent predictors of mid-QRS notching [odds ratio (OR) 1.78; 95% confidence interval (95% CI) 1.10-2.88; P = 0.02 and OR 2.88; 95% CI 1.80-4.62;P 0.0001]. Applying stricter criteria for LBBB according to Strauss, a significant reduction in Class I recommendation and an increase in Class II was observed (90.1 vs. 37%; P 0.0001 and 9.9 vs. 63%; P 0.0001).Applying stricter criteria, only 37% of patients undergoing CRT showed a true-LBBB according to Strauss. Accurate identification of true-LBBB may have a potential additional value in better selecting patients.