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Background: Patients with nonischemic dilated cardiomyopathy (DCM), severe left ventricular (LV) dysfunction, and complete left bundle branch block benefit from cardiac resynchronization therapy (CRT). However, a large heterogeneity of response to CRT is described. Several predictors of response to CRT have been identified, but the role of the underlying genetic background is still poorly explored., Objectives: In the present study, the authors sought to define differences in LV remodeling and outcome prediction after CRT when stratifying patients according to the presence or absence of DCM-causing genetic background., Methods: From our center, 74 patients with DCM subjected to CRT and available genetic testing were retrospectively enrolled. Carriers of causative monogenic variants in validated DCM-causing genes, and/or with documented family history of DCM, were classified as affected by genetically determined disease (GEN+DCM) (n = 25). Alternatively, by idiopathic dilated cardiomyopathy (idDCM) (n = 49). The primary outcome was long-term LV remodeling and prevalence of super response to CRT (evaluated at 24-48 months after CRT); the secondary outcome was heart failure-related death/heart transplant/LV assist device., Results: GEN+DCM and idDCM patients were homogeneous at baseline with the exception of QRS duration, longer in idDCM. The median follow-up was 55 months. Long-term LV reverse remodeling and the prevalence of super response were significantly higher in the idDCM group (27% in idDCM vs 5% in GEN+DCM; P = 0.025). The heart failure-related death/heart transplant/LV assist device outcome occurred more frequently in patients with GEN+DCM (53% vs 24% in idDCM; P = 0.028)., Conclusions: Genotyping contributes to the risk stratification of patients with DCM undergoing CRT implantation in terms of LV remodeling and outcomes., Competing Interests: Funding Support and Author Disclosures This study was supported by CRTrieste Foundation and Cassa di Risparmio di Gorizia Foundation to Dr Sinagra. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The Pacemaker (PM) and Implantable Cardioverter-Defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers., Methods: For the year 2020, the main data about national PM and ICD implantation activity were obtained on the basis of European Cards and subsequently analyzed to create a standard report., Results: PM Registry: data about 22 080 PM implantations were collected (18 027 first implants and 3803 replacements). The number of collaborating centers was 142. Median age of treated patients was 82 years (75 quartile I; 87 quartile III). ECG indications included atrioventricular conduction disorders in 31.0% of first PM implants, sick sinus syndrome in 13.8%, atrial fibrillation plus bradycardia in 9.9%, other unspecified ECG and electrophysiological abnormalities in 36.6%. Use of single-chamber PMs was reported in 29.0% of first implants, of dual-chamber PMs in 68.2%, of PM with cardiac resynchronization therapy (CRT) in 2.7%. ICD Registry: data about 11 931 ICD implantations were obtained (8266 first implants and 3665 replacements). The number of collaborating centers was 330. Median age of treated patients was 72 years [63 quartile I; 79 quartile III]. Primary prevention indication was reported in 85.0% of first implants, secondary prevention in 15.0% (cardiac arrest in 4.2%). A single-chamber ICD was used in 30.2% of first implants, dual-chamber ICD in 31.2% and biventricular ICD in 38.6%., Conclusions: In the calendar year 2020, the Italian PM Registry showed stable ECG and symptom indications, with an important prevalence of dual-chamber pacing. The ICD Registry documented a large use of prophylactic and biventricular ICDs, reflecting a favorable adherence in clinical practice to trials and guidelines. The ICD longevity and the number of recalls demonstrated a favorable trend. In order to increase and optimize the cooperation of Italian PM and ICD implanting centers, the online data entry (https://www.aiac.it/riprid) should be adopted at large scale.

Aims: We developed and validated an algorithm for prediction of heart failure (HF) hospitalizations using remote monitoring (RM) data transmitted by implanted defibrillators., Methods and Results: The SELENE HF study enrolled 918 patients (median age 69 years, 81% men, median ejection fraction 30%) with cardiac resynchronization therapy (44%), dual-chamber (38%), or single-chamber defibrillators with atrial diagnostics (18%). To develop a predictive algorithm, temporal trends of diurnal and nocturnal heart rates, ventricular extrasystoles, atrial tachyarrhythmia burden, heart rate variability, physical activity, and thoracic impedance obtained by daily automatic RM were combined with a baseline risk-stratifier (Seattle HF Model) into one index. The primary endpoint was the first post-implant adjudicated HF hospitalization. After a median follow-up of 22.5 months since enrolment, patients were randomly allocated to the algorithm derivation group (n = 457; 31 endpoints) or algorithm validation group (n = 461; 29 endpoints). In the derivation group, the index showed a C-statistics of 0.89 [95% confidence interval (CI): 0.83-0.95] with 2.73 odds ratio (CI 1.98-3.78) for first HF hospitalization per unitary increase of index value (P < 0.001). In the validation group, sensitivity of predicting primary endpoint was 65.5% (CI 45.7-82.1%), median alerting time 42 days (interquartile range 21-89), and false (or unexplained) alert rate 0.69 (CI 0.64-0.74) [or 0.63 (CI 0.58-0.68)] per patient-year. Without the baseline risk-stratifier, the sensitivity remained 65.5% and the false/unexplained alert rates increased by ≈10% to 0.76/0.71 per patient-year., Conclusion: With the developed algorithm, two-thirds of first post-implant HF hospitalizations could be predicted timely with only 0.7 false alerts per patient-year., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: To analyze temporal trends (2001 -2017) of Pacemakers (PM) and Implantable Cardioverter-Defibrillators (ICD) procedures in Italy, according to the national Hospital Discharge Database (HDD)., Methods: Frequency and implant rate (IR) in the Italian population were analyzed by age groups (<50, 50-79, ≥80 years)., Results: From 2001 (2009 for Cardiac Resynchronization Therapy-Defibrillator - CRT-D) to 2017, first PM implants (1stPM) increased from 36,823 (637/million inhabitants) to 49,716 (820/million), ICD implants from 3,141 (54/million) to 24,255 (400/million) and CRT-D from 2,915 (49/million, 16.5% of ICD) to 8,595 (142/million, 35.4% of ICD). ICD implants due to ventricular tachycardia or ventricular fibrillation decreased from 55.6% to 13.5% and from 15.9% to 4.5% respectively, while the proportion increased among patients with heart failure (from 22.9% to 46.8%), hypertension (from 11.1% to 15.0%), diabetes (from 6.5% to 10.9%), and renal insufficiency (from 4.4% to 7.6%). Both PM and ICD procedures markedly increased in patients ≥80 years old. However, while IR for ICDs increased from 82/million to 1,038/million inhabitants, IR of 1stPM only changed from 6,111/million to 6,212/million as the population in this age group nearly doubled in Italy., Conclusion: Since 2001, the increase of 1stPM in Italy was mainly due to the ultra-octogenarian population growth. No differences were observed for IR in each PM age group, while the absolute number and IR increased in all groups (especially ≥80 years old) for ICDs and CRT-Ds. An increase in comorbidities and a reduction in implants for secondary prevention were observed in the ICD population., (Copyright © 2020. Published by Elsevier B.V.)

Background: 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 2018 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers., Methods: The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards., Results: PM Registry: data about 23 912 PM implantations were collected (20 084 first implants and 3828 replacements). The number of collaborating centers was 180. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 34.5% of first PM implants, sick sinus syndrome in 18.3%, atrial fibrillation plus bradycardia in 13.0%, other in 34.2%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (19.2% of first implants). Use of single-chamber PMs was reported in 24.9% of first implants, of dual-chamber PMs in 67.6%, of PMs with cardiac resynchronization therapy (CRT) in 1.6%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 5.9%. ICD Registry: data about 18 353 ICD implantations were collected (13 944 first implants and 4359 replacements). The number of collaborating centers was 433. Median age of treated patients was 71 years (63 quartile I; 78 quartile III). Primary prevention indication was reported in 84.3% of first implants, secondary prevention in 15.7% (cardiac arrest in 5.3%). A single-chamber ICD was used in 27.9% of first implants, dual-chamber ICD in 31.9% and biventricular ICD in 40.2%., Conclusions: 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. In order to increase and optimize the cooperation of Italian implanting centers, online data entry (http://www.aiac.it/riprid) should be adopted at large scale.

Background: Implantable cardioverter-defibrillators (ICD) have a pivotal role in preventing major arrhythmic events in patients with severely reduced left ventricular ejection fraction (LVEF). Device replacement strategy is still controversial in patients without severely reduced left ventricular ejection fraction (LVEF) at the end of battery life., Objective: To evaluate the long-term arrhythmic outcome of patients with ICD or and cardiac resynchronization therapy defibrillators (CRT-D) with normal or intermediate LVEF at the time of device replacement., Methods: All consecutive patients with reduced ejection fraction heart failure, both from ischemic and non-ischemic origin, implanted with ICD or CRT-D for primary prevention from 2002 to 2009, were considered. The study population included patients without previous ICD interventions and without severe dysfunction (i.e. LVEF ≥ 35%) 60 [53-65] months after implantation (average battery duration). The outcome measure was the occurrence of appropriate ICD interventions in the long-term., Results: Among the 255 patients (150 ICDs; 105 CRT-D) evaluated, 45 (18%) had LVEF ≥ 35% without ICD interventions 5-year follow-up after implantation (15 ICD [10%]; 30 CRT-D [29%]). In the long term, ICD interventions were 4 (27%) in the ICD group and 5 (17%) in the CRT-D group., Conclusions: Despite the absence of severe left ventricular dysfunction at the time of battery replacement, a not negligible number of patients with ICD and CRT-D maintained a high risk of appropriate interventions in the long term, suggesting the opportunity of replacing the ICD regardless the amount of LV dysfunction., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: 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 2017 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers., Methods: The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards., Results: PM Registry: data about 23 457 PM implantations were collected (19 378 first implant and 4079 replacements). The number of collaborating centers was 185. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 37.1% of first PM implants, sick sinus syndrome in 19.5%, atrial fibrillation plus bradycardia in 13.2%, other in 30.2%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (21.0% of first implants). Use of single-chamber PMs was reported in 25.6% of first implants, of dual-chamber PMs in 66.7%, of PMs with cardiac resynchronization therapy (CRT) in 1.4%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 6.3%. ICD Registry: data about 19 023 ICD implantations were collected (13 898 first implants and 5125 replacements). The number of collaborating centers was 437. Median age of treated patients was 71 years (63 quartile I; 78 quartile III). Primary prevention indication was reported in 81.8% of first implants, secondary prevention in 18.2% (cardiac arrest in 6.4%). A single-chamber ICD was used in 27.0% of first implants, dual-chamber in 33.6% and biventricular in 39.3%., Conclusions: 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. In order to increase and optimize the cooperation of Italian implanting centers, online data entry (http://www.aiac.it/riprid) should be adopted at large scale.

Background: 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 2016 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers., Methods: The registry collects prospectively national PM and ICD implantation activity on the basis of European cards., Results: PM Registry: data about 23 496 PM implantations were collected (19 003 first implant and 4493 replacements). The number of collaborating centers was 204. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 39.8% of first PM implants, sick sinus syndrome in 22.1%, atrial fibrillation plus bradycardia in 14.1%, other in 24.0%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (22.18% of first implants). Use of single-chamber PMs was reported in 26.9% of first implants, of dual-chamber PMs in 65.0%, of PMs with cardiac resynchronization therapy (CRT) in 1.5%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 6.6%. ICD Registry: data about 20 350 ICD implantations were collected (14 763 first implants and 5587 replacements). The number of collaborating centers was 430. Median age of treated patients was 72 years (63 quartile I; 78 quartile III]. Primary prevention indication was reported in 79.0% of first implants, secondary prevention in 21.0% (cardiac arrest in 7.9%). A single-chamber ICD was used in 32.2% of first implants, dual-chamber in 31.1% and biventricular in 36.7%., Conclusions: 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.

Introduction: Cardiac resynchronization therapy (CRT) device implantation guided by an electroanatomic mapping system (EAMS) is an emerging technique that may reduce fluoroscopy and angiography use and provide information on coronary sinus (CS) electrical activation. We evaluated the outcome of the EAMS-guided CRT implantation technique in a multicenter registry., Methods: During the period 2011-2014 we enrolled 125 patients (80% males, age 74 [71-77] years) who underwent CRT implantation by using the EnSite system to create geometric models of the patient's cardiac chambers, build activation mapping of the CS, and guide leads positioning. Two hundred and fifty patients undergoing traditional CRT implantation served as controls. Success and complication rates, fluoroscopy and total procedure times in the overall study population and according to center experience were collected. Centers that performed ≥10 were defined as highly experienced., Results: Left ventricular lead implantation was successful in 122 (98%) cases and 242 (97%) controls (P = 0.76). Median fluoroscopy time was 4.1 (0.3-10.4) minutes in cases versus 16 (11-26) minutes in controls (P < 0.001). Coronary sinus angiography was performed in 33 (26%) cases and 208 (83%) controls (P < 0.001). Complications occurred in 5 (4%) cases and 17 (7%) controls (P = 0.28). Median fluoroscopy time (median 11 minutes vs. 3 minutes, P < 0.001) and CS angiography rate (55% vs. 21%, P < 0.001) were significantly higher in low experienced centers, while success rate and complications rate were similar., Conclusions: EAMS-guided CRT implantation proved safe and effective in both high- and low-experienced centers and allowed to reduce fluoroscopy use by ≈75% and angiography rate by ≈70%., (© 2016 Wiley Periodicals, Inc.)

Aims: Right ventricular (RV) dysfunction has been associated with a worse outcome in heart failure patients undergoing CRT. However, evidence on the RV response to CRT is controversial and there are no data regarding the early effects of CRT on RV function (RVF). We sought to investigate whether a CRT device favourably influences the RVF acutely after implantation, impacting on long-term outcomes., Methods and Results: Patients who successfully underwent CRT device implantation from January 2005 to January 2014 were retrospectively analysed. RV dysfunction was defined by an RV fractional area change <35%. Post-procedural echocardiographic evaluation was performed at a median time of 2 days (interquartile range 1-6 days). The primary endpoint was a composite of all-cause mortality and urgent heart transplantation. A total of 194 patients with available pre- and post-procedural RVF assessment were included. Sixty-two (32%) presented an impaired RVF before the procedure. Of them, 32% showed prompt normalization of RVF following CRT. This occurred in parallel with a large improvement in pulmonary arterial pressure, mitral regurgitation, E/E' ratio, and diastolic function. Pre-implantation independent predictors of early RVF normalization were LBBB (P = 0.034) and higher systolic blood pressure (P = 0.026). Improvement in RVF was independently associated with a better long-term prognosis at multivariable analysis [hazard ratio 0.124; 95% confidence interval 0.016-0.966, P = 0.04)., Conclusions: Acute normalization of RVF can be observed after CRT along with haemodynamic improvement, and therefore can be used as an independent predictor of transplant-free survival., (© 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.)

Background: Functional mitral regurgitation (FMR) is associated with reduced survival in dilated cardiomyopathy (DCM). Cardiac resynchronization therapy (CRT) can improve FMR. We sought to identify the predictors of FMR improvement after CRT in DCM., Methods: From January 2003 to December 2013, 430 DCM patients consecutively enrolled were retrospectively analyzed. Inclusion criteria were successful CRT implantation in the presence of conventional indications (i.e., left bundle branch block, left ventricular ejection fraction ≤35%, New York Heart Association functional class ≥II) and moderate-to-severe FMR at the time of procedure. Early echocardiographic evaluation after CRT implantation (median 2.5 days) has been performed in each patient. Improvement in FMR (absent/mild) at midterm (7 months; interquartile range 4-10) was considered as the primary study end point., Results: A total of 44 patients (10% of the overall cohort) were included. A significant reduction in FMR severity was observed in 21 patients (48%) at midterm after CRT (median time 7 months). No preimplantation variables predicted FMR evolution, but FMR improvement at midterm was strongly predicted by an acute favorable hemodynamic response (persistence/development of normal right ventricular function and 10-mm Hg decrease or normalization [≤35 mm Hg] of systolic pulmonary artery pressure) at postimplantation echocardiography (odds ratio: 13.7; 95% confidence interval: 1.27-42.8; P = 0.016). FMR improvement at midterm was stable during follow-up and was associated with superior long-term transplant-free survival (P = 0.022)., Conclusions: Stable FMR improvement frequently occurs after CRT implantation in DCM and is associated with improved transplant-free survival. Echocardiographic evaluation of acute hemodynamic response to CRT is helpful to early identification of the favorable FMR evolution., (© 2015 Wiley Periodicals, Inc.)

Aims: To evaluate the long-term changes of clinical and echocardiographic parameters, the incidence of cardiac events and parameters associated with late cardiac events in 'super-responders' to cardiac resynchronization therapy (CRT) with [CRT defibrillator (CRT-D)] or without defibrillator back-up., Methods and Results: In all consecutive patients treated with CRT in two Italian centres (Trieste and Udine) with left ventricular ejection fraction (LVEF) ≤0.35 at implantation (Timp) and LVEF > 0.50 1 and/or 2 years (Tnorm) after implantation, the long-term outcome and the evolution of echocardiographic parameters were assessed; factors associated with a higher risk of cardiac events, defined as hospitalization or death for heart failure (HF), sudden death, or CRT-D appropriate interventions, were also analysed. Among the 259 patients evaluated, 62 (24%) had LVEF ≥ 0.50 at Tnorm (n = 44 with at 1 year, n = 18 at 2 years). During a mean follow-up of 68 ± 30 months, one cardiac death (for HF) and eight cardiovascular events (two hospitalization for HF and six appropriate CRT-D interventions) occurred. At the last echo evaluation (Tfup) performed 51 ± 26 months after Timp, LVEF was <0.50 in five patients (>0.45 in four of them). At univariable analysis, only LV end-systolic volume evaluated at Tfup was associated with a higher risk of cardiac events during follow-up., Conclusion: In 'super-responders' to CRT long-term outcome is excellent. However, cardiac events, mainly CRT-D appropriate interventions, can occur despite the persistence of LVEF > 0.50. Early identification of these patients is still an unsolved issue.

Background: Cardiac resynchronization therapy (CRT) has proved to be very effective in improving morbidity and mortality in patients affected with severe congestive heart failure. Its efficacy has been shown to be greater in patients with left bundle branch block (LBBB). The aim of our study was to verify if newly proposed criteria for true LBBB identify patients with a better clinical and instrumental response to CRT., Methods: Between May 2007 and April 2011, 111 patients with left ventricular ejection fraction (LVEF) ≤ 35% and LBBB morphology received a CRT device and were divided into two groups according to QRS morphology. Group 1 (61 patients) consisted of patients with "true" LBBB morphology; group 2 (50 patients) consisted of patients with "false" LBBB. The primary endpoint was the utility of criteria for true LBBB to predict a composite endpoint of all-cause mortality and hospital admission with heart failure. The secondary endpoint was the utility of the same criteria to predict an absolute increase in LVEF ≥ 10%., Results: "False" LBBB morphology and a dose of bisoprolol <5 mg at last follow-up were the only parameters related to clinical outcome in multivariate analysis (respectively: hazard ratio [HR] 3.98, confidence interval [CI] 95% 1.51-10.48; HR 0.15, CI 95% 0.05-0.43). "True" LBBB morphology was the only variable significantly related to a greater increase in LVEF (HR 4.57, CI 95% 1.36-8.28)., Conclusion: True LBBB morphology is related to a higher event-free survival rate in CRT patients and better echocardiographic response., (©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.)

There are no parameters predicting the individual probability of "full response" to cardiac resynchronization therapy (CRT). The aim of this work was to find prognostic factors of full clinical and echocardiographic responses (i.e., ≥50% left ventricular ejection fraction [LVEF] and New York Heart Association class I) after 1 year of CRT. This was a prospective follow-up study that involved 2 hospitals. Patients (n = 75) with advanced heart failure (64 ± 9 years of age, 87% men, LVEF 24 ± 7%) who received CRT were followed for 17 ± 9 months. Univariate and multivariate regression analyses were used to identify predictors of full CRT response. A nomogram predicting the individual probability of full CRT response during follow-up was calculated. There were 13 patients with restoration of normal LVEF versus 62 without (mean LVEF 56% ± 5% vs 31% ± 8%, respectively, p <0.001). Predictors of full response included cause of heart disease, baseline QRS width, and degree of QRS shortening in response to CRT. Patients with nonischemic heart disease, baseline QRS width ≤150 ms, and QRS shortening ≥40 ms in response to CRT had a >75% probability of restoration of normal LVEF. In conclusion, our nomogram using a combination of cause, baseline QRS width, and degree of QRS shortening in response to CRT allows assessment of individual probability of full response. This observation awaits further confirmation from larger series., (Copyright © 2011 Elsevier Inc. All rights reserved.)