Implantable Cardioverter-defibrillator Interventions Research Articles

Impact of preventive substrate catheter ablation on implantable cardioverter-defibrillator interventions in patients with ischaemic cardiomyopathy and infarct-related coronary chronic total occlusion.

Primary prevention patients with ischaemic cardiomyopathy and chronic total occlusion of an infarct-related coronary artery (CTO) are at a particularly high risk of implantable cardioverter-defibrillator (ICD) therapy occurrence. The trial was designed to evaluate the efficacy of preventive CTO-related substrate ablation strategy in ischaemic cardiomyopathy patients undergoing primary prevention ICD implantation. The PREVENTIVE VT study was a prospective, multicentre, randomized trial including ischaemic patients with ejection fraction ≤40%, no documented ventricular arrhythmias (VAs), and evidence of scar related to the coronary CTO. Patients were randomly assigned 1:1 to a preventive substrate ablation before ICD implantation or standard therapy with ICD implantation only. The primary outcome was a composite of appropriate ICD therapy or unplanned hospitalization for VAs. Secondary outcomes included the primary outcome's components, the incidence of appropriate ICD therapies, cardiac hospitalization, electrical storm, and cardiovascular (CV) mortality. Sixty patients were included in the study. During the mean follow-up of 44.7 ± 20.7 months, the primary outcome occurred in 5 (16.7%) patients undergoing preventive substrate ablation and in 13 (43.3%) patients receiving only ICD [hazard ratio (HR): 0.33; 95% confidence interval (CI): 0.12-0.94; P = 0.037]. Patients in the preventive ablation group also had fewer appropriate ICD therapies (P = 0.039) and the electrical storms (Log-rank: P = 0.01). While preventive ablation also reduced cardiac hospitalizations (P = 0.006), it had no significant impact on CV mortality (P = 0.151). Preventive ablation of the coronary CTO-related substrate in patients undergoing primary ICD implantation is associated with the reduced risk of appropriate ICD therapy or unplanned hospitalization due to VAs.

Impact of High-Voltage Device Implantation in Elderly Japanese Patients With Heart Failure as Primary Prevention - Post Hoc Analysis of HINODE.

Despite an increased incidence of chronic heart failure (HF) and sudden cardiac death (SCD), the use of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) is much lower in Japan than in Western countries. The HF Indication and SCD Prevention Trial Japan (HINODE) prospectively assessed the mortality rate, appropriately treated ventricular arrhythmias (VA), and HF in Japanese patients with a higher risk of HF.Methods and Results: HINODE consisted of ICD, CRT-defibrillator (CRT-D), pacing, and non-device treatment cohorts. This subanalysis evaluated the impact of the implantation of high-voltage devices (HVD; ICD and CRT-D) in 171 Japanese patients. We compared all-cause mortality, VA, and HF events between elderly (age >70 years at study enrollment) and non-elderly HVD recipients. The estimated survival rate through 24 months in the HVD cohort was 85.8% (97.5% lower control limit 77.6%). The risk of all-cause mortality was increased for the elderly vs. non-elderly (hazard ratio [HR] 2.82; 95% confidence interval [CI] 1.01-7.91; P=0.039), but did not differ after excluding ICD patients with CRT-D indication (HR 2.32; 95% CI 0.79-6.78; P=0.11). There were no differences in VA and HF event-free rates between elderly and non-elderly HVD recipients (P=0.73 and P=0.55, respectively). Although elderly patients may have a higher risk of mortality in general, the benefit of HVD therapy in this group is comparable to that in non-elderly patients.

Long-term reliability of the phospholamban (PLN) p.(Arg14del) risk model in predicting major ventricular arrhythmia: a landmark study.

Recently, a genetic variant-specific prediction model for phospholamban (PLN) p.(Arg14del)-positive individuals was developed to predict individual major ventricular arrhythmia (VA) risk to support decision-making for primary prevention implantable cardioverter defibrillator (ICD) implantation. This model predicts major VA risk from baseline data, but iterative evaluation of major VA risk may be warranted considering that the risk factors for major VA are progressive. Our aim is to evaluate the diagnostic performance of the PLN p.(Arg14del) risk model at 3-year follow-up. We performed a landmark analysis 3 years after presentation and selected only patients with no prior major VA. Data were collected of 268 PLN p.(Arg14del)-positive subjects, aged 43.5 ± 16.3 years, 38.9% male. After the 3 years landmark, subjects had a mean follow-up of 4.0 years (± 3.5 years) and 28 (10%) subjects experienced major VA with an annual event rate of 2.6% [95% confidence interval (CI) 1.6-3.6], defined as sustained VA, appropriate ICD intervention, or (aborted) sudden cardiac death. The PLN p.(Arg14del) risk score yielded good discrimination in the 3 years landmark cohort with a C-statistic of 0.83 (95% CI 0.79-0.87) and calibration slope of 0.97. The PLN p.(Arg14del) risk model has sustained good model performance up to 3 years follow-up in PLN p.(Arg14del)-positive subjects with no history of major VA. It may therefore be used to support decision-making for primary prevention ICD implantation not merely at presentation but also up to at least 3 years of follow-up.

Mortality Benefit Among Primary Prevention Implantable Cardioverter Defibrillator Recipients on Contemporary HeartFailure Treatment.

Past clinical trials have shown the benefit of implantable cardioverter-defibrillators (ICDs) for reducing sudden cardiac death in at-risk patients. However, heart failure management and ICD technology have changed since these trials were first published. An updated assessment of ICD mortality benefit is needed. The purpose of this study was to compare mortality rates between patients with a primary prevention (PP) indication for an ICD who did or did not receive an ICD using a contemporary, real-world data set. Data was obtained from a large electronic health record data set covering patients in the United States from 2012 through 2020 who had a PP indication for an ICD and survived at least 1-year postindication. A total of 25,296 patients were identified as having a PP indication for ICD implantation, of which 2,118 (8.4%) were treated with an ICD within a year. Treated patients were younger than nontreated patients (63.4 years vs 66.1 years) with a smaller proportion of women (25.0% vs 36.7%). After 4-to-1 propensity matching, treated patients had similar clinical characteristics to nontreated patients. A Cox proportional hazard model estimated a 24.3% lower risk of all-cause mortality in patients when treated vs not treated with an ICD (HR: 0.757; CI: 0.678-0.835; P<0.001). There was no detectable difference in ICD benefit between patients with ischemic and nonischemic heart disease (P = 0.50). ICD treatment of patients with a PP indication is associated with improved mortality even in the context of evolving adjunctive HF treatment, consistent with earlier landmark trials.

Incorporating machine learning into the decision-making process regarding implantable cardioverter-defibrillator treatment.

Incorporating machine learning into the decision-making process regarding implantable cardioverter-defibrillator treatment.

Prognostic value of right atrial strains in arrhythmogenic right ventricular cardiomyopathy.

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an inherited cardiomyopathy characterized by progressive fibrofatty infiltration of atrial and ventricular myocardium resulting in adverse cardiac events. Atrial function has been increasingly recognized as prognostically important for cardiovascular disease. As the right atrial (RA) strain is a sensitive parameter to describe RA function, we aimed to analyze the prognostic value of the RA strain in ARVC. RA strain parameters were derived from cardiac magnetic resonance (CMR) images of 105 participants with definite ARVC. The endpoint was defined as a combination of sudden cardiac death, survival cardiac arrest, and appropriate implantable cardioverter-defibrillator intervention. Cox regression and Kaplan-Meier survival analyses were performed to evaluate the association between RA strain parameters and endpoint. Concordance index (C index), net reclassification index (NRI), and integrated discrimination improvement (IDI) were calculated to assess the incremental value of RA strain in predicting the endpoint. After a median follow-up of 5years, 36 (34.3%) reaching the endpoint displayed significantly reduced RA strain parameters. At Kaplan-Meier analysis, impaired RA reservoir (RARS) and booster strains (RABS) were associated with an increased risk of the endpoint. After adjusting for conventional risk factors, RARS (hazard ratio [HR], 0.956; p = 0.005) and RABS (HR, 0.906; p = 0.002) resulted as independent predictors for endpoint at Cox regression analyses. In addition, RARS and RABS improved prognostic value to clinical risk factors and CMR morphological and functional predictors (all p < 0.05). RARS and RABS were independent predictors for adverse cardiac events, which could provide incremental prognostic value for conventional predictors in ARVC. We evaluated the prognostic value of right atrial strain in ARVC patients and suggested cardiologists consider RA strain as a predictive parameter when evaluating the long-term outcome of ARVC patients in order to formulate better clinical therapy. • Patients with ARVC had significantly reduced RA strain and strain rates compared with healthy participants. • Participants with lower RA reservoir and booster stains were associated with a significantly higher risk of adverse cardiac events. • RA booster and reservoir strain provide incremental value to conventional parameters.

Brugada syndrome in Iran: Insights from a 12-year longitudinal study.

Brugada syndrome (BrS) is characterized by ST-segment elevation in the right precordial leads, which is not explained by ischemia, electrolyte disturbances, or obvious structural heart disease. In present study, we aim to evaluate presentation, long-term outcome, genetic findings, and therapeutic interventions in patients with BrS. Between September 2001 and June 2022, all consecutive patients with diagnosis of BrS were enrolled in the present study. All patients gave written informed consent for the procedure, and the local ethical committee approved the study. Of the 76 cases, 79% were proband and 21% were detected during screening after diagnosis of BrS in a family member. Thirty-three (43%) patients had a typical spontaneous electrocardiogram (ECG) pattern. Thirty percent of the patients were symptomatic; symptomatic patients were more likely to have spontaneous type 1 Brugada ECG pattern in their ECGs (p = .01), longer PR interval (p = .03), and SCN5A mutation (p = .01) than asymptomatic patients. The mean PR interval was considerably longer in men than women (p = .034). SCN5A mutation was found in 9 out of 50 (18%) studied patients. Fifteen percent received appropriate implantable cardioverter-defibrillator (ICD) therapy and inappropriate ICD interventions were observed in 17%. Presentation with aborted SCD or arrhythmic syncope was the only predictor of adverse outcome in follow-up (odds ratio: 3.1, 95% confidence interval: 0.7-19.6, p = .001). Symptomatic patients with BrS are more likely to present with spontaneous type 1 Brugada ECG pattern, longer PR interval, and pathogenic mutation in SCN5A gene. Appropriate ICD interventions are more likely in symptomatic patients and those with SCN5A mutation.

MRI Assessment of Myocardial Deformation for Risk Stratification of Major Arrhythmic Events in Patients With Non-Ischemic Cardiomyopathy Eligible for Primary Prevention Implantable Cardioverter Defibrillators.

Implantable cardioverter-defibrillator (ICD) intervention is an established prophylactic measure. Identifying high-benefit patients poses challenges. To assess the prognostic value of cardiac magnetic resonance imaging (MRI) parameters including myocardial deformation for risk stratification of ICD intervention in non-ischemic cardiomyopathy (NICM) while accounting for competing mortality risk. Retrospective and prospective. One hundred and fifty-nine NICM patients eligible for primary ICD (117 male, 54 ± 13 years) and 49 control subjects (38 male, 53 ± 5 years). Balanced steady state free precession (bSSFP) and three-dimensional phase-sensitive inversion-recovery late gadolinium enhancement (LGE) sequences at 1.5 T or 3 T. Patients underwent MRI before ICD implantation and were followed up. Functional parameters, left ventricular global radial, circumferential and longitudinal strain, right ventricular free wall longitudinal strain (RV FWLS) and left atrial strain were measured (Circle, cvi42). LGE presence was assessed visually. The primary endpoint was appropriate ICD intervention. Models were developed to determine outcome, with and without accounting for competing risk (non-sudden cardiac death), and compared to a baseline model including LGE and clinical features. Wilcoxon non-parametric test, Cox's proportional hazards regression, Fine-Gray competing risk model, and cumulative incidence functions. Harrell's c statistic was used for model selection. A P value <0.05 was considered statistically significant. Follow-up duration was 1176 ± 960 days (median: 896). Twenty-six patients (16%) met the primary endpoint. RV FWLS demonstrated a significant difference between patients with and without events (-12.5% ± 5 vs. -16.4% ± 5.5). Univariable analyses showed LGE and RV FWLS were significantly associated with outcome (LGE: hazard ratio [HR] = 3.69, 95% CI = 1.28-10.62; RV FWLS: HR = 2.04, 95% CI = 1.30-3.22). RV FWLS significantly improved the prognostic value of baseline model and remained significant in multivariable analysis, accounting for competing risk (HR = 1.73, 95% CI = 1.12-2.66). In NICM, RV FWLS may provide additional predictive value for predicting appropriate ICD intervention. 2 TECHNICAL EFFICACY: Stage 5.

Prognostic value of right ventricular trabecular complexity in patients with arrhythmogenic cardiomyopathy.

The present study aimed to investigate the incremental prognostic value of the right ventricular fractal dimension (FD), a novel marker of myocardial trabecular complexity by cardiac magnetic resonance (CMR) in patients with arrhythmogenic cardiomyopathy (ACM). Consecutive patients with ACM undergoing CMR were followed up for major cardiac events, including sudden cardiac death, aborted cardiac arrest, and appropriate implantable cardioverter defibrillator intervention. Prognosis prediction was compared by Cox regression analysis. We established a multivariable model supplemented with RV FD and evaluated its discrimination by Harrell's C-statistic. We compared the category-free, continuous net reclassification improvement (cNRI) and integrated discrimination index (IDI) before and after the addition of FD. A total of 105 patients were prospectively included from three centers and followed up for a median of 60 (48, 66) months; experienced 36 major cardiac events were recorded. Trabecular FD displayed a strong unadjusted association with major cardiac events (p < 0.05). In the multivariable Cox regression analysis, RV maximal apical FD maintained an independent association with major cardiac events (hazard ratio, 1.31 (1.11-1.55), p < 0.002). The Hosmer-Lemeshow goodness of fit test displayed good fit (X2 = 0.68, p = 0.99). Diagnostic performance was significantly improved after the addition of RV maximal apical FD to the multivariable baseline model, and the continuous net reclassification improvement increased 21% (p = 0.001), and the integrated discrimination index improved 16% (p = 0.045). In patients with ACM, CMR-assessed myocardial trabecular complexity was independently correlated with adverse cardiovascular events and provided incremental prognostic value. The application of FD values for assessing RV myocardial trabeculae may become an accessible and promising parameter in monitoring and early diagnosis of risk factors for adverse cardiovascular events in patients with ACM. • Ventricular trabecular morphology, a novel quantitative marker by CMR, has been explored for the first time to determine the severity of ACM. • Patients with higher maximal apical fractal dimension of RV displayed significantly higher cumulative incidence of major cardiac events. • RV maximal apical FD was independently associated with major cardiac events and provided incremental prognostic value in patients with ACM.

Implantable cardioverter defibrillator and cardiac resynchronization treatment in people with type 2 diabetes: a comparison with age- and sex matched controls from the general population

BackgroundIncreased risk of severe tachyarrhythmias is reported in patients with type 2 diabetes mellitus (T2DM). The aim of this study was to explore if treatment with cardiac implantable electronic device (CIED) such as implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy- pacemaker and -defibrillator (CRT-P/CRT-D) differed in patients with vs. without T2DM. A secondary aim was to identify patient characteristics indicating an increased CIED treatment.Method416 162 adult patients with T2DM from the Swedish National Diabetes Registry and 2 081 087 controls from the Swedish population, matched for age, sex and living area, were included between 1/1/1998 and 31/12/2012 and followed until 31/12/2013. They were compared regarding prevalence of ventricular tachycardia (VT) at baseline and the risk of receiving a CIED during follow-up. Multivariable Cox regression analysis was performed to estimate the risk of CIED-treatment and factors identifying patients with such risk.ResultsVentricular fibrillation (VF) (0.1% vs 0.0004%) and (VT) (0.2% vs. 0.1%) were more frequent among patients with T2DM compared to controls. CIED-treatment was significantly increased in patients with T2DM both in unadjusted and adjusted analyses. HR and 95% CI, after adjustment for sex, age, marital status, income, education, country of birth, coronary artery disease and congestive heart failure, were 1.32 [1.21–1.45] for ICD, 1.74 [1.55–1.95] for CRT-P and 1.69 [1.43–1.99] for CRT-D. Blood-pressure and lipid lowering therapies were independent risk factors associated to receiving CIED, while female sex was protective.ConclusionsAlthough the proportion of VT/VF was low, patients with T2DM had a higher prevalence of these conditions and increased risk for treatment with CIED compared to controls. This underlines the importance of recognizing that T2DM patients have an increased need of CIED.

Prognostic role of data transmitted by implanted cardiac electric devices in patients with advanced heart failure referred for heart transplantation

Abstract Background Patients (pts) with advanced heart failure (HF) are poorly tolerant to GDMT, frequently hospitalized and are often carriers of implantable cardioverter-defibrillators (ICD) or of cardiac resynchronization therapy (CRT-D). These devices allow HF centers to remotely monitor the occurrence of arrhythmic events and of ICD interventions, such as anti-tachycardia pacing (ATP) bursts or DC-shocks. While HF hospitalizations are an established prognostic marker, the role of remote monitoring in a context of pts referred for heart transplantation (HT) is poorly explored. Purpose In this retrospective monocentric study we aim to evaluate the prognostic value of remotely-transmitted information from ICD/CRT in pts with advanced HF followed in a tertiary Center dedicated to HF and HT. Methods We included all adult pts with a remotely transmitting device followed by both Electrophysiology and Heart Failure Teams in our Center between September 2016 and January 2023. We collected data about heart disease, medical therapy, echocardiography, device-delivered therapies, and hospital admissions for any cause. The outcome was the combined incidence of death from any cause or urgent heart transplantation. Results 123 pts were enrolled ( 57±10 yrs, 75% males, LVEF 34%±10%). 68 had an ICD, 55 CRT-D. 50 pts (41%) received at least one device-delivered therapy (34 pts had at least one ATP; 29 pts had at least one DC-shock, of whom 26 were appropriate). During a mean follow-up of 29 months, we recorded 121 hospitalizations (53% for arrhythmias, 47% for acute HF) in 44 pts. The endpoint occurred in 14 pts : 12 (9.8%) died, 2 (1.6%) underwent to urgent HT; overall, 12 pts (9.8%) were transplanted. Pts with arrhythmic events had more frequently a spontaneous QRS &amp;gt;120ms (60% vs. 40%, p=0.04) and a trend towards more hospitalizations for heart failure (64% vs. 35%, p=0.059). The predictor of the combined endpoint of death or urgent transplant was hospitalization for HF (RR: 4.2, p&amp;lt;0.01); ATP and/or DC-shocks (RR 7.3) and intolerance to vasodilators (ACE-I, ARB, ARNI), (RR (1.5) showed a borderline statistical significance (p=0.06 for both). However, in the subgroup of patients without any HF hospitalization, device-delivered therapies from ICDs and CRT-D carried an higher risk of death and urgent HT (p=0.03), see Figure . Conclusion In a population of patients with advanced HF, while confirming the known prognostic role of HF hospitalization, we found that remote monitoring of ICD shocks/ATP in patients not hospitalized for HF identifies a subgroup of patients at high risk of death or urgent HT. These results underscore the importance of considering these patients for advanced HF therapies and of an integrated approach between electrophysiologists and HF specialists.

Abstract 15246: Myocardial Deformation for Prediction of Major Arrhythmic Events in Patients With Non-Ischemic Cardiomyopathy and Primary Prevention Implantable Cardioverter Defibrillators

Introduction: Sudden cardiac death is a major cause of mortality in patients with non-ischemic cardiomyopathy (NICM). Implantable cardioverter-defibrillator (ICD) is an established prophylactic measure. But, optimal identification of patients with greatest likelihood of benefiting poses ongoing challenges. Objective: To assess the prognostic value of myocardial deformation for predicting ICD intervention while accounting for competing mortality risk. Methods: 180 NICM patients eligible for primary prevention ICD underwent cardiac magnetic resonance (CMR). Myocardial strains (left ventricular radial, circumferential, longitudinal; left atrial; and right ventricular free wall longitudinal strain (RV GLS)) were measured via CVI42 feature tracking. In a multivariable Fine-Gray competing risk model, incremental values of strains were assessed, adding to a baseline model based on clinical features and late gadolinium enhancement (LGE). The primary endpoint was ventricular tachycardia/fibrillation treated with ICD intervention, including shocks or anti-tachycardia pacing. Results: 159 patients with ICD (117 male; 54 ± 13 years) were included for final analysis (follow-up: 1176±960 days; median: 896). 26 patients met the primary endpoint. RV GLS showed a statistically significant difference between patients with and without events (-12.5% ± 5 vs -16.4% ± 5.5, p = 0.001). Univariate analyses revealed that LGE and RV GLS were significantly associated with outcome, even after accounting for competing risk (LGE: HR=3.69, 95% CI=1.28-10.62; RV GLS: HR=2.04, 95% CI=1.30-3.22). Adding RV GLS to the baseline model improved its prognostic value, with a c statistic improvement from 0.678 to 0.730. RV GLS hazard ratio remained significant in multivariate analysis after accounting for competing risk (HR=1.73, 95% CI=1.12-2.66) (Table 1). Conclusions: In NICM, RV GLS provides additional predictive value above LGE and clinical features for ICD intervention.

Abstract 18880: Ventricular Arrhythmia Prevalence and Burden in Patients With Third Generation Continuous Flow Left Ventricular Assist Devices

Background: Ventricular arrhythmias (VAs) are common in patients with left ventricular assist devices (LVADs). Little is known about the impact of third-generation LVADs (Heartmate 3, HM3) on VAs prevalence and burden. Aims : To characterize the impact of HM3 LVAD implantation on VAs prevalence and burden in patients with advanced heart failure (HF) and implantable cardioverter-defibrillators (ICDs). Methods: We included consecutive patients with advanced HF and ICDs who received HM3 devices at our center between 2016 and 2022. The study outcomes were the prevalence of sustained VAs, defined as &gt;30s VA episode detected by the ICD monitor zone or appropriately treated (ATP or shock), sustained VA burden (total number of episodes), and VA storm (≥3 appropriate ICD interventions in 24/h period). Data was collected over the 1 year before and after HM3 implantation. Results: A total of 321 patients were included (28% female, mean age 60±12 years, mean INTERMACS score 3±0.95). At 1 year follow-up after HM3 implantation, 27 patients died. A total of 128 patients (43%) had at least one sustained VA episode in the year before the HM3 implantation compared to 51 patients (17%) in the year following the HM3 (p&lt;0.001 for comparison). The sustained VA burden decreased from a mean of 3.8 events per person-year (PPY) to a mean of 0.8 events PPY (p=0.005). Similarly, appropriate ICD therapy occurred in 123 patients (38%) before implantation and 46 patients (14%) after implantation (p&lt;0.001). The burden of appropriate therapy was also reduced (from a mean of 2.57 events PPY to a mean 1.32 events PPY; p=0.03). The prevalence of VA storm was reduced from 19% to 8% (p&lt;0.001). Conclusions: In patients with advanced HF and ICDs undergoing HM3 implantation, the prevalence of sustained VAs, VAs burden, appropriate ICD interventions, and VA storm were all significantly reduced in the year following HM3 implantation.

Abstract 12715: Can 18F-Fluorodeoxyglucose Uptake Stratify the Risk of the Patients With Cardiac Sarcoidosis After Initiation of Immunosuppressive Therapy?

Introduction: While 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) is well-established for diagnosing cardiac sarcoidosis (CS) initially, its potential as a risk stratification tool for patients receiving immunosuppressive therapy remains controversial. Hypothesis: We aim to assess the prognostic value of FDG-PET in CS patients after 12 months of corticosteroid treatment. Methods: Our study consists of a retrospective review of clinical data and patient outcomes of stable CS cases that underwent FDG-PET following 12 months of corticosteroid treatment initiation. We excluded patients in the previous six months who had a heart failure hospitalization, sustained ventricular tachycardia (SVT) or ventricular fibrillation (VF), recent pacemaker implantation or upgrade, changes in corticosteroid dosage, or newly introduced additional immunosuppressive therapy. Major adverse cardiac events (MACE) include a composite of cardiac death, onset of SVT/VF, appropriate implantable cardioverter-defibrillator intervention, heart failure hospitalization, and cardiac functional deterioration. Results: Among the 72 analyzed patients, 35 exhibited cardiac accumulation in FDG-PET scans. Over an average of 49 (22-76) months, 19 patients experienced MACE. The occurrence of MACE was higher in the reduced left ventricle ejection fraction (LVEF) group (&lt;50%) than in the preserved LVEF group (≥50%) (51.5% vs. 5.1%, Log rank p &lt;0.001). Similarly, MACE was more common in the SVT/VF (+) group as compared to the SVT/VF (-) group (50.0% vs. 23.4%, Log rank p =0.041). However, the presence of cardiac accumulation in FDG-PET showed no significant correlation (Log rank p =0.718). Conclusions: The presence of residual cardiac accumulation after initiation of immunosuppressive therapy was not associated with the prognosis of the patients with CS. Established predictors, such as reduced LVEF and the occurrence of SVT/VF, remain integral in predicting MACE.

Implantable-cardioverter-defibrillator after ST-elevation myocardial infarction: when and how frequently is it implanted and what is the rate of appropriate interventions? Insight from Trieste registry.

There are limited data on implantable-cardioverter-defibrillator (ICD) implantation after ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI). Therefore, we evaluated when and how frequently an ICD is implanted after pPCI, the rate of appropriate ICD interventions, and predictors of ICD implantation. We analyzed STEMI patients treated with pPCI at the University Hospital of Trieste, Italy, between January 2010 and December 2019. We cross-matched patients' data with those present in the Trieste ICD registry. Among 1805 consecutive patients treated with pPCI, 3.6% underwent ICD implantation during a median follow-up of 6.7 [interquartile range (IQR) 4.3-9.2] years. At 12 months, the mean number of ICD implantations was 2.3/100 patients [95% confidence interval (95% CI) 1.7-3.1] and remained stable over time (at 24 months: 2.5/100 patients, 95% CI 2.0-3.5 and at 36 months: 2.6/100 patients, 95% CI 2.3-3.8); 83.1% of ICDs were implanted for primary prevention, and more than half (55%) were implanted in patients with ejection fraction more than 35% at the moment of STEMI discharge. The rate of appropriate ICD interventions was 16.9% at a median follow-up of 5.7 years (IQR 3.3-8.3 years) after ICD implantation. At 12 months, the mean number of appropriate ICD interventions was 5/100 patients and 7/100 patients after 24 months. In patients with ejection fraction more than 35% at STEMI discharge (median ejection fraction 43%; IQR 40-48), independent predictors of ICD implantation were male sex, anterior STEMI and troponin peak more than 100 000 ng/dl. The rate of ICD implantations after pPCI is low; however, the rate of appropriate ICD interventions is high. A relevant subgroup of patients received ICD implantations at follow-up despite a nonsevere ejection fraction at discharge after STEMI. Among these patients, those with high troponin release deserve strict follow-up and full optimal medical treatment.

High-risk imaging characteristics in left ventricular apex for the life-threatening arrhythmic events in Japanese hypertrophic cardiomyopathy patients.

Left ventricular (LV) apical aneurysm is known to be associated with the life-threatening arrhythmic events in hypertrophic cardiomyopathy (HCM). However, the current 2014 ESC guideline has not included apical aneurysm as a major risk factor for sudden cardiac death and 2018 JCS guideline includes it only as a modulator, while it has been included as a new major risk marker in 2020 AHA/ACC guideline. Therefore, we sought to identify high-risk imaging characteristics in LV apex which is associated with a higher occurrence of ventricular tachycardia/fibrillation (VT/VF). In 99 consecutive Japanese HCM patients (median age, 65years; 59 males) undergoing implantable cardioverter-defibrillator (ICD) implantation for primary prevention following cardiac magnetic resonance including late gadolinium enhancement (LGE), the occurrence of appropriate ICD interventions for VT/VF was evaluated for 6.2 (median) years after ICD implantation. Overall, appropriate ICD interventions occurred in 43% with annual rates of 7.0% for appropriate interventions. Kaplan-Meier analysis demonstrated that the presence of LV apical aneurysm was significantly associated with a higher occurrence of appropriate interventions (annual rates 18.9% vs. 6.4%, P = 0.013). Similarly, patients with high LV mid-to-apex pressure gradient (annual rates 14.9% vs. 6.2%, P = 0.022) and presence of apical LGE (annual rates 10.9% vs. 4.0%, P = 0.001) experienced appropriate interventions more frequently. An aneurysm, high-pressure gradient, and LGE in an apex are associated with VT/VF. These characteristics in apex should be kept in mind when implanting ICD in Japanese HCM patients as a primary prevention.

Clinical course of hypertrophic cardiomyopathy patients implanted with a transvenous or subcutaneous defibrillator.

The implantable cardioverter-defibrillator (ICD) is a life-saving therapy in patients with hypertrophic cardiomyopathy (HCM) at risk of sudden cardiac death. Implantable cardioverter-defibrillator complications are of concern. The subcutaneous ICD (S-ICD) does not use transvenous leads and is expected to reduce complications. However, it does not provide bradycardia and anti-tachycardia pacing (ATP). The aim of this study was to compare appropriate and inappropriate ICD interventions, complications, disease-related adverse events and mortality between HCM patients implanted with a S- or transvenous (TV)-ICD. Consecutive HCM patients implanted with a S- (n = 216) or TV-ICD (n = 211) were enrolled. Propensity-adjusted cumulative Kaplan-Meier curves and multivariate Cox proportional hazard ratios were used to compare 5-year event-free survival and the risk of events. The S-ICD patients had lower 5-year risk of appropriate (HR: 0.32; 95%CI: 0.15-0.65; P = 0.002) and inappropriate (HR: 0.44; 95%CI: 0.20-0.95; P = 0.038) ICD interventions, driven by a high incidence of ATP therapy in the TV-ICD group. The S- and TV-ICD patients experienced similar 5-year rate of device-related complications, albeit the risk of major lead-related complications was lower in S-ICD patients (HR: 0.17; 95%CI: 0.038-0.79; P = 0.023). The TV- and S-ICD patients displayed similar risk of disease-related complications (HR: 0.64; 95%CI: 0.27-1.52; P = 0.309) and mortality (HR: 0.74; 95%CI: 0.29-1.87; P = 0.521). Hypertrophic cardiomyopathy patients implanted with a S-ICD had lower 5-year risk of appropriate and inappropriate ICD therapies as well as of major lead-related complications as compared to those implanted with a TV-ICD. Long-term comparative follow-up studies will clarify whether the lower incidence of major lead-related complications will translate into a morbidity or survival benefit.

The phospholamban (PLN) p.Arg14del risk model; Longitudinal validation and reevaluation of predictors regarding sudden cardiac death (SCD)

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): PSIDER (ZOn-MW) PREDICT2 (Hartstichting) Background The PLN p.Arg14del risk model is a mutation-specific risk model developed to predict individual malignant ventricular arrhythmia (VA) risk to inform decision-making for primary prevention implantable cardioverter defibrillator (ICD) implantation. While the risk model has proven to be valid, two main points of criticisms remain to be discussed: first, the risk model is only validated at baseline and second, appropriate ICD therapy and sustained ventricular tachycardia (VT) &amp;lt;250 bpm is an imperfect surrogate outcome for SCD. Purpose To evaluate the diagnostic performance of the PLN p.Arg14del risk model longitudinal at 3 year follow-up and to reevaluate the predictors regarding SCD. Methods Clinical data of 278 PLN p.Arg14del mutation carriers with no history of malignant VA at both baseline and 3 year follow-up were collected. During a median follow-up of 4 years (Interquartile range (IQR) 1.8-6.5), 31 (11%) carriers experienced malignant VA, defined as sustained VA, appropriate ICD intervention, or (aborted) SCD. The reevaluation of the predictors with the 3 year follow up data revealed hazard ratio’s (HR) that were similar to the baseline PLN p.Arg14del risk model for left ventricular ejection fraction (HR 1.10 [95% CI, 1.06-1.12], p&amp;lt;0.001), low-voltage ECG (HR 12.24 [95% CI, 5.21-28.8], p&amp;lt;0.001) and the PVC count per 24h (HR 1.51 [1.15-1.98], p=0.003). The 5-year malignant VA risk was divided into tertiles of predicted risk. The tertiles clearly demonstrated good discrimination between risk group as shown in figure 1 and this resulted in an C-statistic of 0.85 (95% CI 0.78-0.92). To reevaluate the predictive performance of the PLN p.Arg14del risk model for a more strict surrogate of SCD we redefined the outcome as VT &amp;gt;250 beats per minute sustained (lasting ≥30 seconds) or terminated by ICD, ventricular fibrillation, aborted SCD and SCD. We included 669 PLN p.Arg14del carriers with no presentation or history of sustained VA or (aborted) SCD. During a median follow-up of 4.75 years (IQR 1.9-7.9), 33 (5%) carriers experienced the outcome. Results of the univariable analysis are shown in table 1. The PLN p.Arg14del risk model yielded a C-statistic of 0.75 (95% CI 0.70-0.80). Adding risk factors sex, age and sustained VT &amp;lt;250 bpm did not change its performance. Conclusion The PLN p.Arg14del risk model was validated longitudinal at 3 year follow-up and it held its performance with a more strict definition of SCD.

PM and ICD trends during COVID-19 pandemic in Italy. A global analysis of the national hospital discharge database

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Italian Minister of Health. Background At the beginning of the COVID-19 emergency, important restrictions in hospital admissions for non-urgent procedures, to reduce the spread of the epidemic and to direct resources for the management of patients affected by the SARS-COV2 virus were required. Furthermore, in the same period there was a significant reduction of admissions for cardiological emergencies, too. The nationwide impact of COVID-19 pandemic on invasive procedures, such Pacemakers (PM) and Implantable Cardioverter-Defibrillators (ICD) interventions, is unknown. Purpose To evaluate the trend of PM and ICD procedures performed in Italy in the last 10 years and particularly in the pandemic period. Methods All the Italian Hospital Discharge Records (Schede di Dimissione Ospedaliera – SDO) from 2012 to 2021, sent by the Italian Ministry of Health to the National Institute of Health (NIH, Istituto Superiore di Sanità-ISS) were reviewed. Among these, only records including ICD or PM procedures, either primary or secondary, and correctly reporting patient’s age and gender, were selected. The ICD9-CM codes, single and combined, relating to PM and ICD procedures were selected a taxonomy arranged into 16 groups of procedures was defined. PM procedures were also divided in 1°implant and replacement, while ICD could be considered as total procedures only. Results From 2012 to 2019 the yearly number of total PM procedures was quite stable, ranging from 63.498 (1.069/million inhabitants) to 68.807 (1.150/million). In 2020, a reduction of total procedures (38.411, 1078/million, -11% towards 2019) and 1st implant of PM (from 52.216 to 43.962, -16%), but not PM replacement, (from 16.591 to 17.331, +4%) was observed; at beginning of pandemic period (April 2020), the drop in total PM procedures in comparison to the 2018 and 2019 average value was 49%. In 2021, an increase to values exceeding the pre-pandemic numbers, was observed (total procedures 69.330, 1170/million, 49.555 1° implants, 19.775 replacements). For ICD, a slow increase of the procedure rate was observed from 2012 (20.774, 350/million) to 2017, 24.255, 400/million); afterwards, a small reduction of implants was observed in 2018 (22.616, 378/million) and 2020 (22.355, 375/million). The drop in ICD procedures observed in April 2020, compared to the 2018 and 2019 average value, was 46%. In 2021 the rate of ICD procedures (25.384, 429/million) increased more than to the pre-pandemic values. No significant changes in PM and ICD indications were observed during the study interval. Conclusions During the first year of COVID-19 pandemic, a reduction of PM and ICD procedures was observed, especially in the first period (April 2020); for PM, no reduction of replacements was observed in 2020, while the reduction of 1° PM implant and ICD procedures was compensated by an increase of activity in 2021.

PO-05-203 RISK OF APPROPRIATE ICD THERAPY IN PATIENTS WITH IMPROVED EF>35% AFTER INITIAL PRIMARY PREVENTION IMPLANT

Implantable cardioverter defibrillator (ICD) replacement in patients with heart failure with improved ejection fraction (HFimpEF, EF>35%) at the time of generator change is controversial. Assess the risk of appropriate ICD intervention (aICDi, anti-tachycardia pacing or shocks) in patients with HFimpEF >35%. Databases were searched for studies reporting patients who received ICD for primary prevention and HFimpEF, and aICDi including Ovid MEDLINE, EMBASE, Web of Science, and Google Scholar. The search was not restricted to time or publication status. The minimal follow up duration was one year. HFimpEF was defined as left ventricular reversed remodeling (LVRR, see Figures) with EF >35%. A total of 25 studies and 6,452 patients (3,061 with improved EF vs 3,391 with EF <35% during follow up) were included; mean follow up was 43 months (ranging between 12 to 74 months). Mean age was 63.5 and 75% were males. HFimpEF was associated with a lower risk of aICDi (OR 0.43, 95% CI 0.3-0.61; P<0.01; annual rate 5.1 vs. 10.3%). Subgroup analysis in HFimpEF patients who had not received aICDi before generator change showed a lower subsequent risk of VA and SCD (OR 0.26, 95% CI 0.12-0.59; P<0.01; annual rate 1.6 vs. 4.8%). Figures (A, B) HFimpEF is associated with reduced risk for aICDi in patients with primary prevention ICDs. HFimpEF patients who had not received aICDi before generator change had even lower subsequent risk, but the 5-year risk of arrhythmia recurrence is still 8%.