Primary Prevention Implantable Cardioverter-defibrillator Research Articles

All-cause mortality and incidence of appropriate therapy from a primary preventive implantable cardioverter defibrillator in patients with non-ischemic dilated cardiomyopathy

Abstract Background The DANISH study published in 2016 indicated limited benefit of primary prevention implantable cardioverter-defibrillator (ICD) in patients with non-ischemic dilated cardiomyopathy (niDCM). We aimed to investigate the long-term outcome and incidence of ICD therapy in patients with niDCM implanted on primary prevention indication during 2014-2022. Methods A total of 116 patients with niDCM were prospectively included for primary prevention ICD implantation between 2014 and 2022 in the multicenter IMPROVE study (clinical trials NCT02286908). All patients were examined with electrocardiogram, echocardiography and blood sampling at inclusion. The primary outcome was all-cause mortality, and the secondary outcome was appropriate ICD therapy. Outcomes were compared in patients included from 2014 to end of 2016 (DCM2014-16, n=49) and from 2017-2022 (DCM2017-22, n=67). Results At inclusion, patients in DCM2017-22 were younger (54 years [interquartile range (IQR) 44-68] vs. 64 years [IQR 55-70], p=0.001), had higher left ventricular ejection fraction (LVEF) (33% [IQR 25-38] vs. 24% [IQR 21-31], p<0.001) and less frequently received cardiac-resynchronization therapy defibrillator (6% vs. 29%, p=0.001) compared to DCM2014-16. Over a median 4.4-year follow-up, the all-cause mortality was 14%, of which 10% occurred in the DCM2017-22 patients (2.6 events/100 person-years), and 18% in the DCM2014-16 patients (4.0 events/100 person-years), p=0.38. There was no difference in appropriate ICD therapy between the two groups (p=0.90). Conclusion Patients receiving primary prevention ICD for niDCM after publication of the DANISH study were younger with higher LVEF, indicating a change in clinical practice after the publication. Despite this, there was no significant reduction in all-cause mortality or difference in appropriate ICD therapies. Unchanged mortality and event-rates may indicate the correct identification of high-risk patients.

Risk stratification for a primary prevention ICD: Performance of the MADIT-ICD Benefit Score in contemporary real world patients

Abstract Background We have recently developed the MADIT-ICD Benefit Score to improve risk stratification for primary implantable cardioverter defibrillator (ICD) implantation by assessing the competing risk of life-threatening ventricular tachyarrhythmia (VTA) vs. non-arrhythmic mortality based using simple clinical variables. Patients with a MADIT-ICD Benefit Score of < 50 are more likely to experience non-arrhythmic mortality than life-threatening VTA, and therefore derive limited benefit from a prophylactic ICD. Purpose We aimed to provide data on the performance of the MADIT-ICD Benefit Score in a real world population, comprising patients with HFrEF and either ischemic or nonischemic cardiomyopathy (ICM/NICM) who are treated with contemporary guideline-directed medical therapy (GDMT). Methods The study population comprised 2875 patients who were implanted with a primary prevention ICD and prospectively followed in a large tertiary healthcare system (the University of Rochester Medical Center, including 3 affiliated hospitals in Upstate New York) between 2017 through 2023. Arrhythmic events were captured from device interrogation data, which were blindly adjudicated by 2 electrophysiologists. Results Among the 2875 study patients, mean age was 62 ± 15 years, 1265 (44%) were women, and 1667 (58%) had ICM. Guideline-directed medical therapies, including angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, angiotensin receptor/neprilysin inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and sodium-glucose transport protein 2 (SGLT2) inhibitors, were prescribed to 43%, 36%, 96%, 67% and 32% of study patients, respectively. The 2-year cumulative incidence of VTA, after accounting for the competing risk of death, was 19% vs. 11% in patients with a Score of ≥50 vs. <50, respectively (p<0.001; Figure 1A). Findings regarding ICD shocks were consistent (8% vs. 4%, respectively, p<0.001; Figure 1B) The rate of VTA events at 4 years was directly correlated with increasing quartiles of the MADIT-ICD Benefit Score, while the corresponding rates of non-arrhythmic mortality were inversely correlated with score quartiles (Figure 1C). A similar direct correlation with increasing Benefit Score quartiles was observed when the endpoint of ICD shocks was assessed (Figure 1D). Accordingly, the benefit of the ICD (calculated as the difference between predicted rates of VTA/shock events and corresponding rates of non-arrhythmic mortality) was attenuated with decreasing quartiles of the MADIT-ICD Benefit Score (Figures 1C and 1D; right column). Conclusions We show good performance of the MADIT-ICD Benefit Score in a large cohort of real world ICD recipients who are treated with contemporary GDMT. These data support the use of the MADIT-ICD Benefit Score for improved risk stratification and for shared decision-making in contemporary candidates for a primary prevention ICD.

Assessment of Antitachycardia Pacing in Primary Prevention Patients

The emergence of novel programming guidelines that reduce premature and inappropriate therapies along with the availability of new implantable cardioverter-defibrillator (ICD) technologies lacking traditional endocardial antitachycardia pacing (ATP) capabilities requires the reevaluation of ATP as a first strategy in terminating fast ventricular tachycardias (VTs) in primary prevention ICD recipients. To assess the role of ATP in terminating fast VTs in primary prevention ICD recipients with contemporary programming. This global, prospective, double-blind, randomized clinical trial had an equivalence design with a relative margin of 35%. Superiority tests were performed at interim analyses and the final analysis if equivalence was not proven. Patients were enrolled between September 2016 and April 2021 at 134 sites in 8 countries, with the last date of follow-up on July 6, 2023. Patients were required to have an indication for a primary prevention ICD, including left ventricular ejection fraction less than or equal to 35%. Patients were randomized in a 1:1 ratio to receive ATP plus shock vs shock only. The primary end point was time to first all-cause shock. Secondary end points included time to first appropriate shock, time to first inappropriate shock, all-cause mortality, and the composite of time to first all-cause shock plus all-cause mortality. A total of 2595 patients were randomized (mean age, 63.9 years; 22.4% were females). At a mean follow-up of 38 months, first all-cause shock occurred in 129 participants in the ATP plus shock group and 178 participants in the shock only group. The hazard ratio (HR) for the primary end point was 0.72 (95.9% CI, 0.57-0.92), with P = .005 for superiority of the ATP plus shock group over the shock only group. During follow-up in an intention-to-treat analysis, the total shock burden per 100 patient-years was not statistically different, at 12.3 and 14.9, respectively (P = .70). The use of a single burst of ATP prior to shock in primary prevention ICD recipients with modern ICD detection programming prolonged the time to first all-cause ICD shock. ClinicalTrials.gov Identifier: NCT02923726.

Motor vehicle crash risk after cardioverter-defibrillator implantation: a population-based cohort study

BackgroundLimited empirical evidence informs driving restrictions after implantable cardioverter-defibrillator (ICD) implantation. We sought to evaluate real-world motor vehicle crash risks after ICD implantation.MethodsWe performed a retrospective cohort study using 22...

Incidence and risk factors for first and recurrent ICD shock therapy in patients with an implantable cardioverter defibrillator.

Advances in medical treatment and outcomes in implantable cardioverter-defibrillator (ICD) recipients incentivize a need for improved candidate selection and identification of risk factors for ICD therapy. We examined contemporary rates of and risk factors for ICD therapy. Patients with ICD for primary (PP) or secondary prevention (SP), implanted between January 2010 and December 2020, were followed for appropriate and inappropriate incident and recurrent shock. Overall, 2998 patients (mean age 61.8 ± 12.7years, 20% female, 73% ICD carriers, and 47.1% SP) were analyzed with a median follow-up of 4.3 (interquartile range (IQR) 2.1-7.4) years. A total of 426/2998 (14.2%) patients had shock; 364/2998 (12.1%) had appropriate and 82/2998 (2.7%) inappropriate shock, with annualized event rates of 2.34 (2.11-2.59) and 0.49 (0.39-0.61) per 100 person-years, respectively. Of those with shock, 133/364 (36.5%) experienced recurrent appropriate shock and 8/364 (2.2%) received recurrent inappropriate shock, with event rates of 10.57 (8.85-12.53) and 0.46 (0.20-0.92), respectively. In multivariable analyses, female sex was associated with a reduced risk of incident appropriate shock (hazard ratio 0.69 [95% confidence interval 0.52; 0.91]). Of other variables, only revascularization status was associated with recurrent appropriate shock in PP, and CRT-D with recurrent appropriate shock in the overall cohort. One in eight ICD recipients received appropriate shock 2-7years after guideline-directed implantation. More than one-third of patients with a first shock experienced recurrent shock. Few clinical variables showed potential in predicting shocks, illustrating a need for more advanced tools to select candidates for implantation.

Arrhythmic prognosis according to left ventricular systolic dysfunction severity in cardiac sarcoidosis

BackgroundCurrent guidelines present varying classes of recommendations for implantable cardioverter-defibrillator (ICD) utilization in patients with cardiac sarcoidosis (CS) and left ventricular ejection fraction (LVEF) <50%. ObjectiveThe purpose of this study was to investigate the ventricular arrhythmia risk in CS patients with ICDs and varying degrees of left ventricular systolic dysfunction. MethodsThe study included CS patients with an ICD and LVEF <50% at index evaluation. The primary outcome was survival free of sustained ventricular tachycardia (VT)/ventricular fibrillation (VF) after ICD implantation and was assessed comparatively for LVEF ≤35% vs 36%–49% and for primary vs secondary prevention ICD indication. ResultsThe study included 61 patients (median age 57 years; 61% male) with LVEF 36%–49% (n = 23) or LVEF ≤35% (n = 38). An ICD was implanted for secondary prevention in 24% and 44% of the LVEF ≤35% and 36%–49% groups, respectively (P = .11). The primary outcome did not differ between the 2 groups in univariable analysis (LVEF ≤35% vs 36%–49%: hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.39–1.82; P = .67). In multivariable analysis, secondary prevention ICD indication was the only significant predictor of incident sustained VT/VF (HR 2.86; 95% CI 1.23–6.67; P = .015). Mean sustained VT/VF event burden was higher in the secondary compared with the primary prevention ICD patients (0.47 vs 0.11 events per patient-year; P = .005) but did not differ significantly between LVEF ≤35% and 36%–49% patients. ConclusionCS patients with ICD indications and LVEF 36%–49% carry similarly high arrhythmic risk as those with LVEF ≤35%. Patients with secondary prevention ICDs have the highest overall risk.

Wearable defibrillator to improve accuracy in selecting candidates to implantable defibrillator: A real-world experience.

The indication for implantable cardioverter defibrillator (ICD) for sudden cardiac death (SCD) prevention relies mostly on left ventricular ejection fraction (LVEF)≤35%. The use of a wearable cardioverter defibrillator (WCD) in the case of dynamic alterations of LVEF may help avoid an improper early ICD implant when a favourable evolution in the post-acute phase is observed and may help reduce costs. This parallel cohort retrospective study included patients with heart failure with reduced ejection fraction (HFrEF) at high risk of arrhythmias recruited in the acute phase and divided into an early ICD cohort and a WCD cohort for primary prevention during the waiting period established by European Society of Cardiology guidelines. A total of 41 consecutive patients were enrolled: 26 in the WCD group and 15 in the early ICD group. Age, LVEF at baseline, causes of HFrEF and drug therapy in the two cohorts were similar. During the waiting period after the inclusion, three patients (11.5%) in the WCD cohort and four (26.7%) in the early ICD cohort developed relevant ventricular arrhythmias (P=0.22); none of them had subsequent LVEF recovery. At the end of the waiting period, 13 patients (50%) in the WCD group and 7 (46.7%) in the early ICD group experienced LVEF recovery (P=0.84). The average cost per patient at the end of the waiting period was €23934 in the early ICD cohort versus €19167 in the WCD cohort (-19.9%). This cost savings from WCD use appears even higher when projected over a 10year period (-41.2%). WCD may represent a cost-effective strategy to more accurately select candidates for the primary prevention ICD implant among high-risk patients with HFrEF. ICD use provides effective protection from SCD and reduces costs compared with an extensive early ICD implant.

Rate of Appropriate and Inappropriate Therapy in Patients with Non-Ischaemic Cardiomyopathy—A Comparison Between Primary and Secondary Prevention Implantable Cardioverter-Defibrillator Patients

Rate of Appropriate and Inappropriate Therapy in Patients with Non-Ischaemic Cardiomyopathy—A Comparison Between Primary and Secondary Prevention Implantable Cardioverter-Defibrillator Patients

A novel tool for arrhythmic risk stratification in desmoplakin gene variant carriers.

Pathogenic desmoplakin (DSP) gene variants are associated with the development of a distinct form of arrhythmogenic cardiomyopathy known as DSP cardiomyopathy. Patients harbouring these variants are at high risk for sustained ventricular arrhythmia (VA), but existing tools for individualized arrhythmic risk assessment have proven unreliable in this population. Patients from the multi-national DSP-ERADOS (Desmoplakin SPecific Effort for a RAre Disease Outcome Study) Network patient registry who had pathogenic or likely pathogenic DSP variants and no sustained VA prior to enrolment were followed longitudinally for the development of first sustained VA event. Clinically guided, step-wise Cox regression analysis was used to develop a novel clinical tool predicting the development of incident VA. Model performance was assessed by c-statistic in both the model development cohort (n = 385) and in an external validation cohort (n = 86). In total, 471 DSP patients [mean age 37.8 years, 65.6% women, 38.6% probands, 26% with left ventricular ejection fraction (LVEF) < 50%] were followed for a median of 4.0 (interquartile range: 1.6-7.3) years; 71 experienced first sustained VA events {2.6% [95% confidence interval (CI): 2.0, 3.5] events/year}. Within the development cohort, five readily available clinical parameters were identified as independent predictors of VA and included in a novel DSP risk score: female sex [hazard ratio (HR) 1.9 (95% CI: 1.1-3.4)], history of non-sustained ventricular tachycardia [HR 1.7 (95% CI: 1.1-2.8)], natural logarithm of 24-h premature ventricular contraction burden [HR 1.3 (95% CI: 1.1-1.4)], LVEF < 50% [HR 1.5 (95% CI: .95-2.5)], and presence of moderate to severe right ventricular systolic dysfunction [HR 6.0 (95% CI: 2.9-12.5)]. The model demonstrated good risk discrimination within both the development [c-statistic .782 (95% CI: .77-.80)] and external validation [c-statistic .791 (95% CI: .75-.83)] cohorts. The negative predictive value for DSP patients in the external validation cohort deemed to be at low risk for VA (<5% at 5 years; n = 26) was 100%. The DSP risk score is a novel model that leverages readily available clinical parameters to provide individualized VA risk assessment for DSP patients. This tool may help guide decision-making for primary prevention implantable cardioverter-defibrillator placement in this high-risk population and supports a gene-first risk stratification approach.

Ventriculo-arterial (VA) coupling and fQRS as new selection criteria for primary prevention ICD placement

For decades, left ventricular ejection fraction (LVEF < 35%) has been a mainstay for identifying heart failure (HF) patients most likely to benefit from an implantable cardioverter defibrillator (ICD). However, LVEF is a poor predictor of sudden cardiac death (SCD) and ignores 50% of HF patients with mildly reduced and preserved LVEF. The current international guidelines for primary prophylaxis ICD therapy are inadequate. Instead of LVEF, which is not a good measure of LV contractility or hemodynamic characterization, we hypothesize ventriculo-arterial (VA) coupling combined with fragmented QRS (fQRS) will improve risk stratification and patient suitability for an ICD. Quantifying cardiac and aortic mechanics, and predicting active arrhythmogenic substrate, from varying fQRS morphologies, may help to stratify ischemic and non-ischemic patients with different functional capacities and predisposition for lethal arrhythmias. We propose HF patients with a low physiological reserve may not benefit from ICD therapy, whereas those patients with higher reserves and extensive arrhythmogenic substrate may benefit. Our hypothesis combining VA coupling with fQRS changes has the potential to widen HF patient participation (low and high LVEF) and advance personalized medicine for HF patients at high risk of SCD.

Aerobic Exercise Improves Heart Rate Variability After an Implantable Cardioverter Defibrillator (ICD).

Clinicaltrials.gov: NCT00522340.

Assisting Black Patients With Decision-Making for Implantable Cardioverter Defibrillator Therapy: Qualitative Findings From the Videos to Reduce Racial Disparities in ICD Therapy via Innovative Designs (VIVID) Trial.

The VIVID (Videos for Addressing Racial Disparities in Implantable Cardioverter Defibrillator Therapy via Innovative Designs) study was a multicenter, randomized controlled trial aimed at evaluating the effectiveness of a video-based decision support tool in enhancing informed consent for implantable cardioverter defibrillator (ICD) implantation among Black patients who met guideline criteria for primary prevention ICDs. Within the broader VIVID randomized trial, a qualitative investigation was conducted to elucidate the decisional factors among Black individuals considering ICD implantation for the primary prevention of sudden cardiac arrest. Between October 2016 and July 2019, in-depth interviews were conducted at 2 time points from randomization, ≈7 days (time interval for the decision) and at 90 days; the time interval for determining ICD implantation. Interview findings were categorized by randomized groups, those assigned to 1 of the 2 encounter-based video decision support tools or standard care (without video). Interview participants were purposefully selected to ensure diversity across gender, age, educational background, research site, and randomization group; participants were sampled from 14 academic and community-based electrophysiology clinics in the United States. Data analysis employed applied thematic analysis techniques. A diverse sample of Black individuals were interviewed at 1 week (n=59; female, 37.3%) and 90 days (n=48; female, 39.6%). The primary factors influencing the decisions of Black individuals considering a primary prevention ICD implantation were (1) their clinicians' recommendations for ICD implantation; (2) their perception of their cardiac health status; and (3) a desire to prolong their lives for the sake of their families. These findings offer valuable insights that may guide clinicians in their communication with Black patients during shared decision-making encounters related to ICD implantation.

Digoxin and Risk of Ventricular Tachyarrhythmia and Death in ICD Recipients

BackgroundSome studies have shown digoxin use to be associated with adverse outcomes, including increased mortality. There are limited data on whether digoxin use is associated with increased risk of ventricular tachycardia/ventricular fibrillation (VT/VF) in heart failure patients with an implantable cardioverter-defibrillator (ICD). ObjectivesThis study sought to assess whether digoxin use is associated with increased risk of VT/VF in patients with heart failure with reduced ejection fraction with a primary prevention ICD in landmark clinical trials. MethodsThe study cohort consisted of patients with an ICD or cardiac resynchronization therapy-defibrillator who were enrolled in 4 landmark MADIT trials (Multicenter Automatic Defibrillator Implantation Trials). We employed propensity score quintile stratification for treatment with digoxin as well as additional multivariable adjustment to assess the risk of digoxin vs no-digoxin therapy for the endpoints of first and recurrent VT/VF and all-cause mortality. The proportional hazards regression models for arrhythmia-specific endpoints incorporated adjustments for the competing risk of death. ResultsAt baseline, 1,155 of 4,499 patients were on digoxin (26%). After propensity score quintile stratification, patients prescribed digoxin were shown to exhibit a statistically significant 48% increased risk of VT/VF (P < 0.001), 42% increased risk of the composite of VT/VF or death (P < 0.001), and a 37% increased risk of all-cause mortality (P = 0.006). Digoxin use was also associated with increased risk of appropriate ICD shocks (HR: 1.91; P < 0.001) and with increased burden of VT/VF events (HR: 1.46; P = 0.001). ConclusionsOur findings suggests that digoxin use is associated with ventricular tachyarrhythmia and death in heart failure with reduced ejection fraction patients with an ICD.

Seattle proportional risk model in GISSI-HF: Estimated benefit of ICD in patients with EF less than 50%

BackgroundThe Seattle Proportional Risk Model (SPRM) estimates the proportion of sudden cardiac death (SCD) in heart failure (HF) patients, identifying those most likely to benefit from implantable cardioverter-defibrillator (ICD) therapy (those with ≥50% estimated proportion of SCD). The GISSI-HF trial tested fish oil and rosuvastatin in HF patients. We used the SPRM to evaluate its accuracy in this cohort in predicting potential ICD benefit in patients with EF ≤50% and an SPRM-predicted proportion of SCD either ≥50% or <50%. MethodsThe SPRM was estimated in patients with EF ≤50% and in a logistic regression model comparing SCD with non-SCD. ResultsWe evaluated 6,750 patients with EF ≤50%. There were 1,892 all-cause deaths, including 610 SCDs. Fifty percent of EF ≤35% patients and 43% with EF 36% to 50% had an SPRM of ≥50%. The SPRM (OR: 1.92, P < 0.0001) accurately predicted the risk of SCD vs non-SCD with an estimated proportion of SCD of 44% vs the observed proportion of 41% at 1 year.By traditional criteria for ICD implantation (EF ≤35%, NYHA class II or III), 64.5% of GISSI-HF patients would be eligible, with an estimated ICD benefit of 0.81. By SPRM >50%, 47.8% may be eligible, including 30.2% with EF >35%. GISSI-HF participants with EF ≤35% with SPRM ≥50% had an estimated ICD HR of 0.64, comparable to patients with EF 36% to 50% with SPRM ≥50% (HR: 0.65). ConclusionsThe SPRM discriminated SCD vs non-SCD in GISSI-HF, both in patients with EF ≤35% and with EF 36% to 50%. The comparable estimated ICD benefit in patients with EF ≤35% and EF 36% to 50% supports the use of a proportional risk model for shared decision making with patients being considered for primary prevention ICD therapy.

Left ventricular ejection fraction and myocardial fibrosis in survivors of ventricular fibrillation and ventricular tachycardia

Abstract Background Primary prevention implantable cardioverter defibrillator (ICD) therapy is indicated in patients with a LVEF&amp;lt;35%. Increasing evidence suggests that LVEF is a poor predictor or ventricular arrhythmias, such as ventricular tachycardia (VT) or fibrillation (VF). Methods Patients hospitalized for VF (55.4%) or VT with hemodynamic compromise underwent late gadolinium enhancement cardiovascular magnetic resonance (CMR). Patients with congenital heart disease, channelopathies, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy and chemotherapy-induced cardiomyopathy were excluded. Results Among patients (n=111, aged 62.1 ± 14.6 years [mean ± SD]) hospitalized for VF (55.4%) or VT with hemodynamic compromise (44.5%) only 29/111 (43.6%) had a history of cardiac disease. At the index hospitalization, an ischemic cause was identified in 69.3%, a non-ischemic cause in 24.8% and no cause emerged in 5.9%. The LVEF (39.1 ± 17.2%) was ≤35% in 55.4% and &amp;gt;35% in 44.6%. Myocardial fibrosis was present in 85.1% (LVEF≤35%: 91.1%; LVEF&amp;gt;35%: 77.8%; p = 0.0619). Conclusions A large proportion of sustained VT or VF survivors would not have previously met LVEF primary prevention criteria for ICD therapy. In this 'ICD treatment gap', myocardial fibrosis was more prevalent than a LVEF≤35%. Further studies are needed to determine whether myocardial scar rather than LVEF≤35% should be used as an indication for primary prevention ICD therapy.

Sex differences in hospitalization for ventricular arrhythmia after a first myocardial infarction in patients without indication for implantable cardioverter-defibrillator implantation

Abstract Background Ventricular arrhythmias (VAs) represent a serious complication of myocardial infarction (MI). Incidence rate of VAs and sudden cardiac death is commonly reported to be lower in women than in men after MI (1,2). While data regarding SCD and VAs after MI in patients with implantable cardioverter defibrillator (ICD) are well described, data regarding the incidence of readmissions for VA in patients without ICD implantation criteria after a first MI are scarce, as well as the impact of sex on their occurrence. Objective This study aims to investigate the impact of sex on VA occurrences in post-MI patients without ICD implantation criteria. Methods This study was conducted using the French national health data system using electronic codes for procedures (CCAM) and hospitalizations data (PMSI). The study population consisted of patients discharged after a first MI and without criteria for ICD implantation. Results Between January 2014 and January 2015, 137,736 patients were hospitalized in France with a diagnosis of first MI and were followed using CCAM and PMSI codes. Among the 112,465 alive at discharge, 6838 patients were excluded due to criteria for the implantation of an ICD for primary or secondary prevention. Of the remaining 105,629 patients, 1600 (1.51%) were rehospitalized for VA with a median delay of 505 days (IQR 110-1208). Men had almost twice the risk of VA than women after initial discharge for MI (OR 1.88, 95% CI 1.65-2.14; p&amp;lt;0.0001). Among the 72,103 men included, 1240 (1.72%) were rehospitalized for VA with a median delay of 514 days (IQR 107-1212). Factors independently associated with VA in men were previous atrial fibrillation (OR 1.91, 95% CI 1.66 - 2.21, p&amp;lt;0.0001), previous vascular disease (OR 1.28, 95% CI 1.10 - 1.50, p=0.002), absence of coronary angioplasty (OR 1.28, 95% CI 1.10 - 1.50, p=0.002), previous diabetes (OR 1.19, 95% CI 1.04 - 1.36, p=0.012), previous hypertension (OR 1.19, 95% CI 1.05 - 1.34, p=0.007), previous or in-hospital congestive heart failure (OR 1.47, 95% CI 1.03-2.08, p=0.032 and OR 1.65, 95% CI 1.32-2.07, p&amp;lt;0.0001), and age (patients between 60 and 79 yo being at the higher risk of VA compared to &amp;lt;60 and &amp;gt;80yo patients, p=0.002 and &amp;lt;0.0001 respectively). Among the 33,526 women included, 360 (1.07%) were rehospitalized for VA with a median (IQR) delay of 461 days (116-1159) after MI. Factors independently associated with VA were previous atrial fibrillation (OR 1.68, 95% CI 1.30 - 2.18, p&amp;lt;0.0001), previous vascular disease (OR 1.37, 95% CI 1.01 - 1.84, p=0.041), and age (patients between 60 and 79 yo being at the higher risk of VA compared to &amp;gt;80yo patients, p=0.001). Conclusion The risk of readmission for VAs after a first MI is significantly lower in women compared to men, with distinct predictive factors. These findings suggest that sex-specific VA risk stratification and management strategies may be warranted after an initial MI.Sexe influence on post-MI VAs occurence

Plasmatic NT-proBNP is strongly associated with atrial fibrillation in patients without severely reduced left ventricular ejection fraction in an ICD collective

Abstract Background and objectives Atrial fibrillation is common in patients with chronic heart failure and associated with poor outcome in these patients. Plasmatic NT-proBNP represents the gold standard biomarker for chronic heart failure. Further, a recent analysis showed a strong association of plasmatic NT-proBNP and atrial fibrillation (AFib). Aim of the study was to assess the association of plasmatic NT-proBNP depending on left ventricular ejection fraction (LVEF) in a cohort of patients with implantable cardioverter defibrillator (ICD). Methods 412 patients were included in the study. Blood samples were used to assess plasmatic NT-proBNP. Follow-up was performed after 45 months. LVEF was estimated by echocardiography according to Simpsons’ method. At enrollment, a 12-lead electrocardiogram was performed (sinus rhythm (SR, n = 306), atrial fibrillation (AFib, n = 79)). Patients were divided into two subgroups by LVEF of 40%. Results Patients suffering from severely reduced LVEF ≤ 40% showed significant higher age, higher rates of chronic kidney disease, diabetes, coronary artery disease, primary prevention ICD indication, coronary artery disease, dilatative cardiomyopathy and plasmatic NT-proBNP compared to patients with LVEF &amp;gt; 40% (each p &amp;lt; 0.05). There were no differences regarding hypertension and occurrence of AFib between patients with LVEF ≤ 40% compared to patients with LVEF &amp;lt; 40% (each p = n.s.). In ROC analysis there was a significantly higher AUC in patients with LVEF &amp;gt; 40% (AUC: 0.87, IQR 0.82-0.92) compared to patients with severely reduced LVEF ≤ 40% (AUC: 0.72, IQR 0.64-0.80) regarding plasmatic NT-proBNP and prediction of AFib (p &amp;lt; 0.002). In patients with LVEF &amp;gt; 40% plasmatic NT-proBNP was shown as significant predictor regarding existence of atrial fibrillation in binary logistic regression analysis, beside age (p &amp;lt; 0.05). Diabetes, hypertension, serum creatinine, coronary artery disease and primary prevention ICD indication were no significant predictors (p = n.s.). In patients with LVEF ≤ 40% plasmatic NT-proBNP was not shown as significant predictor regarding existence of atrial fibrillation in binary logistic regression analysis. Conclusion Elevated levels of plasmatic NT-proBNP are strongly associated with the prevalence of atrial fibrillation in patients without severely reduced LVEF in a cohort of ICD patients.

Plasmatic NT-proBNP is strongly associated with atrial fibrillation in patients with Implantable cardioverter defibrillator

Abstract Background and objectives Atrial fibrillation is common in patients with chronic heart failure and associated with poor outcome in these patients. Plasmatic NT-proBNP represents the gold standard biomarker for chronic heart failure. Further, recent studies showed prognostic impact of urinary NT-proBNP. Aim of the study was to assess the association of plasmatic as well as urinary NT-proBNP and atrial fibrillation in a cohort of patients with implantable cardioverter defibrillator (ICD). Methods 412 patients were included in the study. Fresh spot urine and blood samples were used to assess urinary as well as plasmatic NT-proBNP. Urinary NT-proBNP was normalized to urinary creatinine. Follow-up was performed after 45 months. Heart rhythm history was evaluated and a 12-lead electrocardiogram was performed at enrollment (sinus rhythm (SR, n = 306), atrial fibrillation (AFib, n = 79)). Results Patients suffering from atrial fibrillation showed significant higher age, reduced left ventricular ejection fraction (LVEF), higher rates of chronic kidney disease, hypertension and urinary as well as plasmatic NT-proBNP compared to patients with sinus rhythm (each p &amp;lt; 0.05). There were no differences regarding Diabetes, primary prevention ICD indication, coronary artery disease and dilatative cardiomyopathy (each p = n.s.). In ROC analysis, plasmatic NT-proBNP showed promising predictive values regarding AFib (AUC: 0.80, IQR 0.76-0.85, p &amp;lt; 0.001) as well as urinary NT-proBNP (AUC: 0.76, IQR 0.71-0.81, p &amp;lt; 0.001). There was no significant difference between plasmatic and urinary NT-proBNP according to ROC analysis (p = n.s.). Plasmatic NT-proBNP was shown as a significant predictor regarding existence of atrial fibrillation in binary logistic regression analysis, beside age (p &amp;lt; 0.05). Diabetes, hypertension, serum creatinine, LVEF, coronary artery disease and primary prevention ICD indication were no significant predictors (p = n.s.). Urinary NT-proBNP was not shown as a significant predictor regarding existence of atrial fibrillation in binary logistic regression analysis (p = n.s.). Conclusion Elevated levels of plasmatic NT-proBNP are strongly associated with the prevalence of atrial fibrillation in a cohort of ICD patients.

Safety, efficacy, and reliability evaluation ofa novel small-diameter defibrillation lead: Global LEADR pivotal trial results

BackgroundImplantable cardioverter-defibrillators last longer, and interest in reliable leads with targeted lead placement is growing. The OmniaSecure defibrillation lead is a novel, small-diameter, catheter-delivered lead designed for targeted placement, based on the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform. ObjectiveThis trial assessed safety and efficacy of the OmniaSecure defibrillation lead. MethodsThe worldwide LEADR pivotal clinical trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator, all of whom received the study lead. The primary efficacy end point was successful defibrillation at implantation per protocol. The primary safety end point was freedom from study lead–related major complications at 6 months. The primary efficacy and safety objectives were met if the lower bound of the 2-sided 95% credible interval was >88% and >90%, respectively. ResultsIn total, 643 patients successfully received the study lead, and 505 patients have completed 12-month follow-up. The lead was placed in the desired right ventricular location in 99.5% of patients. Defibrillation testing at implantation was completed in 119 patients, with success in 97.5%. The Kaplan-Meier estimated freedom from study lead–related major complications was 97.1% at 6 and 12 months. The trial exceeded the primary efficacy and safety objective thresholds. There were zero study lead fractures and electrical performance was stable throughout the mean follow-up of 12.7 ± 4.8 months (mean ± SD). ConclusionThe OmniaSecure lead exceeded prespecified primary end point performance goals for safety and efficacy, demonstrating high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures.

New York Heart Association functional class and implantable cardioverter-defibrillator in non-ischaemic heart failure with reduced ejection fraction: Extended follow-up of the DANISH trial.

Current guidelines recommend implantable cardioverter-defibrillator (ICD) therapy in patients with heart failure, a left ventricular ejection fraction of ≤35%, and New York Heart Association (NYHA) class II-III. However, the evidence regarding the benefit of primary prevention ICD is less consistent in patients with NYHA class III. We investigated the long-term effects of primary prevention ICD implantation according to NYHA class in an extended follow-up study of the DANISH trial. The DANISH trial randomized 1116 patients with non-ischaemic heart failure with reduced ejection fraction (HFrEF) to ICD implantation or usual care. Outcomes were analysed according to NYHA class at baseline (NYHA class II and III/IV). The primary outcome was all-cause mortality. Of the 1116 patients randomized in the DANISH trial, 597 (53.5%) were in NYHA class II at baseline, 505 (45.3%) in NYHA class III, and 14 (1.3%) in NYHA class IV. During a median follow-up of 9.5 years, NYHA class III/IV, compared with NYHA class II, were associated with a greater long-term rate of all-cause mortality (hazard ratio [HR] 1.52, 95% confidence interval [CI] 1.20-1.93) and cardiovascular death (HR 1.95 [1.47-2.60]). ICD implantation, compared with usual care, did not reduce the long-term rate of all-cause mortality (all participants: HR 0.89 [95% CI 0.74-1.08]; NYHA class II: HR 0.85 [0.64-1.13]; NYHA class III/IV: HR 0.89 [0.69-1.14]; pinteraction = 0.78) or cardiovascular death (all participants: HR 0.87 [95% CI 0.70-1.09]; NYHA class II: HR 0.78 [0.54-1.12]; NYHA class III/IV: HR 0.89 [0.67-1.19]; pinteraction = 0.58), irrespective of NYHA class. Similarly, NYHA class did not modify the beneficial effects of ICD implantation on sudden cardiovascular death (all participants: HR 0.60 [95% CI 0.40-0.92]; NYHA class II: HR 0.73 [0.40-1.36]; NYHA class III/IV: HR 0.52 [0.29-0.94]; pinteraction = 0.39). In patients with non-ischaemic HFrEF, ICD implantation, compared with usual care, did not reduce the overall mortality rate, but it did reduce sudden cardiovascular death, regardless of baseline NYHA class. ClinicalTrials.gov NCT00542945.