Implantable Cardioverter Defibrillator Indication Research Articles

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.

A comparison of symptoms of anxiety and depression in patients with a primary and secondary prophylactic indication for an implantable cardioverter defibrillator. [Data from the ACQUIRE-ICD RCT

Abstract Introduction Indication for the implantable cardioverter defibrillator (ICD) is either primary or secondary prophylactic. Symptoms of anxiety and depression are known to be evident in patients with an ICD. However, research has not shown agreement in whether there is a difference in the degree of symptoms in these two indication groups. Purpose We investigated the association between anxiety and depression and indication for ICD from implantation and up to 24 months of follow-up. Methods Data was derived from a national randomized controlled trial the "Web-based healthcare innovation to advance the quality of life and care of patients with an implantable cardioverter defibrillator [ACQUIRE-ICD]" to perform a secondary analysis. A total of 478 patients with a first-time ICD were included and completed the Generalized Anxiety Disorder Assessment (GAD-7) and the Patient Health Questionnaire (PHQ-9) after ICD implantation and at 6, 12 and 24 months. Mixed effects regression models and estimated marginal means were used to analyze longitudinal data. Results Anxiety mean scores did not differ statistically between patients with a primary prophylactic ICD as compared to patients with a secondary prophylactic ICD. Most patients showed limited symptoms of anxiety. However, 9% reported values above the cut-off for clinical relevant anxiety. Depression mean scores were significantly higher at 24 months in patients with primary prophylactic ICD as compared to patients with a secondary prophylactic ICD (mean 4.15 vs. 3.05; p=0.014) but not statistically significant at other time points. Most patients showed limited levels of depression. However, 13.2% reported values above the cut-off for clinical relevant depression. Both anxiety and depression scores decreased over time from baseline in both groups. Conclusion Patients with a primary prophylactic ICD did not differ in symptoms of anxiety and had mostly the same level of depression as compared to patients with a secondary prophylactic ICD. However, at 24 months patients with a primary prophylactic ICD reported more symptoms of depression as compared to patients with a secondary prophylactic ICD.Table 1

Depression and Implantable Cardioverter-Defibrillator Implantation in Black Patients at Risk for Sudden Cardiac Death.

Black patients meeting indications for implantable cardioverter-defibrillators (ICDs) have lower rates of implantation compared with White patients. There is little understanding of how mental health impacts the decision-making process among Black patients considering ICDs. Our objective was to assess the association between depressive symptoms and ICD implantation among Black patients with heart failure. This is a secondary analysis of the VIVID (Videos to Address Racial Disparities in ICD Therapy via Innovative Designs) randomized trial, which enrolled self-identified Black individuals with chronic systolic heart failure. Depressive symptoms were assessed by the Patient Health Questionnaire-2 and the Mental Component Summary of the 12-Item Short-Form Health Survey. Decisional conflict was measured by an adapted Decisional Conflict Scale (DCS). ANCOVA was used to assess differences in Decisional Conflict Scale scores. Multivariable logistic regression was used to examine the association between depressive symptoms and ICD implantation. Among 306 participants, 60 (19.6%) reported depressed mood, and 142 (46.4%) reported anhedonia. Participants with the lowest Mental Component Summary of the 12-Item Short-Form Health Survey scores (poorer mental health and higher likelihood of depression) had greater decisional conflict regarding ICD implantation compared with those with the highest Mental Component Summary of the 12-Item Short-Form Health Survey scores (adjusted mean difference in Decisional Conflict Scale score, 3.2 [95% CI, 0.5-5.9]). By 90-day follow-up, 202 (66.0%) participants underwent ICD implantation. There was no association between either the Patient Health Questionnaire-2 score or the Mental Component Summary of the 12-Item Short-Form Health Survey score and ICD implantation. Depressed mood and anhedonia were prevalent among ambulatory Black patients with chronic systolic heart failure considering ICD implantation. The presence of depressive symptoms did not impact the likelihood of ICD implantation in this population.

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 > 40% (each p < 0.05). There were no differences regarding hypertension and occurrence of AFib between patients with LVEF ≤ 40% compared to patients with LVEF < 40% (each p = n.s.). In ROC analysis there was a significantly higher AUC in patients with LVEF > 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 < 0.002). In patients with LVEF > 40% plasmatic NT-proBNP was shown as significant predictor regarding existence of atrial fibrillation in binary logistic regression analysis, beside age (p < 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 < 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 < 0.001) as well as urinary NT-proBNP (AUC: 0.76, IQR 0.71-0.81, p < 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 < 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.

Perceived benefits of patient support groups and their format for people with an implantable cardioverter defibrillator

BackgroundSupport groups for people with Implantable Cardioverter Defibrillators (ICDs) are widely used, however, it is not clear what people with ICDs gain from a support group or what format they should take. ObjectivesThe aim of the present study is to define the perceived benefit of ICD support groups and develop practical recommendations for group format. Methods14 individuals with ICDs were interviewed using a semi-structured interview guide. Reflexive thematic analysis methods were utilised to code and analyse the transcripts before generating themes. ResultsFour themes were defined: confronting mortality, coping through sharing, coping through learning, and providing space. Making connections with other people with ICDs, reassurance, access to information, and advice from health care professionals were important perceived benefits of the support group. ConclusionPeople with ICDs may have to confront their own mortality and adapt to considerable life changes after implant. The findings from the present study have improved understanding of how support groups are perceived and how ICD indication and group format influence the experience. A blended format of in-person community meetings, online forums, HCP-led education and space for person-person interaction is recommended. Importantly, provision of support should not be time-limited to allow people to access it when it most likely to be of benefit to them.

Long QT syndrome: importance of reassessing arrhythmic risk after treatment initiation.

Risk scores are proposed for genetic arrhythmias. Having proposed in 2010 one such score (M-FACT) for the long QT syndrome (LQTS), this study aims to test whether adherence to its suggestions would be appropriate. LQT1/2/3 and genotype-negative patients without aborted cardiac arrest (ACA) before diagnosis or cardiac events (CEs) below age 1 were included in the study, focusing on an M-FACT score ≥2 (intermediate/high risk), either at presentation (static) or during follow-up (dynamic), previously associated with 40% risk of implantable cardioverter defibrillator (ICD) shocks within 4 years. Overall, 946 patients (26 ± 19 years at diagnosis, 51% female) were included. Beta-blocker (βB) therapy in 94% of them reduced the rate of those with a QTc ≥500 ms from 18% to 12% (P < .001). During 7 ± 6 years of follow-up, none died; 4% had CEs, including 0.4% with ACA. A static M-FACT ≥2 was present in 110 patients, of whom 106 received βBs. In 49/106 patients with persistent dynamic M-FACT ≥2, further therapeutic optimization (left cardiac sympathetic denervation in 55%, mexiletine in 31%, and ICD at 27%) resulted in just 7 (14%) patients with CEs (no ACA), with no CEs in the remaining 57. Additionally, 32 patients developed a dynamic M-FACT ≥2 but, after therapeutic optimization, only 3 (9%) had CEs. According to an M-FACT score ≥2, a total of 142 patients should have received an ICD, but only 22/142 (15%) were implanted, with shocks reported in 3. Beta-blockers often shorten QTc, thus changing risk scores and ICD indications for primary prevention. Yearly risk reassessment with therapy optimization leads to fewer ICD implants (3%) without increasing life-threatening events.

WEARABLE CARDIOVERTER–DEFIBRILLATORS IN CLINICAL PRACTICE IMPLEMENTATION OF THE ANMCO POSITION PAPER FOR APPROPRIATE USE OF THE WEARABLE CARDIOVERTER DEFIBRILLATOR

Abstract Introduction Wearable cardioverter–defibrillators (WCD) have emerged as a valuable tool in the management of patients at risk for life–threatening arrhythmias. These devices offer a non–invasive and temporary solution, providing continuous monitoring and the potential for prompt defibrillation when needed. In this study, we explore the indications for WCD and evaluate arrhythmic events through comprehensive monitoring. Methods From November 2022 to December 2023, we conducted an outpatient follow–up of 18 patients receiving WCD. Regular check–ups and comprehensive echocardiography were performed to optimize therapy based on specific indications for each patient. Results The average age of the patients was 59.3±17.4 years, with 79% being male. Among the cohort, 58% had hypertension, and a similar percentage comprised smokers and individuals with dyslipidemia, while 32% were diabetic. The indications for receiving WCD were: de novo diagnosis of dilated cardiomyopathy with reduced ejection fraction in 9 (50%) patients, recent acute coronary syndrome and ejection fraction &amp;lt; 35% in 5 (28%), cardiac electronic device infections in 3 (17%) patients and myocarditis with electrical instability in 1 (5%) patient. Patients were in optimal medical therapy (OMT) tailored to their specific comorbidities, with 84% on renin–angiotensin–aldosterone system inhibitors, 95% on beta–blockers, 53% on mineralocorticoid receptor antagonists, 53% on sodium–glucose cotransporter–2 inhibitors, and 37% on antiarrhythmics. The average follow–up was 64±45 days according to specific etiology, with a daily wearing time of 22.9±1.1 hours. No device interventions were recorded. At the end of the follow–up period, 6 (33%) patients still required implantable cardioverter–defibrillator (ICD). Among these, 4 patients (22%) underwent to ICD implantation, 3 for secondary prevention, and 1 for primary prevention, while notably, 2 (11%) patients, declined the procedure. Conclusions The use of wearable cardioverter–defibrillators in the outpatient setting for patients at risk of life–threatening arrhythmias allowed to optimize therapy and restrict the indications for ICD, in our cohort up to 67%, with a good safety profile due to the low incidence of device interventions.

Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter defibrillator (ICD) or wearable cardioverter defibrillator (WCD) (TRANSITION JAPAN‐ICD/WCD study): Rationale and design of a prospective, multicenter, observational, comparative study

AbstractBackgroundDespite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often withheld especially in Japanese heart failure patients with reduced left ventricular ejection fraction (HFrEF) who have not experienced ventricular tachycardia (VT) or ventricular fibrillation (VF) for uncertain reasons. Recent advancements in heart failure (HF) medications have significantly improved the prognosis for HFrEF. Given this context, a critical reassessment of the treatment and prognosis of ICDs and WCDs is essential, as it has the potential to reshape awareness and treatment strategies for these patients.MethodsWe are initiating a prospective multicenter observational study for HFrEF patients eligible for ICD in primary and secondary prevention, and WCD, regardless of device use, including all consenting patients. Study subjects are to be enrolled from 31 participant hospitals located throughout Japan from April 1, 2023, to December 31, 2024, and each will be followed up for 1 year or more. The planned sample size is 651 cases. The primary endpoint is the rate of cardiac implantable electronic device implementation. Other endpoints include the incidence of VT/VF and sudden death, all‐cause mortality, and HF hospitalization, other events. We will collect clinical background information plus each patient's symptoms, Clinical Frailty Scale score, laboratory test results, echocardiographic and electrocardiographic parameters, and serial changes will also be secondary endpoints.ResultsNot applicable.ConclusionThis study offers invaluable insights into understanding the role of ICD/WCD in Japanese HF patients in the new era of HF medication.

Regional disparities and risk factors of mortality among patients at high risk of sudden cardiac death in emerging countries: a nonrandomized controlled trial

BackgroundComprehensive data on patients at high risk of sudden cardiac death (SCD) in emerging countries are lacking. The aim was to deepen our understanding of the SCD phenotype and identify risk factors for death among patients at high risk of SCD in emerging countries.MethodsPatients who met the class I indication for implantable cardioverter-defibrillator (ICD) implantation according to guideline recommendations in 17 countries and regions underrepresented in previous trials were enrolled. Countries were stratified by the WHO regional classification. Patients were or were not implanted with an ICD at their discretion. The outcomes were all-cause mortality and SCD.ResultsWe enrolled 4222 patients, and 3889 patients were included in the analysis. The mean follow-up period was 21.6 ± 10.2 months. There were 433 (11.1%) instances of all-cause mortality and 117 (3.0%) cases of SCD. All-cause mortality was highest in primary prevention (PP) patients from Southeast Asia and secondary prevention (SP) patients from the Middle East and Africa. The SCD rates among PP and SP patients were both highest in South Asia. Multivariate Cox regression modelling demonstrated that in addition to the independent predictors identified in previous studies, both geographic region and ICD use were associated with all-cause mortality in patients with high SCD risk. Primary prophylactic ICD implantation was associated with a 36% (HR = 0.64, 95% CI 0.531–0.802, p < 0.0001) lower all-cause mortality risk and an 80% (HR = 0.20, 95% CI = 0.116–0.343, p < 0.0001) lower SCD risk.ConclusionsThere was significant heterogeneity among patients with high SCD risk in emerging countries. The influences of geographic regions on patient characteristics and outcomes were significant. Improvement in increasing ICD utilization and uptake of guideline-directed medical therapy in emerging countries is urgent.Trial registrationClinicalTrials.gov, NCT02099721.

Distinguishing Primary Prevention From Secondary Prevention Implantable Cardioverter Defibrillators Using Administrative Health and Cardiac Device Registry Data

BackgroundAdministrative health data and cardiac device registries can be used to empirically evaluate outcomes and costs after implantable cardioverter defibrillator (ICD) implantation. These datasets often have incomplete information on the indication for implantation (primary vs secondary prevention of sudden cardiac death). MethodsWe used 16 years of population-based cardiac device registry and administrative health data from British Columbia, Canada, to derive and internally validate statistical models that predict the likely indication for ICD implantation. We used chart review data as the reference standard for ICD indication in the Cardiac Device Registry database (CDR; 2004-2012 [Cardiac Services BC]) and nonmissing indication as the reference standard in the Heart Information System registry database (HEARTis; 2013-2019 [Cardiac Services BC]). We created 3 logistic regression prediction models in each database: one using only registry data, one using only administrative data, and one using both registry and administrative data. We assessed the predictive performance of each model using standard metrics after optimism correction with 200 bootstrap resamples. ResultsModels that used registry data alone demonstrated excellent predictive performance (sensitivity ≥ 89%; specificity ≥ 87%). Models that used only administrative data performed well (sensitivity ≥ 84%; specificity ≥ 70%). Models that used both registry and administrative data showed modest gains over those that used registry data alone (sensitivity ≥ 90%; specificity ≥ 89%). ConclusionsAdministrative health data and cardiac device registry data can distinguish secondary prevention ICDs from primary prevention ICDs with acceptable sensitivity and specificity. Imputation of missing ICD indication might make these data resources more useful for research and health system monitoring.

Are We Implanting Too Many Primary-Prevention Implantable Cardioverter-Defibrillators?

Canadian Cardiovascular Society/Canadian Heart Failure Society guidelines recommend optimizing patients with heart failure with reduced ejection fraction (HFrEF) on guideline directed medical therapy (GDMT) prior to implanting primary prevention implantable cardioverter defibrillators (ICDs). However, often GDMT is suboptimal at the time of ICD implantation, and is associated with reduced survival. Furthermore, with evidence for declining sudden cardiac death (SCD) rates in patients with cardiomyopathy, there is a need for better risk stratification to determine the indication for ICD.1 This raises concern for potentially unnecessary ICD implantation in this population, and efforts are needed to address this issue in clinical practice.

Expanded application of wearable cardioverter defibrillators beyond current guidelines: proposal for a European register explained through single clinical scenarios

The wearable cardioverter defibrillator (WCD) is becoming a more and more widely used instrument for the prevention of sudden cardiac death of patients either with a secondary prevention implantable cardioverter...

The Role of the Wearable Defibrillator in Heart Failure.

Wearable cardioverter defibrillators (WCDs) have been developed as a temporary measure for protecting patients at risk for sudden cardiac death that do not meet the indication for implantable cardioverter defibrillator (ICD), most notably in the early stages of heart failure with reduced ejection fraction before reassessment of their left ventricular ejection fraction. In this review, we report available evidence in the literature and guidelines regarding WCD use in order to try to define the role WCDs may have in heart failure. In the last decade, most observational studies found WCDs to be both safe and effective in terminating ventricular arrhythmias in various indications, mostly centered around heart failure with reduced ejection fraction. The only available randomized controlled trial using WCD did not however show a benefit on patients' survival. Hence, recent guidelines only recommended its use in limited indications. Recent data also suggest a possible interest of WCD in monitoring patients, a finding that may prove useful in the context of new-onset heart failure. Data regarding WCD benefit is scarce, and definitive conclusions on its utility are hard to draw. In the context of heart failure, and particularly new-onset heart failure, WCD might find a role in a global comprehensive management of the disease, both acting as an educational tool, a monitoring tool, and, most importantly, a safe and effective tool in preventing sudden cardiac death. The low level of evidence however invites caution, and the decision of prescribing a WCD needs to be individualized and thoroughly discussed with the patient whose compliance is key with this device.

Global Longitudinal Strain May Be the One that Appropriately Identifies Candidates of ICD Implantation.

Hypertrophic cardiomyopathy (HCM) significantly contributes to an elevated risk of sudden cardiac death. Primary prevention is implemented by using an implantable cardioverter defibrillator (ICD). However, all of the HCM patients do not really need ICD therapy. Providing a superior index for ICD indication compared with the current indices like ejection fraction is essential to differentiate high-risk patients efficiently. The present study assessed the potential of global longitudinal strain (GLS) for the differentiation of HCM patients based on their need for ICD shocks. Patients with HCM were considered in four defined centers between March and June 2021. Those with previous ICD implantation or current candidates for ICD therapy were included in the study. Participants were subjected to speckle-tracking echocardiography, and GLS as well as some other echocardiographic parameters were recorded. Afterwards, data from implanted ICDs were extracted. Patients who received ICD shocks (appropriate) due to ventricular tachycardia (VT)/ventricular fibrillation (VF) were categorized in group A. The remaining patients were constituted group B who received inappropriate shocks, i.e., other than VT/VF. Overall, 34 patients were found eligible to participate with a mean age of 62 ± 16.1 years including 64.7% of males. Among a variety of echocardiographic parameters, GLS was the sole one that was significantly higher in group A compared with that in group B. Our findings revealed that only GLS could predict fatal arrhythmias. To substantiate, the odds of VT were raised by 43% with a single increase in GLS unit. GLS showed the highest accuracy for ICD indication among HCM patients and, therefore, could be a solid and early criterion to predict the incidence of life-threatening arrhythmias. In this regard, identifying appropriate HCM patients with respect to their need for ICD therapy is feasible.

Sex-Related Differences in Ventricular Tachyarrhythmia Events in Patients With Implantable Cardioverter-Defibrillator and Prior Ventricular Tachyarrhythmias

BackgroundData on the risk of ventricular tachycardia (VT), ventricular fibrillation (VF), and death by sex in patients with prior VT/VF are limited. ObjectivesThis study aimed to assess sex-related differences in implantable cardioverter-defibrillator (ICD)-treated VT/VF events and death in patients implanted for secondary prevention or primary prevention ICD indications who experienced VT/VF before enrollment in the RAID (Ranolazine Implantable Cardioverter-Defibrillator) trial. MethodsSex-related differences in the first and recurrent VT/VF requiring antitachycardia pacing or ICD shock and death were evaluated in 714 patients. ResultsThere were 124 women (17%) and 590 men observed during a mean follow-up of 26.81 ± 14.52 months. Compared to men, women were at a significantly lower risk of VT/VF/death (HR: 0.67; P = 0.029), VT/VF (HR: 0.68; P = 0.049), VT/VF treated with antitachycardia pacing (HR: 0.59; P = 0.019), and VT/VF treated with ICD shock (HR: 0.54; P = 0.035). The risk of recurrent VT/VF was also significantly lower in women (HR: 0.35; P < 0.001). HR for death was similar to the other endpoints (HR: 0.61; P = 0.162). In comparison to men, women presented with faster VT rates (196 ± 32 beats/min vs 177 ± 30 beats/min, respectively; P = 0.002), and faster shock-requiring VT/VF rates (258 ± 56 beats/min vs 227 ± 57 beats/min, respectively; P = 0.30). There was a significant interaction for the risk of VT/VF by race (P = 0.013) with White women having significantly lower risk than White men (HR: 0.36; P < 0.001), whereas Black women had a similar risk to Black men (HR: 1.06; P = 0.851). ConclusionsWomen with a history of prior VT/VF experienced a lower risk recurrent VT/VF requiring ICD therapy when compared to men. Black Women had a risk similar to men, whereas the lower risk for VT/VF in women was observed primarily in White women. (Ranolazine Implantable Cardioverter-Defibrillator Trial; NCT01215253)

Temporal trends in baseline characteristics of implantable cardioverter defibrillator recipients for primary prevention of sudden cardiac death- The DAIPP program

Abstract Introduction Since expanding the indication for implantable cardioverter defibrillators (ICD) to primary prevention, the patient population of ICD carriers continues to evolve over time. In pursuit of progressively decreasing the burden of sudden cardiac death, improved patient selection and risk-benefit assessment demand, among others, awareness of these temporal changes in clinical baseline characteristics of the ICD population. Purpose The aim was to explore the temporal differences in baseline characteristics of ICD recipients implanted for primary prevention of sudden cardiac death (SCD), and perioperative complications, to improve understanding of ICD population selection over the last two decades in a real-world setting. Methods The Primary Prevention ICD French Registry (DAI-PP program) was initiated in 2002 with an overall aim to assess the risk-benefit ratio of the introduction of ICD for primary prevention over a 20-year period, including a pilot evaluation that finished in 2012. The pilot study laid ground for the ongoing prospective DAIPP Consortium that started in 2018 and is aiming to follow 10000 patients under remote monitoring, using a specific integrational research platform. The two cohorts are in this study compared with regards to baseline characteristics as well as perioperative outcomes, i.e., early mortality and procedural complications. Results This study included 8432 participants, 5521 from the pilot study and 2211 from the prospective trial, with a median follow up of 2.36 (IQR 1.25-3.75) years. Median age was 64 (IQR 56-71) years, 17% female and 61% had ischemic heart disease. Baseline characteristics that remained stable over time were age, cancer burden. Compared to the 2002-2012 period, recent findings found a significant increase in the proportion of females (15 vs 20%, p &amp;lt;0.001), pauci-symptomatic patients (New York Heart Association Functional class-NYHA II, 41 vs. 57%, p &amp;lt;0.001), narrow QRS patients (31 vs. 43%, p&amp;lt;0.001), use of subcutaneous ICD (0 vs. 14%, P&amp;lt;0.001) and more comorbidities including an increase in diabetes, and slight increase in stroke. Regarding pharmacological treatment, there was an increase in use of 2 or 3 medications (2: 6.5% to 16% p&amp;lt;0.001; 3: 20% to 33%, p&amp;lt;0.001) where more received beta blockers and amiodarone in the contemporary study. Perioperative complications decreased over time (13% to 7.9% p&amp;lt;0.001) with a decrease in early reinterventions (1.3% to 0.1% p&amp;lt;0.001) and discrete fall in number of infections (0.7% to 0.1%, p&amp;lt;0.001) and pocket hematoma (4.4% to 3.0% p&amp;lt;0.001). A slight upward trend in number of lead dislodgements was seen over time (1.3% to 1.7% p&amp;lt;0.001). See Table 1 for perioperative complications. Conclusion The primary prevention ICD population has significantly changed over time. An increase in women, comorbidities, and use of 2-3 medications was seen, coupled with more participants receiving a subcutaneous ICD. Perioperative complications decreased over time.

Effect of ICD on patients with improved EF in idiopathic dilated cardiomyopathy

Abstract Background The efficacy of implantable cardioverter defibrillator (ICD) therapy in patients who had heart failure with improved ejection fraction (HFimpEF) above guidelines indication for ICD (&amp;gt;35%) during generator change is still controversial. This meta-analysis assesses the impact of ICD therapy in patients with HFimpEF with EF &amp;gt;35% and patient with NICM. Methods Databases were searched for studies reporting the association between ICD in patients with NICM and HFimpEF and ventricular arrhythmias (VA) and sudden cardiac death (SCD); 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. Results A total of 38 studies and 13,538 patients (5,829 with improved EF vs 7,709 with EF &amp;lt;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. Patients with HFimpEF with ICD, wither alone or as part of CRT therapy, was associated with lower risk of VA and SCD (OR 0.39, 95% CI 0.32-0.47; P&amp;lt;0.01; annual rate 4.1 vs. 8%). Sub-analysis for patients with ICD for patient with NICM was associated with lower risk of VA and SCD (OR 0.25, 95% CI 0.1-0.62; P&amp;lt;0.01; annual rate 2.9 vs. 10.2%). (Figure) Conclusion Improved EF is associated with reduced VA but with still elevated risk in HFimpEF especially in NICM.

Neurohormonal status is associated with long-term appropriate implantable cardioverter defibrillator therapy for life-threatening ventricular arrhythmia

Abstract Background Neurohormonal status is associated with the risk of life-threatening ventricular arrhythmia. Purpose We aimed to assess whether neurohormonal status in patients with an implantable cardioverter defibrillator (ICD) is correlated with the risk of long-term appropriate shock or overdrive delivered by the ICD for life-threatening arrhythmia. Methods A total of 331 clinically stable patients with ICD without any past history of shock or overdrive for life-threatening ventricular arrhythmia were enrolled in a two-center prospective cohort and followed up for a median time of 7.9 years. At enrolment, patients’ medical history, treatment, clinical and imaging data were recorded and, blood and, blood samples were drawn for the assessment of standard biological parameters as well as 3 neurohormones (aldosterone, A type NT-pro-Atrial natriuretic peptide (ANP) and MR-pro-Adrenomedullin (ADM). The primary endpoint of the study was the occurrence of appropriate shock or overdrive delivered by the ICD (ICD therapy). A multivariable cox model adjusted on age, gender, primary or secondary prevention ICD as well as all baseline variables unequally distributed between groups with or without ICD therapy was used for the assessment of the relationship between the 3 neurohormones and the primary endpoint. Results The population consisted of patients with a mean age of 60±15 years, among which 59(18%) women and 160(48%) with a secondary prevention indication for ICD. At baseline all data were similar between patients with or without ICD therapy with the exception of weight, systolic blood pressure, left ventricular ejection fraction (LVEF) and serum potassium and creatinine levels. No other variable, including MADIT and SHOCKED score were significantly associated with the risk of ICD therapy. Death was recorded in 114(34%) patients and a total of 78(24%), 76(23%) and 106(33%) patients had appropriate shock, overdrive and ICD therapy respectively during the follow-up. On multivariable analysis, highest levels of ANP and lowest levels of ADM but not aldosterone were independently associated with life-threatening ventricular arrhythmia requiring ICD therapy (table). Other correlates of ICD therapy were lower LVEF and, higher weight, serum potassium and creatinine concentrations. ANP and ADM had a stepwise additive impact on the risk of ICD therapy. (Figure 1) Conclusions In a stable all comer population with ICD and no history of ICD therapy, blood levels of neurohormones ANP and ADM are associated with the risk of life-threatening ventricular arrhythmia requiring ICD-delivered shock or overdrive independent of other correlates. ANP and ADM concentrations may be useful in identifying patients at high risk of such arrhythmia and who may most benefit from ICD implantation.

N-terminal pro-B-type natriuretic peptide for prediction of ventricular arrhythmias: data from the SMASH Study

Abstract Background Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations predict heart failure (HF) and mortality, but whether NT-proBNP predicts ventricular arrhythmias (VA) is not clear. Purpose We hypothesize that high NT-proBNP concentrations associate with the risk of incident VA, defined as adjudicated ventricular fibrillation or sustained ventricular tachycardia. Methods In a prospective, observational study of patients treated with implantable cardioverter defibrillator (ICD), we analyzed NT-proBNP concentrations at baseline and after mean 1.4 years in association to incident VA. Results We included 491 patients (age 66±12 years, 83% men) out of whom 51% had a primary prevention ICD indication. The median NT-proBNP concentration was 567 (25-75 percentile 203-1480) ng/L, and patients with higher concentrations were older with more HF and ICD for primary prevention. During mean 3.1±0.7 years, 136 patients (28%) had ≥1 VA. Baseline NT-proBNP concentrations were associated with risk of incident VA (HR 1.39 [95%CI 1.22-1.58], p&amp;lt;0.001) (Figure1), HF hospitalizations (HR 3.38 [95%CI 2.69-4.25], p&amp;lt;0.001) and all-cause mortality (HR 2.49 [2.05-3.04], p&amp;lt;0.001) (Figure2), which persisted after adjusting for age, sex, BMI, CAD, HF, renal function, and LVEF. The association with VA was stronger in secondary vs primary prevention ICD indication: HR 1.59 (95% CI 1.34-1.88 C-statistics 0.71) vs HR 1.25 (1.02-1.52, C-statistics 0.55), p-for-interaction=0.06. Changes in NT-proBNP during the first 1.4 years did not associate with subsequent VA. Conclusions NT-proBNP concentrations are associated with the risk of incident VA after adjustment for established risk factors, with the strongest association in patients with a secondary prevention ICD indication.