Implantable Cardioverter Defibrillator Research Articles

Design of a Post-Market Registry for the Extravascular Implantable Cardioverter‐Defibrillator: The Enlighten Study

BackgroundThe extravascular implantable cardioverter-defibrillator (EV-ICD) with substernal lead placement has been shown to terminate ventricular arrhythmias safely and effectively while being outside the vasculature. The performance of the EV-ICD system with a novel inappropriate shock reducing algorithm in a real-world setting has yet to be investigated. ObjectiveThe objective of the Enlighten Study: the EV-ICD Post Approval Registry is to provide a comprehensive measure of the safety and performance of the EV-ICD system in real-world clinical practice over the lifetime of the device. MethodsThe Enlighten Study is a global, prospective, observational, multi-center, post-approval study utilizing the manufacturer’s Product Surveillance Registry (PSR). Eligible patients implanted with an Aurora EV-ICDTM system at participating centers will be included. Follow-up clinical data will be collected approximately every 6 months throughout the lifetime of the device, enrolling a minimum of 500 patients. ResultsThe primary endpoint of the study is major system-related complication-free survival at 5-years post-implant, with a minimum threshold of >79%. The study will also characterize device performance which includes, but is not limited to, freedom from system- or procedure-related complications, performance of antitachycardia pacing, characterization of sensing and detection, inappropriate therapy, shock effectiveness, battery depletion, and system revisions. ConclusionThe Enlighten Study: the EV-ICD Post Approval Registry will examine the real-world performance of the post-market EV-ICD system. Additionally, this study will allow for a robust assessment of EV-ICD-related complications, device revisions, and extractions over chronic (>5 year) implant durations.

Cardiac Resynchronization Therapy with Defibrillator in Ischemic Versus Nonischemic Cardiomyopathy.

Cardiac resynchronization therapy with implantable cardioverter defibrillators (CRT-Ds) are established therapy options for patients suffering from heart failure (HF). Several aspects of HF modification have yet to be described regarding etiology-dependent outcome differences in the long-term.The Mannheim CArdiac Resynchronization TherApy RetrospeCtive ObservAtioNAl (MARACANA) Registry retrospectively included all patients provided with CRTs in our center from 2013 to 2021. CRT-D recipients (n = 380) were grouped to either ischemic cardiomyopathy (ICM, n = 206) or nonischemic cardiomyopathy (NICM, n = 174). Both groups were compared regarding survival, left ventricular ejection fraction (LVEF), hospitalizations due to HF, intrinsic and paced QRS width, NYHA classification, and several further aspects of HF modification in the long-term (59.1 ± 4.81 months).Patients with ICM were older (73.3 ± 8.4 versus 67.7 ± 10.8 years) and predominantly male (86.4 versus 74.7%) and presented with higher creatinine values (1.57 ± 0.92 versus 1.31 ± 0.66 mg/dL, each P < 0.05) at baseline. The mean survival for patients with NICM was better (51.9 ± 1.2 versus 54.4 ± 1.1 months, P = 0.03). Improvements in NYHA (2.93 ± 0.4 versus 2.79 ± 0.5-2.19 ± 0.7 versus 1.79 ± 0.7) and LVEF (26.4 ± 6.8 versus 27% ± 6.9% to 35.7 ± 9.6 versus 44 ± 11%, each P < 0.05) were similar for both groups after 5 years. Patients with ICM experienced more hospitalizations due to HF within the first year (odds ratio 1.9, P < 0.05), whereas electrical remodeling was more impressive for NICM (QRS width 157.1 ± 19.4 milliseconds versus intrinsic 116.6 ± 12.7 milliseconds and paced 131.9 ± 21 milliseconds after 5 years, both P < 0.05).Patients with HF might experience long-term improvements in functional status and left ventricular reverse remodeling following CRT-D, regardless of underlying etiology. Alterations in some aspects of HF modification could be influenced by time- and etiology-associated comorbidities.

Implantable Cardioverter Defibrillators in Prevention of Sudden Cardiac Death in Kidney Transplant Recipients: A Case Series and an Appraisal of Current Evidence.

Background: Cardiovascular diseases, including sudden cardiac death (SCD), are the leading cause of mortality among kidney transplant recipients (KTRs). While implantable cardioverter defibrillators (ICDs) are established for SCD prevention in the general population, data on the benefits in patients with CKD is scarce and controversial, and there is no established general consensus on their use in this group of patients. Furthermore, data for KTRs are lacking. The aim of this study is to present our experience with ICDs in KTRs and evaluate the outcomes in this population. Methods: We retrospectively analyzed medical records of KTRs who received a kidney allograft between October 1973 and December 2023 and received ICDs for the prevention of SCD. Results: Of 2282 KTRs, 10 patients (0.44%) underwent an ICD implantation with an average age of 60.6 years at the time of implantation; 9 were male. Primary prevention of SCD was the most common indication, with only one patient receiving an ICD following sudden cardiac arrest. The female patient received an ICD while on dialysis, and the rest of the patients received ICDs in the posttransplant period with an average time of 9.1 years after KT. Kidney allograft function was reduced in all patients at the time of the ICD implantation with an average estimated glomerular filtration rate (eGFR) of 44 mL/min/1.73 m2. No ICD-related complications were recorded. Six patients are alive with an average follow-up of 5.2 years. Conclusions: ICD implantation in carefully selected KTRs may offer survival benefits and can be a valuable tool in preventing SCD. Larger studies are needed to confirm these findings and establish clear guidelines for ICD use in this specific population.

The impact of defibrillation lead position on electrical parameters measured perioperatively and in long-term follow-up

Introduction: Implantable cardioverter-defibrillators (ICD) with transvenous defibrillation leads remain the leading therapeutic method in the treatment of patients at high risk of sudden cardiac death. The lack of clear data confirming the superiority of any position in the right ventricle for placement of the defibrillation lead results in significant individualization of practice between operators.Aims: The study aims to assess the electrical parameters of defibrillation leads obtained intraoperatively and in the long-term follow-up, depending on the position of the lead in the right ventricle.Methods: Between 2018 and 2021, consecutive patients were enrolled in an observational study after the implantation of a device with defibrillation capability. Electrical parameters were measured during each control visit, 3 months after the implantation procedure, and then every 6-months during follow-up visits. The data regarding intraprocedural course (procedure time, an X-ray time, intraprocedural electrical parameters) were collected retrospectively. The patients were divided into two groups depending on the placement of the defibrillation lead in the right ventricle: the RVA (right ventricular apex group) and the non-RVA group consisting of patients with the lead implanted in the alternative position.Results: Of the 167 patients included in the study, 90 patients (54%) were assigned to the RVA group and 77 patients (46%) to the non-RVA group. The mean follow-up time was 26.1 12.6 months. Electrical parameters (pacing threshold, ventricular sensing amplitude and impedance) observed intraoperatively and measured on the first day following the procedure did not differ significantly between the groups. There was no significant difference in the incidence of abnormal electrical parameters between the apical and non-apical electrodes throughout the observation period. A total of 4 patients (4%) in the RVA group and 3 patients (4%) in the non-RVA group required lead replacement during the follow-up period.Conclusions: The position of the defibrillation lead has no clinically significant influence on the electrical parameters observed both intraoperatively and in long-term follow-up.

Performance and Safety of the Extravascular Implantable Cardioverter-Defibrillator Through Long-Term Follow-Up: Final Results From the Pivotal Study.

Substernal lead placement of the extravascular implantable cardioverter-defibrillator (EV ICD) permits both defibrillation at thresholds similar to those seen with transvenous ICDs and effective antitachycardia pacing (ATP), while avoiding the vasculature and associated complications. The global Pivotal study has shown the EV ICD system to be safe and effective through 6 months, but long-term experience has yet to be published. We aim to report the performance and safety of the EV ICD system throughout the study. The EV ICD Pivotal study was a prospective, global, single-arm, pre-market clinical study. Individuals with a class I or IIa indication for a single-chamber ICD per guidelines were enrolled. Freedom from major system- or procedure-related complications, as well as appropriate and inappropriate therapy rates, were assessed through 3 years using the Kaplan-Meier method. Anti-tachycardia pacing success was calculated using simple proportions. An implant was attempted in 316 patients [25.3% female, 53.8±13.1 years old, 81.6% primary prevention, LVEF 38.9%±15.4%]. Of 299 patients with a successful implant, 24 experienced 82 spontaneous arrhythmic episodes that were appropriately treated with either ATP only (38, 46.3%), shock only (34, 41.5%), or both (10, 12.2%) for a Kaplan-Meier-estimated rate of first any appropriate therapy of 9.2% at 3 years. Antitachycardia pacing was successful in 77.1% (37/48) of episodes, and ATP usage significantly increased from discharge to last follow-up visit (P<0.0001). Shock therapy was successful in 100% (27/27) of discrete, spontaneous ventricular arrhythmias. The inappropriate shock rates at 1 and 3 years were 9.8% and 17.5%, respectively, with P-wave oversensing the predominant cause. No major intraprocedural complications were reported and the estimated freedom from system- or procedure-related major complications was 91.9% at 1 year and 89.0% at 3 years. The most common major complications were lead dislodgement (10 events; n=9 patients, 2.8%), postoperative wound or device pocket infection (n=8, 2.5%), and device inappropriate shock delivery (n=4, 1.3%). Twenty-four system revisions were performed as a result of major complications related to the EV ICD system or procedure. From implant to study completion, the EV ICD Pivotal study demonstrated that a single integrated system with an extravascular lead placed in the substernal space maintains high ATP success, effective defibrillation, and a consistent safety profile.

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...

Lifetime cumulative activity burden is associated with symptomatic heart failure and arrhythmic risk in patients with arrhythmogenic right ventricular cardiomyopathy: a retrospective cohort study.

Sports-related physical activity is associated with an increased risk of ventricular dysfunction and arrhythmias in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC). However, there are currently no standardized strategies for activity assessment. Thresholds for harmful levels of physical activity suggested by previous studies vary substantially and neither lifetime activity burden nor continuous modelling approaches were considered. For this single-centre retrospective study, ARVC patients were interviewed to assess sports-related and non-sports-related physical activity between the age of 10 years and the last follow-up. Activity data were aggregated to the median metabolic equivalent of task-hours (METh) per week for each year. The association between cumulative physical activity burden and clinical study endpoints was investigated using Cox regression models. A total of 124 patients (median age: 39.5 years, 48% male) were included in the analysis, of whom 93 had been diagnosed with definite ARVC. Study participants reported a median overall activity of 202.3 METh/week, with 38.7 METh/week attributed to sports-related activity. In the continuous model, cumulative overall activity burden was associated with the occurrence of symptomatic heart failure [hazard ratio (HR) per 100 METh/week: 1.017, 95% CI (1.003, 1.032), P = 0.015], sustained ventricular tachycardia [HR: 1.021, 95% CI (1.006, 1.037), P = 0.007], and implantable cardioverter defibrillator interventions [HR: 1.017, 95%CI (1.000, 1.034), P = 0.048]. This finding was consistent when considering sports-related activity separately as a predictor variable, whereas the resulting hazard ratios did not show a significant association for non-sports-related physical activity. This study demonstrates for the first time that cumulative physical activity as a continuous predictor variable is associated with symptomatic heart failure and arrhythmic risk in ARVC patients. Collaborative research is required in larger cohorts to investigate the influence of potential confounders on event occurrence and to develop threshold recommendations for clinical practice.

Relationship between activity and sleep, as measured through a wearable accelerometer, and appropriate cardioverter defibrillator interventions: a prospective SafeHeart substudy.

Physical activity has shown association with ventricular arrhythmia, however, the role of specific behavioral patterns over a 24 h cycle remains unknown. Therefore, we aimed to explore associations between physical behavior and appropriate implantable cardioverter defibrillator (ICD) therapy. We included patients with an ICD at two European sites, who wore wrist-based accelerometers capturing 24 h movement and sleep behaviours for 28 days. Behavioural measures included activity volume, duration and intensity, sleep duration, and efficiency. Participants were followed for 12 months for the outcome of appropriate ICD therapy. Cox proportional hazard models with restricted cubic splines were used for the analysis. Lastly, the predictive capacity was tested. A total of 253 ICD patients were included (mean age 63.5 (±10.2), 48 (19.0%) female). During follow-up, 40 participants (15.8%) received appropriate ICD therapy; 32 anti-tachycardia pacing (ATP) only (12.6%), 5 shock only (2.0%), and 3 combined ATP and shock (1.2%). In the adjusted model, high inactive duration (HR 1.40 (95% 1.10-1.78)), peak walking cadence (HR 1.07 (95% 1.03-1.12)), and total sleep duration (HR 1.50 (1.02-2.22)) were associated with the outcome. The dose-response relationship was U-shaped for inactive duration with a cut-off at 16 h, and linear for peak cadence and sleep. The prediction model reached an area under the receiver operating characteristic curve of 0.70 ± 0.03, with highest accuracy in the first months. Wearable-derived 24 h movement and sleep behaviours collected over 28 days were associated with later appropriate ICD therapy risk. Testing of the predictive value of digital biomarkers for enhanced risk stratification of ventricular arrhythmia warrants larger prospective studies. National Trial Registration (NL9218, http://onderzoekmetmensen.nl/).

Prognostic value of ventricular arrhythmia in early post-infarction left ventricular dysfunction: the French nationwide WICD-MI study.

Prophylactic implantable cardioverter-defibrillators (ICDs) are not recommended until left ventricular ejection fraction (LVEF) has been reassessed 40 to 90 days after an acute myocardial infarction. In the current therapeutic era, the prognosis of sustained ventricular arrhythmias (VAs) occurring during this early post-infarction phase (i.e. within 3 months of hospital discharge) has not yet been specifically evaluated in post-myocardial infarction patients with impaired LVEF. Such was the aim of this retrospective study. Data analysis was based on a nationwide registry of 1032 consecutive patients with LVEF ≤ 35% after acute myocardial infarction who were implanted with an ICD after being prescribed a wearable cardioverter-defibrillator (WCD) for a period of 3 months upon discharge from hospital after the index infarction. ICDs were implanted either because a sustained VA occurred while on WCD (VA+/WCD, n = 72) or because LVEF remained ≤35% at the end of the early post-infarction phase (VA-/WCD, n = 960). The median follow-up was 30.9 months. Sustained VAs occurred within 1 year after ICD implantation in 22.2% and 3.5% of VA+/WCD and VA-/WCD patients, respectively (P < .0001). The adjusted multivariable analysis showed that sustained VAs while on WCD independently predicted recurrence of sustained VAs at 1 year (adjusted hazard ratio [HR] 6.91; 95% confidence interval [CI] 3.73-12.81; P < .0001) and at the end of follow-up (adjusted HR 3.86; 95% CI 2.37-6.30; P < .0001) as well as 1-year mortality (adjusted HR 2.86; 95% CI 1.28-6.39; P = .012). In patients with LVEF ≤ 35%, sustained VA during the early post-infarction phase is predictive of recurrent sustained VAs and 1-year mortality.

Benefit of implantable cardioverter defibrillator use in Japanese patients based on modified MADIT‐ICD benefit score

Benefit of implantable cardioverter defibrillator use in Japanese patients based on modified MADIT‐ICD benefit score

Importance of Zinc Homeostasis for Normal Cardiac Rhythm

&lt;p&gt;Current arrhythmia therapies such as ion channel blockers, catheter ablation, or implantable cardioverter defibrillators have limitations and side effects, and given the proarrhythmic risk associated with conventional, ion channel-targeted anti-arrhythmic drug therapies, a new approach to arrhythmias may be warranted. Measuring and adjusting the level of particular ions that impact heart rhythm can be a simple and low-complication strategy for preventing or treating specific arrhythmias. In addition, new medicines targeting these ions may effectively treat arrhythmias. Numerous studies have shown that intracellular and extracellular zinc concentrations impact the heart's electrical activity. Zinc has been observed to affect cardiac rhythm through a range of mechanisms. These mechanisms encompass the modulation of sodium, calcium, and potassium ion channels, as well as the influence on beta-adrenergic receptors and the enzyme adenylate cyclase. &lt;/p&gt;&lt;p&gt; Moreover, zinc can either counteract or induce oxidative stress, hinder calmodulin or the enzyme Ca (2+)/calmodulin-dependent protein kinase II (CaMKII), regulate cellular ATP levels, affect the processes of aging and autophagy, influence calcium ryanodine receptors, and control cellular inflammation. Additionally, zinc has been implicated in the modulation of circadian rhythm. Additionally, zinc has been implicated in the modulation of circadian rhythm. In all the above cases, the effect of zinc largely depends on the normal or increased cellular level of zinc, which shows the importance of maintaining the serum and intracellular levels of zinc within the normal range.&lt;/p&gt;

Implantable Cardioverter-Defibrillators Among Older Survivors of Out-of-Hospital Cardiac Arrest.

Although current guidelines recommend implantable cardioverter-defibrillator (ICD) placement in survivors of out-of-hospital cardiac arrest, contemporary data on secondary-prevention ICDs in survivors of out-of-hospital cardiac arrest remain limited. Using 2013 to 2019 CARES (Cardiac Arrest Registry to Enhance Survival) linked to Medicare, we identified 3226 patients aged ≥65 years with an initial shockable rhythm who survived to discharge without severe neurological disability. Multivariable hierarchical regression models were used to examine the association between patient variables and ICD placement and quantify hospital variation in ICD implantation. The mean age was 72.2 years, 23.5% were women, 10% were Black individuals, and 4% were Hispanic individuals. Overall, 997 (30.9%) patients received an ICD before discharge, 1266 (39.2%) at 90 days, and 1287 (39.9%) within 6 months. Older age (≥85 years), female sex, history of diabetes, calendar year, and presentation with acute myocardial infarction were associated with lower odds of ICD implantation, but race or ethnicity was not associated with ICD implantation. Among 297 hospitals, the median proportion of survivors receiving ICD at discharge was 28.6% (interquartile range, 20%-50%). The relative odds of ICD implantation varied by 62% across hospitals (median odds ratio, 1.62 [95% CI, 1.38-1.82]) after adjusting for case mix. Fewer than 1 in 3 survivors of out-of-hospital cardiac arrest due to a shockable rhythm received a secondary-prevention ICD before discharge. Although patient variables were associated with ICD implantation, there was no difference by race or ethnicity. Even after adjusting for patient case mix, ICD implantation varied markedly across hospitals.

Thrombosis of the superior vena cava in a patient with an implanted cardioverter–defibrillator: A case report

BACKGROUND: Superior vena cava syndrome results from the occlusion of blood flow in the superior vena cava due to external compression, internal obstruction, or infiltration of the vessel wall by a tumor. Although thrombotic complications caused by electrodes of cardiac implantable devices are uncommon in clinical practice, their incidence has been increasing due to the increasing need for such devices, which effectively correct the compromised electrical or mechanical functions of the heart chambers. CLINICAL CASE DESCRIPTION: Herein, we have presented a case of superior vena cava thrombosis syndrome in a patient who had undergone cardioverter–defibrillator implantation for dilated cardiomyopathy. We have discussed the classification of superior vena cava syndromes, its pathogenesis, and the types of collateral circulation. CONCLUSION: As observed in our patient, the concurrent presence of chronic heart failure syndrome can make it challenging to recognize superior vena cava syndrome in the early stages of diagnosis.

Brugada syndrome precipitated by uncomplicated malaria treated with dihydroartemisinin piperaquine: a case report

BackgroundCardiovascular events following anti-malarial treatment are reported infrequently; only a few studies have reported adverse outcomes. This case presentation emphasizes cardiological assessment of Brugada syndrome, presenting as life-threatening arrhythmia during anti-malarial treatment. Without screening and untreated, this disease may lead to sudden cardiac death.Case presentationThis is a case of 23-year-old male who initially presented with palpitations followed by syncope and shortness of breath with a history of malaria. He had switched treatment from quinine to dihydroartemisinin-piperaquine (DHP). Further investigations revealed the ST elevation electrocardiogram pattern typical of Brugada syndrome, confirmed with flecainide challenge test. Subsequently, anti-malarial treatment was stopped and an Implantable Cardioverter Defibrillator (ICD) was inserted.ConclusionsAnother possible cause of arrhythmic events happened following anti-malarial consumption. This case highlights the possibility of proarrhytmogenic mechanism of malaria infection and anti-malarial drug resulting in typical manifestations of Brugada syndrome.

Smoking and sudden cardiac death in patients with previous coronary artery disease.

Smoking is a known risk for sudden cardiac death (SCD) in the general population. However, its significance in patients with acute coronary syndrome (ACS), a condition that also elevates the risk of SCD, is disputable. A total of 9704 consecutive ACS patients with available smoking data were included in the analysis. Comprehensive patient data were obtained from the Mass Data in Detection and Prevention of Serious Adverse Events in Cardiovascular Disease research database. A composite endpoint of SCD, SCD aborted by successful resuscitation and accurate implantable cardioverter defibrillator therapy to otherwise potentially fatal ventricular fibrillation/ventricular tachycardia was used. Univariate, age- and sex-adjusted, and a multivariate fine-gray competing risk regression with adjustment to traditional risk factors was conducted. Median follow-up time was 6.8 years (IQR, 4.1-10.2), and 454 (4.7%) SCD cases were identified. At the baseline, 23.7% (N = 2444) were active smokers, and 20.8% (N = 2146) were ex-smokers. In the multivariate model, active smokers had an elevated risk of 1.79 (95% CI, 1.41-2.27; P < 0.001) for future SCD. Ex-smokers had no elevated risk for SCD in fine-gray subdistribution hazard. Also, active smokers were notably younger (mean age 58.7 years) than non- or ex-smokers (71.1 years and 68.9 years, respectively, P < 0.001 for both comparisons). Active smokers had a 79% higher risk of SCD when compared with nonsmokers. Smoking cessation should be heavily encouraged after ACS. Also, a person's smoking status should be considered in further studies developing SCD and implantable cardioverter defibrillator-benefit risk scores.

Implementing stereotactic arrhythmia radioablation with STOPSTORM.eu consortium support: intermediate results of aprospective Israeli single-institutional trial.

Ventricular tachycardia (VT) is alife-threatening arrhythmia originating from the heart's ventricles. Traditional treatments include antiarrhythmic medications, implantable cardioverter-defibrillators (ICDs), and catheter ablation. Stereotactic body radiation therapy (SBRT) targeting the arrhythmogenic focus in the left ventricle-stereotactic arrhythmia radioablation (STAR)-is an emerging treatment and may offer apotential solution for patients with refractory VT. We designed an interventional prospective clinical trial in Israel aligned with the STOPSTORM.eu consortium's benchmarks, recommendations, and directives to assess the safety and efficacy of STAR in patients with refractory VT. Our phaseI/II single-institutional trial was approved by the Ministry of Health of Israel for 10patients, initially assessing safety in the first 3patients. We included patients with ICDs experiencing symptomatic monomorphic VT after an inadequate response to previous therapies. The primary endpoints were treatment-related serious adverse events and areduction in VT burden as assessed by ICD interrogation. Secondary outcomes included areduction in antiarrhythmic medications and changes in quality of life. From August 2023 to August 2024, 3patients underwent STAR treatment. The prescription dose was asingle fraction of 25 Gy. Planning target volumes were 47.8, 49.7, and 91.8 cc, and treatment was successfully delivered with no grade3 or higher adverse events reported. Over afollow-up period of 12months for the first patient and 8months for the second one, no VT events were recorded after treatment. The third patient died from progressive heart failure 3months after treatment. Left ventricular ejection fraction remained stable, and no significant radiation-induced inflammatory changes were noted. The initial results of this trial suggest that STAR can reduce VT episodes in patients with refractory VT without severe adverse effects. The study highlights the importance of international collaboration and standardization in pioneering new treatments. Further follow-up and additional patient data will be necessary to confirm these findings and evaluate long-term outcomes, including potential adjustments to antiarrhythmic medication regimens.

Deep behavioural representation learning reveals risk profiles for malignant ventricular arrhythmias

We aimed to identify and characterise behavioural profiles in patients at high risk of SCD, by using deep representation learning of day-to-day behavioural recordings. We present a pipeline that employed unsupervised clustering on low-dimensional representations of behavioural time-series data learned by a convolutional residual variational neural network (ResNet-VAE). Data from the prospective, observational SafeHeart study conducted at two large tertiary university centers in the Netherlands and Denmark were used. Patients received an implantable cardioverter-defibrillator (ICD) between May 2021 and September 2022 and wore wearable devices using accelerometer technology during 180 consecutive days. A total of 272 patients (mean age of 63.1 ± 10.2 years, 81% male) were eligible with a total sampling of 37,478 days of behavioural data (138 ± 47 days per patient). Deep representation learning identified five distinct behavioural profiles: Cluster A (n = 46) had very low physical activity levels and a disturbed sleep pattern. Cluster B (n = 70) had high activity levels, mainly at light-to-moderate intensity. Cluster C (n = 63) exhibited a high-intensity activity profile. Cluster D (n = 51) showed above-average sleep efficiency. Cluster E (n = 42) had frequent waking episodes and poor sleep. Annual risks of malignant ventricular arrhythmias ranged from 30.4% in Cluster A to 9.8% and 9.5% for Clusters D-E, respectively. Compared to low-risk profiles (D-E), Cluster A demonstrated a three-to-four fold increased risk of malignant ventricular arrhythmias adjusted for clinical covariates (adjusted HR 3.63, 95% CI 1.54–8.53, p < 0.001). These behavioural profiles may guide more personalised approaches to ventricular arrhythmia and SCD prevention.

Validation of the German Purpose in Life Questionnaire (PLQ) in a healthy population and patients with cardiovascular disease

In this cross-sectional study, a German translation of the subscale “Purpose in Life” (PLQ) from the Scales of Psychological Well-being (SPWB) was validated in a representative sample of participants from healthy and cardiovascular populations. The main objectives were to assess the reliability, convergent, and discriminant validity using a large and representative sample (N = 466 healthy sample, N = 247 patients with an implanted cardioverter-defibrillator (ICD), N = 70 patients with a cardiovascular disease (CVD)).The findings indicated that the German PLQ is a reliable and valid measure of positive psychological well-being, showing a positive correlation with health-related quality of life, optimism, and positive affect. In turn, the PLQ score was significantly and negatively correlated with depressive symptom severity, anxiety, pessimism, and negative affect, while being distinct from these constructs. The comparability of the measurement properties of the German PLQ with the original English version further supports the validity of the translation. Additionally, the unidimensional structure of the German version mirrored that of the English PLQ.As this study used a large and representative sample, it provides the most up-to-date normative population value for the subscale of the SPWB. Moreover, this study represents the first known exploration of the questionnaire in a cardiovascular sample, revealing relationships between health-related quality of life, optimism, positive affect, and the German PLQ. However, in patients with ICD, the positive correlation between the PLQ and the physical component of the SF-12 did not reach significance. Despite these valuable findings, future research to enhance the understanding of the PLQ and its implications is warranted.

(LV)EF is a poor predictor of sudden cardiac death : Pro/Contra

For more than two decades the left ventricular ejection fraction (LVEF) has been utilized with practically uncritical absolutism for the risk stratification of patients with ischemic and, historically, also nonischemic cardiomyopathy, in order to identify patients who could be threatened by sudden cardiac death. Based on historical data and in the absence of other better predictive parameters, the LVEF continues to appear in the guidelines unchanged, with cut-off values that lie in the region of the measurement accuracy of LVEF as determined by echocardiography. The basic identification of high-risk patients who then really benefit from an implantable cardioverter defibrillator (ICD) must be re-evaluated under the aspect of a meaningfully altered interventional and pharmaceutical treatment of heart failure.

Factors associated with stellate ganglion block success in recurrent ventricular arrhythmias.

One treatment option for refractory ventricular arrythmias is stellate ganglion block (SGB). We examined differences in SGB success by patient and arrhythmia characteristics and predictors of successful SGB. This was a multicenter analysis of patients treated for refractory ventricular arrythmias in the Czech Republic and the United States. The primary outcome was absence of ventricular arrythmias at 24h post SGB. SGB effectiveness was examined according to aetiology of cardiomyopathy, arrhythmia type, laterality of SGB, presence of inotropes, and presence of mechanical circulatory support. Binary logistic regression was used to examine variables associated with the primary outcome. In total there were 117 patients with refractory ventricular arrythmias treated with SGB. Overall, the mean age was 63.5±11.0years, majority of patients were male (94.0%), White (87.2%), and had an implantable cardioverter defibrillator in situ (70.1%). There were no differences in efficacy of SGB based on aetiology of cardiomyopathy (P=0.623), arrhythmia type (0.852), laterality of block (P=0.131), and presence of inotropes (P=0.083). Multivariable analysis demonstrated that increased age was associated with decreased odds of SGB success (odds ratio: 0.96, confidence interval: 0.92-0.99, P=0.039) whereas increased left ventricular ejection fraction trended towards increased odds of SGB success (odds ratio: 1.05, confidence interval: 0.995-1.11, P=0.077). In this multicentre experience, SGB was similarly effective despite the aetiology of cardiomyopathy, type of arrhythmia, laterality, and inotropic or mechanical support. SGB was less effective for the suppression of ventricular arrythmias at 24h for the elderly.