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

INTRODUCTION: Physical activity has shown association with ventricular arrhythmia, however, the role of specific behavioral patterns over a 24-hour cycle remains unknown. Therefore, we aimed to explore associations between physical behavior and appropriate implantable cardioverter-defibrillator (ICD) therapy. METHODS: We included patients with an ICD at two European sites, who wore wrist-based accelerometers capturing 24-hour movement and sleep behaviors for 28 days. Behavioral measures included activity volume, duration and intensity, sleep duration and efficiency. Patients 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. RESULTS: : A total of 253 ICD patients were included (mean age 63.8 (±10.2), 50 (19.8%) female). During follow-up, 40 patients (15.8%) received appropriate ICD therapy; 32 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 cutoff at 16 hours, and linear for peak cadence and sleep. The prediction model reached an AUROC of 0.70 ±0.03, with highest accuracy in the first months. CONCLUSION: Wearable-derived 24-hour movement and sleep behaviors 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. TRIAL REGISTRATION: National Trial Registration (NL9218, http://onderzoekmetmensen.nl/).

Scar border zone mass and presence of border zone channels assessed with cardiac magnetic resonance imaging are associated with ventricular arrhythmia in patients with ST-segment elevation myocardial infarction.

AIMS: Late gadolinium enhancement cardiac magnetic resonance (CMR) permits characterization of left ventricular ischaemic scars. We aimed to evaluate if scar core mass, border zone (BZ) mass, and BZ channels are risk markers for subsequent ventricular arrhythmia (VA) in ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: A sub-study of the DANish Acute Myocardial Infarction-3 multi-centre trial and Danegaptide phase II proof-of-concept clinical trial in which a total of 843 STEMI patients had a 3-month follow-up CMR. Of these, 21 patients subsequently experienced VA during 100 months of follow-up and were randomly matched 1:5 with 105 controls. A VA event was defined as: ventricular tachycardia, ventricular fibrillation, or sudden cardiac death. Ischaemic scar characteristics were automatically detected by specialized software. We included 126 patients with a median left ventricular ejection fraction of 51.0 ± 11.6% in cases with VA vs. 55.5 ± 8.5% in controls (P = 0.10). Cases had a larger mean BZ mass and more often BZ channels compared to controls [BZ mass: 17.2 ± 10.3 g vs. 10.3 ± 6.0 g; P = 0.0002; BZ channels: 17 (80%) vs. 44 (42%); P = 0.001]. A combination of ≥17.2 g BZ mass and the presence of BZ channels was five times more prevalent in cases vs. controls (P ≤ 0.00001) with an odds ratio of 9.40 (95% confidence interval 3.26-27.13; P ≤ 0.0001) for VA. This identified cases with 52% sensitivity and 90% specificity. CONCLUSION(S): Scar characterization with CMR indicates that a combination of ≥17.2 g BZ mass and the presence of BZ channels had the strongest association with subsequent VA in STEMI patients. CLINICALTRIALS.GOV: Unique identifier: NCT01435408 (DANAMI 3-iPOST and DANAMI 3-DEFER), NCT01960933 (DANAMI 3-PRIMULTI), and NCT01977755 (Danegaptide).

Long-term risk of new-onset arrhythmia in ST-segment elevation myocardial infarction according to revascularization status.

AIMS: Emerging data show that complete revascularization (CR) reduces cardiovascular death and recurrent myocardial infarction in ST-segment elevation myocardial infarction (STEMI). However, the influence of revascularization status on development of arrhythmia in the long-term post-STEMI phase is poorly described. We hypothesized that incomplete revascularization (ICR) compared with CR in STEMI is associated with an increased long-term risk of new-onset arrhythmia. METHODS AND RESULTS: Patients with STEMI treated with primary percutaneous coronary intervention (PPCI) at Copenhagen University Hospital, Rigshospitalet, Denmark, with CR or ICR were identified via the Eastern Danish Heart registry from 2009 to 2016. Using unique Danish administrative registries, the outcomes were assessed. The primary outcome was new-onset arrhythmia defined as a composite of atrial fibrillation/flutter (AF), sinoatrial block, advanced second- or third-degree atrioventricular block, ventricular tachycardia/fibrillation (VT), or cardiac arrest (CA), with presentation >7 days post-PPCI. Secondary outcomes were the components of the primary outcome and all-cause mortality. A total of 5103 patients (median age: 62.0 years; 76% men) were included, of whom 4009 (79%) and 1094 (21%) patients underwent CR and ICR, respectively. Compared with CR, ICR was associated with a higher risk of new-onset arrhythmia [hazard ratio (HR), 1.33; 95% confidence interval (CI), 1.07-1.66; P = 0.01], AF (HR, 1.29; 95% CI, 1.00-1.66; P = 0.05), a combined outcome of VT and CA (HR, 1.77; 95% CI, 1.10-2.84; P = 0.02) and all-cause mortality (HR, 1.27; 95% CI, 1.05-1.53; P = 0.01). All HRs adjusted. CONCLUSION: Among patients with STEMI, ICR was associated with an increased long-term risk of new-onset arrhythmia and all-cause mortality compared with CR.

Severity of Brugada syndrome disease manifestation and risk of new-onset depression or anxiety: a Danish nationwide study.

AIMS: Reduced psychological health is associated with adverse patient outcomes and higher mortality. We aimed to examine if a Brugada syndrome (BrS) diagnosis and symptomatic disease presentation were associated with an increased risk of new-onset depression or anxiety and all-cause mortality. METHODS AND RESULTS: All Danish patients diagnosed with BrS (2006-2018) with no history of psychiatric disease and available for ≥6 months follow-up were identified using nationwide registries and followed for up to 5 years after diagnosis. The development of clinical depression or anxiety was evaluated using the prescription of medication and diagnosis codes. Factors associated with developing new-onset depression or anxiety were determined using a multivariate Cox proportional hazards regression model. Disease manifestation was categorized as symptomatic (aborted cardiac arrest, ventricular tachycardia, or syncope) or asymptomatic/unspecified at diagnosis. A total of 223 patients with BrS and no history of psychiatric disease were identified (72.6% male, median age at diagnosis 46 years, 45.3% symptomatic). Of these, 15.7% (35/223) developed new-onset depression or anxiety after BrS diagnosis (median follow-up 5.0 years). A greater proportion of symptomatic patients developed new-onset depression or anxiety compared with asymptomatic patients [21/101 (20.8%) and 14/122 (11.5%), respectively, P = 0.08]. Symptomatic disease presentation (HR 3.43, 1.46-8.05) and older age (lower vs. upper tertile: HR 4.41, 1.42-13.63) were significantly associated with new-onset depression or anxiety. All-cause mortality in this group of patients treated according to guidelines was low (n = 4, 1.8%); however, 3/4 developed depression or anxiety before death. CONCLUSION: Approximately, one-sixth of patients with BrS developed new-onset depression or anxiety following a diagnosis of BrS. Symptomatic BrS disease manifestation was significantly associated with new-onset depression or anxiety.

Comparison of the Anterior Septal Line and Mitral Isthmus Line for Perimitral Atrial Flutter Ablation Using Robotic Magnetic Navigation.

BACKGROUND: Perimitral atrial flutter (PMAFL) is one of the most common macro-reentrant left atrial tachycardias. Mitral isthmus (MI) linear ablation is a common strategy for the treatment of PMAFLs, and anterior septum (AS) linear ablation has emerged as a novel ablation approach. We aimed at assessing the effectiveness of AS linear ablation using robotic magnetic navigation for PMAFL ablation. METHODS: In this retrospective study, a total of 36 consecutive patients presented with AFL as the unique arrhythmia or accompanied with atrial fibrillation (AF) who underwent catheter ablation were enrolled. Patients were classified into two groups according to the different ablation strategies, the MI line group (10 patients) and the AS line group (26 patients). RESULTS: The clinical baseline characteristics of patients in the two groups were nearly identical. There were no significant differences in procedure time (148.7 ± 46.1 vs. 123.2 ± 30.1 min, P=0.058) or radiofrequency ablation time (25.9 ± 11.4 vs. 23.5 ± 12.6 min) between the two groups. Fluoroscopy time was longer in the MI line group (8.0 ± 4.4 vs. 5.1 ± 2.7 min, P=0.024), and the acute success rate was higher in the AS line group versus the MI line group (96.2% vs. 70%, P=0.025). The long-term freedom from arrhythmia survival rate was higher in the AS line group (73%) than in the MI line group (40%) after a mean follow-up time of 37.4 months with a 3-month blanking period (P=0.049). CONCLUSIONS: AS linear ablation is an effective and safe strategy for PMAFL ablation using robotic magnetic navigation.

Validation of the national Danish ablation database: a retrospective, registry-based validation study.

Aim.To validate the National Danish Ablation Database (NDAD) by investigating to what extent data in NDAD correspond to medical records.Type of study. Non-blinded, registry-based, retrospective, validation study. Material and methods. A sample of patients who underwent ablation for atrial fibrillation in Denmark between 1 January 2016 and 31 December 2016 were included. By utilizing medical records as gold standard, positive predictive (PPV) and negative predictive values (NPV) for NDAD were assessed and presented as five main categories: arrhythmia characteristics, demographics, cardiac history, complications, and medication. PPV's and NPV's exceeding 90% were considered as high agreement. Results. 597 patients (71.0% males) were included in the study. Median age was 63.1 (IQR: 54.9-68.4) years. The median PPV and NPV estimates across all variables were respectively 90.4% (95% CI: 68%-95.2%) (PPV) and 99.4% (95% CI: 98.4%-99.8%) (NPV) at baseline, and 91.7% (95% CI: 67.4%-95.4%) (PPV) and 99.3% (98.2%-99.3%) (NPV) at follow-up. Conclusion. The data registered in NDAD agrees to a great extent with the patients' medical records, suggesting NDAD is a database with high validity. As a result of low complication rate, the PPV- and NPV-estimates among complication variables were prone to somewhat greater uncertainty compared to the rest.

Risk of arrhythmias after myocardial infarction in patients with left ventricular systolic dysfunction according to mode of revascularization: a Cardiac Arrhythmias and RIsk Stratification after Myocardial infArction (CARISMA) substudy.

AIMS: The Cardiac Arrhythmias and RIsk Stratification after Myocardial infArction (CARISMA) study was an observational trial including 312 patients with acute myocardial infarction (MI) and left ventricular ejection fraction (LVEF) <40%. Primary percutaneous intervention (pPCI) was introduced 2 years after start of the enrolment, dividing the population into two groups: pre- and post-pPCI. This substudy sought to describe the influence of the mode of revascularization on long-term risk of new-onset atrial fibrillation (AF), bradyarrhythmia, and ventricular tachycardia and the subsequent risk of relevant major cardiovascular events (MACE). METHODS AND RESULTS: The study included the 268 patients without a history of AF. All patients received an implantable cardiac monitor (ICM) and were followed for 2 years. The choice of revascularization was made by the treating team independently of the trial and retrospectively divided into pPCI, subacute PCI, primary thrombolysis, or no revascularization. Endpoints were new-onset arrhythmia and MACE.A total of 77 patients received no revascularization, whereas 49 received thrombolysis only and 142 received any PCI. The adjusted hazard ratio (HR) for developing any arrhythmia and the subsequently risk of MACE were increased in non-revascularized or thrombolysed patients compared with PCI-patients (any arrhythmia, non-revascularization: HR = 1.7, P = 0.01 and thrombolysis: HR = 1.6, P = 0.05; MACE, non-revascularization: HR = 3.1, P = 0.05 and thrombolysis: HR = 3.1, P = 0.08). All HRs were adjusted for significant baseline and clinically considered covariates and stratified for calendar year. CONCLUSION: This study is the first to demonstrate that the long-term risk of arrhythmia documented by an ICM and the subsequent risk of MACE were increased in non-revascularized or thrombolysed patients compared with PCI-patients in a post-MI population with LVEF <40%.

Cardiac arrhythmias in critically ill patients with coronavirus disease 2019: A retrospective population-based cohort study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) may be associated with cardiac arrhythmias in hospitalized patients, but data from the ICU setting are limited. We aimed to describe the epidemiology of cardiac arrhythmias in ICU patients with COVID-19. METHODS: We conducted a multicenter, retrospective cohort study including all ICU patients with an airway sample positive for severe acute respiratory syndrome corona-virus 2 from March 1st to June 1st in the Capital Region of Denmark (1.8 million inhabitants). We registered cardiac arrhythmias in ICU, potential risk factors, interventions used in ICU and outcomes. RESULTS: From the seven ICUs we included 155 patients with COVID-19. The incidence of cardiac arrhythmias in the ICU was 57/155 (37%, 95% confidence interval 30-45), and 39/57 (68%) of these patients had this as new-onset arrhythmia. Previous history of tachyarrhythmias and higher disease severity at ICU admission were associated with cardiac arrhythmias in the adjusted analysis. Fifty-four of the 57 (95%) patients had supraventricular origin of the arrhythmia, 39/57 (68%) received at least one intervention against arrhythmia (eg amiodarone, IV fluid or magnesium) and 38/57 (67%) had recurrent episodes of arrhythmia in ICU. Patients with arrhythmias in ICU had higher 60-day mortality (63%) as compared to those without arrhythmias (39%). CONCLUSION: New-onset supraventricular arrhythmias were frequent in ICU patients with COVID-19 and were related to previous history of tachyarrhythmias and severity of the acute disease. The mortality was high in these patients despite the frequent use of interventions against arrhythmias.

Transmission and loss of ECG snapshots: Remote monitoring in implantable cardiac monitors.

INTRODUCTION: Remote monitoring including transmission of electrocardiogram (ECG) strips has been implemented in implantable cardiac monitors (ICM). We appraise whether the physician can rely on remote monitoring to be informed of all possibly significant arrhythmias. METHODS: We analyzed remote monitoring transmissions of patients in the ongoing BIO|GUARD-MI study, in which Biotronik devices are used. Once per day, the devices automatically transmit messages with up to six ECG snapshots to the Home Monitoring Service Center. If more than one type of arrhythmia is recorded during a day, at least one ECG of each arrhythmia type is transmitted. RESULTS: 212 study patients were registered at the service center. The mean age of the patients was 70 ±â€¯8 years, and 74% were male. Patients were followed for an average of 13 months. The median time from device implantation until the first message receipt in the service center was 2 days. The median patient-individual transmission success was 98.0% (IQR 93.6-99.8) and remained stable in the second and third year. The most frequent arrhythmias were atrial fibrillation, bradycardia and high ventricular rate. 17.3% of the messages with ECG snapshots contained more than one arrhythmia type. DISCUSSION: Our analysis confirms that the physician can rely on Home Monitoring to be informed of all possibly significant arrhythmias during long-term follow-up. We have found hints that the transmission of only one episode per day may lead to the loss of clinically relevant information if patients with ICMs are followed by remote monitoring only.

Catheter ablation of incisional atrial tachycardia using remote magnetic navigation in patients after heart surgery: comparison between acquired and congenital heart disease.

Aims: The objectives of this study were to assess the acute and long-term outcomes of catheter ablation in incisional atrial tachycardia (IAT) using remote magnetic navigation (RMN) in patients after heart surgery. Methods and results: A total of 46 patients with IAT after heart surgery who underwent catheter ablation using RMN were included. Of these patients, 22 patients had acquired heart disease (AHD) and the remaining 24 patients had various types of congenital heart disease (CHD). In these 46 patients, 57 re-entry circuits were found in 56 procedures. The re-entry circuits were mainly distributed in right atrium (RA). Acute success of first ablation reached in 42 of 46 (91%) patients. Mean procedure duration was 115 ± 39 min, ablation duration was 678 (920.5) s, X-ray time was 4 (4.8) min, and X-ray dose was 3 (6.0) gy cm2. After a mean follow-up of 28 ± 19 months, 39 of 46 (85%) patients were free from IAT. No major complications were observed. There were no significant differences in procedure durations (AHD 113 ± 40 min vs. CHD 119 ± 38 min), ablation durations [AHD 643 (1027) s vs. CHD 712 (929) s], X-ray time [AHD 4 (4.5) min vs. CHD 4 (5.0) min], circuits in RA (AHD 85% vs. CHD 86%), acute success rates (AHD 91% vs. CHD 92%), and long-term success rates (AHD 86% vs. CHD 83%) between the two groups (P > 0.05). Conclusion: Catheter ablation of IAT in patients after heart surgery using RMN is safe and effective. No significant differences related to success rates and procedure characteristics were found between patients with AHD and CHD.

Initial experience of a novel mapping system combined with remote magnetic navigation in the catheter ablation of atrial fibrillation.

BACKGROUND: There have been advancements of sophisticated mapping systems used for ablation procedures over the last decade. Utilization of these novel mapping systems in combination with remote magnetic navigation (RMN) needs to be established. We investigated the new EnSite Precision mapping system (St. Jude Medical, Inc., St. Paul, MN, USA), which collects magnetic data for checking navigation field stability and is built on an open platform, allowing physicians to choose diagnostic and ablation catheters. We address its compatibility with RMN. OBJECTIVE: To assess the clinical utility of a novel 3D mapping system (EnSite Precision mapping system) combined with RMN (Niobe ES, Stereotaxis, Inc., St. Louis, MO, USA) for atrial fibrillation (AF) ablation. METHODS: In this prospective nonrandomized study, two groups of patients were treated in our center for drug refractory AF. Patients were consecutively enrolled in each group. Group A (n = 35, 14 persistent AF [PsAF]) was treated using the novel 3D mapping system combined with RMN. Group B (n = 38, 16 PsAF) was treated using Carto® 3 (Biosense Webster, Inc., Diamond Bar, CA, USA) combined with RMN. In Group A, the left atrium (LA) was mapped with a circular magnetic catheter manually and was then replaced by a RMN ablation catheter. At the end of the procedures in Group A, the circular catheter was used for confirming field stability. In Group B, an ablation catheter was controlled by RMN to perform both LA mapping and ablation. All patients underwent pulmonary vein antrum isolation. Additional complex fractionated atrial electrograms (CFAEs) ablation was performed for PsAF. Procedural, ablation, and fluoroscopy times were recorded and complications were assessed. RESULTS: Electrophysiological end points were achieved in all patients. Using the novel mapping system, LA mapping time was fast (308 ± 60 seconds) with detailed anatomy points (178,831 ± 70,897) collected and magnetic points throughout LA. At the end of the procedures in Group A, the LA model was confirmed to be stable and its location was within the distance threshold (1 mm). Procedure time (117.9 ± 29.6 minutes vs. 119.2 ± 29.7 minutes, P = 0.89), fluoroscopy time (6.1 ± 2.4 minutes vs. 4.8 ± 2.2 minutes, P = 0.07), and ablation time (28.0 ± 12.9 minutes vs. 27.9 ± 15.8 minutes, P = 0.98) were similar in Group A versus Group B, respectively. No complications occurred in either group. CONCLUSIONS: LA mapped by the novel system is stable and reliable. Combined with RMN, it could be effectively used for AF ablation without impacting overall procedural times.

Efficacy and Safety of Atrial Fibrillation Ablation Using Remote Magnetic Navigation: Experience from 1,006 Procedures.

BACKGROUND: The objective of this study was to assess the procedural outcomes of catheter ablation guided by remote magnetic navigation (RMN) in a large cohort of patients with paroxysmal trial fibrillation (PAF) and persistent AF (PerAF). METHODS: A total of 726 patients (547 male, age: 58.5 ± 10.3 years) with symptomatic AF (61% PAF) were analyzed from a prospective ablation registry. Procedural parameters including pulmonary venous (PV) anatomy, left atrial (LA) volume, procedural time, ablation time, fluoroscopy time, total X-ray dose, and complications were assessed. RESULTS: One thousand and six ablation procedures were analyzed. One-third of the patients (240/726) were ablated on more than one occasion, resulting in a mean of 1.3 ± 0.6 times for the entire group. When analyzing all procedures, the mean procedural time and ablation time was 134 ± 35 minutes and 2,130 ± 1,025 seconds, respectively. The mean fluoroscopy time was 5.4 ± 3.7 minutes. Compared to PAF patients, procedural time and ablation time were significantly increased in patients with PerAF by 10% (P < 0.001) and 19% (P < 0.001), respectively. However, fluoroscopy time was not increased (5.3 ± 3.5 minutes, PAF vs. 5.6 ± 4.0 minutes, PerAF, P = 0.17). The overall complication rate was 0.6%. One PAF patient experienced cardiac tamponade. AF repeat ablations by RMN significantly reduced the procedural and ablation times when compared with their first ablation times. CONCLUSIONS: AF ablation guided by RMN is safe as evidenced by a low complication rate. Fluoroscopy time was relatively short for both PAF and PerAF ablation.

Additive prognostic value of plasma N-terminal pro-brain natriuretic peptide and coronary artery calcification for cardiovascular events and mortality in asymptomatic patients with type 2 diabetes.

BACKGROUND: In patients with type 2 diabetes, cardiovascular disease (CVD) is the major cause of morbidity and mortality. We evaluated the combination of NT-proBNP and coronary artery calcium score (CAC) for prediction of combined fatal and non-fatal CVD and mortality in patients with type 2 diabetes and microalbuminuria (>30 mg/24-h), but without known coronary artery disease. Moreover, we assessed the predictive value of a predefined categorisation of patients into a high- and low-risk group at baseline. METHODS: Prospective study including 200 patients. All received intensive multifactorial treatment. Patients with baseline NT-proBNP > 45.2 ng/L and/or CAC ≥ 400 were stratified as high-risk patients (n = 133). Occurrence of fatal- and nonfatal CVD (n = 40) and mortality (n = 26), was traced after 6.1 years (median). RESULTS: High-risk patients had a higher risk of the composite CVD endpoint (adjusted hazard ratio [HR] 10.6 (95 % confidence interval [CI] 2.4-46.3); p = 0.002) and mortality (adjusted HR 5.3 (95 % CI 1.2-24.0); p = 0.032) compared to low-risk patients. In adjusted continuous analysis, both higher NT-proBNP and CAC were strong predictors of the composite CVD endpoint and mortality (p ≤ 0.0001). In fully adjusted models mutually including NT-proBNP and CAC, both risk factors remained associated with risk of CVD and mortality (p ≤ 0.022). There was no interaction between NT-proBNP and CAC for the examined endpoints (p ≥ 0.31). CONCLUSIONS: In patients with type 2 diabetes and microalbuminuria but without known coronary artery disease, NT-proBNP and CAC were strongly associated with fatal and nonfatal CVD, as well as with mortality. Their additive prognostic capability holds promise for identification of patients at high risk.

Mapping strategy for multiple atrial tachyarrhythmias in a transplant heart.

BACKGROUND: Different atrial arrhythmias can coexist in the recipient and donor atria after heart transplantation. CASE PRESENTATION: We report an unusual case of a patient with three different types of atrial arrhythmia after heart transplantation: an atrial fibrillation in the recipient atria, and a cavotricuspid isthmus dependent atrial flutter and a focal atrial tachycardia in the donor atria. 3D electroanatomical mapping and ablation were guided by remote magnetic navigation (RMN). Atrial fibrillation continued in the recipient atria even after the donor heart was converted to sinus rhythm by ablation. CONCLUSIONS: It is critical to understand the surgical anatomy of a bi-atrial anastomosis and its relevant electrical activation pattern before ablation. Appropriate electroanatomical mapping strategy with RMN can facilitate the successful ablation of post-transplant atrial arrhythmias.

Asymptomatic children with ventricular pre-excitation/WPW pattern.

Paediatric patients with ventricular pre-excitation/asymptomatic WPW syndrome have a higher risk of atrial fibrillation degenerating into ventricular fibrillation and sudden cardiac death (SCD). In more than half of these patients this can be the first symptom presenting. Hence, it is important to conduct a risk stratification for SCD in asymptomatic patients with pre-excitation/delta wave in the ECGs. In this review, invasive risk stratification by electrophysiologic testing and ablation is recommended when possible. Catheter ablation is reported to have a high rate of success and low risk of complications.

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

BACKGROUND: 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. METHODS: 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. RESULTS: Overall, 2998 patients (mean age 61.8 ± 12.7 years, 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. CONCLUSION: One in eight ICD recipients received appropriate shock 2-7 years 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.

Long-term adherence to a wearable for continuous behavioural activity measuring in the SafeHeart implantable cardioverter defibrillator population.

Aims: Wearable health technologies are increasingly popular. Yet, wearable monitoring only works when devices are worn as intended, and adherence reporting lacks standardization. In this study, we aimed to explore the long-term adherence to a wrist-worn activity tracker in the prospective SafeHeart study and identify patient characteristics associated with adherence. Methods and results: This study enrolled 303 participants, instructed to wear a wrist-worn accelerometer day and night for 6 months. Long-term adherence was defined as valid days (≥22 h of wear time) divided by expected days, and daily adherence as mean hours of wear time per 24 h period. Optimal, moderate, and low long-term and daily adherence groups were defined as long-term adherence above or below 95 and 75% and daily adherence above or below 90 and 75%. Regression models were used to identify patient characteristics associated with long-term adherence. In total, 296 participants [median age 64 years; interquartile range (IQR) 57-72; 19% female] were found eligible, yielding 44 003 days for analysis. The median long-term adherence was 88.2% (IQR 74.6-96.5%). A total of 83 (28%), 127 (42.9%), and 86 (29.1%) participants had optimal, moderate, and low long-term adherence, and 163 (55.1%), 87 (29.4%), and 46 (15.5%) had optimal, moderate, and low daily adherence, respectively. Age and smoking habits differed significantly between adherence levels, and increasing changeover intervals improved the degree of long-term adherence. Conclusion: Long-term adherence to a wearable activity tracker was 88.2% over a 6-month period. Older age and longer changeover interval were positively associated with long-term adherence. This serves as a benchmark for future studies that rely on wearable devices. Trial registration number: The National Trial Registration number: NL9218 (https://onderzoekmetmensen.nl/).

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.

Association between obstructive coronary disease and diabetic retinopathy: Cross-sectional study of coronary angiotomography and multimodal retinal imaging.

AIMS: To investigate the association between diabetic retinopathy (DR) and coronary artery disease (CAD) using coronary angiotomography (CCTA) and multimodal retinal imaging (MMRI) with ultra-widefield retinography and optical coherence tomography angiography and structural domain. METHODS: Single-center, cross-sectional, single-blind. Patients with diabetes who had undergone CCTA underwent MMRI. Uni and multivariate analysis were used to assess the association between CAD and DR and to identify variables independently associated with DR. RESULTS: We included 171 patients, 87 CAD and 84 non-CAD. Most CAD patients were males (74 % vs 38 %, P < 0.01), insulin users (52 % vs 38 %, p < 0.01) and revascularized (64 %). They had a higher prevalence of DR (48 % vs 22 %, p = 0.01), microaneurysms (25 % vs 13 %, p = 0.04), intraretinal cysts (22 % vs 8 %, p = 0.01) and areas of reduced capillary density (46 % vs 20 %, p < 0.01). CAD patients also had lower mean vascular density (MVD) (15.7 % vs 16.5,%, p = 0.049) and foveal avascular zone (FAZ) circularity (0.64 ± 0.1 vs 0.69 ± 0.1, p = 0.04). There were significant and negative correlations between Duke coronary score and MVD (r = -0.189; p = 0.03) and FAZ circularity (r = -0,206; p = 0.02). CAD, DM duration and insulin use independently associated with DR. CONCLUSIONS: CAD patients had higher prevalence of DR and lower MVD. CAD, DM duration and insulin use were independently associated with DR.

Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial.

Objectives: Cardiac arrhythmias predict poor outcome after myocardial infarction (MI). We studied if arrhythmia monitoring with an insertable cardiac monitor (ICM) can improve treatment and outcome. Design: BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment. Setting: Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians. Participants: Patients after ST-elevation (STEMI) or non-ST-elevation MI with an ejection fraction >35% and a CHA2DS2-VASc score ≥4 (men) or ≥5 (women). Interventions: Patients were randomly assigned to receive or not receive an ICM in addition to standard post-MI treatment. Device-detected arrhythmias triggered immediate guideline recommended therapy changes via remote monitoring. Main outcome measures: MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes. Results: 790 patients (mean age 71 years, 72% male, 51% non-STEMI) of planned 1,400 pts were enrolled and followed for a median of 31.6 months. At 2 years, 39.4% of the device group and 6.7% of the control group had their therapy adapted for an arrhythmia [hazard ratio (HR) = 5.9, P < 0.0001]. Most frequent arrhythmias were atrial fibrillation, pauses and bradycardia. The use of an ICM did not improve outcome in the entire cohort (HR = 0.84, 95%-CI: 0.65-1.10; P = 0.21). In secondary analysis, a statistically significant interaction of the type of infarction suggests a benefit in the pre-specified non-STEMI subgroup. Risk factor analysis indicates that this may be connected to the higher incidence of MACE in patients with non-STEMI. Conclusions: The burden of asymptomatic but actionable arrhythmias is large in post-infarction patients. However, arrhythmia monitoring with an ICM did not improve outcome in the entire cohort. Post-hoc analysis suggests that it may be beneficial in non-STEMI patients or other high-risk subgroups. Clinical Trial Registration: [https://www.clinicaltrials.gov/ct2/show/NCT02341534], NCT02341534.