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Introduction: English yew is an evergreen conifer frequently planted in household gardens and, when ingested in large doses, results in severe cardiotoxicity characterized by difficult to control ventricular arrhythmias with high rates of mortality. Case report: A previously healthy teenage female presented as an out-of-hospital cardiac arrest with refractory ventricular arrhythmias and severe biventricular dysfunction. Due to rapid deterioration in her clinical status, she was cannulated onto venoarterial extracorporeal membrane oxygenation (ECMO) which resulted in rapid normalization of her rhythm and ventricular function. Discussion: Our case highlights the importance of keeping a broad differential diagnosis when considering etiologies of ventricular arrhythmias in the pediatric population. The final diagnosis was not made until after discharge and implantable cardiac defibrillator (ICD) placement. Conclusion: The delayed diagnosis of this intentional English yew ingestion ultimately resulted subsequent ICD removal. Early ECMO activation in cases of English yew toxicity can be essential for patient survival. [ABSTRACT FROM AUTHOR]

Purpose: Wideband phase‐sensitive inversion recovery (PSIR) late gadolinium enhancement (LGE) enables myocardial scar imaging in implantable cardioverter defibrillators (ICD) patients, mitigating hyperintensity artifacts. To address subendocardial scar visibility challenges, a 2D breath‐hold single‐shot electrocardiography‐triggered black‐blood (BB) LGE sequence was integrated with wideband imaging, enhancing scar‐blood contrast. Methods: Wideband BB, with increased bandwidth in the inversion pulse (0.8–3.8 kHz) and T2 preparation refocusing pulses (1.6–5.0 kHz), was compared with conventional and wideband PSIR, and conventional BB, in a phantom and sheep with and without ICD, and in six patients with cardiac devices and known myocardial injury. ICD artifact extent was quantified in the phantom and specific absorption rate (SAR) was reported for each sequence. Image contrast ratios were analyzed in both phantom and animal experiments. Expert radiologists assessed image quality, artifact severity, and scar segments in patients and sheep. Additionally, histology was performed on the sheep's heart. Results: In the phantom, wideband BB reduced ICD artifacts by 62% compared to conventional BB while substantially improving scar‐blood contrast, but with a SAR more than 24 times that of wideband PSIR. Similarly, the animal study demonstrated a considerable increase in scar‐blood contrast with wideband BB, with superior scar detection compared with wideband PSIR, the latter confirmed by histology. In alignment with the animal study, wideband BB successfully eliminated severe ICD hyperintensity artifacts in all patients, surpassing wideband PSIR in image quality and scar detection. Conclusion: Wideband BB may play a crucial role in imaging ICD patients, offering images with reduced ICD artifacts and enhanced scar detection. [ABSTRACT FROM AUTHOR]

The "5 gauss line" is a phrase that is likely to be familiar to everyone working with MRI, but what is its significance, how was it defined, and what changes are currently in progress? This review explores the history of 5 gauss (0.5 mT) as a threshold for protecting against inadvertently putting cardiac pacemakers, implantable cardioverter defibrillators, and other active implantable medical devices into a "magnet mode." Additionally, it describes the background to the recent change of this threshold to 9 gauss (0.9 mT) in the International Standard IEC 60601‐2‐33 edition 4.0 that defines basic safety requirements for MRI. Practical implications of this change and some ongoing and emerging issues are also discussed. [ABSTRACT FROM AUTHOR]

Background: Patient education is a crucial strategy for promoting prevention and diabetes self-management since glycemic control achievement involves taking medications, medical nutrition therapy, physical exercise, and behavior changes. However, patient education programs are still barely implemented in low- and middle-income countries. This trial aims to investigate whether a lifestyle education intervention added to physical exercising is superior to sole physical exercising regarding functional capacity, disease-related knowledge, health behaviors, cardiometabolic health parameters, quality of life, depression, and diet quality in individuals with prediabetes or diabetes. Methods: Multicenter double-blinded randomized controlled trial with two parallel arms involving 12-week intervention and 6-month follow-up. The eligible individuals (≥ 18 years, living with prediabetes or diabetes, literate, no clinical decompensation and/or physical and/or mental limitations that contraindicate physical exercising, written physician permission for exercise, no cognitive impairment, no vision limitations for reading, no confirmed diagnosis of unstable coronary disease or heart failure, no pacemaker and/or implantable cardioverter-defibrillator, no complex ventricular arrhythmias, no intermittent claudication, no recent cardiovascular event or cardiac surgery, and no currently enrolled in a structured exercise program) were recruited from two Brazilian cities and randomized to either (1) an Exercise and Lifestyle Education Program (ExLE) or (2) an Exercise Program (Ex), which can be delivered on-site or remotely based on the participants' internet access and technology literacy. The primary outcomes will be changes in functional capacity and disease-related knowledge. The secondary outcomes will involve changes in health behaviors (health literacy, physical activity level, exercise self-efficacy, and medication adherence) and cardiometabolic health parameters (glycemic control, anthropometric measures, and cardiac autonomic control). Program adherence, satisfaction with the program, diabetes-related morbidity, and changes in quality of life, depression, and diet quality will be the tertiary outcomes. Assessments will occur at baseline, post-intervention, and after 6-month follow-up. Discussion: If superior effectiveness of ExLE compared to Ex program to improve the outcomes measures is found, this program could be delivered broadly in the Brazilian health system, especially in the primary care facilities where most individuals living with prediabetes and diabetes in our country are assisted. Trial registration: ClinicalTrials.gov, NCT03914924. Registered on April 16, 2019. [ABSTRACT FROM AUTHOR]

BACKGROUND The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICI) cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacingis safe remains unknown. METHODS We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 8696. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 8890) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 8096). RESULTS We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (*SD) left ventricular ejection fraction was 33.1112.6%. The percentage of patients who were free from leadless pacemakerrelated major complications was 9Z5°/o, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.496) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3°/0, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.996); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. CONCLUSIONS The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadiess pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.). [ABSTRACT FROM AUTHOR]

Introduction: Infection is a significant complication of cardiac implantable electronic device (CIED) therapy. The European TauroPace™ Registry investigates the safety and efficacy of TauroPace™ (TP), an antimicrobial solution containing taurolidine, designed to prevent CIED infections. Methods: This multicenter study included patients undergoing CIED procedures at participating centers where TP was used as a disinfectant for external hardware surfaces and an antiseptic for irrigating surgical sites. All patients eligible for CIED placement with adjunctive TP as the standard of care were included. Other aspects of CIED procedures adhered to current guidelines. Data on CIED-related infective endocarditis, CIED pocket infection, device and procedure-related complications, adverse events, and all-cause mortality were prospectively collected for 12 months. In cases of revision, the previous procedure was censored, and a new procedure was created. Binomial and Kaplan–Meier statistics were employed to analyze event rates. Results: From January 2020 to November 2022, TP was used in 822 out of 1170 CIED procedures. Among patients who completed the 3-month follow-up, no CIED pocket infections were observed, and one case of CIED-related infective endocarditis was reported. In the 12-month follow-up cohort, two additional local pocket CIED infections were observed, resulting in a total of three major CIED infections within 1 year after the CIED placement procedure. The 3-month and 12-month major CIED infection rates were 0.125% and 0.51%, respectively. During the observation a complication rate of 4.4% was reported. No adverse events related to TP were observed. Conclusions: TP appears to be effective and safe in preventing CIED infections. ClinicalTrials.gov Identifier: NCT04735666. [ABSTRACT FROM AUTHOR]

Background Purpose Methods Results Conclusions Stereotactic arrhythmia radioablation (STAR) is a novel treatment approach for refractory ventricular tachycardia (VT). The risk of treatment‐induced toxicity and geographic miss can be reduced with online MRI‐guidance on an MR‐linac. However, most VT patients carry cardiac implantable electronic devices (CIED), which compromise MR images.Robust MR‐linac imaging sequences are required for cardiac visualization and accurate motion monitoring in presence of a CIED during MRI‐guided STAR. We optimized two clinically available cine sequences for cardiorespiratory motion estimation in presence of a CIED on a 1.5 T MR‐linac. The image quality, motion estimation accuracy, and geometric fidelity using these cine sequences were evaluated.Clinically available 2D balanced steady‐state free precession (bSSFP, voxel size = 3.0 ×$\times$ 3.0 ×$\times$ 10 mm3, Tscan = 96 ms, bandwidth (BW) = 1884 Hz/px) and T1${\rm T}_{1}$‐spoiled gradient echo (T1${\rm T}_{1}$‐GRE, voxel size = 4.0 ×$ \times$ 4.0 ×$ \times$ 10 mm3, Tscan = 97 ms, BW = 500 Hz/px) sequences were adjusted for real‐time cardiac visualization and cardiorespiratory motion estimation on a 1.5 T Unity MR‐linac (Elekta AB, Stockholm, Sweden), while complying with safety guidelines for MRI in presence of CIEDs (specific absorption rate <$ <$ 2 W/kg and dBdt<$\frac{dB}{dt}<$ 80 mT/s). Cine acquisitions were performed in five healthy volunteers, with and without an implantable cardioverter– defibrillator (ICD) placed on the clavicle, and a VT patient. Generalized divergence‐curl (GDC) deformable image registration (DIR) was used for automated landmark motion estimation in the left ventricle (LV). Gaussian processes (GP), a machine‐learning technique, was trained using GDC landmarks and deployed for real‐time cardiorespiratory motion prediction. B0$B_{0}$‐mapping was performed to assess geometric image fidelity in the presence of CIEDs.CIEDs introduced banding artifacts partially obscuring cardiac structures in bSSFP acquisitions. In contrast, the T1${\rm T}_{1}$‐GRE was more robust to CIED‐induced artifacts at the expense of a lower signal‐to‐noise ratio. In presence of an ICD, image‐based cardiorespiratory motion estimation was possible for 85% (100%) of the volunteers using the bSSFP (T1${\rm T}_{1}$‐GRE) sequence. The in‐plane 2D root‐mean‐squared deviation (RMSD) range between GDC‐derived landmarks and manual annotations using the bSSFP (T1‐GRE) sequence was 3.1–3.3 (3.3–4.1) mm without ICD and 4.6–4.6 (3.2–3.3) mm with ICD. Without ICD, the RMSD between the GP‐predictions and GDC‐derived landmarks ranged between 0.9 and 2.2 mm (1.3–3.0 mm) for the bSSFP (T1‐GRE) sequence. With ICD, the RMSD between the GP‐predictions and GDC‐derived landmarks ranged between 1.3 and 2.2 mm (1.2–3.2 mm) using the bSSFP (T1‐GRE) sequence resulting in an RMSD‐increase of 42%–143% (bSSFP) and −61%–142% (T1‐GRE). Lead‐induced spatial distortions ranged between −0.2 and 0.2 mm (−0.7–1.2 mm) using the bSSFP (T1${\rm T}_{1}$‐GRE) sequence. The 98th percentile range of the spatial distortions in the gross target volume of the patient was between 0.0 and 0.4 mm (0.0–1.8 mm) when using bSSFP (T1${\rm T}_{1}$‐GRE).Tailored bSSFP and T1${\rm T}_{1}$‐GRE sequences can facilitate real‐time cardiorespiratory estimation using GP trained with GDC‐derived landmarks in the majority of landmark locations in the LV despite the presence of CIEDs. The need for high temporal resolution noticeably reduced achievable spatial resolution of the cine MRIs. However, the effect of the CIED‐induced artifacts is device, patient and sequence dependent and requires specific assessment per case. [ABSTRACT FROM AUTHOR]

Background: Cardiac resynchronization therapy (CRT) is a standard treatment for patients with heart failure and electrical dyssynchrony. Cardiac magnetic resonance (CMR) is the gold standard for assessing left ventricular (LV) function. However, the feasibility of using CMR with active CRT is still uncertain. Purpose: To assess the feasibility of a CRT "off‐on" protocol during CMR and measure the acute effects of CRT interruption on LV function. Methods: Patients underwent CMR before (pre‐CRT) and 6 months after (post‐CRT) an MR‐conditional CRT defibrillator implantation. The post‐CRT scan included two complete sets of cine images, one with inactive (post‐CRTOFF) and one with active CRT (post‐CRTON), maintaining a continuous connection between device and programmer. Results: Out of 29 enrolled patients, 8 (28%) had complete and analyzable post‐CRT data. Unsuccessful procedures were attributed to connection problems between the CRT device and the programmer (n = 10), poor image quality (n = 7), and lack of patient cooperation (n = 4). LV ejection fraction significantly increased between pre‐CRT scan (28.1%) and both post‐CRTOFF (37.9%; p = 0.046) and post‐CRTON CMR (35.0%; p = 0.037), with a nonstatistically significant trend toward decreased LV volumes. No adverse events or significant changes in device electrical parameters (including battery level) were detected during the post‐CMR scan period. Conclusion: A CRT "off‐on" protocol during CMR studies can be safely executed in patients with an MR‐conditional CRT defibrillator. However, technical improvements are needed to facilitate high‐quality scans during active CRT. Favorable changes in LV function induced by CRT remodeling were not acutely reversed with the interruption of electrical therapy. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Conventional transvenous implantable cardioverter‐defibrillator (TV‐ICD) is the standard device used for primary prevention of sudden cardiac death (SCD) in patients with reduced left ventricular ejection fraction (LVEF). Nonetheless its use is associated with lead‐related complications including infection and malfunction. A subcutaneous implantable cardioverter‐defibrillator (S‐ICD) offers an alternative option without the need for a transvenous lead but has limitations. The decision to implant a TV‐ICD or S‐ICD in patients with impaired LVEF for primary prevention of SCD is controversial. Several randomised controlled trials and large observational studies have confirmed similar safety and efficacy of S‐ICDs and TV‐ICDs in such population. Methods: A literature review was conducted to compare the outcomes of subcutaneous (S‐ICD) versus transvenous (TV‐ICD) implantable cardioverter‐defibrillators. Databases including PubMed, MEDLINE, and Cochrane were searched for relevant peer‐reviewed articles. Studies were selected based on relevance and quality. Key outcomes like complication rates, efficacy, and patient survival were summarized in a comparative table. Results: Different factors that influence the choice between an TV‐ICD and S‐ICD for primary prevention of SCD in patients with LVEF are highlighted to guide selection of the appropriate device in different patient populations. Moreover, future perspective on the combination of SICD with leadless pacemaker, and the latest development of the extravascular implantable cardioverter defibrillator are also discussed. Conclusions: S‐ICD offers a safe and efficacious option to primary prevention in reduced ejection fraction. Future development including incorporation of leadless pacemaker will add to the arsenal of choice to protect patients from sudden cardiac death. [ABSTRACT FROM AUTHOR]

Background: Transvenous lead extraction (TLE) for cardiovascular implantable electronic device (CIED)‐related infections has increased. The incidence of TLE in nonagenarians is low, with limited reports outlining the outcomes of this procedure. Therefore, in this study, we aimed to clarify the outcomes of TLE in nonagenarians. Methods: Patients with TLE treated at our hospital between 2014 and 2023 were retrospectively examined; patient characteristics, device type, indications, procedures, complications, and clinical data of nonagenarians were analyzed. Results: Of 12 patients with 24 leads (active fixation lead, n = 11; passive fixation lead, n = 13) who underwent TLE, the indication for TLE was infection (pocket infection, n = 8; sepsis, n = 4). Methicillin‐resistant Staphylococcus epidermidis was the most frequently identified causative agent (n = 4). The median patient age was 91 years; five patients were female. The median lead dwell time was 9 years. Excimer laser sheath (16 leads), mechanical sheath (five leads), Evolution RL (one lead), and manual traction (two leads) were employed in TLE. The procedure was successful in all patients, and only one had a minor complication. Six patients required CIED re‐implantation, and leadless pacemakers were selected for five patients. The 30‐day mortality after TLE was 0%. Conclusion: TLE can be safely performed in nonagenarians. The decision to perform TLE should not be based on old age alone; the suitability of removing infected CIEDs should be determined based on each patient's condition. [ABSTRACT FROM AUTHOR]

Background: Heart failure (HF) patients are at constant risk of decompensation, and urgent hospital admissions can be life‐threatening events. Monitoring biological variables has been proved to be an important mechanism to anticipate decompensations. TriageHF is a validated diagnostic algorithm tool available on Medtronic® cardiac implantable electronic devices that combines physiological data to stratify a patient's risk of HF hospitalization in the following 30 days in low, medium or high risk. We aimed to evaluate the utility of TriageHF algorithm to predict the occurrence of acute clinical decompensation events (ACDE), including HF and non‐HF cardiovascular events, within a 30‐day period in a population of HF patients with reduced ejection fraction. Methods: We reviewed the transmissions received by the Medtronic® Carelink™ Network between August 2022 and July 2023. The heart failure risk status (HFRS) and the device parameters contributing to that risk, from the previous 30 days, were collected, along with the occurrence of ACDEs within 30 days. Results: We retrospectively assessed 207 transmissions from the 64 patients included in the study. Among the 93 medium HFRS transmissions, 16 (17.2%) resulted in ACDEs. For the 21 high HFRS transmissions, 10 (47.6%) resulted in ACDEs. Considering the ACDEs, 60.7% were preceded by an alarm‐initiated transmission. Except for heart rate variability, each diagnostic parameter demonstrated effectiveness in stratifying risk for ACDEs. Optivol® and the Combined Heart Rhythm showed independent association with ACDEs (p <.001). Patients with medium and high HFRS were, respectively, 8.6 and 29.1 times more likely to experience an ACDE in the next 30 days than low risk patients. A medium‐high HFRS conferred a sensitivity of 92.9% and a NPV of 97.8% for an ACDE. Conclusion: TriageHF is a useful method for predicting ACDEs and has the potential to trigger medical actions to prevent hospitalizations. [ABSTRACT FROM AUTHOR]

Background: Implantable Cardioverter Defibrillator (ICD) implantation has significantly modified the natural history of patients at high risk of sudden cardiac death (SCD) in various types of heart diseases. However there is a high rate of psychological distress and reduced quality of life in patients with an ICD, more evident in younger individuals. The ICD removal upon patient request is a very rare event and causes many clinical and ethical issues. Methods: The article discusses the case of a young patient affected by hypertrophic obstructive cardiomyopathy, who underwent implantable cardioverter defibrillator (ICD) implantation as a primary prevention of sudden cardiac death (SCD). Two years after the implantation, the patient repeatedly requested removal of the ICD due to of a significant and untreatable psychological device intolerance. Results: Intervention became possible only after extensive psychological evaluation, which excluded specific pathology, and the ratification of Italian law 219/2017 on informed consent and advance directives, which guarantees the patient's independent decisions on current and future medical treatment. The explantation was performed 7 years after the implant. The patient is alive and in good health. Conclusions: The paper debates the issues related to establishing a patient–physician relationship based on respect for the patient's autonomy and experience of illness, in reference to principles such as beneficence and non‐maleficence, and the conflicts that sometimes arise between them. If a paternalistic approach in the patient–physician relationship evolves into a patient‐centered model, it is more certain that the patient's choice is realistically known and shared, and that it is consistent with the patient's values and life goals. The shared decision making (SDM) process and the use of pathology‐specific decision aids are able to transform the informed consent tool, usually related to medical‐legal issues, into an aid for true partnership between the patient and the medical care team. [ABSTRACT FROM AUTHOR]

Introduction: In patients with cardiac sarcoidosis (CS), implantable cardioverter‐defibrillators (ICDs) are important for preventing sudden cardiac death. This study aimed to investigate sex disparities in CS patients undergoing ICD implantation. Methods: The 2016–2020 National Inpatient Sample (NIS) database compared the characteristics and outcomes of males and females with CS receiving ICDs. Results: Among 760 CS patients who underwent inpatient ICD implantation, 66.4% were male. Males were younger (55.0 vs. 56.9 years, p <.01), had higher rates of diabetes (31.7% vs. 21.6%, p <.01) and chronic kidney disease (CKD) (16.8% vs. 7.8%, p <.01) but lower prevalence of atrial fibrillation (AF) (11.9% vs. 23.5%, p <.01), sick sinus syndrome (4.0% vs. 7.8%, p =.024), ventricular fibrillation (VF) (9.9% vs. 15.7%, p =.02), and black ancestry (31.9% vs. 58.0%, p <.01). Unadjusted major adverse cardiovascular events (MACE), defined as a composite of in‐hospital death, myocardial infarction (MI), and ischemic stroke, was higher in females (11.8% vs. 6.9%, p =.024), but when adjusted for age and tCharlson Comorbidity Index (CCI), females demonstrated significantly lower odds of experiencing MACE (aOR: 0.048, 95% CI: 0.006–0.395, p =.005). Incidence of acute kidney injury (AKI) post‐ICD was significantly lower in females (15.7% vs. 23.8%, p =.01) as was the adjusted odds (aOR: 0.282, 95% CI: 0.146–0.546, p <.01). There was comparable mean length of stay and hospital charges. Conclusion: ICD utilization in CS patients is more common among males, who have a higher prevalence of diabetes and CKD but a lower prevalence of AF, sick sinus syndrome, and VF. Adjusted MACE and AKI were significantly lower in females. [ABSTRACT FROM AUTHOR]

Introduction: Transvenous lead extraction (TLE) is generally considered a safe procedure, albeit not without risks. While gender‐based disparities have been noted in short‐term outcomes following TLE, a notable gap exists in understanding the long‐term consequences of this procedure. The objective of this analysis was to investigate sex differences in both acute and long‐term outcomes among patients who underwent TLE at a tertiary referral center. Methods: In this retrospective cohort study, consecutive patients who underwent TLE between January 2014 and January 2016 were enrolled. The primary outcome comprised a composite of all‐cause mortality and need for repeated TLE procedures. Secondary outcomes included fluoroscopy time, lead extraction techniques, success rates, and major and minor complications. Results were compared between female and male cohorts. Results: The study population comprised 191 patients (median age, 70 years), 29 (15.2%) being women and 162 men (84.8%). Study groups had similar baseline characteristics. Complete procedural success was achieved in 189 out of 191 patients (99.0%), with no significant difference observed between the two groups (p =.17). No major complications were reported in the total cohort. However, there was a significantly higher incidence of minor complications in women compared to men (17.2% vs. 2.5%, p <.01). Following a median follow‐up of 6.5 years, the incidence of the primary composite outcome occurred similarly between the study groups (log‐rank p =.68). Conclusion: Women who underwent TLE exhibited a significantly higher incidence of minor acute intra‐ and peri‐procedural complications than men. However, no differences in long‐term outcomes between genders were observed. [ABSTRACT FROM AUTHOR]

Introduction: Early‐onset atrial fibrillation (AF) has already been observed in approximately 2% of patients with genetically proven long QT syndrome (LQTS). This frequency is higher than population‐based estimates of early‐onset AF. However, the concomitant expression of AF in LQTS is likely underestimated. The purpose of this study was to examine the clinical presentation, genetic background, and outcomes of a cohort of patients with LQTS and early‐onset AF referred to a single tertiary center. Methods: Twenty‐seven patients diagnosed with congenital LQTS were included in the study based on the documentation of early‐onset (age ≤50 years) clinical or subclinical AF episodes in all available medical records, including standard electrocardiograms, wearable monitor or cardiac implantable electronic devices. Results: Seventeen patients experienced clinical AF during the follow‐up period. Subclinical AF was detected in 10 patients through insertable or wearable cardiac monitors. In our series, the mean heart rate during AF episodes was found to be relatively low despite the patients' young age and the low or minimal effective doses of beta‐blockers used for QTc interval control. All patients exhibiting LQTS and early‐onset AF were genotype positive, carrying mutations in the KCNQ1 (66%), KCNH2, KCNE1, and SCN5A genes. Notably, most of these patients carried the same p.(R231C) mutation in the KCNQ1 gene (59%) and were from the same families, suggesting concurrent expression of familial AF and LQTS. Conclusion: LQTS patients are prone to developing clinical and subclinical AF, even at a younger age. The occurrence of early‐onset AF in the LQTS population could be more frequent than previously assumed. AF should be considered as a potential dysrhythmia related to LQTS. Our study emphasizes the importance of carefully researching clinical and/or subclinical episodes of AF through strict heart rhythm monitoring in the LQTS population. [ABSTRACT FROM AUTHOR]

Objective: Examine the temporal trends in medical device implant procedures in the Australian population. Methods: We used data from the Australian Institute of Health and Welfare from the financial years 2007–08 to 2021–22 and chose the most frequently performed medical device implant procedures. We estimated the annual change in volume of procedures and age-standardised rates by calculating the compound annual growth rate (CAGR), and used regression with the Newey–West robust variance estimator to examine whether there was a linear trend in the age-standardised rates for each procedure. Results: For procedures including cardiac pacemakers, heart valves, hip and knee arthroplasties, and intraocular lenses, the crude CAGR was over 3%. For the age-standardised rates, the CAGR was largest for cardiac pacemaker, followed by heart valve replacement and hip arthroplasty procedures. For some procedures, the growth was more than in the Australian population, including cardiac pacemakers (β = 1.00; 95% CI: 0.14–1.86), heart valve replacements (β = 0.41; 95% CI: 0.28–0.54), hip arthroplasty (β = 3.50; 95% CI: 1.61–5.38), and knee arthroplasty (β = 4.31; 95% CI: 0.54–8.09) procedures. The trend of standardised rates of procedures, including incisional hernia with mesh, breast implants, coronary stents, and cardiac defibrillators, grew at the same rate as the population, whereas the rate for gastric banding procedures decreased (β = −3.14; 95% CI: −4.92 to −1.34). Conclusion: The findings from the current study, showing a large increase in medical device implant procedures, will assist in future healthcare planning and efforts in post-market surveillance of safety of medical devices. What is known on this topic? Previous studies investigated trends in medical device implants on either a particular medical procedure or total procedures conducted on particular anatomical sites. What this study adds? Unlike previous studies, this study investigates a general population-level trend analysis of all major device implants using the most recent national-level database, covering all hospitals in Australia. What are the implications for practitioners? Findings from this study are useful for future healthcare planning and allocation of resources for the healthcare delivery of necessary healthcare to patients in Australia. In addition, the results can be used to inform efforts to improve post-marked surveillance of medical devices by providing estimates of the volume and standardised rates of procedures for type of devices. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the study was to determine the effect of moderately strenuous aerobic exercise training on heart rate variability (HRV) and heart rate turbulence (HRT) in patients with an implantable cardioverter defibrillator (ICD). Methods: Patients were randomized to a 24-week home-based aerobic exercise (EX) training program (n = 84) or to usual care (UC) (n = 76). All subjects underwent 24-h Holter monitoring at baseline, 8 and 24 weeks. Generalized estimating equations were used to test the effects of exercise on HRV and HRT outcomes. Results: The study group was comprised of n = 160 patients (124 M, 36 F, age 54.9 ± 12.2 years) with an ICD for primary (43%) or secondary prevention (57%). Compared to UC, EX was associated with a significant improvement in parasympathetic HRV for root mean square of successive differences (rMSSD; p =.05) at 8 weeks and global HRV for standard deviation of all normal (N-N) intervals (SDNN; p =.05) and standard deviation of 5-min averages N-N intervals (SDANN; p =.03) at 24 weeks. When stratified by adherence, those who were ≥80% adherent (minutes/week) had significant improvements in parasympathetic HRV (rMSSD, pNN50) and global HRV (SDNN, SDANN) at 8 weeks, and a further significant improvement in global HRV (SDNN, SDANN, SDNN index) at 24 weeks. Neither HRT nor ventricular ectopy changed with exercise training. Conclusion: Moderately strenuous aerobic exercise improved parasympathetic and global HRV indices following an ICD, with greater adherence associated with greater improvements. Clinical trial registration: Clinicaltrials.gov: NCT 00522340. [ABSTRACT FROM AUTHOR]

Heart failure and chronic kidney disease are common and clinically important conditions that regularly coexist. Electrophysiologic changes of advanced heart failure often result in abnormal conduction, causing dyssynchronous contraction, and development of ventricular arrhythmias, which can lead to sudden cardiac arrest. In the last 2 decades, implantable cardioverter-defibrillator and cardiac resynchronization therapy devices have been developed to address these complications. However, when the coexisting chronic kidney disease is advanced, the associated pathophysiologic cardiovascular changes can alter the efficacy and safety of those interventions and complicate the management. This review explores the impact of comorbid advanced heart failure and advanced chronic kidney disease on the efficacy and safety of implantable cardioverter-defibrillator and cardiac resynchronization therapy, the currently available evidence, and potential future directions. [Display omitted] • The efficacy and safety of ICD and CRT devices have not been established for patients with advanced CKD, and available data suggest that they may be less favorable than in patients without advanced CKD. • Factors limiting the effectiveness of these devices in patients with advanced CKD include the frequency of nonshockable arrhythmias, increased defibrillation thresholds, noncapture, myocardial fibrosis, coexisting atrial fibrillation, limited use of guideline-directed therapies for heart failure, and relatively high rates of nonarrhythmic mortality. • Randomized trials are needed to improve selection of patients with advanced CKD for these device-based therapies. [ABSTRACT FROM AUTHOR]

Asymptomatic paroxysmal atrial fibrillation (AF) is often found in patients implanted with cardiac implantable electronic devices (CIEDs). Second-generation atrial antitachycardia pacing (A-ATP) is effective in managing AF in patients implanted with CIEDs. The purpose of this study was to evaluate the efficacy and safety of A-ATP in patients implanted with CIEDs. This was a single-center retrospective study involving 91 patients (male 46 patients, mean age 74 ± 9 years) implanted with Reactive A-ATP equipped devices (84 patients with pacemakers, 6 with ICDs, and 1 with a CRT-D). The AF burden, rate of AF termination, and details of the activation of the A-ATP were analyzed in each patient. During a mean follow-up period of 21 ± 13 months, A-ATP was activated in 45 of 91 patients (49.5%). No patients had adverse events. Although the efficacy of the A-ATP varied among the patients, the median rate of AF termination was 44%. In comparison to the A-ATP start time, "0 min" had a higher AF termination rate by the A-ATP (39.4% vs. 24.4%, P = 0.011). The rate of termination by the A-ATP was high for AF with a long cycle length and a relatively regular rhythm. A-ATP successfully terminated AF episodes in some patients implanted with CIEDs. The optimal settings of the A-ATP will be determined in future studies. [ABSTRACT FROM AUTHOR]

Background and Objectives: Cardiovascular implantable electronic devices can detect atrial high‐rate episodes (AHREs). However, the predictors of clinically relevant AHREs have not been well identified. Methods: This prospective study included 145 patients (median age 64.5 ± 16.4 years, 53.1% females) without atrial fibrillation (AF) from December 2020 to January 2022. AHREs were defined as a programmed atrial detection rate >190 beats per minute. Cox regression analysis was used to identify the risk factors of AHREs. Results: During 6 months of follow‐up, AHREs occurred in 30.3% of patients. Multivariable Cox regression analysis showed factors related to development of AHREs including using anti‐arrhythmic drugs (AAD) before implantation (Hazard ratio (HR) 7.71; 95% confidence interval [95% CI], 2.58–23.02, p <.001), history of paroxysmal supraventricular tachycardia (PSVT; HR 2.45; [95% CI], 1.18–5.09, p =.016), the percentage of premature atrial contraction (PAC) on 24‐h Holter electrocardiogram (ECG) monitoring (HR 1.008; [95% CI], 1.003–1.014, p =.003), and left ventricular global longitudinal strain (GLS‐LV; HR 0.92;[95% CI], 0.84–0.99, p =.049). Conclusions: This study showed that a history of PSVT and using AAD, the percentage of PAC on 24‐h Holter ECG monitoring, and GLS‐LV were the independent predictors of new‐onset AHREs. [ABSTRACT FROM AUTHOR]

Background: Various surgical procedures have employed microporous polysaccharide hemosphere (MPH) hemostatic agents. However, data regarding their effectiveness in preventing pocket hematomas (PHs) during the implantation of cardiac implantable electronic devices (CIED) among the Asian population are limited. Therefore, this study aimed to investigate the potential benefits of using MPH hemostatic agents during CIED implantations as a preventive measure against post‐procedural PHs. Methods: We conducted a retrospective, single‐center, observational study involving 255 consecutive Japanese patients who underwent CIED implantation between November 2017 and April 2021. We compared PH occurrences within 28 days after CIED implantation between patients who received MPH hemostatic agents (n = 145) and those who did not (n = 110). Results: PH development was observed in nine (6.2%) patients who received MPH hemostatic agents and in 13 (11.8%) patients without MPH hemostatic (p =.111). Kaplan–Meier analysis of PH development revealed no significant difference between the two groups (log‐rank p =.102). However, utilizing MPH hemostatic agents among patients taking antithrombotic drugs, including antiplatelet medications, direct oral anticoagulants, and warfarin, significantly reduced PH incidence (log‐rank p =.03). The multivariate Cox proportional hazards model demonstrated that MPH hemostatic agent utilization independently correlated with a decreased PH risk (hazard ratio 0.22, 95% confidence interval 0.08–0.63, p =.004). Conclusions: The findings of this study suggest that the incorporation of MPH hemostatic agents into standard practice may benefit to mitigate PH risk during CIED implantations in patients on antithrombotic therapy. This simple and practical measure may be valuable, especially in high‐risk patients, such as those taking antithrombotic medications. [ABSTRACT FROM AUTHOR]

Introduction: The novel Confirm Rx™ implantable cardiac monitor (ICM) with SharpSense™ technology incorporates a new P‐wave discriminator designed to improve AF detection. This study aimed to evaluate the diagnostic performance of the Confirm Rx™ ICM in detecting AF episodes of varying durations. Methods: We conducted a multicenter retrospective analysis of consecutive patients implanted with a Confirm Rx™ ICM (v1.2) across nine UK hospitals, all with documented AF lasting at least 6 min. Electrocardiograms (ECGs) were manually adjudicated by cardiologists. To account for intra‐ and inter‐reviewer variability, a random sample of 10% of ECGs underwent additional review. Disagreements were resolved by a third reviewer. Diagnostic performance was determined by calculating the gross and patient‐averaged positive predictive value (PPV) for AF episodes of different duration. The source of false positive (FP) detection was also categorized. Results: Overall, 16,230 individual ECGs from 232 patients were included. The median AF episode duration was 14 min. R‐wave amplitude remained stable during follow‐up (0.52 ± 0.27 mV [initial] vs. 0.54 ± 0.29 mV [end of follow‐up], p =.10). The gross and patient‐averaged PPV were 75.0% and 67.0%, respectively. Diagnostic performance (gross) increased with progressively longer AF episodes: 88.0% for ≥1 h, 97.3% for 6 h, and 100% for 24 h. The main source of FP during tachycardia was T‐wave oversensing (54.2%), while in non‐tachycardic episodes it was predominantly ectopy (71.2%). The AF burden precision was excellent (93.3%). Conclusion: The Confirm Rx™ ICM diagnostic performance was modest for all AF episodes (75%), with accuracy increasing for longer AF episodes. [ABSTRACT FROM AUTHOR]

Background: Sodium-glucose cotransporter 2 inhibitors (SGLT2is) have beneficial pleiotropic effects, contributing to improved cardiovascular and renal outcomes for patients with and without diabetes. The impact of SGLT2is on arrhythmic burden remains largely unexplored through randomized trials. Methods: In this multicenter, double-blind, randomized, placebo-controlled trial, we investigated the effects of ertugliflozin on arrhythmic burden among patients with heart failure with an ejection fraction less than 50%. All patients had an implantable cardioverter-defibrillator (ICD) with or without a cardiac resynchronization therapy device (CRT-D) and were randomized (1:1) to receive either ertugliflozin 5 mg once daily or placebo. The primary end point was the number of incident sustained (>30 seconds) ventricular tachycardia or ventricular fibrillation events from baseline to week 52. Secondary end points included the total number of non-sustained ventricular tachycardias, appropriate ICD therapies, changes in N-terminal pro-brain-type natriuretic peptide (NTproBNP) levels, and the number of heart failure hospitalizations. Results: Randomization was prematurely terminated, after class IA guideline recommendations were published for SGLT2is in patients with heart failure regardless of the ejection fraction. The final analysis included 46 patients (11% of the originally planned sample size). The yearly rate of the primary end point was 3.5 (95% confidence interval [CI] 2.8 to 4.4) with ertugliflozin compared with 13.3 with placebo (95% CI 11.8 to 14.8; rate ratio 0.16, 95% CI 0.04 to 0.61; P<0.001). There were no apparent differences in appropriate ICD therapies, hospitalizations, NTproBNP levels, or predefined adverse and serious adverse events. Conclusions: Ertugliflozin reduced sustained ventricular tachycardia or ventricular fibrillation events in adults with heart failure and an ICD compared with placebo; however, our trial ended early and thus results should be interpreted with caution. (Funded by Investigator-initiated Studies Program of Merck Sharp & Dohme Corp and Pfizer; EudraCT number, 2020-002581-14; ClinicalTrials.gov number NCT04600921.) [ABSTRACT FROM AUTHOR]

Purpose: Patients with non-beta-hemolytic streptococcal bacteremia (NBHSB) are at risk of infective endocarditis (IE). Patients with cardiac implantable electronic device (CIED) have been described to have an increased risk of IE. The aim of the study was to describe a population-based cohort of patients with NBHSB and CIED and variables associated with IE and recurrent NBHSB. Methods: All episodes with NBHSB in blood culture from 2015 to 2018 in a population of 1.3 million inhabitants were collected from the Clinical Microbiology Laboratory, Lund, Sweden. Through medical records, patients with CIED during NBHSB were identified and clinical data were collected. Patients were followed 365 days after NBHSB. Results: Eighty-five episodes in 79 patients with CIED and NBHSB constituted the cohort. Eight patients (10%) were diagnosed with definite IE during the first episode, five of whom also had heart valve prosthesis (HVP). In 39 patients (49%) transesophageal echocardiography (TEE) was performed of which six indicated IE. Four patients had the CIED extracted. Twenty-four patients did not survive (30%) the study period. Four patients had a recurrent infection with NBHSB with the same species, three of whom had HVP and had been evaluated with TEE with a negative result during the first episode and diagnosed with IE during the recurrency. Conclusion: The study did not find a high risk of IE in patients with NBHSB and CIED. Most cases of IE were in conjunction with a simultaneous HVP. A management algorithm is suggested. [ABSTRACT FROM AUTHOR]

Pacemakers (PM) and implantable cardioverter-defibrillators are vital devices in contemporary clinical practice, but their growing adoption poses challenges. Complications, including lead migration, infections, and post-implantation venous thrombosis, underscore the importance of comprehensive investigation. This retrospective observational study enrolled patients diagnosed with upper limb deep vein thrombosis (DVT) secondary to intracardiac devices at a tertiary hospital from 2015 to 2022. The aim of the study was to determine the incidence and long-term outcomes (bleeding, DVT recurrence and sequelae) in these patients. Across the study period, 2681 intracardiac devices were implanted, with 12 cases of upper limb DVT documented. The majority of patients were male (91.7%), with a mean age of 63.92 years. DVT occurred in patients with PM (50%), implantable cardioverter-defibrillators (25%) and implantable cardioverter-defibrillators with Cardiac Resynchronization Therapy (25%). Treatment encompassed low-molecular-weight heparin (91.7%) during the acute episode and long-term anticoagulation with direct oral anticoagulants (75%) or vitamin K antagonists (25%). Over a mean follow-up period of 33.17 months, half of the patients exhibited long-term sequelae, notably collateral circulation (66.7%). Remarkably, no thrombosis recurrences were observed during follow-up. However, one patient (8.3%) experienced a major bleeding event during treatment, and one patient (8.3%) required device removal (PM) due to persistent symptoms. This study revealed upper limb DVT occurred in 0.45% of patients after intracardiac device implantation. Rate of thrombosis recurrence was low during follow-up. Although half of the patients developed long-term sequelae, the need for prolonged anticoagulant therapy in these cases remains uncertain. DVT (deep vein thrombosis), VTE (venous thromboembolism), PM (pacemakers), ICD (implantable cardioverter-defibrillators), ICD-CRT (ICD with cardiac resynchronization therapy), LMWH (low-molecular-weight heparin), DOACs (direct oral anticoagulants), VKAs (vitamin K antagonists). [ABSTRACT FROM AUTHOR]

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Introduction: Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry a risk of pocket- and lead-related complications in particular. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on patient or centre characteristics related to the actual adoption of EVDs are lacking. Objective: To assess real-world nationwide trends in EVD adoption in the Netherlands. Methods: Using the Netherlands Heart Registration, all consecutive patients with a de novo S‑ICD or conventional single-chamber ICD implantation between 2012–2020, or de novo LP or conventional single-chamber pacemaker implantation between 2014–2020 were included. Trends in adoption are described for various patient and centre characteristics. Result: From 2012–2020, 2190 S‑ICDs and 10,683 conventional ICDs were implanted; from 2014–2020, 712 LPs and 11,103 conventional pacemakers were implanted. The general use has increased (S-ICDs 8 to 21%; LPs 1 to 8%), but this increase seems to have reached a plateau. S‑ICD recipients were younger than conventional ICD recipients (p < 0.001) and more often female (p < 0.001); LP recipients were younger than conventional pacemaker recipients (p < 0.001) and more often male (p = 0.03). Both S‑ICDs and LPs were mainly implanted in high-volume centres with cardiothoracic surgery on-site, although over time S‑ICDs were increasingly implanted in centres without cardiothoracic surgery (p < 0.001). Conclusion: This nationwide study demonstrated a relatively quick adoption of innovative EVDs with a plateau after approximately 4 years. S‑ICD use is especially high in younger patients. EVDs are mainly implanted in high-volume centres with cardiothoracic surgery back-up, but S‑ICD use is expanding beyond those centres. [ABSTRACT FROM AUTHOR]

Copyright of Herz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Cardiovascular 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 presentation: This 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. Conclusions: Another 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. [ABSTRACT FROM AUTHOR]

Electrophysiological aspects of cardiac amyloidosis (CA) are still poorly explored compared to other aspects of the disease. However, electrocardiogram (ECG) abnormalities play an important role in CA diagnosis and prognosis and the management of arrhythmias is a crucial part of CA treatment. Low voltages and a pseudonecrosis pattern with poor R-wave progression in precordial leads are especially common findings. These are useful for CA diagnosis and risk stratification, especially when combined with clinical or echocardiographic findings. Both ventricular and supraventricular arrhythmias are common in CA, especially in transthyretin amyloidosis (ATTR), and their prevalence is related to disease progression. Sustained and non-sustained ventricular tachycardias' prognostic role is still debated, and, to date, there is a lack of specific indications for implantable cardiac defibrillator (ICD). On the other hand, atrial fibrillation (AF) is the most common supraventricular arrhythmia with a prevalence of up to 88% of ATTR patients. Anticoagulation should be considered irrespective of CHADsVA score. Furthermore, even if AF seems to not be an independent prognostic factor in CA, its treatment for symptom control is still crucial. Finally, conduction disturbances and bradyarrhythmias are also common, requiring pacemaker implantation in up to 40% of patients. [ABSTRACT FROM AUTHOR]

The use of cardiac implantable electronic devices (CIEDs) has increased considerably, becoming a cornerstone of management for patients with brady- or tachyarrhythmia or for the prevention of sudden cardiac death. On the other hand, tricuspid regurgitation (TR) associated with CIEDs is progressively accepted as a serious clinical issue; the prognostic impact of TR is profound, as it is independently associated with increased mortality and a higher risk of heart failure hospitalization. Additionally, the management of established CIED-related TR continues to be challenging, with limited options for intervention once significant TR has developed. The balance between the lifesaving benefits of CIEDs and the risk of TR underlines the necessity for cautious patient selection and innovative approaches to device implantation and management. This review highlights the clinical importance, underlying mechanisms and challenges associated with lead-related tricuspid regurgitation in patients with CIEDs. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Mutations in genes encoding desmosomal proteins are the leading cause of arrhythmogenic cardiomyopathy (ACM). The majority of the inherited ACM cases demonstrate autosomal dominant genotype. Several cases with the homozygous DSG2 c.1592T>G (p.F531C) variant genotype demonstrate adverse clinical outcomes, but the roles of associated genetic mutations are not clear. In this report, we describe three ACM cases with the homozygous DSG2 c.1592T>G (p.F531C) variant genotype combined with additional heterozygous cardiomyopathy-related genetic mutations that cause aggravated clinical manifestations and worse clinical outcomes. Case presentation: The three reported probands demonstrated similar clinical presentations such as heart failure, cardiac enlargement, and lethal arrhythmias. All of them experienced sudden cardiac death (SCD) before undergoing implantable cardioverter defibrillator (ICD) or heart transplantations. Wholeexome sequencing analysis demonstrated that the three patients inherited the homozygous DSG2 c.1592T>G (p.F531C) variant. Furthermore, probands I, II, and III also inherited additional heterozygous cardiomyopathy-associated mutations, including DSP c.7883T>C, SCN5a c.3577C>T, or MYH7 c.427C>T, respectively. These variants were confirmed as pathogenetic variants. A systematic review of all the reported ACM cases with the homozygous DSG2 variants suggested that the additional genetic mutations contributed to the early age onset of ACM and lethal cardiac events. Conclusion: In conclusion, we report three rare cases of ACM with the same homozygous DSG2 variant in combination with additional heterozygous mutations in cardiomyopathy-associated genes. A systematic review of all the ACM cases with homozygous DSG2 variants demonstrated that the additional genetic variants contributed to the aggravated clinical manifestations and worse clinical symptoms of the ACM patients because of homozygous DSG2 mutations, including early disease onset and lethal cardiac events. Our data suggested that comprehensive genetic evaluation should be performed to identify any potential additional pathogenic variants that may significantly influence the clinical prognosis and outcomes of patients with ACM. The knowledge of underlying molecular mutations would be useful in designing better therapeutic strategies for ACM patients with multiple genetic mutations. [ABSTRACT FROM AUTHOR]

The article focuses on heart rate variability (HRV) in neonates and its significance in understanding their cardiac function. Topics discussed include the historical context of heart rate measurement and its variations, the methods for calculating HRV, and the implications of HRV findings in the neonatal intensive care unit (NICU) setting.

Background Staphylococcus aureus bacteremia (SAB) is a high-risk condition associated with high morbidity and mortality. In the presence of cardiac implantable electronic devices (CIEDs), SAB may cause or clinically indicate device infection. We aimed to estimate the 10-year absolute risk of SAB in adult Danish first-time CIED carriers. Secondary aims included identification of risk factors associated with SAB. Methods A registry-based study utilizing Danish nationwide registers and including consecutive Danish patients undergoing first CIED implantation between 2000 and 2020 was conducted. The primary outcome was first-time SAB after CIED implantation. Results A total of 87 257 patients with first CIED implantation in the study period were identified (median age, 75 years; 62.6% were male; median follow-up, 3.8 years). Patients with pacemakers (PMs) were older and with more noncardiovascular comorbidities compared to patients with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with or without defibrillator capacity (CRTs). In total, 1366 patients (1.6%) developed SAB. The 10-year absolute risk (95% confidence interval) of SAB was 2.0% (1.9%–2.1%) for PM, 2.6% (2.2%–3.1%) for ICD, and 3.7% (3.0%–4.5%) for CRT. A multivariable Cox analysis identified hemodialysis (hazard ratio [HR], 8.51), SAB before CIED (HR, 2.76), liver disease (HR, 2.35), and carrying a CRT device (HR, 1.68) among the covariates associated with increased risk of SAB. Conclusions The absolute risk of SAB in Danish CIED carriers increased with more advanced CIED systems. The risk was highest within the first 3 months after CIED implantation and increased with the presence of certain covariates including renal dialysis, SAB before CIED, male sex, and advancing age. [ABSTRACT FROM AUTHOR]

Diastolic wall strain (DWS), an echocardiographic index based on linear elasticity theory, has been identified as a predictor of heart failure (HF) in patients with sinus rhythm. However, its effectiveness in atrial fibrillation (AF) patients remains uncertain. This study aims to assess DWS as a predictor of HF in AF patients with preserved ejection fraction. We analysed a prospective database of AF patients undergoing transthoracic echocardiography. AF patients with reduced left ventricular ejection fraction (< 50%), posterior wall motion abnormality, hypertrophic cardiomyopathy, valvular heart disease, pericardial disease, congenital heart disease, or history of pacemaker/implantable cardioverter-defibrillator implantation or cardiac surgery were excluded. The study followed patients until HF development, death, or last visit. Follow-up for patients who underwent catheter ablation was censored on the date of their procedure. HF was ascertained based on the Framingham criteria. DWS was calculated using a validated formula: DWS = (PWs -PWd)/PWs, where PWs is the posterior wall thickness at end-systole and PWd is the posterior wall thickness at end-diastole. Among 411 study patients (mean age 69.6 years, 66% men), 20 (5%) was underwent catheter ablation and 57 (14%) developed HF during a mean follow-up of 82 months. Cox-proportional hazards demonstrated that low DWS (≤ 0.33) significantly predicted HF events (hazard ratio [HR] 3.28, 95% confidence interval [CI]) 1.81–5.94, P < 0.0001), independent of age (per 10 years; HR 1.99, 95% CI 1.35–2.93, P < 0.001), indexed left ventricular mass (per 10 g/m2; HR 1.16, 95% CI 1.05–1.27, P < 0.01), and indexed left atrial volume (per 10 mL/m2; HR 1.14, 95% CI 1.04–1.24, P < 0.01). Additionally, global log-likelihood ratio chi-square statistics indicated that DWS incrementally predicts HF development beyond age, indexed left ventricular mass, and left atrial volume (P < 0.001). [ABSTRACT FROM AUTHOR]

Background Desmoplakin (DSP) cardiomyopathy is a distinct form of cardiomyopathy characterized by frequent left ventricular involvement with extensive fibrosis, high arrhythmic risk, and episodes of acute myocardial injury. Case summary We are reporting diagnosis and management of a rare case of DSP cardiomyopathy. A patient in his 70s was investigated for mild shortness of breath, recurrent chest infection, and multiple ventricular ectopic. His echocardiogram showed impaired systolic function and found to have 53% ectopic burden with run of non-sustained ventricular tachycardia on 24 h electrocardiogram. Cardiac magnetic resonance imaging showed findings highly suggestive of DSP cardiomyopathy. High-resolution computed tomography chest suggested connective tissue–related interstitial lung disease. The diagnosis of DSP cardiomyopathy was confirmed by genetic testing that demonstrated mutation in DSP protein. The patient had implantable cardioverter-defibrillator implantation for primary prevention. Discussion Implantable cardioverter-defibrillator implantation should be considered with left ventricular ejection fraction thresholds >35%, particularly in the presence of additional risk factors. [ABSTRACT FROM AUTHOR]

Implantable cardioverter-defibrillators (ICD) are increasingly being used among the pediatric population for indications of both primary and secondary prevention. There is limited long-term data on the outcomes of pediatric patients following ICD implantation. The aim of this study was to investigate the characteristics of this population, burden of appropriate and inappropriate shock and complication rate in a large tertiary pediatric medical center. Included were children under the age of 18 years who underwent ICD implantation and had clinical follow up at our center. Data were retrospectively collected between study period 2005–2020. Primary outcome was the incidence of ICD shock appropriate and inappropriate. Secondary outcome was defining our patient population characteristics. Our cohort included 51 patients who underwent ICD implantation. Mean age at implantation was 10.9 ± 4.7 years and average follow-up time was 67 months. Diagnoses of implanted patients were: 28 (55%) patients with syndromes with risk for sudden death, cardiomyopathy in 14 patients (27%) and congenital heart disease (CHD) in 9 patients (18%). Forty-two (82%) patients had an ICD implanted for secondary prevention after experiencing a life-threatening arrhythmia and 9 (18%) for primary prevention. An endocardial system was implanted in 39 (76%) patients and an epicardial systems in 12 (24%) patients. A total of 20 (39%) patients received appropriate shocks for ventricular fibrillation(VF). 5 patients received inappropriate shocks, 4 due to sinus tachycardia and 1 due to rapidly conducted atrial fibrillation. Those who received an inappropriate shock had a significantly shorter ICD-programmed VF detection cycle length compared to those who did not receive an inappropriate shock (320 ms versus 270 ms, p = 0.062). This single center study demonstrates a high rate of appropriate ICD shocks (39%) and a low rate of inappropriate ICD shocks. Accurate programming of ICD devices in the pediatric population is paramount to avoid inappropriate ICD shocks. [ABSTRACT FROM AUTHOR]

Abstract In this systematic review and meta-analysis, we aim to evaluate the efficacy and safety of catheter ablation as the first-line treatment of ventricular tachycardia (VT) in patients with structural heart disease (SHD) and preserved left ventricular ejection fraction (LVEF). Patients with SHD are particularly susceptible to VT, a condition that increases the risk of sudden cardiac death (SCD). Implantable cardioverter-defibrillators (ICDs) can terminate VT and prevent SCD but do not prevent VT recurrence. The efficacy and safety of CA as a first-line treatment in SHD patients with preserved LVEF remain unclear. We searched PubMed/Medline, EMBASE, Web of Science, and Cochrane CENTRAL for studies reporting the outcomes of CA therapy in patients with VT and preserved LVEF, published up to January 19, 2023. The primary outcome was the incidence of SCD following catheter ablation as the first-line treatment of VT in patients with SHD and preserved LVEF. Secondary outcomes included all-cause mortality, VT recurrence, procedural complications, CA success rate, and ICD implantation after catheter ablation. We included seven studies in the meta-analysis, encompassing a total of 920 patients. The pooled success rate of catheter ablation was 84.6% (95% CI 67.2–93.6). Complications occurred in 6.4% (95% CI 4.0–9.9) of patients, and 13.9% (95% CI 10.1–18.8) required ICD implantation after ablation. VT recurrence was observed in 23.2% (95% CI 14.8–34.6) of patients, while the rate of sudden cardiac death (SCD) was 3.1% (95% CI 1.7–5.6). The overall prevalence of all-cause mortality in this population was 5% (95% CI 1.8–13). CA appears promising as a first-line VT treatment in patients with SHD and preserved LVEF, especially for monomorphic hemodynamically tolerated VT. However, due to the lack of direct comparisons with ICDs and anti-arrhythmic drugs, further research is needed to confirm these findings.

Introduction: Patients with hypertrophic cardiomyopathy (HCM) are at risk for lethal ventricular arrhythmia, but the electrophysiological substrate behind this is not well-understood. We used non-invasive electrocardiographic imaging to characterize patients with HCM, including cardiac arrest survivors. Methods: HCM patients surviving ventricular fibrillation or hemodynamically unstable ventricular tachycardia (n = 17) were compared to HCM patients without a personal history of potentially lethal arrhythmia (n = 20) and a pooled control group with structurally normal hearts. Subjects underwent exercise testing by non-invasive electrocardiographic imaging to estimate epicardial electrophysiology. Results: Visual inspection of reconstructed epicardial HCM maps revealed isolated patches of late activation time (AT), prolonged activation-recovery intervals (ARIs), as well as reversal of apico-basal trends in T-wave inversion and ARI compared to controls (p < 0.005 for all). AT and ARI were compared between groups. The pooled HCM group had longer mean AT (60.1 ms vs. 52.2 ms, p < 0.001), activation dispersion (55.2 ms vs. 48.6 ms, p = 0.026), and mean ARI (227 ms vs. 217 ms, p = 0.016) than structurally normal heart controls. HCM ventricular arrhythmia survivors could be differentiated from HCM patients without a personal history of life-threatening arrhythmia by longer mean AT (63.2 ms vs. 57.4 ms, p = 0.007), steeper activation gradients (0.45 ms/mm vs. 0.36 ms/mm, p = 0.011), and longer mean ARI (234.0 ms vs. 221.4 ms, p = 0.026). A logistic regression model including whole heart mean activation time and activation recovery interval could identify ventricular arrhythmia survivors from the HCM cohort, producing a C statistic of 0.76 (95% confidence interval 0.72-0.81), with an optimal sensitivity of 78.6% and a specificity of 79.8%. Discussion: The HCM epicardial electrotype is characterized by delayed, dispersed conduction and prolonged, dispersed activation-recovery intervals. Combination of electrophysiologic measures with logistic regression can improve differentiation over single variables. Future studies could test such models prospectively for risk stratification of sudden death due to HCM. [ABSTRACT FROM AUTHOR]

Background and Aims In patients with chronic heart failure (HF), the MONITOR-HF trial demonstrated the efficacy of pulmonary artery (PA)-guided HF therapy over standard of care in improving quality of life and reducing HF hospitalizations and mean PA pressure. This study aimed to evaluate the consistency of these benefits in relation to clinically relevant subgroups. Methods The effect of PA-guided HF therapy was evaluated in the MONITOR-HF trial among predefined subgroups based on age, sex, atrial fibrillation, diabetes mellitus, left ventricular ejection fraction, HF aetiology, cardiac resynchronization therapy, and implantable cardioverter defibrillator. Outcome measures were based upon significance in the main trial and included quality of life-, clinical-, and PA pressure endpoints, and were assessed for each subgroup. Differential effects in relation to the subgroups were assessed with interaction terms. Both unadjusted and multiple testing adjusted interaction terms were presented. Results The effects of PA monitoring on quality of life, clinical events, and PA pressure were consistent in the predefined subgroups, without any clinically relevant heterogeneity within or across all endpoint categories (all adjusted interaction P -values were non-significant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (P interaction =.03; adjusted P interaction =.33) and diabetics (P interaction =.01; adjusted P interaction =.06) were observed. However, these interaction effects did not persist after adjusting for multiple testing. Conclusions This subgroup analysis confirmed the consistent benefits of PA-guided HF therapy observed in the MONITOR-HF trial across clinically relevant subgroups, highlighting its efficacy in improving quality of life, clinical, and PA pressure endpoints in chronic HF patients. [ABSTRACT FROM AUTHOR]

This article discusses several hot topics in the field of cardiovascular health. It includes a review of left atrial appendage closure (LAAC) as an alternative treatment for stroke prevention in patients with atrial fibrillation (AF). The article also examines the safety of home treatment for acute pulmonary embolism (PE) patients and the efficacy of pulmonary artery (PA)-guided therapy for chronic heart failure (HF) patients. Additionally, the article presents a novel tool for arrhythmic risk stratification in patients with desmoplakin gene variants and evaluates the risk of thromboembolic events after COVID-19 vaccination in patients with AF. The authors provide insights, data, and recommendations for each topic, highlighting the need for further research and individualized care. [Extracted from the article]

Background: Catheter ablation (CA) is a well-established treatment in patients with ventricular tachycardia and appropriate implantable cardioverter defibrillator (ICD) therapies. Methods: We enrolled 57 consecutive carriers of ICD undergoing CA for electrical storm (ES). Our aim was to investigate differences in clinical, device-related, and electroanatomic features among patients who had history of appropriate ICD interventions before the ES compared to those who had not. The primary endpoint was a composite of death from any cause and recurrences of sustained VT, ventricular fibrillation, appropriate ICD therapy, or ES. Results: During a median follow up of 39 months, 28 patients (49%) met the primary endpoint. Those with previous ICD interventions had a higher prevalence of late potentials and a greater unipolar low-voltage area at electroanatomic mapping. Patients who met the primary endpoint had a higher prevalence of ATP/shock episodes preceding the ES event. At Cox regression analysis, non-ischemic dilated cardiomyopathy (NIDCM), QRS duration, and previous ATP and/or shock before the ES were associated with arrhythmic recurrences and/or death. At multivariate analysis, NIDCM and previous shock were associated with arrhythmic recurrences and/or death. Conclusions: A history of recurrent ICD therapies predicts worse outcomes when CA is needed because of ES. Although more studies are needed to definitively address this question, our data speak in support of an early referral for CA of ES. [ABSTRACT FROM AUTHOR]

Background: Undifferentiated shock is recognized as a criticality state that is transitional in immune-mediated topology for casual risk of lethal microcirculatory dysfunction. This was a sensitivity analysis of a drug (tetracosactide; TCS10) targeting melanocortin receptors (MCRs) in a phase 3 randomized controlled trial to improve cardiovascular surgical rescue outcome by reversing mortality and hemostatic disorders. Methods: Sensitivity analysis was based on a randomized, two-arm, multicenter, double-blind, controlled trial. The Naïve Bayes classifier was performed by density-based sensitivity index for principal strata as proportional hazard model of 30-day surgical risk mortality according to European System for Cardiac Operative Risk Evaluation inputs-outputs in 100 consecutive cases (from August to September 2013 from Emilia Romagna region, Italy). Patients included an agent-based TCS10 group (10 mg, single intravenous bolus before surgery; n = 56) and control group (n = 44) and the association with cytokines, lactate, and bleeding-blood transfusion episodes with the prior-risk log-odds for mortality rate in time-to-event was analyzed. Results: Thirty-day mortality was significantly improved in the TCS10 group vs. control group (0 vs. 8 deaths, P < 0.0001). Baseline levels of interleukin (IL)-6, IL-10, and lactate were associated with bleeding episodes, independent of TCS10 treatment [odds ratio (OR) = 1.90, 95% confidence interval (CI) 1.39–2.79; OR = 1.53, 95%CI 1.17–2.12; and OR = 2.92, 95%CI 1.40–6.66, respectively], while baseline level of Fms-like tyrosine kinase 3 ligand (Flt3L) was associated with lower bleeding rates in TCS10-treated patients (OR = 0.31, 95%CI 0.11–0.90, P = 0.03). For every 8 TCS10-treated patients, 1 bleeding case was avoided. Blood transfusion episodes were significantly reduced in the TCS10 group compared to the control group (OR = 0.32, 95%CI 0.14–0.73, P = 0.01). For every 4 TCS10-treated patients, 1 transfusion case was avoided. Conclusions: Sensitivity index underlines the quality target product profile of TCS10 in the runway of emergency casualty care. To introduce the technology readiness level in real-life critically ill patients, further large-scale studies are required. Trial registration: European Union Drug Regulating Authorities Clinical Trials Database (EudraCT Number: 2007-006445-41). [ABSTRACT FROM AUTHOR]

BACKGROUND: Whether vigorous exercise increases risk of ventricular arrhythmias for individuals diagnosed and treated for congenital long QT syndrome (LQTS) remains unknown. METHODS: The National Institutes of Health-funded LIVE-LQTS study (Lifestyle and Exercise in the Long QT Syndrome) prospectively enrolled individuals 8 to 60 years of age with phenotypic and/or genotypic LQTS from 37 sites in 5 countries from May 2015 to February 2019. Participants (or parents) answered physical activity and clinical events surveys every 6 months for 3 years with follow-up completed in February 2022. Vigorous exercise was defined as =6 metabolic equivalents for >60 hours per year. A blinded Clinical Events Committee adjudicated the composite end point of sudden death, sudden cardiac arrest, ventricular arrhythmia treated by an implantable cardioverter defibrillator, and likely arrhythmic syncope. A National Death Index search ascertained vital status for those with incomplete follow-up. A noninferiority hypothesis (boundary of 1.5) between vigorous exercisers and others was tested with multivariable Cox regression analysis. RESULTS: Among the 1413 participants (13% <18 years of age, 35% 18-25 years of age, 67% female, 25% with implantable cardioverter defibrillators, 90% genotype positive, 49% with LQT1, 91% were treated with beta-blockers, left cardiac sympathetic denervation, and/or implantable cardioverter defibrillator), 52% participated in vigorous exercise (55% of these competitively). Thirty-seven individuals experienced the composite end point (including one sudden cardiac arrest and one sudden death in the nonvigorous group, one sudden cardiac arrest in the vigorous group) with overall event rates at 3 years of 2.6% in the vigorous and 2.7% in the nonvigorous exercise groups. The unadjusted hazard ratio for experience of events for the vigorous group compared with the nonvigorous group was 0.97 (90% CI, 0.57-1.67), with an adjusted hazard ratio of 1.17 (90% CI, 0.67-2.04). The upper 95% one-sided confidence level extended beyond the 1.5 boundary. Neither vigorous or nonvigorous exercise was found to be superior in any group or subgroup. CONCLUSIONS: Among individuals diagnosed with phenotypic and/or genotypic LQTS who were risk assessed and treated in experienced centers, LQTS-associated cardiac event rates were low and similar between those exercising vigorously and those not exercising vigorously. Consistent with the low event rate, CIs are wide, and noninferiority was not demonstrated. [ABSTRACT FROM AUTHOR]

In this systematic review and meta-analysis, we aim to evaluate the efficacy and safety of catheter ablation as the first-line treatment of ventricular tachycardia (VT) in patients with structural heart disease (SHD) and preserved left ventricular ejection fraction (LVEF). Patients with SHD are particularly susceptible to VT, a condition that increases the risk of sudden cardiac death (SCD). Implantable cardioverter-defibrillators (ICDs) can terminate VT and prevent SCD but do not prevent VT recurrence. The efficacy and safety of CA as a first-line treatment in SHD patients with preserved LVEF remain unclear. We searched PubMed/Medline, EMBASE, Web of Science, and Cochrane CENTRAL for studies reporting the outcomes of CA therapy in patients with VT and preserved LVEF, published up to January 19, 2023. The primary outcome was the incidence of SCD following catheter ablation as the first-line treatment of VT in patients with SHD and preserved LVEF. Secondary outcomes included all-cause mortality, VT recurrence, procedural complications, CA success rate, and ICD implantation after catheter ablation. We included seven studies in the meta-analysis, encompassing a total of 920 patients. The pooled success rate of catheter ablation was 84.6% (95% CI 67.2–93.6). Complications occurred in 6.4% (95% CI 4.0–9.9) of patients, and 13.9% (95% CI 10.1–18.8) required ICD implantation after ablation. VT recurrence was observed in 23.2% (95% CI 14.8–34.6) of patients, while the rate of sudden cardiac death (SCD) was 3.1% (95% CI 1.7–5.6). The overall prevalence of all-cause mortality in this population was 5% (95% CI 1.8–13). CA appears promising as a first-line VT treatment in patients with SHD and preserved LVEF, especially for monomorphic hemodynamically tolerated VT. However, due to the lack of direct comparisons with ICDs and anti-arrhythmic drugs, further research is needed to confirm these findings. [ABSTRACT FROM AUTHOR]

The pro- and antiarrhythmic effects of omega-3 polyunsaturated fatty acids (n-3 PUFAs) have been extensively studied in preclinical and human trials. Despite early evidence of an antiarrhythmic role of n-3 PUFA in the prevention of sudden cardiac death and postoperative and persistent atrial fibrillation (AF), subsequent well-designed randomized trials have largely not shown an antiarrhythmic benefit. Two trials that tested moderate and high-dose n-3 PUFA demonstrated a reduction in sudden cardiac death, but these findings have not been widely replicated, and the potential of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to reduce arrhythmic death in combination, or as monotherapy, remains uncertain. The accumulated clinical evidence does not support supplementation of n-3 PUFA for postoperative AF or secondary prevention of AF. Several large, contemporary, randomized controlled trials of high-dose n-3 PUFA for primary or secondary cardiovascular prevention have demonstrated a small, significant, dose-dependent increased risk of incident AF compared with mineral oil or corn oil comparator. These findings were reproduced with both icosapent ethyl monotherapy and a mixed EPA+DHA formulation. The proarrhythmic mechanism of increased AF in contemporary cohorts exposed to high-dose n-3 PUFA is unknown. EPA and DHA and their metabolites have pleiotropic cardiometabolic and pro- and antiarrhythmic effects, including modification of the lipid raft microenvironment; alteration of cell membrane structure and fluidity; modulation of sodium, potassium, and calcium currents; and regulation of gene transcription, cell proliferation, and inflammation. Further characterization of the complex association between EPA, EPA+DHA, and DHA and AF is needed. Which formulations, dose ranges, and patient subgroups are at highest risk, remain unclear. [ABSTRACT FROM AUTHOR]

For many patients, sudden cardiac arrest (SCA) risk is elevated temporarily. Wearable cardioverter-defibrillators (WCDs) can monitor and treat SCA during these temporary periods. Traditional WCDs can be uncomfortable, require frequent maintenance, and cannot be used when showering, resulting in poor compliance and avoidable SCA deaths. The Jewel is a novel, water-resistant patch–wearable cardioverter-defibrillator (P-WCD) with a machine learning detection algorithm designed to improve compliance and protection against SCA. This study aims to demonstrate the safety and clinical effectiveness of a novel P-WCD. The Jewel IDE Study, a prospective, single-arm study conducted at 30 U.S. sites, enrolled patients at SCA risk due to ventricular tachycardia/ventricular fibrillation who were not candidates for or refused an implantable defibrillator. The primary safety endpoint was <15% patients with clinically significant cutaneous adverse device effects and the primary effectiveness endpoint was <2 inappropriate shocks/100 patient-months. Secondary endpoints were ≥1 successful ventricular tachycardia/ventricular fibrillation conversion and wear time compliance of >14.1 h/d. A total of 305 patients (mean age: 57.9 years; 30.2% female, 27.9% non-White) were enrolled, of which 290 had available device data. The clinically significant cutaneous adverse device effect rate was 2.30% (upper 1-sided 98% CI: 4.80); none were severe. No device-related deaths or serious adverse events were reported. The inappropriate shock rate was 0.36/100 patient-months (upper 1-sided 98% CI: 1.53). Of 11 shocks in 9 patients, 9 shocks were adjudicated to be appropriate. Eight of 9 shocks were successful with a single shock. Median wear time compliance was 23.5 (20.7-23.9) h/d. The novel P-WCD is a safe and effective WCD with high patient compliance. There were no deaths due to noncompliance and a high number of successful conversions (Jewel IDE study [A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest]; NCT05201495) [ABSTRACT FROM AUTHOR]

Background and Aims In patients with de novo heart failure with reduced ejection fraction (HFrEF), improvement of left ventricular ejection fraction (LVEF) is expected to occur when started on guideline-recommended medical therapy. However, improvement may not be completed within 90 days. Methods Patients with HFrEF and LVEF ≤ 35% prescribed a wearable cardioverter-defibrillator between 2017 and 2022 from 68 sites were enrolled, starting with a registry phase for 3 months and followed by a study phase up to 1 year. The primary endpoints were LVEF improvement > 35% between Days 90 and 180 following guideline-recommended medical therapy initiation and the percentage of target dose reached at Days 90 and 180. Results A total of 598 patients with de novo HFrEF [59 years (interquartile range 51–68), 27% female] entered the study phase. During the first 180 days, a significant increase in dosage of beta-blockers, renin–angiotensin system inhibitors, and mineralocorticoid receptor antagonists was observed (P <.001). At Day 90, 46% [95% confidence interval (CI) 41%–50%] of study phase patients had LVEF improvement > 35%; 46% (95% CI 40%–52%) of those with persistently low LVEF at Day 90 had LVEF improvement > 35% by Day 180, increasing the total rate of improvement > 35% to 68% (95% CI 63%–72%). In 392 patients followed for 360 days, improvement > 35% was observed in 77% (95% CI 72%–81%) of the patients. Until Day 90, sustained ventricular tachyarrhythmias were observed in 24 wearable cardioverter-defibrillator carriers (1.8%). After 90 days, no sustained ventricular tachyarrhythmia occurred in wearable cardioverter-defibrillator carriers. Conclusions Continuous optimization of guideline-recommended medical therapy for at least 180 days in HFrEF is associated with additional LVEF improvement > 35%, allowing for better decision-making regarding preventive implantable cardioverter-defibrillator therapy. [ABSTRACT FROM AUTHOR]