Standard Defibrillator Leads for Left Bundle Branch Area Pacing: First-in-Man Experience and Short-Term Follow-Up.

The authors report for the first time to their knowledge, implantation of a standard implantable cardioverter-defibrillator lead for permanent delivery of left bundle branch area pacing. Implantation was successful and safe in 11 of 12 patients, with adequate defibrillation testing, good electrical and electrocardiographic parameters, and uneventful device-related short-term follow-up.

[(LV)EF is a poor predictor of sudden cardiac death : Pro/Contra]. / Die (LV)EF ist ein schlechter Prädiktor für den plötzlichen Herztod : Pro/Contra.

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

Prediction of sudden cardiac death using artificial intelligence: Current status and future directions.

Sudden cardiac death (SCD) remains a pressing health issue, affecting hundreds of thousands each year globally. The heterogeneity among SCD victims, ranging from individuals with severe heart failure to seemingly healthy individuals, poses a significant challenge for effective risk assessment. Conventional risk stratification, which primarily relies on left ventricular ejection fraction, has resulted in only modest efficacy of implantable cardioverter-defibrillators (ICD) for SCD prevention. In response, artificial intelligence (AI) holds promise for personalised SCD risk prediction and tailoring preventive strategies to the unique profiles of individual patients. Machine and deep learning algorithms have the capability to learn intricate non-linear patterns between complex data and defined endpoints, and leverage these to identify subtle indicators and predictors of SCD that may not be apparent through traditional statistical analysis. However, despite the potential of AI to improve SCD risk stratification, there are important limitations that need to be addressed. We aim to provide an overview of the current state-of-the-art of AI prediction models for SCD, highlight the opportunities for these models in clinical practice, and identify the key challenges hindering widespread adoption.

PTSD and mood disorders in implantable cardioverter defibrillator patients: is more psychological assessment needed?

INTRODUCTION: The aim of this review is to identify common mood concerns in ICD patients and suggest brief psychological screeners essential for early detection and monitoring in patient care. AREAS COVERED: Reliable and valid psychological assessment tools are reviewed, including those specifically designed for ICD patient populations. EXPERT OPINION: Psychological assessment, in combination with cardiologic standard of care, can help overcome many barriers associated with poor implantable cardioverter-defibrillator (ICD) management and related cardiovascular outcomes. Earlier identification and treatment of mood concerns in ICD patients has been shown to improve quality of life (QOL) and patient outcomes. At this time, however, logistical challenges and time restraints, in addition to knowledge of appropriate treatment plans or referral options, remain central barriers to providing integrated, patient-centered care. Ultimately, all cardiology clinics would benefit from a collaborative care team that includes a mental health consultant or in-house psychologists who can provide consultations or referral services. Additionally, all patients that come to the clinics should complete proactive screening measures as routine component of care to assess the presence of mood concerns to improve patient outcomes and aid in treatment planning.

Factors Associated With Non-Uptake of Implantable Cardioverter-Defibrillator (ICD) Among Eligible Patients at a Tertiary Hospital in Kenya.

Background: Efficacy of Implantable Cardioverter-Defibrillator (ICD) implantation in both primary and secondary prevention of Sudden Cardiac Death (SCD) in at-risk population is well established. ICD implantation rates remain low particularly in Africa with a paucity of data regarding factors associated with non-uptake. Objectives: The primary study objective was to determine the factors associated with non-uptake of ICD among heart failure (HF) patients with reduced ejection fraction (EF<35%). Reasons for ICD refusal among eligible patients were reviewed as a secondary objective. Methods: This was a retrospective study among HF patients eligible for ICD implantation evaluated between 2018 to 2020. Comparison between ICD recipient and non-recipient categories was made to establish determinants of non-uptake. Results: Of 206 eligible patients, only 69 (33.5%) had an ICD. Factors independently associated with non-uptake were lack of private insurance (42.3% vs 63.8%; p = 0.005), non-cardiology physician (16.1% vs 5.8%; p = 0.045) and non-ischemic cardiomyopathy (54.7% vs 36.4% p = 0.014). The most common (75%) reason for ICD refusal was inability to pay for the device. Conclusion: ICDs are underutilized among eligible HF with reduced EF patients in Kenya. The majority of patients without ICD had no private insurance, had non-ischemic cardiomyopathy and non-cardiology primary physician. Early referral of HF with reduced EF patients to HF specialists to optimize guideline-directed medical therapy and make ICD recommendation is needed.

Implantable cardioverter defibrillator explantation upon patient request: Clinical and ethical considerations.

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.

A manual synchronous low energy shock impedance as a predictor of successful defibrillation testing during subcutaneous ICD implantation.

BACKGROUND: Guidelines recommend defibrillation testing (DFT) during subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation. Implant position, patient characteristics and device factors, such as shock impedance, influence defibrillation success. To evaluate the shock impedance, a manual synchronous 10J shock (low energy synchronous shock [LESS]) can be delivered, without the need to induce ventricular fibrillation (VF). OBJECTIVE: To compare LESS and DFT impedance values and to evaluate the diagnostic accuracy of LESS impedance for predicting a successful DFT during S-ICD implantation. METHODS: Consecutive S-ICD implantations were included. Shock impedances were compared by paired t-tests. Univariate analysis was performed to investigate factors associated with successful DFT. A prediction model of successful DFT based on LESS impedance was assessed by logistic regression. Receiver operating characteristic (ROC) curve, area under the ROC curve and the Hosmer-Lemeshow tests were used to evaluate the accuracy of LESS impedance. RESULTS: Sixty patients were included (52 ± 14 years; 69% male). LESS and DFT impedance values were highly correlated (r2 = 0.97, p < .01). Patients with a failed first shock had higher body mass index (BMI) (30 ± 3 vs. 25.7 ± 4.3, p = .014), higher mean LESS (120 ± 35Ω vs. 86. ± 23Ω, p = .0013) and DFT impedance (122 ± 33Ω vs. 87 ± 24Ω, p = .0013). ROC analysis showed that LESS impedance had a good diagnostic performance in predicting a successful conversion test (AUC 84% [95% CI: 0.72-0.92]) with a cutoff value of <94Ω to identify a successful DFT (sensitivity 71%, specificity 73%). CONCLUSION: LESS impedance values without the need to induce VF can intraoperatively predict a successful DFT.

Ventricular fibrillation during football training as a consequence of kratom and caffeine use in an adolescent: case report.

Background: There is an increase in the sale of legal drugs in our country. One of these substances is kratom. Kratom (Mitragyna speciosa) is a partial agonist of the opioid kappa, mu, and delta receptors. It acts as a stimulant at low concentrations, making users feel more energetic and euphoric. It has sedative and antinociceptive effects at higher doses. Case summary: An 18-year-old man collapsed during football training and required cardiopulmonary resuscitation; the initial rhythm was ventricular fibrillation managed by defibrillation. Laboratory parameters were unremarkable. Blood samples sent for toxicological evaluation were positive for kratom and caffeine. Echocardiographic examination, coronary computed tomography angiography, and cardiac magnetic resonance imaging did not prove the cause. Genetic testing did not find a pathogenic gene variant associated with familial ventricular fibrillation, but a variant of unknown significance was found in MYOM1. Given this situation, we implanted an implantable cardioverter-defibrillator (ICD) from the secondary prevention of sudden cardiac death (SCD) according to the guidelines of the European Society of Cardiology (ESC). No recurrence of ventricular arrhythmia has been reported by ambulatory ICD memory checks on our patient. Discussion: In some country, kratom is freely available and sold as a plant, not a drug. Only incident cases of ventricular fibrillation after kratom use are described in the literature. There is insufficient scientific evidence linking kratom to ventricular fibrillation. This is an absolutely crucial case report of this type, which has not yet been published in similar circumstances in the world. Therefore, the development of ventricular fibrillation was assumed to be due to a combination of kratom, caffeine, and exercise. The safety profile and effects of kratom should be the subject of future research. We would like to stress the importance of reporting further case series for more scientific evidence and thus increasing the pressure for stricter availability and regulation of kratom in some countries, especially where it is over-the-counter.

Current status of wearable cardioverter-defibrillator use in Japan.

Background: The current status of wearable cardiovascular defibrillators (WCD) use in Japan is unclear. Methods: Using a nationwide claims database of Japan, we assessed characteristics of patients using WCD and factors influencing subsequent implantable cardioverter-defibrillator (ICD) implantation. Results: In 1049 cases, those with prior cardiopulmonary arrest (CPA) or ventricular arrhythmia, cardiomyopathy, or device-related issues were more likely to require permanent ICDs, whereas females were less likely. Conclusions: Prior CPA or fatal arrhythmia, underlying cardiomyopathy, or device-related issues were associated with future permanent ICD implantation. These findings offer insights into the current status of WCD use in Japan.

[Practical guidance for the implantation of non-transvenous ICD systems]. / Praktische Anleitung zur Implantation nicht-transvenöser ICD-Systeme.

As an alternative to transvenous ICD systems, two non-transvenous ICD systems have been established in recent years: The subcutaneous ICD (S-ICD), which has been established for several years, has a presternal electrode that is implanted subcutaneously and offers a shock function and, to a limited extent, post-shock pacing. In addition, the extravascular ICD (EV-ICD) has been available in Europe since 2023 which does not require transvenous electrodes and offers the option of providing patients with antibradycardic and antitachycardic stimulation in combination with a conventional ICD function. The lead of this device is implanted substernally. Initial implantation results are promising in terms of safety and effectiveness. Both systems avoid possible complications of transvenous electrodes. This article provides practical guidance for the implantation technique and possible complications.

When pacing or defibrillator leads become redundant: Extract or abandon?

The 2017 Heart Rhythm Society expert consensus paper on lead management and extraction did not express a preference for either extracting or abandoning pacing or defibrillator leads that are dysfunctional or superfluous after an upgrade (hereafter referred to as redundant leads). However, no randomized or even nonrandomized trials show a better patient outcome with extraction. Many experienced centers currently advise patients to have redundant leads removed to prevent more complicated procedures after years of abandonment. According to the literature, however, not all abandoned leads need to be extracted as >90% will have an uneventful follow-up. As immediate extraction of redundant leads has a small but significant risk, this will generate more adverse events at the population level than when extraction is limited to the patients with future lead complications, even considering a higher extraction risk at that time. Lead extraction is also limited to specialized centers and often necessitates expensive tools, in contrast to abandoning leads, which can be safely performed by any experienced device specialist without additional cost.

Innominate Vein Thrombosis: A Case Report and Literature Review.

The brachiocephalic vein (BCV), also known as the innominate vein, is a central vein in the upper chest formed by merging the internal jugular and subclavian veins. It plays a crucial role in venous return from the head, neck, and upper extremities and is significant in procedures such as pacemaker and implantable cardioverter-defibrillator (ICD) placement, chemotherapy ports, and central venous catheter insertions. The presence of foreign bodies and local malignancy are major risk factors for thrombosis in the BCV. As part of the deep venous system, BCV thrombosis (BCVT) is a rare condition but can lead to serious complications like superior vena cava syndrome and, rarely, pulmonary embolism. This case report presents an 82-year-old woman with a history of heart failure with reduced ejection fraction, coronary artery disease, atrial fibrillation, HIV, pulmonary embolism, systemic lupus erythematosus, and breast cancer who required an ICD placement due to persistent systolic dysfunction. During the procedure, chronic BCVT leading to the stenosis was incidentally discovered, necessitating urgent vascular intervention to establish venous patency. The patient's complex medical history, including previous chemotherapy through a central venous catheter, contributed to the risk factors for BCVT. The multidisciplinary approach led to successful ICD placement and the reinstatement of anticoagulation therapy. This case underscores the rarity and severity of BCVT and highlights the importance of pre-procedural imaging, such as CT venography, in patients with multiple risk factors. Additionally, the report suggests considering leadless ICD technology for patients with limited venous access to avoid complications. The findings emphasize the critical need for thorough evaluation and planning in complex cases to ensure successful outcomes.

Arrhythmogenic Mitral Valve Prolapse: Can We Risk Stratify and Prevent Sudden Cardiac Death?

Ventricular arrhythmias associated with mitral valve prolapse (MVP) and the capacity to cause sudden cardiac death (SCD), referred to as 'malignant MVP', are an increasingly recognised, albeit rare, phenomenon. SCD can occur without significant mitral regurgitation, implying an interaction between mechanical derangements affecting the mitral valve apparatus and left ventricle. Risk stratification of these arrhythmias is an important clinical and public health issue to provide precise and targeted management. Evaluation requires patient and family history, physical examination and electrophysiological and imaging-based modalities. We provide a review of arrhythmogenic MVP, exploring its epidemiology, demographics, clinical presentation, mechanisms linking MVP to SCD, markers of disease severity, testing modalities and management, and discuss the importance of risk stratification. Even with recently improved understanding, it remains challenging how best to weight the prognostic importance of clinical, imaging and electrophysiological data to determine a clear high-risk arrhythmogenic profile in which an ICD should be used for the primary prevention of SCD.

Gender Disparity of Automatic Implantable Cardioverter-Defibrillator Placement for Primary Prevention: National Inpatient Sample Analysis.

INTRODUCTION: Automatic implantable cardioverter-defibrillators (AICDs) for the primary prevention of sudden cardiac death have become standard care for patients with systolic heart failure (sHF) and ejection fraction ≤35%. While the prevalence of sHF and rates of hospitalization are higher in men, one would expect equivalent rates of implantation in women. METHODS: We used the Healthcare Cost and Utilization Project's National Inpatient Sample (NIS) from 2009 to 2018 to identify patient visits with sHF and AICD implantation. The comorbidities and outcomes were compared based on gender. RESULTS: There were 15,247,854 inpatient admissions for sHF, of which 60.3% were males (95% CI: 60.1%-60.4%) and 39.8% females (95% CI: 39.7%-39.9%). Approximately 2% of patients (294,726) underwent the insertion of an AICD for primary prevention: 72.3% males (95% CI: 71.9%-72.7%) and 27.72% females (95% CI: 27.3%-28.1%). There was no significant difference in age (p = 0.29), length of stay (p = 0.09), and inpatient mortality (p = 0.18). CONCLUSION: In this study, women accounted for approximately 40% of patients admitted with the diagnosis of sHF; however, they accounted for less than 30% of patients who underwent the insertion of an AICD. Further research is needed to better understand this gender disparity and identify reasons for the lower rates of AICD placement in women.

Failure to Treat Ventricular Tachycardia or Ventricular Fibrillation by Implantable Cardioverter-Defibrillators.

BACKGROUND: Normally-functioning implantable cardioverter-defibrillators (ICDs) with intact lead systems occasionally fail to deliver therapy for ventricular tachycardia/ fibrillation (VT/VF) or deliver it only after clinically-significant delays ("failure-to-treat"). OBJECTIVE: To investigate ICD failure-to-treat VT/VF in a large patient cohort. METHODS: We searched the United States (US) Food and Drug Association's online Manufacturer and User Facility Device Experience (MAUDE) database from 2019 to 2023 for manufacturer-verified reports in which normally-functioning ICDs failed to treat VT/VF. RESULTS: We identified 854 reports classified as deaths (n=96, 11.2%), injuries (n=585, 68.5%), or malfunctions (n=173, 20.4%) for normally-functioning ICDs. The most common causes were misclassification as supraventricular tachycardia (SVT) or atrial fibrillation (AF) (54.8%), undersensing (21.1%), and failure to satisfy programmed rate/duration criteria (8.7%). Most events caused by misclassification as SVT/AF (89.5%) and failure to satisfy rate/duration criteria (70.3%) were VT; most caused by undersensing were either VF (54.4%) or not specified as VT or VF (19.4%). Undersensing caused 65.6% of deaths, although it comprised only 21.1% of reports. In the United States, the number of reports increased faster than that of ICD patients. CONCLUSIONS: In the largest reported series of failure-to-treat VT/VF by normally-functioning ICDs, the most common cause was misclassification of VT as SVT/AF; the most common cause of death was undersensing of VF. Although relatively few patients with normally-functioning ICDs experience failure-to-treat VT/VF, the absolute number of verified MAUDE reports suggests that more work is needed to quantify the magnitude of the problem, identify root causes, and develop solutions.