Clinical outcomes of subcutaneous implantable cardiac defibrillator implantation - Iran SICD registry.

BACKGROUND: The subcutaneous implantable-defibrillator (S-ICD) is a relatively new alternative to the transvenous ICD system to minimize intravascular lead-related complications. This paper presents outcome of SICD implantation in patients enrolled in Iran S-ICD registry. METHODS: Between October 2015 and June 2022, this prospective multicenter national registry included 223 patients with a standard indication for an ICD, who neither required bradycardia pacing nor needed cardiac resynchronization to evaluate the early post-implant complications and long-term follow-up results of the S-ICD system. RESULTS: The mean age of the patients was 45 ± 17 years. The majority (79.4%) were male. Ischemic cardiomyopathy (39.5%) was the most common underlying disorder among patients selected for S-ICD implant. Most study patients (68.6%) had ICD for primary prevention of sudden cardiac death. Seven patients (3.1%) were found to have suboptimal lead positions. Six patients (2.7%) developed a pocket hematoma; all were managed medically. During a mean follow-up of 2 years, the appropriate therapy was recorded in 13% of the patients and inappropriate ICD intervention mainly due to supraventricular tachycardia in 8.9%. Pocket infection was observed in four patients (1.8%) and five patients (2.2%) died mainly due to heart failure. CONCLUSION: S-ICDs were effective at detecting and treating both induced and spontaneous ventricular arrhythmias. Major clinical complications were rare.

Role of deep learning methods in screening for subcutaneous implantable cardioverter defibrillator in heart failure.

INTRODUCTION: S-ICD eligibility is assessed at pre-implant screening where surface ECG traces are used as surrogates for S-ICD vectors. In heart failure (HF) patients undergoing diuresis, electrolytes and fluid shifts can cause changes in R and T waves. Subsequently, T:R ratio, a major predictor of S-ICD eligibility, can be dynamic. METHODS: This is a prospective study of patients with structurally normal hearts and HF patients undergoing diuresis. All patients were fitted with Holters® to record their S-ICD vectors. Our deep learning model was used to analyze the T:R ratios across the recordings. Welch two sample t-test and Mann-Whitney U were used to compare the data between the two groups. RESULTS: Twenty-one patients (age 58.43 ± 18.92, 62% male, 14 HF, 7 normal hearts) were enrolled. There was a significant difference in the T:R ratios between both groups. Mean T: R was higher in the HF group (0.18 ± 0.08 vs 0.10 ± 0.05, p < .001). Standard deviation of T: R was also higher in the HF group (0.09 ± 0.05 vs 0.07 ± 0.04, p = .024). There was no difference between leads within the same group. CONCLUSIONS: T:R ratio, a main determinant for S-ICD eligibility, is higher and has more tendency to fluctuate in HF patients undergoing diuresis. We hypothesize that our novel neural network model could be used to select HF patients eligible for S-ICD by better characterization of T:R ratio reducing the risk of T-wave over-sensing (TWO) and inappropriate shocks. Further work is required to consolidate our findings before applying to clinical practice.

Case report: Removal of a subcutaneous implantable cardiac defibrillator in a pediatric patient with hypertrophic cardiomyopathy after a septal myectomy. Insights on current indications of type of ICD in children with hypertrophic cardiomyopathy and left ventricular tract obstruction.

Hypertrophic cardiomyopathy is a heart muscle disease with an annual incidence between 0.24 and 0.47/100000 in childhood. Sudden cardiac death is the most common cause of death in this population. Although some medical treatment can decrease the risk of sudden cardiac death, implantable cardioverter defibrillator continues to be the most reliable treatment. Different types of devices and programming strategies can be used in patients with hypertrophic cardiomyopathy depending on each center and specific patient condition. We report a pediatric patient affected with hypertrophic cardiomyopathy who had and ICD implantation in primary prevention. Four years later he developed symptomatic left ventricular outflow tract obstruction and a surgical septal myectomy was performed. After the myectomy the patient developed complete left bundle branch block on his 12 lead ECG, and unfortunately none of the S-ICD vectors were suitable after the myectomy and it had to be explanted and replaced for a new transvenous ICD.

Implantation of Implantable Cardioverter Defibrillators in Kazakhstan.

Background and Objectives: Implantation of implantable cardioverter-defibrillators (ICD) has increased significantly over the past decade. However, limited data exist regarding practices and policies of ICD implantations in Kazakhstan. We aimed to provide an overview of the current use of ICD in Kazakhstan. Methods: Using the Unified Healthcare Information System database of the entire Kazakh adult population, statistical and cost data of ICD implantations in 2017-2019 were evaluated. Cardiologists and electrophysiologists working in cardio surgery centers and departments were asked to go through an online survey focused on subcutaneous-ICD (S-ICD) experience. Results: Implantation of traditional transvenous cardioverter-defibrillators for residents of Kazakhstan is fully reimbursed. A total of 2,263 ICD interventions (2,252 new implantations and 11 reimplantations) were performed across the country during the study period. According to the tariffs approved by the Ministry of Health, the reimbursement cost for one ICD case is about 14,061.80 US dollars. The survey showed that only two hospitals have implanted S-ICDs. Among the main reasons why S-ICD is not widely used in the country the following were named: lack of trained staff (61.1% of respondents); the cost of device and lack of reimbursement (38.7%); and lack of pacing function (27.8%). Conclusion: The number of ICD implantation in Kazakhstan is steadily continuing to grow, although, compared to developed countries, the implantation rate especially for S-ICD remains low. There is a need in deliberate strategies to remove policy barriers for implementation the most innovative cardiac implantable electronic devices implantations such as S-ICD in the country.

Deep learning-based insights on T:R ratio behaviour during prolonged screening for S-ICD eligibility.

BACKGROUND: A major predictor of eligibility of subcutaneous implantable cardiac defibrillators (S-ICD) is the T:R ratio. The eligibility cut-off of the T:R ratio incorporates a safety margin to accommodate for fluctuations of ECG signal amplitudes. We introduce a deep learning-based tool that accurately measures the degree of T:R ratio fluctuations and explore its role in S-ICD screening. METHODS: Patients were fitted with Holters for 24 h to record their S-ICD vectors. Our tool was used to assess the T:R ratio over the duration of the recordings. Multiple T:R ratio cut-off values were applied, identifying patients at high risk of T-wave oversensing (TWO) at each of the proposed values. The purpose of our study is to identify the ratio that recognises patients at high risk of TWO while not inappropriately excluding true S-ICD candidates. RESULTS: Thirty-seven patients (age 54.5 + / - 21.3 years, 64.8% male) were recruited. Fourteen patients had heart-failure, 7 hypertrophic cardiomyopathy, 7 had normal hearts, 6 had congenital heart disease, and 3 had prior inappropriate S-ICD shocks due to TWO. 54% of patients passed the screening at a T: R of 1:3. All patients passed the screening at a T: R of 1:1. The only subgroup to wholly pass the screening utilising all the proposed ratios are the participants with normal hearts. CONCLUSION: We propose adopting prolonged screening to select patients eligible for S-ICD with low probability of TWO and inappropriate shocks. The appropriate T:R ratio likely lies between 1:3 and 1:1. Further studies are required to identify the optimal screening thresholds.

Combined therapy with subcutaneous implantable cardiac defibrillator and leadless pacemaker in a patient with persistent left superior vena cava and mega coronary sinus: A challenging case for the best treatment.

In a patient requiring pacing and defibrillation therapy, but without superior venous access, combined therapy with S-ICD and leadless pacemaker could be the best solution. An appropriate programming of both devices represents the technical challenge in order to avoid inappropriate shocks due to leadless pacing oversensing.

High defibrillation threshold with a subcutaneous implantable cardiac defibrillator due to the lead having been positioned in the fat layer.

A 46-year-old female with a body mass index of 38.9 kg/m2 and no organic heart disease underwent a subcutaneous implantable cardioverter-defibrillator implantation for secondary prevention of sudden cardiac death in the setting of idiopathic ventricular fibrillation. Defibrillation threshold (DFT) testing during implantation detected high shock impedance and high DFT. Fluoroscopy revealed subcoil fat between the lead and the sternum, which we suspected was the reason for the high shock impedance and high DFT. We repositioned the lead to a site just above the sternum and the shock impedance and DFT improved to within the respective normal ranges.