Incidence, implications, and management of sense-B-noise failure in subcutaneous cardioverter-defibrillator patients: insights from a large multicentre registry.

AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) offer potentially distinct advantages over transvenous defibrillator systems. Recent randomized trials showed significantly lower lead failure rates than transvenous ICD. Still, S-ICDs remain associated with the risk of inappropriate shocks (IAS). While previous studies have reported varying causes of IAS, this study explores a rare cause of IAS, referred to as 'sense-B-noise.' It was recently described in case series, but its incidence has not been studied in a large cohort of S-ICD patients. METHODS AND RESULTS: We retrospectively reviewed data from patients implanted with S-ICD models 1010, A209, and A219 between October 2009 and July 2023 across nine centres in Europe and the USA. The analysis concentrated on determining the incidence and understanding the implications of sense-B-noise events. Sense-B-noise represents a rare manifestation of distinct electrogram abnormalities within the primary and alternate sensing vectors. Data were collected from medical records, device telemetry, and manufacturer reports for investigation. This registry is registered on clinicaltrials.gov (NCT05713708). Subcutaneous implantable cardioverter-defibrillator devices of the 1158 patients were analysed. The median follow-up time for all patients was 46 (IQR 23-64) months. In 107 patients (9.2%) ≥1 IAS was observed during follow-up. Sense-B-noise failure was diagnosed in six (0.5 and 5.6% of all IAS) patients, in all patients, the diagnosis was made after an IAS episode. Median lead dwell time in the affected patients was 23 (2-70) months. To resolve the sense-B-noise defect, in three patients reprogramming to the secondary vector was undertaken, and two patients underwent system removal with subsequent S-ICD reimplantation due to low amplitude in the secondary vector. In one patient, the secondary vector was initially programmed, and subsequently, an S-ICD system exchange was performed due to T-wave-oversensing IAS episodes. CONCLUSION: This multicentre analysis' findings shed light on a rare but clinically highly significant adverse event in S-ICD therapy. To our knowledge, we provide the first systematic multicentre analysis investigating the incidence of sense-B-noise. Due to being difficult to diagnose and limited options for resolution, management of sense-B-noise is challenging. Complete system exchange may be the only option for some patients. Educating healthcare providers involved in S-ICD patient care is crucial for ensuring accurate diagnosis and effective management of sense-B-noise issues.

Occurrence of premature battery depletion in a large multicentre registry of subcutaneous cardioverter-defibrillator patients.

AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients. METHODS AND RESULTS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory. CONCLUSION: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.

Preoperative Prediction of Shock Impedance for Subcutaneous Implantable Cardioverter Defibrillator Using Chest Computed Tomography.

BACKGROUND: High shock impedance is associated with conversion failure among patients with subcutaneous implantable cardioverter defibrillators (S-ICD). Currently, there is no preoperative assessment method for predicting high shock impedance. This study examined the efficacy of chest computed tomography (CT) as a preoperative evaluation tool to assess the shock impedance of S-ICDs. METHODS AND RESULTS: The amount of adipose tissue adjacent to the device and anteroposterior diameter at the basal heart region were measured preoperatively using chest CT. We examined the correlation between these measurements and shock impedance at the conversion test. We enrolled 43 patients with S-ICDs (mean [±SD] age 54±15 years; body mass index 23±4 kg/m2; PRAETORIAN score 30-270 points; amount of adipose tissue 1,250±716 cm3), who underwent intraoperative conversion tests by inducing ventricular fibrillation, which was terminated with a 65-J shock. A sufficient concordance correlation coefficient was observed between the shock impedance and the amount of adipose tissue (r=0.616, P<0.01) and anteroposterior diameter (r=0.645, P<0.01). In multiple regression analysis, the amount of adipose tissue (ß=0.439, P=0.009) and anteroposterior diameter (ß=0.344, P=0.038) were identified as independent predictive factors of shock impedance. CONCLUSIONS: The preoperative CT-measured amount of adipose tissue and basal heart anteroposterior diameter are independent predictors of shock impedance. These parameters may be more accurate in identifying higher shock impedance in patients with S-ICDs.

Two-incision versus three-incision implantation technique of subcutaneous implantable cardioverter defibrillator: Systematic review and meta-analysis of 2076 patients.

INTRODUCTION: The implantable cardioverter-defibrillator (ICD) was designed to detect and treat ventricular arrhythmias, which account for nearly half of all cardiovascular fatalities. Transvenous ICD (TV-ICD) complications were reduced by introducing subcutaneous ICD (S-ICD). S-ICD can be implanted using a three (3IT)- or two (2IT)-incision technique. This systematic review and meta-analysis was conducted to compare the 3IT to the 2IT. METHODS: We searched medical electronic databases of Cochrane Central, Embase, PubMed, Scopus, and Web of Science (WOS) from the study's inception until March 8, 2023. We compared 2IT and 3IT techniques of S-ICDs in terms of procedural, safety, and efficacy outcomes. We used Review Manager software for the statistical analysis. We calculated the risk ratio (RR) with its 95% confidence interval (CI) for dichotomous variables; and the mean difference with its 95% CI for continuous variables. We measured the heterogeneity using the chi-squared and I-squared tests. If the data were heterogeneous, the random-effect (RE) model was applied; otherwise, the fixed-effect model (FE) was used. RESULTS: We included three retrospective observational studies of 2076 patients, 1209 in the 2IT group and 867 in the 3IT. There was no statistically significant difference in erosion after S-ICD when 2IT compared with 3IT (RR = 0.27, 95% CI: [0.07, 1.02]; P = .05) (I2 = 0%, P = .90). There was no difference in risk of infection, lead dislocation, or inappropriate shock with either incision technique (RR = 0.78, 95% CI: [0.48, 1.29]; P = .34) (I2 = 0%, P = .71) and (RR = 0.37, 95% CI: [0.02, 8.14]; P = .53) (I2 = 66%, P = .05) respectively. Our meta-analysis showed that the efficacy of both techniques is comparable; Appropriate shock (RR = 0.94, 95% CI: [0.78, 1.12]; P = .48) (I2 = 0%, P = .81) and first shock efficacy (RR = 0.89, 95% CI: [0.44, 1.82]; P = .76) (I2 = 0%, P = .87). CONCLUSION: 2IT and 3IT of S-ICD have comparable efficacy and complication rates; however, the 3IT exposes patients to an additional incision without any additional benefits. These findings may provide clinicians with a simpler method for subcutaneous ICD implantation and likely result in improved cosmetic outcomes. Before the 2IT technique can be considered the standard of care, randomized controlled trials (RCTs) must be conducted to assess its long-term safety and efficacy.

Inappropriate shock incidence in patients with subcutaneous implantable cardioverter-defibrillators with concomitant cardiac implantable electronic devices: A single-center cohort study.

BACKGROUND: Subcutaneous implantable cardioverter defibrillators (S-ICDs) are occasionally used in combination with other cardiac implantable electronic devices (CIEDs). However, whether the incidence of inappropriate shock increases in patients with S-ICDs and concomitant CIEDs remains unclear. This study aimed to investigate the association between the concomitant use of CIEDs and the incidence of inappropriate shock in patients with current-generation S-ICDs. METHODS: A total of 127 consecutive patients received an S-ICD. Patients were assigned to two groups depending on concomitant use of CIEDs at the time of S-ICD implantation: patients without other CIEDs (non-combined group, 106 patients) and patients with other CIEDs (combined group, 21 patients). CIEDs included pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy pacemakers, and cardiac resynchronization therapy defibrillators. The primary outcome was inappropriate shock, defined as a shock other than ventricular arrhythmia. Hazard ratios and 95% confidence intervals were calculated using a time-varying Cox proportional hazards model which was adjusted for age because age differed between the groups and could be a confounder. RESULTS: During a median follow-up period of 2.2 years (interquartile range, 1.0-3.4 years), inappropriate shock events occurred in 17 (16%) and five (19%) patients of the non-combined and combined groups, respectively. While the age-adjusted hazard ratio for inappropriate shock was 24% higher in the combined than in the non-combined group (hazard ratio = 1.24, 95% confidence interval, 0.39-3.97), this difference was insignificant (p = .71). CONCLUSION: The incidence of inappropriate shock did not differ between patients with and without concomitant use of CIEDs, suggesting that S-ICDs could potentially be combined with other CIEDs without increasing the number of inappropriate shocks. Further studies are warranted to confirm the safety and feasibility of concomitant use of S-ICDs and CIEDs.

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.

Chronic phase subcutaneous implantable cardioverter defibrillator lead dislodgement in a patient with arrhythmogenic right ventricular cardiomyopathy.

The subcutaneous implantable cardioverter defibrillator (S-ICD) is often used in young patients such as arrhythmogenic right ventricular cardiomyopathy (ARVC) and Brugada syndrome due to long-term lead durability issues. Although S-ICD lead dislodgement is rare, we encountered such an incident in a young ARVC patient during the chronic phase following the two-incision technique. Remote monitoring system is useful for early diagnosis of electrode movement (Graphical abstract image). When S-ICD lead dislodgement occurs in active young patients, lead revision using the three-incision technique may be an option.

Contact allergy to subcutaneous implantable cardioverter defibrillator in a child with Brugada syndrome.

Allergic reactions to components of cardiac implantable electronic devices are rare and often go undiagnosed, which can lead to a misdiagnosis of device infection. Contact allergy to subcutaneous implantable cardioverter defibrillator (S-ICD) is extremely rare. In this report, we present a case of cobalt-related contact allergy in a pediatric patient with Brugada syndrome who underwent S-ICD implantation.

A cluster of inappropriate shocks in a pediatric S-ICD patient - how to troubleshoot?

We present the case of a 16-year-old male pediatric patient diagnosed with hypertrophic cardiomyopathy (HCM, identified as having a high risk of sudden cardiac death (SCD), who underwent a successful subcutaneous implantable cardiac defibrillator (S-ICD) implantation as a primary prevention measure in 2018. His past medical history included ADHD, Autism, and panic attacks. The patient experienced appropriate shocks that successfully terminated VF episodes. However, he also experienced multiple inappropriate shocks from the S-ICD, triggered by anxiety-induced tachycardia during panic episodes. Meticulous assessment of S-ICD tracings and electrocardiograms (ECGs) revealed the erroneous classification of sinus tachycardia as sustained ventricular tachycardia, leading to unwarranted therapeutic interventions. Clinical intervention involved reprogramming of the S-ICD, emphasizing the pivotal role of personalized device configuration in pediatric cases where fine margins matter. While literature on S-ICD use in pediatric populations remains limited, emerging registries underscore the efficacy and safety of S-ICDs in preventing sudden cardiac death while reducing complications associated with intravascular leads. This case underscores the critical nature of customized device programming in pediatric patients, underscoring S-ICDs as a practical defibrillation alternative that addresses distinct concerns within this cohort of patients.

The relationship between the incision line and position of the latissimus dorsi muscle for subcutaneous implantable cardioverter-defibrillator intermuscular implantations.

INTRODUCTION: Intermuscular implantations of subcutaneous implantable cardioverter-defibrillators (S-ICD) have been recommended, but the position of the anterior border of the latissimus dorsi muscle (LDM) has not previously been evaluated in establishing an incision line to facilitate the intermuscular approach. The objective of this study is to evalua the position and trend of the anterior border of the LDM in patients who are candidates for implantable cardioverter-defibrillators. METHODS: The distance from the back to the anterior border of the LDM (A) and the anterior-posterior width of the chest wall (B) were measured on computed tomography retrospectively, and the ratio (=A/B) was used as the position of the anterior border of the LDM. In addition, the variability and factors affecting the values were evaluated. RESULTS: An analysis was performed on 78 patients, and the position of the anterior border of the LDM (=A/B) exhibited a normal distribution, with a mean value of 0.53 ± 0.062 (0.41-0.69). The position of the anterior border of the LDM tended to be more anterior in younger, taller, male, primary prevention, nonheart failure, low brain natriuretic peptide level, and nondiabetic patients. CONCLUSION: The position of the anterior border of the LDM varied from case to case with variable results. Conventional incisions on the midaxillary line may be inappropriate for intermuscular implantations, and the position of the anterior border of the LDM should be evaluated in each individual case to establish the incision line.