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AIMS: Women have been historically underrepresented in implantable cardioverter-defibrillator (ICD) trials. No data on sex differences regarding subcutaneous ICDs (S-ICD) carriers have been described. Aim of our study was to investigate sex-related differences among unselected S-ICD recipients. METHODS AND RESULTS: Consecutive patients enrolled in the multicentre, international i-SUSI registry were analysed. Comparisons between sexes were performed using a 1:1 propensity matching adjusted analysis for age, body mass index (BMI), left ventricular function, and substrate. The primary outcome was the rate of appropriate shocks during follow-up. Inappropriate shocks and other device-related complications were deemed secondary outcomes. A total of 1698 patients were extracted from the i-SUSI registry; 399 (23.5%) were females. After propensity matching, two cohorts of 374 patients presenting similar baseline characteristics were analysed. Despite similar periprocedural characteristics and a matched BMI, women resulted at lower risk of conversion failure as per PRAETORIAN score (73.4% vs. 81.3%, P = 0.049). Over a median follow-up time of 26.5 [12.7-42.5] months, appropriate shocks were more common in the male cohort (rate/year 3.4% vs. 1.7%; log-rank P = 0.049), while no significant differences in device-related complications (rate/year: 6.3% vs. 5.8%; log-rank P = 0.595) and inappropriate shocks (rate/year: 4.3% vs. 3.1%; log-rank P = 0.375) were observed. After controlling for confounders, sex remained significantly associated with the primary outcome (aHR 1.648; CI 0.999-2.655, P = 0.048), while not resulting predictor of inappropriate shocks and device-related complications. CONCLUSION: In a propensity-matched cohort of S-ICD recipients, women are less likely to experience appropriate ICD therapy, while not showing higher risk of device-related complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0473876.
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Desfibriladores Implantáveis , Cardioversão Elétrica , Pontuação de Propensão , Sistema de Registros , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Fatores Sexuais , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/efeitos adversos , Fatores de Risco , Resultado do Tratamento , Arritmias Cardíacas/terapia , Medição de Risco , Europa (Continente) , Fatores de Tempo , Morte Súbita Cardíaca/prevenção & controleRESUMO
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.
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Desfibriladores Implantáveis , Fontes de Energia Elétrica , Sistema de Registros , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Idoso , Estados Unidos/epidemiologia , Morte Súbita Cardíaca/prevenção & controle , Morte Súbita Cardíaca/epidemiologia , Europa (Continente)/epidemiologia , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/efeitos adversos , Falha de Equipamento/estatística & dados numéricos , Fatores de Tempo , Análise de Falha de Equipamento/estatística & dados numéricos , AdultoRESUMO
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.
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Desfibriladores Implantáveis , Cardioversão Elétrica , Sistema de Registros , Humanos , Masculino , Estudos Retrospectivos , Feminino , Pessoa de Meia-Idade , Incidência , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/efeitos adversos , Idoso , Europa (Continente)/epidemiologia , Falha de Equipamento/estatística & dados numéricos , Estados Unidos/epidemiologia , Fatores de RiscoRESUMO
BACKGROUND: Electromagnetic interference (EMI) encompasses electromagnetic field signals that can be detected by a device's circuitry, potentially resulting in adverse effects such as inaccurate sensing, pacing, device mode switching, and defibrillation. EMI may impact the functioning of Cardiac Implantable Electronic Devices (CIEDs) and lead to inappropriate therapy. METHOD: An experimental measuring device, a loop antenna mimicking the implantable cardioverted defibrillator (ICD) antenna, was developed, and validated at the US Food and Drug Administration (FDA) and sent to Wright State University for testing. Two sets of measurements were conducted while the vehicle was connected to a 220-Volt outlet with charging at ON and OFF. Each measurement set involved three readings at various locations, with the antenna oriented in three different positions to account for diverse patient postures. The experiment utilized a Tesla Model 3 electric vehicle (EV), assessing scenarios both inside and outside the car, including the driver's seat, driver's seat floor, passenger's seat, rear seat, rear seat floor, cup holder, charging port (car), and near the charging station. RESULTS: The detected voltage (max 400 to 504 millivolts) around the cup holder inside the car differed from all other measurement scenarios. CONCLUSION: The investigation highlights the identification of EMI signals originating from an EV) that could potentially interrupt the functionality of a Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD). These signals fell within the R-wave Spectrum of 30-300 Hz. Further in-vivo studies are essential to determine accurately the level of interference between S-ICDs and EMI from Electric Vehicles.
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Desfibriladores Implantáveis , Campos Eletromagnéticos , Humanos , Análise de Falha de Equipamento , AutomóveisRESUMO
INTRODUCTION: The risk of complications associated with transvenous ICDs make the subcutaneous implantable cardiac defibrillator (S-ICD) a valuable alternative in patients with adult congenital heart disease (ACHD). However, higher S-ICD ineligibility and higher inappropriate shock rates-mostly caused by T wave oversensing (TWO)- are observed in this population. We report a novel application of deep learning methods to screen patients for S-ICD eligibility over a longer period than conventional screening. METHODS: Adult patients with ACHD and a control group of normal subjects were fitted with a 24-h Holters to record their S-ICD vectors. Their T:R ratio was analysed utilising phase space reconstruction matrices and a deep learning-based model to provide an in-depth description of the T: R variation plot for each vector. T: R variation was compared statistically using t-test. RESULTS: 13 patients (age 37.4 ± 7.89 years, 61.5 % male, 6 ACHD and 7 control subjects) were enrolled. A significant difference was observed in the mean and median T: R values between the two groups (p < 0.001). There was also a significant difference in the standard deviation of T: R between both groups (p = 0.04). CONCLUSIONS: T:R ratio, a main determinant for S-ICD eligibility, is significantly higher with more tendency to fluctuate in ACHD patients when compared to a population with normal hearts. We hypothesise that our novel model could be used to select S-ICD eligible patients by better characterisation of T:R ratio, reducing the risk of TWO and inappropriate shocks in the ACHD patient cohort.
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INTRODUCTION: Defibrillation testing (DFT) is recommended during subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation. Previous studies analyzing the potential interference of propofol with defibrillation threshold are inconsistent. The purpose of this study was to analyze whether propofol affects DFT post S-ICD placement. METHODS: All patients with S-ICD implantation between 01/2017 and 11/2020 at the University Heart Center Freiburg were retrospectively analyzed. Two groups were generated depending on the success of the first shock during DFT. Implantation characteristics and dose of anesthetics were analyzed. RESULTS: In 12 of the included 80 (15%) patients, first shock during DFT failed. The absolute dose of propofol was significantly higher in patients with first shock failure (median 653 mg [IQR 503-855]) compared to patients with first shock termination (376 mg [200-600]; p = 0.027). Doses of opioids and midazolam as well as type of anesthesia did not differ between the groups. A multivariable binary logistic regression analysis confirmed an independent association of first shock termination and propofol dose (per 100 mg: OR 0.73 (95% CI: 0.56-0.95); p = 0.021). CONCLUSION: There is an independent association of propofol dose and first shock failure in routine S-ICD defibrillation testing.
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Desfibriladores Implantáveis , Propofol , Humanos , Desfibriladores Implantáveis/efeitos adversos , Propofol/efeitos adversos , Estudos de Coortes , Estudos Retrospectivos , Implantação de Prótese/efeitos adversos , Cardioversão Elétrica/efeitos adversosRESUMO
AIMS: Subcutaneous implantable cardioverter defibrillators (S-ICDs) are well established. However, inappropriate shocks (IAS) remain a source of concern since S-ICDs offer very limited troubleshooting options. In our multicentre case series, we describe several patients who experienced IAS due to a previously unknown S-ICD system issue. METHODS AND RESULTS: We observed six patients suffering from this novel IAS entity. The IAS occurred exclusively in primary or alternate S-ICD sensing vector configuration (therefore called 'Sense-B-noise'). IAS were caused by non-physiologic oversensing episodes characterized by intermittent signal saturation, diminished QRS amplitudes, and disappearance of the artefacts after the IAS. Noise/oversensing could not be provoked by manipulation, X-ray did not show evidence for lead/header issues and impedance measurements were within normal limits. The pooled experience of our centres implies that up to â¼5% of S-ICDs may be affected. The underlying root cause was discussed extensively with the manufacturer but remains unknown and is under further investigation. CONCLUSION: Sense-B-noise is a novel cause for IAS due to non-physiologic signal oversensing, arising from a previously unknown S-ICD system issue. Sense-B-noise may be suspected if episodes of signal saturation in primary or alternate vector configuration are present, oversensing cannot be provoked, and X-ray and electrical measurements appear normal. The issue can be resolved by reprogramming the device to secondary sensing vector.
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Desfibriladores Implantáveis , Humanos , Desfibriladores Implantáveis/efeitos adversosRESUMO
AIMS: The SMART Pass™ (SP) algorithm is a high-pass filter that aims to reduce inappropriate therapy (IT) in subcutaneous internal cardiac defibrillator (S-ICD), but SP can deactivate due to low amplitude sensed R waves or asystole. The association between IT and SP deactivation and management strategies were evaluated, hypothesizing SP deactivation increases the risk of IT and device re-programming, or lead/generator re-positioning could reduce this risk. METHODS AND RESULTS: Retrospective single-centre audit of Emblem™ S-ICD devices implanted 2016 to 2020 utilizing health records and remote monitoring data. Cox regression models evaluated associations between SP deactivation and IT. A total of 348 patients (27 ± 16.6 months follow-up) were studied: 73% primary prevention. Thirty-eight patients (11.8%) received 83 shocks with 27 patients (7.8%) receiving a total of 44 IT. Causes of IT were oversensing (98%) and aberrantly conducted atrial fibrillation (2%). SP deactivation occurred in 32 of 348 patients (9%) and was significantly associated with increased risk of IT (hazard ratio 5.36, 95% CI 2.37-12.13). SP deactivation was due to low amplitude R waves (94%), associated with a higher defibrillation threshold at implant and presence of arrhythmogenic right ventricular cardiomyopathy. No further IT occurred 16 ± 15.5 months after corrective interventions, with changing the sensing vector being successful in 59% of cases. CONCLUSION: To reduce the risk of IT, the cause of the SP deactivation should be investigated, and appropriate reprogramming, device, or lead modifications made. Utilizing the alert for SP deactivation and electrograms could pro-actively prevent IT.
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Displasia Arritmogênica Ventricular Direita , Fibrilação Atrial , Desfibriladores Implantáveis , Humanos , Desfibriladores Implantáveis/efeitos adversos , Estudos Retrospectivos , Cardioversão Elétrica , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Fibrilação Atrial/etiologia , Displasia Arritmogênica Ventricular Direita/terapiaRESUMO
BACKGROUNDS: Two technologies, cardiac contractility modulation (CCM) and subcutaneous implantable cardioverter-defibrillator (S-ICD), can be successfully combined and applied to patients with advanced heart failure (HF) with reduced left ventricular ejection fraction (LVEF). CASE REPORT: We reported a case of a 51-year-old man with reduced ejection fraction (LVEF = 33%) and a narrow QRS complex who first underwent simultaneous implantation of CCM and S-ICD. CONCLUSION: Our case report aimed to reveal that the simultaneous implantation of CCM and S-ICD could be successfully used in patients with advanced HF, which could significantly improve the clinical symptoms of such patients during one surgery.
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Desfibriladores Implantáveis , Insuficiência Cardíaca , Marca-Passo Artificial , Disfunção Ventricular Esquerda , Masculino , Humanos , Pessoa de Meia-Idade , Volume Sistólico , Função Ventricular Esquerda , Resultado do Tratamento , DesfibriladoresRESUMO
Inappropriate shock (IAS) is the most frequent device-related complication among patients with subcutaneous implantable cardioverter-defibrillator (S-ICD). Air entrapment (AE) has been described as an underdiagnosed cause of early postimplant IAS. We report 6 consecutive cases of early IAS after S-ICD implant, in whom the electrogram analysis (EGM) and/or chest radiography (CXR) were consistent with AE.
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Background: The subcutaneous ICD (S-ICD) has developed as a valuable alternative to transvenous implantable cardioverter defibrillator (ICD) systems. However there are certain peculiarities which are immanent to the S-ICD and may limit its use. Besides oversensing the main issue is the missing option for antibradycardia pacing. To evaluate the actual need for pacing during follow-up and changes to transvenous ICD we analyzed our large tertiary centre registry and compared it with data from other large cohorts and trials. Methods and Results: We found out that in the 398 patients from our centre, there was a need for changing to a transvenous ICD in only 2 patients (0.5%) during a follow-up duration of almost 3 years. This rate was comparable to data obtained from other large data sets so that in the pooled analysis of almost 4000 patients the rate of bradycardia-associated complications was only 0.3%. Conclusions: The use of the S-ICD is safe in a variety of heart diseases and the need for antibradycardia stimulation is a very rare complication throughout many different large studies. Clinicians may take these results into account when opting for a certain ICD system and the S-ICD may be chosen more often also in elderly patients, in whom the risk for bradycardia is deemed higher.
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AIMS: Air entrapment (AE) has been reported as a potential cause of early inappropriate shocks (ISs) following subcutaneous implantable cardioverter defibrillator (S-ICD) implantation, but a cause-effect relationship is not always evident. This systematic review aims to analyse this phenomenon concerning implantation techniques, electrogram (EGM) features, radiologic findings, and patient management. METHODS AND RESULTS: A systematic search was conducted using PubMed, Embase, and Google Scholar databases following the PRISMA guidelines to obtain all available literature data since 2010 on S-ICD malfunctions possibly due to AE. The final analysis included 54 patients with AE as a potential cause of S-ICD malfunction. Overall, the aggregate incidence of this condition was 1.2%. Of ICD malfunctions possibly due to AE, 93% were ISs, and 95% were recorded within the first week following implantation. Radiologic diagnosis of AE was confirmed in 28% of the entire study cohort and in 68% of patients in whom this diagnostic examination was reported. At the time of device malfunction, EGMs showed artefacts, baseline drift, and QRS voltage reduction in 95, 76, and 67% of episodes, respectively. Management included ICD reprogramming or testing, no action (observation), and invasive implant revision in 57, 33, and 10% of patients, respectively. No recurrences occurred during follow-up, irrespective of management performed. CONCLUSIONS: Device malfunction possibly due to AE may occur in â¼1% of S-ICD recipients. Diagnosis is strongly suggested by early occurrence, characteristic EGM features, and radiologic findings. Non-invasive management, principally device reprogramming, appears to be effective in most patients.
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Desfibriladores Implantáveis , Estudos de Coortes , Desfibriladores Implantáveis/efeitos adversos , Humanos , Incidência , Resultado do TratamentoRESUMO
INTRODUCTION: Pre-implant ECG screening is performed to ensure that S-ICD recipients have at least one suitable sensing vector, yet cardiac over-sensing remains the commonest cause of inappropriate shock therapy in the S-ICD population. One explanation would be the presence of dynamic variations in ECG morphology that result in variations in vector eligibility. METHODS: Adult ICD patients had a 24-h ambulatory ECG performed using a digital Holter positioned to record all three S-ICD vectors. Using an S-ICD simulator, automated screening was then performed at one-minute intervals. In vectors with a mean vector score > 100 (the accepted value for a passing vector when screened on a single occasion), the percentage of all screening assessments that passed, eligible vector time (EVT), was calculated. EVT was compared statistically to QRS duration, corrected time to peak T (pTc) and mean vector score. RESULTS: Ambulatory monitoring was performed in 14 patients (mean age 63.7 ± 5.2 years, 71.4% male) with 42 vectors analysed. In 19 vectors the mean vector score was > 100. Within this "passing" cohort EVT varied between 42.7% and 100%. In 7/19 (37%) the EVT was <75%. A negative correlation was found between QRS duration and EVT (Pearson correlation -.60, p = .007). No correlation was found between EVT and mean vector score or pTc. CONCLUSION: Vector eligibility is dynamic. When "passing" vectors are subjected to repeated screening, 37% are found to be ineligible, more than a quarter of the time. Further investigation is required to determine the clinical significance of these findings.
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Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Eletrocardiografia Ambulatorial , Programas de Rastreamento/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Cuidados Pré-Operatórios , Fatores de RiscoRESUMO
BACKGROUND: Air entrapment has been recently described as a cause of inappropriate shock (IAS) among patients who underwent subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation. Data about this complication are lacking in the literature. METHODS: In this meta-summary 14 case reports describing IAS due to air entrapment were included. Patients' characteristics, S-ICD implant technique and air entrapment properties were collected. RESULTS: All patients experienced IAS within 4 days following S-ICD implant. The subcutaneous air was demonstrated by chest x-ray in 11 cases (73.3%). The sensing vector was reprogrammed in 11 cases (73.3%), and ICD was switched off in 2 cases (1.3%). CONCLUSIONS: IAS due to air entrapment is an early complication of S-ICD implant. No association was observed between the implant technique and air retention. Diagnosis is confirmed by chest x-ray and device interrogation. Management includes switching off the device or, preferably, changing the sensing vector.
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Desfibriladores Implantáveis , Humanos , Desfibriladores Implantáveis/efeitos adversos , Resultado do Tratamento , Fatores de RiscoRESUMO
INTRODUCTION: Haemodialysis patients who require defibrillator therapy are expected to benefit from the entirely avascular subcutaneous defibrillator (S-ICD), but haemodialysis is associated with dynamic changes in R and T wave amplitude which can impact S-ICD eligibility. A continuous assessment of S-ICD eligibility during haemodialysis has not previously been performed. MATERIAL AND METHODS: Continuous surface ECG recordings were obtained from a cohort of patients undergoing maintenance haemodialysis, but without an indication for an ICD. Automated vector screening was retrospectively performed at one-minute intervals throughout the dialysis session. Variations in S-ICD eligibility were calculated and in vectors with high degrees of variation, the underlying mechanism was identified. RESULTS: 72 vector recordings (mean duration 254.1 ± 6.0 min) were obtained from 24 patients (mean age 64.3 ± 5.5 years, 68% male). At the start of haemodialysis 47 vectors were S-ICD eligible (65.2%). At the end of session, all of these vectors had remained eligible, and an additional 6 vectors had also become eligible (73.6%). High vector score variability was observed in 7 patients and the commonest cause was a progressive change in R:T ratio (71.5%). CONCLUSION: In a haemodialysis population, a single haemodialysis session can be associated with a potential change in S-ICD eligibility in 8.4% of vectors, with up to 12.5% of vectors showing high degrees of variability, most commonly due to variations in R:T ratio. In an S-ICD population with similar characteristics S-ICD screening prior to haemodialysis would be expected to more accurately identify vectors that retain eligibility.
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Desfibriladores Implantáveis , Idoso , Morte Súbita Cardíaca/etiologia , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/efeitos adversos , Eletrocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Diálise Renal/efeitos adversos , Estudos RetrospectivosRESUMO
INTRODUCTION: The PRAETORIAN score (PS) was developed to assess the implant position and predict defibrillation success of the subcutaneous implantable cardioverter defibrillators (S-ICD). The main critique moved to the routine use of PS has been its postprocedural timing, that limits its usefulness on procedure guidance. The aim of this proof-of-concept study was to assess the feasibility of an intraprocedural use of PS. METHODS: Forty consecutive patients undergoing S-ICD implantation were enrolled. Intraprocedural PS (IP-PS) obtained with fluoroscopy before closure of the pocket and postprocedural PS (PP-PS) obtained with two-views chest X-ray were compared. Intraprocedural data and PS were compared with the historic cohorts of the involved institutions. RESULTS: When assessing IP-PS and PP-PS, a complete overall agreement was observed (100%, 1.00-κ; p < .001). When assessing a per-step agreement, a very high-degree of concordance in evaluating Step 1 of the PS was observed (95%, 0.81-κ; p < .001). A complete agreement in Step 2-3 (100%, 1.00-κ; p < .001) of the PS was reported. In comparison with our historical cohort, procedural time in the IP-PS cohort did not increase (45 [41-52] vs. 45 [39-49] min; p = .351) while the expected increase in fluoroscopy time resulted scarce (15 [10-15] s). CONCLUSION: An IP-PS can be reliably obtained using fluoroscopy guidance during S-ICD implantation, without a significant increase in procedural duration and may serve as guidance for implanting physicians, to avoid postprocedural S-ICD repositioning, leading to patient discomfort and significantly enhancing infective risks. IP-PS showed a very high agreement with the PP-PS obtained from two-views chest X-ray.
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Desfibriladores Implantáveis , Estudos de Coortes , Humanos , Estudo de Prova de Conceito , Implantação de Prótese/efeitos adversosRESUMO
The EMBLEM subcutaneous implantable cardioverter defibrillator (S-ICD) has an expected longevity of 7 years. In August 2019, Boston Scientific released an advisory regarding a limited subset of ~400 S-ICDs that exhibited an increased likelihood of an electrical component malfunction causing accelerated battery depletion. We observed several cases of nonadvisory S-ICD early battery depletion and sought to systematically evaluate the cohort of EMBLEM devices implanted and followed in our medical center. Out of 118 nonadvisory EMBLEM S-ICDs with a median time to most recent follow-up after implant of 735 days (interquartile range 375-1219 days), there were four premature battery failures identified. Serial device interrogations showed a sudden reduction in battery life at 1 195, 1 205, 1 300, and 678 days after implant. The number of shocks delivered during the lifetime of the devices did not explain the premature depletion. There was a sudden departure from the gradual linear decrease in battery longevity observed over time. We are the first to report a signal of premature battery depletion among S-ICD EMBLEM devices that were not among the initial advisory devices. The prevalence of premature battery failure in our cohort was 3.4%, occurring at an average of 1 095 days. Following these reports, Boston Scientific issued an advisory on EMBLEM devices in December 2020 extending beyond the initial advisory subset. The current projected occurrence rate for hydrogen-induced accelerated battery depletion is 3.7% at 5 years. Increased surveillance of this potential device issue and mitigation to identify patients at risk for this is warranted.
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Desfibriladores Implantáveis , Humanos , Desfibriladores Implantáveis/efeitos adversos , Fontes de Energia Elétrica , Tela Subcutânea , Fatores de TempoRESUMO
Combined implantation of cardiac contractility modulation (CCM) with subcutaneous implantable cardioverter-defibrillator (S-ICD) appears a suitable option to reduce the amount of intracardiac leads and complications for patients. Here we report on a patient with ischemic cardiomyopathy carrying an S-ICD in which a CCM device was implanted. During crosstalk testing post-CCM implantation, the S-ICD misannotated QRS complexes and T waves. The problem was solved through reprogramming the CCM, while preserving S-ICD functionality and improving heart failure symptoms. In conclusion, S-ICD combined with CCM seems to be a good and safe option for patients when device interference is being ruled out.
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Desfibriladores Implantáveis , Eletrocardiografia , Arritmias Cardíacas , Desfibriladores , Humanos , Contração Miocárdica , Resultado do TratamentoRESUMO
A 26-year-old patient with prior surgery for Ebstein's anomaly and a pacemaker (placed for post-surgical heart block and poor underlying rhythm) underwent SICD was placement. During defibrillation testing, device-device interaction led to undersensing of ventricular fibrillation with failure to shock. Increasing the pacemaker sensitivity resolved the problem but post shock pacing was unable to capture the heart after both shocks. The patient underwent removal of both the pacemaker and the SICD and placement of a transvenous ICD. Complex device-device interactions can occur in patients who are pacemaker dependent and undergo placement of a SICD.
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Desfibriladores Implantáveis/efeitos adversos , Bloqueio Cardíaco/terapia , Marca-Passo Artificial/efeitos adversos , Adulto , Técnicas Eletrofisiológicas Cardíacas , Humanos , MasculinoRESUMO
Over the past decade, the emergence of the subcutaneous implantable cardioverter defibrillator (S-ICD) has provided cardiologists with an option to provide both primary or secondary prevention treatment of sudden cardiac death (SCD) without the associated risks that come with the use of intracardiac leads. S-ICD may prove to be a useful option in those who are young, have thromboembolic risk, immunodeficiency states, unfavorable anatomy due to adult congenital heart disease (ACHD). This article reviews the existing literature to determine whether S-ICD can prove to be a safe alternative in comparison to Transvenous implantable cardioverter defibrillator (TV-ICD) and in which patient population should S-ICD be considered over TV-ICD.