Complicaciones y descargas inapropiadas tras el implante de un desfibrilador subcutáneo en pacientes pediátricos / Complications and inappropriate shocks in pediatric patients receiving a subcutaneous implantable cardioverter defibrilator

Introducción y objetivos: La experiencia con el desfibrilador automático implantable subcutáneo (DAI-SC) en pacientes pediátricos aún es reducida. El objetivo de este estudio es determinar la incidencia de complicaciones en pacientes pediátricos de nuestro centro en función del tipo de DAI y del tamaño del paciente.MétodosSe incluyó a pacientes menores de 18 años que recibieron un DAI-SC desde 2016 y pacientes contemporáneos (desde 2014) que recibieron un DAI transvenoso (DAI-TV). El evento principal fue el combinado de complicaciones y descargas inapropiadas.ResultadosSe implantó un DAI-SC a 26 pacientes (edad, 14 [intervalo, 5-17] años; índice de masa corporal [IMC], 20,2). De ellos, 23 (88%) fueron implantes intermusculares y el resto, en subserrato, 24 (92%) con 2 incisiones. Se programaron 2 zonas en todos los pacientes: condicional a 230 (220-230) lpm y de choque a 250 lpm. El grupo de DAI-TV incluyó a 19 pacientes (edad, 11 [5-16] años; IMC, 19,2; el 79% monocamerales). La supervivencia libre del evento principal a 5 años fue el 80% de los pacientes con DAI-SC y el 63% del grupo con DAI-TV (p=0,54); la de descargas inapropiadas fue similar (el 85 frente al 89%; p=0,86), mientras que la de complicaciones fue mayor en el grupo de DAI-SC (el 96 frente al 57%; cloglog p=0.016). En el grupo de DAI-SC no hubo fallo de la terapia ni mayores complicaciones con un IMC ≤ 20.ConclusionesCon las técnicas de implante y programación actuales, el DAI-SC es eficaz y seguro en pacientes pediátricos, con similares descargas inapropiadas y menos complicaciones a corto y medio plazo que el DAI-TV. (AU)

Introduction and objectives: There is limited evidence regarding the use of subcutaneous implantable cardioverter-defibrillators (S-ICD) in pediatric patients. The aim of this study was to determine the incidence of complications in these patients at our center, according to the type of ICD and patient size.MethodsWe included all patients aged<18 years who received an S-ICD since 2016 at our center. As a control group, we also included contemporary patients (since 2014) who received a transvenous ICD (TV-ICD). The primary endpoint was a composite of complications and inappropriate shocks.ResultsA total of 26 patients received an S-ICD (median age, 14 [5-17] years; body mass index [BMI], 20.2 kg/m2). Implantation was intermuscular in 23 patients (88%) and subserratus in the remainder. Two incisions were used in 24 patients (92%). In all patients, 2 zones were programmed: a conditional zone set at 230 (220-230) bpm, and a shock zone set at 250 bpm. Nineteen patients received a TV-ICD (median age, 11 [range, 5-16] years; BMI, 19.2 kg/m2, 79% single-chamber). Survival free from the primary endpoint at 5 years was 80% in the S-ICD group and 63% in the TV-ICD group (P=.54). Survival free from inappropriate shocks was similar (85% vs 89%, P=.86), while survival free from complications was higher in the S-ICD group (96% vs 57%, cloglogP=.016). There were no therapy failures in the S-ICD group, and no increased complication rates were observed in patients with BMI ≤ 20 kg/m2.ConclusionsWith contemporary implantation techniques and programming, S-ICD is a safe and effective therapy in pediatric patients. The number of inappropriate shocks is similar to TV-ICD, with fewer short- and mid-term complications. (AU)

Predictors of Quality of Life, Anxiety and Acceptance in Patients with Implantable Cardioverter-Defibrillator. / Preditores de Qualidade de Vida, Ansiedade e Aceitação em Pacientes com Cardioversor-Desfibrilador Implantável.

BACKGROUND: An implantable cardioverter-defibrillator (ICD) can cause high levels of anxiety and depression, resulting in negative effects on quality of life. OBJECTIVES: To evaluate the quality of life, anxiety, and acceptance of the ICD using standardized measurement instruments and identify predictors of better responses for each of the outcomes studied. METHOD: This is a prospective cohort study with patients undergoing initial ICD implantation or reoperation to maintain the device. The study outcomes included quality of life, anxiety, and acceptance of the ICD. The change in scores (30 and 180 days) was assessed using the minimal important difference (MID). Univariate analysis and the multivariate logistic regression model were used to identify predictors of better responses, adopting a significance level of 5%. RESULTS: A total of 147 patients were included between January/2020 to June/2021, with a mean age of 55.3 ± 13.4 years and a predominance of males (72.1%). The MID for quality of life, anxiety, and ICD acceptance were observed in 33 (22.4%), 36 (24.5%) and 43 (29.3%) patients, respectively. Age equal to or greater than 60 years (OR=2.5; 95%CI=1.14-5.53; p=0.022), absence of atrial fibrillation (OR=3.8; 95%CI=1.26-11.63; p=0.017) and female gender (OR=2.2; 95%CI=1.02-4.97; p=0.045) were independent predictors of better responses to quality of life, anxiety and acceptance of the ICD, respectively. CONCLUSION: The identification of predictors for better quality of life scores, anxiety, and acceptance of the device can support the implementation of specific care for patients with a greater chance of presenting unfavorable results.

FUNDAMENTO: O cardioversor-desfibrilador implantável (CDI) pode causar níveis elevados de ansiedade e depressão, resultando em efeitos negativos na qualidade de vida. OBJETIVOS: Avaliar a qualidade de vida, a ansiedade e a aceitação do CDI por meio de instrumentos de medida padronizados e identificar preditores de melhores respostas para cada um dos desfechos estudados. MÉTODO: Coorte prospectiva com pacientes submetidos a implante inicial de CDI ou reoperação para a manutenção do dispositivo. Os desfechos do estudo incluíram: qualidade de vida, ansiedade e aceitação do CDI. A mudança nos escores (30 e 180 dias) foi avaliada por meio da diferença mínima importante (DMI). Foi utilizada a análise univariada e o modelo de regressão logística multivariada para a identificação de preditores de melhores respostas, adotando-se o nível de significância de 5%. RESULTADOS: De janeiro/2020 a junho/2021 foram incluídos 147 pacientes, com idade média de 55,3 ± 13,4 anos e predomínio do sexo masculino (72,1%). A DMI para qualidade de vida, a ansiedade e a aceitação do CDI foram observadas em 33 (22,4%), 36 (24,5%) e 43 (29,3%) pacientes, respectivamente. Idade igual ou maior que 60 anos (OR=2,5; IC 95%=1,14-5,53; p=0,022), ausência de fibrilação atrial (OR=3,8; IC 95%=1,26-11,63; p=0,017) e sexo feminino (OR=2,2; IC 95%=1,02-4,97; p=0,045) foram preditores independentes de melhores respostas para qualidade de vida, ansiedade e aceitação do CDI, respectivamente. CONCLUSÃO: A identificação de preditores para melhores escores de qualidade de vida, ansiedade e aceitação do dispositivo pode subsidiar a implementação de cuidados específicos para os pacientes com maiores chances de apresentar resultados desfavoráveis.

Factors of mortality in patients with cardiac implantable electronic device: 5-year experience.

OBJECTIVE: The use of cardiac implantable electronic devices has increased in recent years. It has also brought some issues. Among these, the complications of cardiac implantable electronic devices infection and pocket hematoma are difficult to manage. It can be fatal with the contribution of patient-related risk factors. In this study, we aimed to find mortality rates in patients who developed cardiac implantable electronic devices infection and pocket hematoma over 5 years. We also investigated the risk factors affecting mortality in patients with cardiac implantable electronic devices. METHODS: A total of 288 cardiac implantable electronic devices patients were evaluated. Demographic details, history, and clinical data of all patients were recorded. Cardiac implantable electronic devices infection was defined according to the modified Duke criteria. The national registry was used to ascertain the mortality status of the patients. The patients were divided into two groups (exitus and survival groups). In addition, the pocket hematoma was defined as significant bleeding at the pocket site after cardiac implantable electronic devices placement. RESULTS: The cardiac implantable electronic devices infection was similar in both groups (p=0.919), and the pocket hematoma was higher in the exitus group (p=0.019). The exitus group had higher usage of P2Y12 inhibitors (p≤0.001) and novel oral anticoagulants (p=0.031). The Cox regression analysis, including mortality-related factors, revealed that renal failure is the most significant risk factor for mortality. Renal failure was linked to a 2.78-fold higher risk of death. CONCLUSION: No correlation was observed between cardiac implantable electronic devices infection and mortality, whereas pocket hematoma was associated with mortality. Furthermore, renal failure was the cause of the highest mortality rate in patients with cardiac implantable electronic devices.

Forensic perspectives on postmortem CIED interrogation: A systematic review and meta-analysis.

BACKGROUND: Cardiac implantable electronic devices (CIED) are a heterogeneous group of medical devices with increasingly sophisticated diagnostic capabilities, which could be exploited in forensic investigations. However, current guidelines are lacking clear recommendations on the topic. The first aim of this systematic review is to provide an updated assessment of the role of postmortem CIED interrogation, and to give practical recommendations, which can be used in daily practice. Secondly, the authors aim to determine the rates of postmortem CIED interrogation and autopsy investigations, the type of final rhythm detected close to death (with a focus on the significance of documented arrhythmias), as well as the role of postmortem CIED interrogation in the determination of final cause/time of death, and any potentially fatal device malfunctions. METHODS: A systematic search in MEDLINE and Scopus aiming to identify reports concerning postmortem human CIED interrogation was performed, including a systematic screening of reference lists. Case reports, letters to the editors, commentaries, review articles or guidelines were excluded, along with studies related to cardiac devices other than CIED. All data were pooled and analyzed using fixed-effects meta-analysis models, and the I2 statistic was used to assess heterogeneity. RESULTS: A total of 25 articles were included in the systematic review, enrolling 3194 decedent CIED carriers. Ten studies (40%) had a 100% autopsy rate, whereas in further 6 studies autopsy findings were variably reported; CIED interrogation was available from 22 studies (88%), and it was never performed prior to autopsy. The overall rate of successful postmortem CIED interrogation was 89%, with high heterogeneity among studies, mainly due to device deactivation/battery discharge. Twenty-four percent of CIED carriers experienced sudden cardiac death (SCD), whereas non-sudden cardiac and non-cardiac death (NSCD, NCD) were reported in 37% and 30% of decedents, respectively. Ventricular tachyarrhythmias were recorded in 34% of overall successfully interrogated CIED, and in 62% of decedents who experienced a SCD; of all ventricular tachyarrhythmias recorded, 40% was found in NSCD or NCD. A clear interpretation of the etiological role of recorded arrhythmias in the causation of death required integration with autopsy findings. Overall, potentially fatal device malfunctions were detected in 12% of cases. CONCLUSIONS: Postmortem CIED interrogation is a valuable tool for the determination of the cause of death, and may complement autopsy. Forensic pathologists need to know the potential utility, pitfalls, and limitations of this diagnostic examination to make this tool as much reliable as possible.

SBRT for Cardiac Ablation in Patients With Refractory Ventricular Tachycardia.

BACKGROUND: This case details a 44-year-old man with end-stage ischemic cardiomyopathy with refractory ventricular tachycardia (VT). The patient has a single-chamber implantable cardioverter-defibrillator, has had 2 VT ablations, and uses medication to manage his VT. Despite these interventions, he continued to have episodes of VT. The patient underwent stereotactic body radiation therapy (SBRT) to help reduce the burden of his VT. The patient received a dose of 25 Gy to his right inferior lateral region of the heart and a dose of 15 Gy to the inferior portion of the heart closer to the stomach. The patient followed up 1 month later and reported that his energy levels improved and that no arrhythmias had occurred since his SBRT treatment. DISCUSSION: The options for treating end-stage VT are limited. However, a treatment option using SBRT has been introduced to reduce the VT burden in patients. Cardiac SBRT is a noninvasive outpatient procedure that, while still awaiting U.S. Food and Drug Administration approval, reduces arrhythmia episodes and offers favorable short-term benefits for patients who have not responded to traditional treatment modalities. CONCLUSION: Cardiac SBRT is a novel treatment for VT in patients where standard treatments have failed. This case study demonstrates that SBRT effectively reduced arrhythmias in a patient with VT. The long-term clinical outcomes are not known, but the opportunity SBRT offers for treatment-refractory patients is favorable and should be considered.

Long-term follow-up of patients with Brugada syndrome: Foremost risk factors associated with overall arrhythmic events.

Brugada syndrome (BS) is characterized by ST segment elevation in right precordial leads (V1-V3), ventricular tachycardia (VT), ventricular fibrillation (VF), and sudden cardiac death (SCD) in individuals without structural heart disease. The aim of this study is to contribute to the controversial issue of finding the most valuable marker that can predict poor prognosis during follow-up in patients with a diagnosis of BS. A total of 68 patients diagnosed with BS or had Brugada-type ECG change between January 1997 and July 2012 at the Department of Cardiology of Baskent University Faculty of Medicine, Ankara, Turkey, were included in this cohort study. Patients were screened every 6 months for arrhythmia-related syncope, SCD, appropriate and inappropriate defibrillation (shock), AF development and death; collectively defined as "arrhythmic events" and were the primary endpoints. Patients with and without arrhythmic events were compared. The mean age was 34.9 ±â€…12.2 years (9-71 years), and 52 (76.5%) patients were male. Mean follow-up was 49.6 ±â€…37.6 months (4-188 months). Univariate analysis showed that male sex (P = .004), type 1 electrocardiographic pattern (P = .008), SCD (P = .036), VT/VF history (P = .046), requirement for electrophysiological studies (P = .034), implantable cardioverter-defibrillator placement (P = .014) were found to demonstrate significant differences in patients with and without arrhythmic events. In multivariable analyzes, spontaneous type 1 ECG presence (HR = 8.54, 95% CI: 0.38-26.37; P = .003) and VT/VF history (HR = 9.21, 95% CI: 0.004-1.88; P = .002) were found to be independently associated with arrhythmic events. We found the presence of spontaneous type 1 ECG and a history of VT/VF to be associated with increased likelihood of overall arrhythmic events in BS. Given the higher risk of poor prognosis, we recommend additional measures in patients with BS who have these features.

Infective Endocarditis Involving Implanted Cardiac Electronic Devices: JACC Focus Seminar 1/4.

Cardiac implantable electronic device-related infective endocarditis (CIED-IE) encompasses a range of clinical syndromes, including valvular, device lead, and bloodstream infections. However, accurately diagnosing CIED-IE remains challenging owing in part to diverse clinical presentations, lack of standardized definition, and variations in guideline recommendations. Furthermore, current diagnostic modalities, such as transesophageal echocardiography and [18F]-fluorodeoxyglucose positron emission tomography-computed tomography have limited sensitivity and specificity, further contributing to diagnostic uncertainty. This can potentially result in complications and unnecessary costs associated with inappropriate device extraction. Six hypothetical clinical cases that exemplify the diverse manifestations of CIED-IE are addressed herein. Through these cases, we highlight the importance of optimizing diagnostic accuracy and stewardship, understanding different pathogen-specific risks for bloodstream infections, guiding appropriate device extraction, and preventing CIED-IE, all while addressing key knowledge gaps. This review both informs clinicians and underscores crucial areas for future investigation, thereby shedding light on this complex and challenging syndrome.

The association between GRACE score at admission for myocardial infarction and the incidence of sudden cardiac arrests in long-term follow-up - the MADDEC study.

Background. Sudden cardiac arrest (SCA), often also leading to sudden cardiac death (SCD), is a common complication in coronary artery disease. Despite the effort there is a lack of applicable prediction tools to identify those at high risk. We tested the association between the validated GRACE score and the incidence of SCA after myocardial infarction. Material and methods. A retrospective analysis of 1,985 patients treated for myocardial infarction (MI) between January 1st 2015 and December 31st 2018 and followed until the 31st of December of 2021. The main exposure variable was patients' GRACE score at the point of admission and main outcome variable was incident SCA after hospitalization. Their association was analyzed by subdistribution hazard (SDH) model analysis. The secondary endpoints included SCA in patients with no indication to implantable cardioverter-defibrillator (ICD) device and incident SCD. Results. A total of 1985 patients were treated for MI. Mean GRACE score at baseline was 118.7 (SD 32.0). During a median follow-up time of 5.3 years (IQR 3.8-6.1 years) 78 SCA events and 52 SCDs occurred. In unadjusted analyses one SD increase in GRACE score associated with over 50% higher risk of SCA (SDH 1.55, 95% CI 1.29-1.85, p < 0.0001) and over 40% higher risk for SCD (1.42, 1.12-1.79, p = 0.0033). The associations between SCA and GRACE remained statistically significant even with patients without indication for ICD device (1.57, 1.30-1.90, p < 0.0001) as well as when adjusting with patients LVEF and omitting the age from the GRACE score to better represent the severity of the cardiac event. The association of GRACE and SCD turned statistically insignificant when adjusting with LVEF. Conclusions. GRACE score measured at admission for MI associates with long-term risk for SCA.

What is already known about this subject?Nearly 50% of cardiac mortality is caused by sudden cardiac death, often due to sudden cardiac arrest.Despite the effort, there is a lack of applicable prediction tools to identify those at high risk.What does this study add?This study shows that GRACE score measured at the point of admission for myocardial infarction can be used to evaluate patients' risk for sudden cardiac arrest in a long-term follow-up.How might this impact on clinical practice?Based on our findings, the GRACE score at the point of admission could significantly affect the patients' need for an ICD device after hospitalization for MI and should be considered as a contributing factor when evaluating the patients' follow-up care.

Long-term reliability of the phospholamban (PLN) p.(Arg14del) risk model in predicting major ventricular arrhythmia: a landmark study.

AIMS: Recently, a genetic variant-specific prediction model for phospholamban (PLN) p.(Arg14del)-positive individuals was developed to predict individual major ventricular arrhythmia (VA) risk to support decision-making for primary prevention implantable cardioverter defibrillator (ICD) implantation. This model predicts major VA risk from baseline data, but iterative evaluation of major VA risk may be warranted considering that the risk factors for major VA are progressive. Our aim is to evaluate the diagnostic performance of the PLN p.(Arg14del) risk model at 3-year follow-up. METHODS AND RESULTS: We performed a landmark analysis 3 years after presentation and selected only patients with no prior major VA. Data were collected of 268 PLN p.(Arg14del)-positive subjects, aged 43.5 ± 16.3 years, 38.9% male. After the 3 years landmark, subjects had a mean follow-up of 4.0 years (± 3.5 years) and 28 (10%) subjects experienced major VA with an annual event rate of 2.6% [95% confidence interval (CI) 1.6-3.6], defined as sustained VA, appropriate ICD intervention, or (aborted) sudden cardiac death. The PLN p.(Arg14del) risk score yielded good discrimination in the 3 years landmark cohort with a C-statistic of 0.83 (95% CI 0.79-0.87) and calibration slope of 0.97. CONCLUSION: The PLN p.(Arg14del) risk model has sustained good model performance up to 3 years follow-up in PLN p.(Arg14del)-positive subjects with no history of major VA. It may therefore be used to support decision-making for primary prevention ICD implantation not merely at presentation but also up to at least 3 years of follow-up.

Implementation of remote monitoring strategies to improve chronic heart failure management.

PURPOSE OF REVIEW: The goal of this review is to describe the current evidence available for remote monitoring devices available for patients with chronic heart failure, and also detail practical clinical recommendations for implementing these tools in daily clinical practice. RECENT FINDINGS: Several devices ranging from sophisticated multiparametric algorithms in defibrillators, implantable pulmonary artery pressure sensors, and wearable devices to measure thoracic impedance can be utilized as important adjunctive tools to reduce the risk of heart failure hospitalization in patients with chronic heart failure. Pulmonary artery pressure sensors provide the most granular data regarding hemodynamic status, while alerts from wearable devices for thoracic impedance and defibrillator-based algorithms increase the likelihood of worsening clinical status while also having high negative predictive value when values are within normal range. SUMMARY: Multiple device-based monitoring strategies are available to reduce longitudinal risk in patients with chronic heart failure. Further studies are needed to best understand a practical pathway to integrate multiple signals of data for early clinical decompensation risk predictionVideo abstract: http://links.lww.com/HCO/A95.

Activated rate-response is associated with increased mortality risk in cardiac device carriers with acute heart failure.

AIMS: This study investigated whether an activated R-mode in patients carrying a cardiac implantable electronic device (CIED) is associated with worse prognosis during and after an episode of acutely decompensated heart failure (AHF). METHODS: Six hundred and twenty-three patients participating in an ongoing prospective cohort study that phenotypes and follows patients admitted for AHF were studied. We compared CIED carriers with activated R-mode stimulation (CIED-R) to CIED carriers not in R-mode (CIED-0) and patients without CIEDs (no-CIED). The independent impact of R-mode activation on 12-month all-cause death was examined using uni- and multivariable Cox proportional hazards regression taking into account potential confounders, and hazard ratios (HR) with their 95% confidence intervals (CI) were reported. RESULTS: Mean heart rate on admission was lower in CIED-R (n = 37, 16% women) vs. CIED-0 (n = 64, 23% women) or no-CIED (n = 511, 43% women): 70 bpm vs. 80 bpm or 82 bpm; both p<0.001. In-hospital mortality was similar across groups, but age- and sex-adjusted all-cause 12-month mortality risk was differentially affected by R-mode activation; CIED-R vs. CIED-0: HR 2.44, 95%CI 1.25-4.74; CIED-R vs. no-CIED: HR 2.61, 95%CI 1.59-4.29. These effects persisted after multivariable adjustment for potential confounders. Within CIED-R, mortality risk was similar in patients with pacemakers vs. ICDs and in subgroups with left ventricular ejection fraction (LVEF) <50% vs. ≥50%. CONCLUSION: In patients admitted with AHF, R-mode stimulation was associated with a significantly increased 12-month mortality risk. Our findings shed new light on "admission heart rate" as a potentially treatable target in AHF. Our data are compatible with the concept that chronotropic incompetence contributes to an adverse outcome in these patients and may not be adequately treated through accelerometer-based R-mode stimulation.

Ethical use of artificial intelligence to prevent sudden cardiac death: an interview study of patient perspectives.

BACKGROUND: The emergence of artificial intelligence (AI) in medicine has prompted the development of numerous ethical guidelines, while the involvement of patients in the creation of these documents lags behind. As part of the European PROFID project we explore patient perspectives on the ethical implications of AI in care for patients at increased risk of sudden cardiac death (SCD). AIM: Explore perspectives of patients on the ethical use of AI, particularly in clinical decision-making regarding the implantation of an implantable cardioverter-defibrillator (ICD). METHODS: Semi-structured, future scenario-based interviews were conducted among patients who had either an ICD and/or a heart condition with increased risk of SCD in Germany (n = 9) and the Netherlands (n = 15). We used the principles of the European Commission's Ethics Guidelines for Trustworthy AI to structure the interviews. RESULTS: Six themes arose from the interviews: the ability of AI to rectify human doctors' limitations; the objectivity of data; whether AI can serve as second opinion; AI explainability and patient trust; the importance of the 'human touch'; and the personalization of care. Overall, our results reveal a strong desire among patients for more personalized and patient-centered care in the context of ICD implantation. Participants in our study express significant concerns about the further loss of the 'human touch' in healthcare when AI is introduced in clinical settings. They believe that this aspect of care is currently inadequately recognized in clinical practice. Participants attribute to doctors the responsibility of evaluating AI recommendations for clinical relevance and aligning them with patients' individual contexts and values, in consultation with the patient. CONCLUSION: The 'human touch' patients exclusively ascribe to human medical practitioners extends beyond sympathy and kindness, and has clinical relevance in medical decision-making. Because this cannot be replaced by AI, we suggest that normative research into the 'right to a human doctor' is needed. Furthermore, policies on patient-centered AI integration in clinical practice should encompass the ethics of everyday practice rather than only principle-based ethics. We suggest that an empirical ethics approach grounded in ethnographic research is exceptionally well-suited to pave the way forward.