Impacto de la pandemia por COVID-19 en el implante de dispositivos cardiacos implantables y las activaciones de la monitorización a distancia / Impact of the COVID-19 pandemic on implantation of cardiac implantable electronic devices and remote monitoring activations

Introducción y objetivos La monitorización a distancia (MD) de los dispositivos cardiacos implantables (DCI) se considera más fiable, eficiente y segura que los convencionales seguimientos presenciales, aunque su implantación es aún subóptima. Este estudio pretende analizar el impacto de la pandemia de COVID-19 en las tasas de implantes y activaciones de MD de DCI en España. Métodos Se utilizó el Registro COVID-19 de MD en España para analizar el número mensual de todos los implantes de DCI y activaciones de MD desde enero de 2018 hasta diciembre de 2021 en España. Se sumaron los datos de los 5 principales fabricantes de DCI y se analizaron de manera descriptiva. Resultados Se registró un total de 205.345 DCI. El número de implantes disminuyó bruscamente (48,2%) con el confinamiento (marzo a junio de 2020) y aumentó progresivamente después hasta compensar la reducción previa, excepto en marcapasos y desfibriladores automáticos implantables (DAI), con una pérdida agregada (2020-2021) del 7 y el 3%, respectivamente, respecto a la media anual. Aumentaron la terapia de resincronización cardiaca con desfibrilador (TRC-D, 17%) y con marcapasos (TRC-P, 4,5%) a los 2 años. El porcentaje de activaciones de MD aumentó del 24,5% en 2018 al 49,0% en 2021, con un fuerte aumento durante el confinamiento. Las tasas de activación de MD aumentaron invariablemente durante el confinamiento con todos los dispositivos: marcapasos (el 14,4 frente al 37,2%; p<0,001); DAI (el 75,6 frente al 94,2%; p<0,001); TRC-D/TRC-P (del 68,6/44,2% al 81,6/61%; p<0,001), y Holters implantables (el 50,2 frente al 68,7%; p<0,001). Conclusiones La significativa reducción de los implantes que se produjo durante el confinamiento se recuperó gradualmente después, excepto los de marcapasos y DAI. La pandemia de COVID-19 impulsó la MD de todos los DCI en España. (AU)

Introduction and objectives Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is considered more reliable, efficient, and safer than conventional in-person follow-up. However, the implementation of RM is still suboptimal. This study aimed to analyze the impact of the COVID-19 pandemic on the rates of CIED implants and RM activations in Spain. Methods The COVID-19 RM Spain Registry was used to analyze the monthly number of all CIED implantations and RM activations from January 2018 to December 2021. A descriptive analysis was performed using aggregated data from the five major CIED manufacturers. Results A total of 205 345 CIEDs were recorded. The number of implants decreased sharply (48.2%) during the pandemic lockdown (March-June 2020) but gradually increased thereafter, compensating for the previous reduction. However, pacemakers and implantable cardiac defibrillators (ICD) showed an aggregate loss of 7% and 3%, respectively, from the annual average during 2020-2021. In contrast, cardiac resynchronization therapy defibrillators (CRT-D) increased by 17%, and pacemakers (CRT-P) by 4.5% over the 2-year period. The percentage of RM activations increased from 24.5% in 2018 to 49.0% in 2021, with a sharp increase during the lockdown. The RM activation rates consistently increased during the lockdown for all devices: pacemakers (14.4% vs 37.2%; P<.001); ICD (75.6% vs 94.2%; P<.001); CRT-D/CRT-P (68.6-44.2% vs 81.6-61%; P<.001), and implantable loop recorders (50.2% vs 68.7%; P<.001). Conclusions The significant decline in implants during the lockdown gradually recovered, except for pacemakers and ICD. However, the COVID-19 pandemic boosted RM for all CIEDs in Spain. (AU)

Impact of the COVID-19 pandemic on implantation of cardiac implantable electronic devices and remote monitoring activations.

INTRODUCTION AND OBJECTIVES: Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is considered more reliable, efficient, and safer than conventional in-person follow-up. However, the implementation of RM is still suboptimal. This study aimed to analyze the impact of the COVID-19 pandemic on the rates of CIED implants and RM activations in Spain. METHODS: The COVID-19 RM Spain Registry was used to analyze the monthly number of all CIED implantations and RM activations from January 2018 to December 2021. A descriptive analysis was performed using aggregated data from the five major CIED manufacturers. RESULTS: A total of 205 345 CIEDs were recorded. The number of implants decreased sharply (48.2%) during the pandemic lockdown (March-June 2020) but gradually increased thereafter, compensating for the previous reduction. However, pacemakers and implantable cardiac defibrillators (ICD) showed an aggregate loss of 7% and 3%, respectively, from the annual average during 2020-2021. In contrast, cardiac resynchronization therapy defibrillators (CRT-D) increased by 17%, and pacemakers (CRT-P) by 4.5% over the 2-year period. The percentage of RM activations increased from 24.5% in 2018 to 49.0% in 2021, with a sharp increase during the lockdown. The RM activation rates consistently increased during the lockdown for all devices: pacemakers (14.4% vs 37.2%; P <.001); ICD (75.6% vs 94.2%; P <.001); CRT-D/CRT-P (68.6-44.2% vs 81.6-61%; P <.001), and implantable loop recorders (50.2% vs 68.7%; P <.001). CONCLUSIONS: The significant decline in implants during the lockdown gradually recovered, except for pacemakers and ICD. However, the COVID-19 pandemic boosted RM for all CIEDs in Spain.

Treatment with gentamicin-impregnated collagen sponges in reducing infection of implantable cardiac devices: 10-year analysis with propensity score matching.

INTRODUCTION AND OBJECTIVES: The incidence of device infection has increased over time and is associated with increased mortality in patients with cardiac implantable electronic devices (CIEDs). Gentamicin-impregnated collagen sponges (GICSs) are useful in preventing surgical site infection (SSI) in cardiac surgery. Nevertheless, to date, there is no evidence concerning their use in CIED procedures. Our study aims to determine the effectiveness of treatment with GICSs in preventing CIED infection. METHODS: A total of 2986 adult patients who received CIEDs between 2010 and 2020 were included. Before device implantation, all patients received routine periprocedural systemic antibiotic prophylaxis. The study endpoints were the CIED infection rate at one year and the effectiveness of the use of GICSs in reducing CIED infection. RESULTS: Among 1524 pacemaker, 942 ICD and 520 CRT implantations, CIED infection occurred in 36 patients (1.2%). Early reintervention (OR 9 [95% CI 3.180-25.837], p<0.001), pocket hematoma (OR 11 [95% CI 4.195-28.961], p<0.001), diabetes (OR 2.9 [95% CI 1.465-5.799], p=0.002) and prolonged procedural time (OR 1.02 [95% CI 1.008-1.034], p=0.001) were independent risk factors for CIED infection. Treatment with GICSs reduced CIED infections significantly ([95% CI -0.031 to -0.001], p<0.001). CONCLUSIONS: The use of GICSs may help in reducing infections associated with CIED implantation.

Dispositivos cardíacos implantables y uso de resonancia magnética / Cardiac implantable devices and use of magnetic resonance / Dispositivos cardíacos implantáveis e utilização da ressonância magnética

El uso de la resonancia magnética (RM) en las distintas áreas de la medicina se ha expandido de manera significativa y de forma diaria se solicitan numerosos estudios. El hecho de que los resonadores pueden interaccionar con algunos objetos ha llevado a que históricamente se les niegue la realización de este estudio a pacientes portadores de dispositivos cardíacos porque se entiende que existen contraindicaciones absolutas. El avance de la tecnología de los dispositivos y la creciente evidencia publicada han cambiado este concepto. Nos proponemos revisar los mecanismos por los cuales un dispositivo implantable puede interactuar con el resonador y las implicancias clínicas que esto podría tener si las hubiera. La mayoría de los pacientes portadores de dispositivos cardíacos de estimulación podrán realizarse una RM, pero para que este procedimiento sea seguro es importante conocer las características y el tipo específico de dispositivo implantado. Proponemos finalmente puntos clave y algoritmos para tener en cuenta para el manejo adecuado de estos pacientes.

The use of magnetic resonance imaging (MRI) in different areas of medicine has expanded significantly and numerous procedures are indicated daily. The fact that resonators could interact with some objects has historically led to patients with cardiac devices being denied an MRI on the understanding that they suppose an absolute contraindication. Advances in device technology and the increasing evidence have changed this concept. We intend to review the mechanisms by which an implantable device could interact with the resonator and the clinical implications that this could have if any. Most patients will be able to undergo these studies, but to determine the safety of performing an MRI it is important to know the characteristics and specific type of implanted device. Finally, we provide key points and algorithms to take into account for these patients.

O uso da ressonância magnética em diferentes áreas da medicina tem se expandido significativamente e inúmeros exames são indicados diariamente. A possibilidade de que os ressonadores interajam com alguns objetos historicamente levou os pacientes com dispositivos cardíacos a terem a ressonância magnética negada por entender que existem contraindicações absolutas. Os avanços na tecnologia de dispositivos e o aumento das evidências publicadas mudaram esse conceito. Pretendemos revisar os mecanismos pelos quais um dispositivo implantável pode interagir com o ressonador e as implicações clínicas que isso pode ter, se houver. A grande maioria dos pacientes poderá se submeter a esses estudos, mas para determinar a segurança de realizar uma ressonância magnética é importante conhecer as características e o tipo específico de dispositivo implantado. Por fim, propomos pontos e algoritmos para a gestão dos pacientes.

Imágenes en endocarditis infecciosa: no todo es ecocardiografía / Imaging in infective endocarditis: not all is ultrasonography

Resumen La endocarditis infecciosa (EI) es una enfermedad de alta mortalidad, caracterizada por una infección endocárdica y frecuentes complicaciones multiorgánicas, que requiere un diagnóstico rápido y preciso, y un manejo agresivo, ya sea médico o quirúrgico. Su diagnóstico se realiza tomando en cuenta criterios bacteriológicos, clínicos y ecocardiográficos. Es objetivo de este artículo realizar una actualización del estudio imagenológico en paciente con EI, con especial énfasis en aquellos exámenes no ecocardiográficos disponibles en nuestro medio. En los últimos años, estudios de imagen avanzados han adquirido un rol creciente en su estudio inicial, particularmente la tomografía computada multicorte (TCMC) cardiaca y el positron emission tomography/computed tomography (PET/CT), y han sido recomendados como criterios diagnósticos en las guías recientes para el manejo de esta entidad. La TCMC cardiaca proporciona información anatómica detallada de las válvulas cardiacas y tejido perivalvular, identificando pseudoaneurismas, abscesos y dehiscencias valvulares. El PET/CT con F18-fluorodeoxiglucosa (F18-FDG) permite aumentar la sensibilidad en la detección de EI, y pesquisar con alta eficiencia fenómenos embólicos sistémicos, de elevada frecuencia en esta población. Ambos métodos prestan particular utilidad en EI de válvula protésica, donde la ecocardiografía presenta menor rendimiento diagnóstico. La resonancia magnética (RM) cerebral es el mejor método de imagen para descartar eventos isquémicos/embólicos del sistema nervioso central.

Abstract Infective endocarditis (IE) is an entity characterized by endocardial infection and frequent multiorgan complications, resulting in high mortality. It requires a rapid and accurate diagnosis, and a medical or surgical aggressive treatment. Currently, IE diagnosis rests on bacterial, clinical and ultrasonographic criteria. The objective of this article is to update the imaging study in patients with IE, with special emphasis on those non-echocardiographic examinations available in our environment. Last years, advanced imaging had achieved a growing role in IE diagnosis, especially cardiac multislice computed tomography (MSCT) and positron emission tomography/computed tomography (PET/CT), which have been recommended in recent clinical guidelines to be included as part of diagnostic criteria. Cardiac MSCT provides detailed anatomic information of cardiac valves and perivalve tissue, allowing identification of pseudoaneurysm, abscess and valve dehiscence. F18-FDG PET/CT increases sensitivity for IE detection and shows high accuracy in searching for extracranial systemic embolic events. Both MSCT and PET/CT have particular utility in cases of prosthetic valve endocarditis, where cardiac ultrasonography shows lower performance. Brain magnetic resonance imaging (MRI) is the best imaging method for evaluating ischemic/embolic events of central nervous system.

Consensus document on magnetic resonance imaging in patients with cardiac implanted electronic devices. / Documento de Consenso sobre a realização de ressonância magnética em doentes com dispositivos cardíacos electrónicos implantados.

Magnetic resonance imaging (MRI) is currently considered an essential complementary method for diagnosis in many conditions. Exponential growth in its use is expected due to the aging population and a broader spectrum of clinical indications. Growth in its use, coupled with an increasing number of pacemaker implants, implantable cardioverter-defibrillators and cardiac resynchronization therapy, has led to a frequent clinical need for this diagnostic modality in patients with cardiac implantable electronic devices (CIED). This clinical need has fueled the development of devices specifically designed and approved for use in a magnetic resonance (MR) environment under certain safety conditions (MR-conditional devices). More than a decade after the introduction of the first MR-conditional pacemaker, there are now several dozen MR-conditional devices with different safety specifications. In recent years, increasing evidence has indicated there is a low risk to MRI use in conventional (so-called non-MR-conditional) CIED patients in the right circumstances. The increasing number, as well as the greater diversity and complexity of implanted devices, justify the need to standardize procedures, by establishing institutional agreements that require close collaboration between cardiologists and radiologists. This consensus document, prepared jointly by the Portuguese Society of Cardiology and the Portuguese Society of Radiology and Nuclear Medicine, provides general guidelines for MRI in patients with CIED, ensuring the safety of patients, health professionals and equipment. In addition to briefly reviewing the potential risks of MRI in patients with CIED and major changes to MRI-conditional devices, this article provides specific recommendations on risk-benefit analysis, informed consent, scheduling, programming strategies, devices, monitoring and modification of MRI sequences. The main purpose of this document is to optimize patient safety and provide legal support to facilitate easy access by CIED patients to a potentially beneficial and irreplaceable diagnostic technique.

Recomendações para o manejo de dispositivos cardíacos eletrônicos implantáveis post mortem / Recommendations for the post-mortem management of cardiac implantable electronic devices

O manejo de dispositivos cardíacos eletrônicos implantáveis de pacientes que evoluem a óbito tem sido motivo de controvérsia. Em nosso meio, não há recomendações uniformes, estando baseadas exclusivamente em protocolos institucionais e em costumes regionais. Quando o cadáver é submetido para cremação, além de outros cuidados, recomenda-se a retirada do dispositivo devido ao risco de explosão e dano do equipamento crematório. Principalmente no contexto da pandemia causada pelo SARS-Cov-2, a orientação e organização de unidades hospitalares e serviços funerários é imprescindível para minimizar o fluxo de pessoas em contato com fluidos corporais de indivíduos falecidos por COVID-19. Nesse sentido, a Sociedade Brasileira de Arritmias Cardíacas elaborou este documento com orientações práticas, tendo como base publicações internacionais e recomendação emitida pelo Conselho Federal de Medicina do Brasil.

The management of cardiac implantable electronic devices after death has become a source of controversy. There are no uniform recommendations for such management in Brazil; practices rely exclusively on institutional protocols and regional custom. When the cadaver is sent for cremation, it is recommended to remove the device due to the risk of explosion and damage to crematorium equipment, in addition to other precautions. Especially in the context of the SARS-CoV-2 pandemic, proper guidance and organization of hospital mortuary facilities and funeral services is essential to minimize the flow of people in contact with bodily fluids from individuals who have died with COVID-19. In this context, the Brazilian Society of Cardiac Arrhythmias has prepared this document with practical guidelines, based on international publications and a recommendation issued by the Brazilian Federal Medical Council.

Real-life data on heart failure before and after implantation of resynchronization and/or defibrillation devices - the Síncrone study. / Implantação de dispositivos de ressincronização e/ou desfibrilhação em doentes com insuficiência cardíaca: dados da vida real ­ o Estudo Síncrone.

INTRODUCTION: The aim of this study was to document clinical practice in Portugal regarding the use of electronic cardiac devices in patients with heart failure (HF) and reduced left ventricular ejection fraction (LVEF). METHODS: The Síncrone study was an observational prospective multicenter registry conducted in 16 centers in Portugal between 2006 and 2014. It included adult patients with a diagnosis of HF, LVEF <35% and indication for implantable cardioverter-defibrillator (ICD) and/or cardiac resynchronization therapy (CRT) devices, according to the recommendations of the European Society of Cardiology at the beginning of the study. Patients were followed for one year according to the practice of each center. RESULTS: A total of 486 patients were included in the registry, half of whom received an ICD and the other half a CRT pacemaker (CRT-P) or CRT defibrillator (CRT-D). Mean age was 65±12 years and the most frequent causes of HF were ischemic (47%) and idiopathic dilated cardiomyopathy (28%). Overall mortality at one year was 3.6% and the hospitalization rate was 11%, significantly higher in patients with CRT-P/CRT-D than with ICD (17% vs. 5.6%, p<0.001). Patients who received CRT-P/CRT-D experienced significant reductions in QRS duration (160±21 vs. 141±24 ms, p<0.001) as well as improvement in New York Heart Association functional class. CONCLUSION: The Síncrone study shows that the use of implantable devices in HF with reduced LVEF in Portugal is in accordance with international recommendations and that patients presented functional improvement and reduced one-year mortality.

Cuidado perioperatorio de pacientes portadores de dispositivos electrónicos cardíacos implantables / Perioperative care in patients with cardiac implantable electronic devices

Dado el creciente número de pacientes con dispositivos electrónicos cardíacos implantables (DECI), que incluyen marcapasos y/o cardiovertores-desfibriladores implantables, el manejo perioperatorio de aquellos que serán sometidos a cirugía requiere que el equipo quirúrgico esté familiarizado con estos dispositivos y sus implicancias, con la finalidad de disminuir los eventos adversos. Las guías clínicas actuales recomiendan un manejo multidisciplinario. Sin embargo, cuando estas condiciones no son posibles, tanto el equipo quirúrgico como anestésico deben ser capaces de proveer un manejo perioperatorio seguro y efectivo. Este debe ser individualizado a cada paciente, tipo de dispositivo y procedimiento quirúrgico al que será sometido, por lo que una única recomendación no es apropiada para todos los casos. En esta revisión se describen las principales recomendaciones para el manejo perioperatorio de pacientes usuarios de marcapasos y/o cardiovertores-desfibriladores implantables.

With the increased number of patients with cardiac implantable electronic devices (CIED), which include pacemakers and/or implantable cardioverter- defibrillators, the perioperative management of those patients who will be undergoing surgery requires that surgical team to become familiar with these devices and their implications, in order to reduce the adverse outcomes. Current guidelines recommend a multidisciplinary approach of these patients. However, when these conditions are not feasible, both surgical and anesthesia team should be able to provide a safe and effective perioperative environment. This management should be individualized for each patient, type of device and surgical procedure; therefore a single recommendation is not appropriate for all cases. The main recommendations for the perioperative management of patients with pacemakers and/or implantable cardioverter-defibrillators are described in this review.

Cardiac device infection: Review based in the experience of a single center. / Endocardite de dispositivos, revisão com base na experiência de um centro.

INTRODUCTION: The incidence of cardiac implantable electronic device infections has increased significantly over the years and they are associated with significant morbidity and mortality. The epidemiology in the Central region of Portugal is not known. OBJECTIVE AND METHODS: To characterize cardiac implantable electronic device infections through a retrospective study of 3158 patients admitted to our center between January 2008 and September 2014 and to review the subject in the light of the current state of the art. RESULTS: The infection rate was 1.48% (pacemakers 1.21%, cardiac defibrillator/resynchronization devices 5.40%). The study population consisted of 47 patients with a mean age of 65±19 years, predominantly male (72.3%). Infections were mainly of pacemakers, the main device implanted in our population (n=2954), and most occurred late after first implantation. Clinically, most patients presented with fever and local inflammation. Blood cultures identified mainly Gram-positive microorganisms. Empiric antibiotic therapy with vancomycin was instituted in all patients, associated with gentamicin in 57%. The device was extracted in the majority of cases (72%). During follow-up (32±22 months) eight patients died (17%), seven of cardiovascular cause (15%), and seven were readmitted with device infection (15%). CONCLUSIONS: Our rate of infection was low, similar to other published series, with a higher rate in cardiac defibrillator/resynchronization devices. After standard treatment with antibiotic therapy and device extraction, the prognosis was good.

Capacidad de agencia de autocuidado y calidad de vida de las personas que tienen dispositivos cardiacos implantables / Self-care agency capacity and quality of life of people with implantable cardiac devices

El objetivo de este estudio fue describir la relación que existe entre la capacidad de agencia de autocuidado y la calidad de vida relacionada con la salud de las personas que tienen dispositivos cardiacos implantables en la ciudad de Bogotá. Este estudio es cuantitativo correlacional, de corte transversal. El Autocuidado se midió con la escala "Capacidad de Agencia de Autocuidado" diseñada por Isemberg, Evers y Otros; y la calidad de vida con el cuestionario de salud SF-36 desarrollado por Ware y Sherbourne, ambos cuentan con validez y confiabilidad para el contexto colombiano. Fueron aplicados a 125 personas, quienes voluntariamente accedieron a participar. Se encontró una relación débil positiva (r=0,34, p< 0,01) entre autocuidado y calidad de vida. Existen asociaciones estadísticamente significativas entre las dimensiones. Desde el autocuidado, el bienestar personal, actividad y reposo y promoción del funcionamiento y desarrollo personal, se relacionó con todas las dimensiones de calidad de vida. La promoción del funcionamiento y desarrollo personal es la dimensión que mostró mejor asociación con la calidad de vida, específicamente con el desempeño físico. Análisis adicionales del estudio, determinaron que la calidad de vida se relaciona de manera significativa con el género y el estado civil. Estadísticamente, no existen diferencias significativas entre la calidad de vida y el autocuidado según el tiempo de convivencia con el dispositivo cardiaco y el tipo de terapia. Se reporta un alfa de Cronbach de 0,78 para la escala que mide la Capacidad de Agencia de Autocuidado y 0,93 para el cuestionario de salud SF-36.

The objective of this study was to determine the existing relation between the capacity of self-care agency and the quality of life related to the health of people that have implantable cardiac devices in the city of Bogotá. This quantitative study is corelational and cross-sectional. Self-care was measured with a scale titled "Self-care Agency Capacity", designed by Isemberg, Evers second version in Spanish; quality of life was measured with the SF-36 Health Questionnaire, developed by Ware y Sherbourne. Both measurements are reliable and valid within the Colombian context. These were applied to 125 people, which volunteered to participate. A weak, positive co-relation was found (r=0.34, p< 0.01) between self-care and quality of life. Some statistically significant associations exist between these dimensions. Personal healthcare, physical activity and rest, and promotion regarding personal development and functions have all been related to all the dimensions of quality of life, all derived from selfcare. The promotion of personal development and functions is the most co-related dimension in regards to quality of life, especially in terms of physical performance. Additional analysis from the study determined that quality of life has a significant corelation with gender and civil status. Statistically, there is no significant difference between quality of life and self-care, according to time spent with the cardiac device and the type of therapy. The alfa Chronbach's reliability coefficient was applied to the "Self-care Agency Capacity" scale and a value of 0,78 was obtained, and a value of 0,93 was obtained for SF-36 Health Questionnaire.