Registro Costarricense de Resincronizadores, Desfibriladores Automáticos y Marcapasos Endovasculares (RECORDAME). I Informe oficial de la Comisión de Electrofisiología de la Asociación Costarricense de Cardiología (2019-2020) / Costa Rican Registry of Resynchronizers, Automatic Defibrillators and Endovascular Pacemakers (RECORDAME). I Official Report of the Electrophysiology Commission of the Costa Rican Cardiology Association (2019-2020)

Resumen Introducción y objetivo: Comunicar el primer informe del del registro nacional de dispositivos de estimulación cardíaca de agosto 2019 a agosto 2020, registro prospectivo de participación voluntaria. Métodos: Se analiza la información registrada, en forma voluntaria, por los centros implantadores con respecto a la población de pacientes a quienes se implantó un marcapaso, un desfibrilador o un resincronizador entre el 22 de agosto de 2019 hasta setiembre de 2020. Resultados: Se registraron un total de 317 procedimientos de marcapasos, por 10 centros implantadores, lo que corresponde a una participación en el registro de un 40%. La tasa de uso de marcapasos de 6,27 x 100 mil habitantes. Un 83% de los marcapasos fueron implantados en centros públicos, un 70% correspondió a dispositivos bicamerales. La edad media de la población fue de 73,7 años. La indicación más frecuente fue el trastorno de conducción AV (70,3%). Los electrodos de fijación activa fueron los más utilizados (97,8%). Un 83,3% de los sistemas implantados tuvieron compatibilidad con resonancia magnética. El uso de marcapasos unicamerales fue más frecuente en pacientes con 80 o más años. Con respecto a la terapia DAI se registraron un total de 63 procedimientos, por 5 centros implantadores, con una participación del 41%. La tasa total de implantes durante el período fue de 1,25 x 100 mil habitantes. La cardiomiopatía dilatada no isquémica fue la cardiopatía más frecuente en la población registrada. Conclusiones: El registro permite conocer la dinámica de procedimientos e indicaciones más usuales para el uso de dispositivos electrónicos cardíacos así como establecer la tasa de uso de las terapias en nuestro país. El porcentaje de participación en el registro puede mejorar. La implantación de dispositivos de estimulación cardíaca es financiada predominantemente por el sistema de seguridad social. La tasa de implantación es baja con respecto a otras regiones.

Abstract Costa Rican Registry of Resynchronizers, Automatic Defibrillators and Endovascular Pacemakers (RECORDAME). I Official Report of the Electrophysiology Commission of the Costa Rican Cardiology Association (2019-2020) Introduction and objective: To communicate the results of the first national registry of cardiac stimulation devices from August 2019 to August 2020. Methods: We analyze the information recorded prospectively, on a voluntary basis, by the implant centers with respect to the population of patients who were implanted with a pacemaker, a defibrillator or a resynchronizer between August 22, 2019 and September 2020. Results: A total of 317 pacemaker procedures were registered from 10 centers participated. Participation was 40% of total procedures reported by companies. The pacemaker implantation rate was 6.27 per hundred thousand. A 83% of pacemakers were implanted in public centers, 70% corresponded to dual chamber devices. Mean age of the population was 73.7 years. Most frequent indication was AV conduction disorder (70.3%). Active fixation electrodes were the most used (97.8%). A 83.3% were MRI conditional. Use of single chamber pacemakers was more frequent in patients aged 80 years or older. Regarding ICD therapy, a total of 63 procedures were registered. from 5 centers, with a participation of 41%. Rate of ICD use was 1.25 per hundred thousand. Non-ischemic dilated cardiomyopathy was the most common heart disease in the recorded population. Conclusions: The registry allowed to know the frequency of procedures and more usual indications as well as to establish the rate of use of therapies in our country. The percentage of participation in the registration can be improved. The implementation of cardiac stimulation devices is predominantly financed by the social security system. The implantation rate is low compared to other regions.

Unscheduled Emergency Visits after Cardiac Devices Implantation: Comparison between Cardioverter Defibrillators and Cardiac Resynchronization Therapy Devices in less than one year of Follow Up / Consultas Não Programadas em Emergência após Implante de Dispositivos Cardíacos: Comparativo entre Cardiodesfibriladores e Ressincronizadores em Seguimento Inferior a 1 Ano

Abstract Background: The use of Cardiovascular Implantable Electronic Devices (CIED), such as the Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT), is increasing. The number of leads may vary according to the device. Lead placement in the left ventricle increases surgical time and may be associated with greater morbidity after hospital discharge, an event that is often confused with the underlying disease severity. Objective: To evaluate the rate of unscheduled emergency hospitalizations and death after implantable device surgery stratified by the type of device. Methods: Prospective cohort study of 199 patients submitted to cardiac device implantation. The groups were stratified according to the type of device: ICD group (n = 124) and CRT group (n = 75). Probability estimates were analyzed by the Kaplan-Meier method according to the outcome. A value of p < 0.05 was considered significant in the statistical analyses. Results: Most of the sample comprised male patients (71.9%), with a mean age of 61.1 ± 14.2. Left ventricular ejection fraction was similar between the groups (CRT 37.4 ± 18.1 vs. ICD 39.1 ± 17.0, p = 0.532). The rate of unscheduled visits to the emergency unit related to the device was 4.8% in the ICD group and 10.6% in the CRT group (p = 0.20). The probability of device-related survival of the variable "death" was different between the groups (p = 0.008). Conclusions: Patients after CRT implantation show a higher probability of mortality after surgery at a follow-up of less than 1 year. The rate of unscheduled hospital visits, related or not to the implant, does not differ between the groups.

Resumo Fundamento: O uso de dispositivos cardíacos eletrônicos implantáveis (DCEI) como o cardiodesfibrilador (CDI) e terapia de ressincronização cardíaca (TRC) - é cada vez maior. O número de eletrodos de estimulação e desfibrilação varia de acordo com o dispositivo. A colocação do eletrodo no ventrículo esquerdo aumenta o tempo cirúrgico podendo associar-se a maior morbidade no acompanhamento após alta hospitalar, evento muitas vezes confundível com a gravidade da patologia base. Objetivo: Avaliar a taxa de internação não programada na emergência e óbito após cirurgia de dispositivos implantáveis estratificados pelo tipo de aparelho. Métodos: Estudo de coorte prospectivo analisando 199 pacientes submetidos à implante de dispositivos cardíacos. Os grupos foram divididos de acordo com o tipo de dispositivo: CDI (n = 124) e TRC (n = 75). Estimativas de probabilidades foram analisadas pelo método de Kaplan-Meier de acordo com o desfecho. Valor de p < 0,05 foi considerado significativo nas análises estatísticas. Resultados: A maioria da amostra era do sexo masculino (71,9%) - idade média de 61,1 ± 14,2. A fração de ejeção do ventrículo esquerdo foi similar entre os grupos (TRC 37,4 ± 18,1 vs. CDI 39,1 ± 17,0; p = 0,532). A taxa de visita não programada na emergência relacionada ao dispositivo foi de 4,8% no grupo CDI e de 10,6% no grupo TRC (p = 0,20). A probabilidade de sobrevida relacionada ao dispositivo da variável "óbito" mostrou-se diferente entre os grupos (p = 0,008). Conclusões: Paciente após o implante de TRC apresenta maior probabilidade de mortalidade após o procedimento cirúrgico no seguimento menor que 1 ano. A taxa de visita hospitalar não programada, relacionadas ou não ao implante, não difere entre os grupos.

Development and Validation of Predictive Models of Cardiac Mortality and Transplantation in Resynchronization Therapy / Desenvolvimento e Validação de Modelos Preditores de Mortalidade Cardíaca e Transplante na Terapia de Ressincronização Cardíaca

AbstractBackground:30-40% of cardiac resynchronization therapy cases do not achieve favorable outcomes.Objective:This study aimed to develop predictive models for the combined endpoint of cardiac death and transplantation (Tx) at different stages of cardiac resynchronization therapy (CRT).Methods:Prospective observational study of 116 patients aged 64.8 ± 11.1 years, 68.1% of whom had functional class (FC) III and 31.9% had ambulatory class IV. Clinical, electrocardiographic and echocardiographic variables were assessed by using Cox regression and Kaplan-Meier curves.Results:The cardiac mortality/Tx rate was 16.3% during the follow-up period of 34.0 ± 17.9 months. Prior to implantation, right ventricular dysfunction (RVD), ejection fraction < 25% and use of high doses of diuretics (HDD) increased the risk of cardiac death and Tx by 3.9-, 4.8-, and 5.9-fold, respectively. In the first year after CRT, RVD, HDD and hospitalization due to congestive heart failure increased the risk of death at hazard ratios of 3.5, 5.3, and 12.5, respectively. In the second year after CRT, RVD and FC III/IV were significant risk factors of mortality in the multivariate Cox model. The accuracy rates of the models were 84.6% at preimplantation, 93% in the first year after CRT, and 90.5% in the second year after CRT. The models were validated by bootstrapping.Conclusion:We developed predictive models of cardiac death and Tx at different stages of CRT based on the analysis of simple and easily obtainable clinical and echocardiographic variables. The models showed good accuracy and adjustment, were validated internally, and are useful in the selection, monitoring and counseling of patients indicated for CRT.

ResumoFundamento:A terapia de ressincronização cardíaca pode demonstrar resultados desfavoráveis em 30-40% dos casos.Objetivo:Este estudo teve por objetivo desenvolver modelos preditores para o desfecho combinado de morte cardíaca ou transplante (Tx) em diferentes estágios da terapia de ressincronização cardíaca (TRC).Métodos:Estudo prospectivo observacional de 116 pacientes com idade média de 64,8 ± 11,1 anos, dos quais 68,1% estavam em classe funcional (CF) III e 31,9% em classe IV ambulatorial. Variáveis clínicas, eletrocardiográficas e ecocardiográficas foram avaliadas com regressão de Cox e curvas de Kaplan-Meier.Resultados:O desfecho mortalidade/Tx cardíacos foi de 16,3% durante seguimento de 34,0 ± 17,9 meses. No período pré-implante, disfunção ventricular direita (DVD), fração de ejeção < 25% e uso de altas doses de diuréticos (ADD) aumentaram o risco de morte e Tx cardíacos em 3,9, 4,8 e 5,9 vezes, respectivamente. No primeiro ano após TRC, DVD, AHDD e hospitalização por insuficiência cardíaca congestiva elevaram o risco de morte (razões de risco de 3,5, 5,3 e 12,5, respectivamente). No segundo ano após TRC, DVD e CF III/IV foram fatores de risco significativos de mortalidade no modelo multivariado de Cox. As acurácias dos modelos foram 84,6% na pré-implante, 93% no primeiro ano após TRC e 90,5% no segundo ano após TRC. Os modelos foram validados por bootstrapping.Conclusão:Desenvolvemos modelos preditores de morte e Tx cardíacos em diferentes estágios de TRC com base na análise de variáveis clínicas e ecocardiográficas simples e de fácil obtenção. Os modelos mostraram boa acurácia e ajuste, foram validados internamente e são úteis para a seleção, o monitoramento e a orientação de pacientes indicados para TRC.

Mid-Term Outcomes in Patients Implanted with Cardiac Resynchronization Therapy

We applied cardiac resynchronization therapy (CRT) for desynchronized heart failure patients. We evaluated clinical outcomes including morbidity, mortality, and echocardiographic parameters in 47 patients with implanted CRT in Korea from October 2005 to May 2013. The combined outcomes of hospitalization from heart failure, heart transplantation and death were the primary end point. Median follow-up period was 17.5 months. The primary outcomes listed above occurred in 10 (21.3%) patients. Two patients (4.3%) died after CRT and 8 (17%) patients were hospitalized for recurrent heart failure. Among patients hospitalized for heart failure, 2 (4.3%) patients underwent heart transplantation. The overall free rate of heart failure requiring hospitalization was 90.1% (95% CI, 0.81-0.99) over one year and 69.4% (95% CI, 0.47-0.91) over 3 yr. We observed improvement of the New York Heart Association classification (3.1+/-0.5 to 1.7+/-0.4), decreases in QRS duration (169.1 to 146.9 ms), decreases in left ventricular (LV) end-diastolic (255.0 to 220.1 mL) and end-systolic (194.4 to 159.4 mL) volume and increases in LV ejection fraction (22.5% to 31.1%) at 6 months after CRT. CRT improved symptoms and echocardiographic parameters in a relatively short period, resulting in low mortality and a decrease in hospitalization due to heart failure.