Efetividade e Segurança da Remoção de Cabos-Eletrodos Transvenosos de Marca-Passos e Desfibriladores Implantáveis no Cenário da Prática Clínica Real / Effectiveness and Safety of Transvenous Removal of Cardiac Pacing and Implantable Cardioverter-defibrillator Leads in the Real Clinical Scenario

Resumo Fundamento Remoção de cabos-eletrodos de dispositivos cardíacos eletrônicos implantáveis (DCEI) é procedimento pouco frequente e sua realização exige longo treinamento profissional e infraestrutura adequada. Objetivos Avaliar a efetividade e a segurança da remoção de cabos-eletrodos de DCEI e determinar fatores de risco para complicações cirúrgicas e mortalidade em 30 dias. Métodos Estudo prospectivo com dados derivados da prática clínica. De janeiro/2014 a abril/2020, foram incluídos, consecutivamente, 365 pacientes submetidos à remoção de cabos-eletrodos, independentemente da indicação e técnica cirúrgica utilizada. Os desfechos primários foram: taxa de sucesso do procedimento, taxa combinada de complicações maiores e morte intraoperatória. Os desfechos secundários foram: fatores de risco para complicações intraoperatórias maiores e morte em 30 dias. Empregou-se análise univariada e multivariada, com nível de significância de 5%. Resultados A taxa de sucesso do procedimento foi de 96,7%, sendo 90,1% de sucesso completo e 6,6% de sucesso clínico. Complicações maiores intraoperatórias ocorreram em 15 (4,1%) pacientes. Fatores preditores de complicações maiores foram: tempo de implante dos cabos-eletrodos ≥ 7 anos (OR= 3,78, p= 0,046) e mudança de estratégia cirúrgica (OR= 5,30, p= 0,023). Classe funcional III-IV (OR= 6,98, p<0,001), insuficiência renal (OR= 5,75, p=0,001), infecção no DCEI (OR= 13,30, p<0,001), número de procedimentos realizados (OR= 77,32, p<0,001) e complicações maiores intraoperatórias (OR= 38,84, p<0,001) foram fatores preditores para mortalidade em 30 dias. Conclusões Os resultados desse estudo, que é o maior registro prospectivo de remoção de cabos-eletrodos da América Latina, confirmam a segurança e a efetividade desse procedimento no cenário da prática clínica real. (Arq Bras Cardiol. 2020; 115(6):1114-1124)

Abstract Background Transvenous lead extraction (TLE) of cardiac implantable electronic devices (CIED) is an uncommon procedure and requires specialized personnel and adequate facilities. Objectives To evaluate the effectiveness and safety of the removal of CIED leads and to determine risk factors for surgical complications and mortality in 30 days. Methods Prospective study with data derived from clinical practice. From January 2014 to April 2020, we included 365 consecutive patients who underwent TLE, regardless of the indication and surgical technique used. The primary outcomes were: success rate of the procedure, combined rate of major complications and intraoperative death. Secondary outcomes were: risk factors for major intraoperative complications and death within 30 days. Univariate and multivariate analysis were used, with a significance level of 5%. Results Procedure success rate was 96.7%, with 90.1% of complete success and 6.6% of clinical success. Major intraoperative complications occurred in 15 (4.1%) patients. Predictors of major complications were: lead dwelling time ≥ 7 years (OR = 3.78, p = 0.046) and change in surgical strategy (OR = 5.30, p = 0.023). Functional class III-IV (OR = 6.98, p <0.001), renal failure (OR = 5.75, p = 0.001), CIED infection (OR = 13.30, p <0.001), number of procedures performed (OR = 77.32, p <0.001) and major intraoperative complications (OR = 38.84, p <0.001) were predictors of 30-day mortality. Conclusions The results of this study, which is the largest prospective registry of consecutive TLE procedures in Latin America, confirm the safety and effectiveness of this procedure in the context of real clinical practice. (Arq Bras Cardiol. 2020; 115(6):1114-1124)

Comparación de dos protocolos de antibiótico profiláctico en implantes de dispositivos de estimulación cardíaca. "COMPROFILAXIA" / Comparison of two prophylactic antibiotic protocols in implantable cardiac stimulation devices: "COMPROFILAXIA"

Resumen Introducción: El aumento de los implantes de dispositivos de estimulación cardiaca en los últimos años, aunado a la longevidad y al perfil de morbilidad de los pacientes, ha hecho que la incidencia de infecciones asociadas a estos procedimientos aumente. Sin embargo, existe disparidad en Colombia y en el mundo respecto al esquema apropiado de profilaxis antibiótica. Objetivo: Evaluar la incidencia de infecciones postoperatorias con dos protocolos de antibiótico-profilaxia. Métodos: Ensayo clínico controlado aleatorizado en el que se incluyeron 360 pacientes que recibieron implante de dispositivos cardíacos y fueron aleatorizados en dos grupos para recibir una dosis de antibiótico (cefazolina 1 g) (240 pacientes) o tres dosis (120 pacientes). Se realizó seguimiento durante un año. El desenlace principal fue la incidencia de infecciones postoperatorias. Resultados: No se observó una diferencia significativa entre la incidencia de infección postoperatoria en los dos grupos (tres dosis vs. una dosis: OR crudo 0.92; IC95% 0.23 - 3.64; p 0.912), con una tasa de 2.9% (7/238) en el grupo de una dosis y de 2.7% (3/110) en el grupo de tres dosis. Tras el análisis multivariado se identificó a la enfermedad renal crónica como un predictor independiente para el desarrollo de complicaciones infecciosas (OR ajustado 4.71; IC95% 1,13 - 19,60). Conclusión: El uso de un protocolo de única dosis de antibiótico profiláctico una hora antes del implante de dispositivos de estimulación cardiaca parece no ser inferior al protocolo de tres dosis postoperatorias.

Abstract Introduction: The increase in implantable cardiac stimulation devices in the last few years, along with the longevity and morbidity characteristics of the patient, has led to an increase in infections associated with these procedures. However, there are differences in Colombia and in the rest of the world as regards a suitable antibiotic prophylaxis scheme. Objective: To evaluate the incidence of post-operative infections with two antibiotic prophylaxis protocols. Methods: A controlled, randomised clinical trial was performed, in which 360 patients that had received a cardiac device implant were randomised into two groups: one with 240 patients to receive one dose of antibiotic (1 g cephazolin), and another of 120 patients to receive 3 doses. The patients were followed-up for one year. The primary outcome was the incidence of post-operative infections. Results: No significant difference was observed in the incidence of post-operative infections between the two groups (three doses versus one dose: crude OR, 0.92; 95% CI; 0.23 - 3.64; P = .912), with a rate of 2.9% (7/238) in the one-dose group, and 2.7% (3/110) in the three-dose group. After the multivariate analysis, chronic kidney disease was identified as an independent predictor of developing infectious complications (adjusted OR = 4.71; 95% CI; 1.13 - 19.60). Conclusion: The use of a single-dose prophylaxis antibiotic protocol one hour before the implantation of cardiac stimulator devices does not appear to be inferior to the three-dose post-operative protocol.

Tomografía por emisión de positrones en endocarditis infecciosa asociada a dispositivos y válvulas protésicas / Positron emission tomography in infective endocarditis associated with intracardiac devices and prosthetic valves

La endocarditis infecciosa (EI) es una enfermedad grave y potencialmente letal. La capacidad diagnóstica de los criterios de Duke modificados es alta para válvulas nativas, pero decae en el caso de EI de válvulas protésicas o EI asociadas a dispositivos. El ecocardiograma y los hallazgos microbiológicos son fundamentales para el diagnóstico, pero pueden resultar insuficientes en este grupo de pacientes. Nuestro objetivo fue evaluar la utilidad de la tomografía por emisión de positrones y fusión con tomografía computarizada (PET/TC) en pacientes con sospecha de EI, portadores de válvulas protésicas o dispositivos intracardiacos. Se estudiaron 32 pacientes, a los cuales se les realizó un PET/CT con 18F-Flúor desoxiglucosa (18F-FDG). Se consideraron sugestivos de infección aquellos con captación intensa de tipo focal y/o heterogénea con un punto de corte de Standard Uptake Value (SUV) mayor o igual a 3.7. Los diagnósticos iniciales según los criterios de Duke modificados, se compararon con el diagnóstico final establecido por la Unidad de Endocarditis institucional. El agregado del PET/CT a esos criterios, proporcionó un diagnóstico concluyente en 22 de los 32 casos iniciales, reclasificando a 11 casos en EI definitivas y a otros 5 casos como negativos para ese diagnóstico. La EI continúa siendo un grave problema clínico. En aquellos casos donde los criterios de Duke no son suficientes para establecer el diagnóstico y la sospecha clínica persiste, el PET/CT puede ser una herramienta complementaria útil para aumentar la sensibilidad diagnóstica.

Infective endocarditis (IE) is a serious and potentially lethal condition. The diagnostic capacity of the modified Duke criteria is high for native valves, but it declines in the case of EI of prosthetic valves or EI associated with devices. Echocardiography and microbiological findings are essential for diagnosis but may be insufficient in this group of patients. Our objective was to evaluate the usefulness of positron emission tomography and fusion with computed tomography (PET / CT) in patients with suspected IE, carriers of prosthetic valves or intracardiac devices; 32 patients were studied, who underwent PET / CT with 18F-Fluorine deoxyglucose (18F-FDG). Those with intense focal and/or heterogeneous uptake with a Standard Uptake Value (SUV) cut-off point greater than or equal to 3.7 were considered suggestive of infection. The initial diagnoses according to the modified Duke criteria were compared with the final diagnosis established by the Institutional Endocarditis Unit. The addition of PET / CT to these criteria, provided a conclusive diagnosis in 22 of the 32 initial cases reclassifying 11 cases in definitive EI; another 5 cases were negative for that diagnosis. EI continues to be a serious clinical problem. In those cases where the Duke criteria are not sufficient to establish the diagnosis and clinical suspicion persists, PET / CT can be a useful complementary tool to increase the diagnostic sensitivity.

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.

Usefulness of preoperative venography in patients with cardiac implantable electronic devices submitted to lead replacement or device upgrade procedures / Utilidade da Venografia Pré-Operatória em Procedimentos de Troca de Cabos-Eletrodos ou Mudança do Modo de Estimulação

Abstract Background: Venous obstructions are common in patients with transvenous cardiac implantable electronic devices, but they rarely cause immediate clinical problems. The main consequence of these lesions is the difficulty in obtaining venous access for additional leads implantation. Objectives: We aimed to assess the prevalence and predictor factors of venous lesions in patients referred to lead reoperations, and to define the role of preoperative venography in the planning of these procedures. Methods: From April 2013 to July 2016, contrast venography was performed in 100 patients referred to device upgrade, revision and lead extraction. Venous lesions were classified as non-significant (< 50%), moderate stenosis (51-70%), severe stenosis (71-99%) or occlusion (100%). Collateral circulation was classified as absent, discrete, moderate or accentuated. The surgical strategy was defined according to the result of the preoperative venography. Univariate analysis was used to investigate predictor factors related to the occurrence of these lesions, with 5% of significance level. Results: Moderate venous stenosis was observed in 23%, severe in 13% and occlusions in 11%. There were no significant differences in relation to the device side or the venous segment. The usefulness of the preoperative venography to define the operative tactic was proven, and in 99% of the cases, the established surgical strategy could be performed according to plan. Conclusions: The prevalence of venous obstruction is high in CIED recipients referred to reoperations. Venography is highly indicated as a preoperative examination for allowing the adequate surgical planning of procedures involving previous transvenous leads.

Resumo Fundamento: Obstruções venosas são frequentes em portadores de dispositivos cardíacos eletrônicos implantáveis (DCEI) endocárdicos, mas raramente causam problemas clínicos imediatos. A principal consequência destas lesões é a dificuldade para obtenção de via de acesso para o implante de novos cabos-eletrodos. Objetivos: Determinar a prevalência de lesões venosas em candidatos a reoperações envolvendo o manuseio de cabos-eletrodos, e definir o papel da venografia pré-operatória no planejamento desses procedimentos. Métodos: De abril de 2013 a julho de 2016, 100 pacientes com indicação de troca de cabos-eletrodos, ou mudança no modo de estimulação, realizaram venografia com subtração digital no período pré-operatório. As lesões venosas foram classificadas em: não significativas (< 50%), moderadas (51-70%), graves (71-99%) ou oclusivas (100%), e a circulação colateral, em ausente, discreta, moderada ou acentuada. A estratégia cirúrgica foi definida a partir do resultado deste exame. Empregou-se análise univariada para a pesquisa de fatores de risco relacionados à ocorrência dessas lesões, com nível de significância de 5%. Resultados: Obstruções venosas moderadas foram observadas em 23%, graves em 13% e oclusões em 11% dos pacientes estudados, não sendo identificadas diferenças significativas em sua distribuição em relação ao lado do implante, ou do segmento venoso. A utilidade do exame para definição da tática operatória foi comprovada, sendo que em 99% dos casos, a estratégia cirúrgica estabelecida pode ser executada. Conclusões: A prevalência de obstruções venosas é elevada em portadores de DCEI que serão submetidos a reoperações. A venografia é altamente indicada como exame pré-operatório para o adequado planejamento cirúrgico de procedimentos envolvendo cabos-eletrodos transvenosos previamente implantados.

Percutaneous lead extraction in infection of cardiac implantable electronic devices: a systematic review

Abstract Introduction: In the last two decades, the increased number of implants of cardiac implantable electronic devices has been accompanied by an increase in complications, especially infection. Current recommendations for the appropriate treatment of cardiac implantable electronic devices-related infections consist of prolonged antibiotic therapy associated with complete device extraction. The purpose of this study was to analyze the importance of percutaneous extraction in the treatment of these devices infections. Methods: A systematic review search was performed in the PubMed, BVS, Cochrane CENTRAL, CAPES, SciELO and ScienceDirect databases. A total of 1,717 studies were identified and subsequently selected according to the eligibility criteria defined by relevance tests by two authors working independently. Results: Sixteen studies, describing a total of 3,354 patients, were selected. Percutaneous extraction was performed in 3,081 patients. The average success rate for the complete percutaneous removal of infected devices was 92.4%. Regarding the procedure, the incidence of major complications was 2.9%, and the incidence of minor complications was 8.4%. The average in-hospital mortality of the patients was 5.4%, and the mortality related to the procedure ranged from 0.4 to 3.6%. The mean mortality was 20% after 6 months and 14% after a one-year follow-up. Conclusion: Percutaneous extraction is the main technique for the removal of infected cardiac implantable electronic devices, and it presents low rates of complications and mortality related to the procedure.

Subcutaneous implantable cardioverter defibrillator: early experience

Abstract Introduction: The implantable cardioverter defibrillator had been increasing the survival of patients at high risk for sudden cardiac death. The subcutaneous implantable cardioverter defibrillator was developed to mitigate the complications inherent to lead placement into cardiovascular system. Objective: To report the initial experience of 18 consecutive cases of subcutaneous implantable cardioverter defibrillator implantation showing the indications, potential pitfalls and perioperative complications. Methods: Between September 2016 and March 2017, 18 patients with indication for primary and secondary prevention of sudden cardiac death, with no concomitant indication for artificial cardiac pacing, were included. Results: The implantation of the subcutaneous implantable cardioverter defibrillator successfully performed in 18 patients. It was difficult to place the subcutaneous lead at the parasternal line in two patients. One patient returned a week after the procedure complaining about an increase in pain intensity at pulse generator pocket site, which was associated with edema, temperature rising and hyperemia. Two patients took antialgic medication for five days after surgery. A reintervention was necessary in one patient to replace the lead in order to correct inappropriate shocks caused by myopotential oversensing. Conclusion: In our initial experience, although the subcutaneous implantable cardioverter defibrillator implantation is a less-invasive, simple-accomplishment procedure, it resulted in a bloodier surgery perhaps requiring an operative care different from the conventional. Inappropriate shock by oversensing is a reality in this system, which should be overcame in order not to become a limiting issue for its indication.

Predictors of Total Mortality and Echocardiographic Response for Cardiac Resynchronization Therapy: A Cohort Study / Preditores de Mortalidade Total e de Resposta Ecocardiográfica à Terapia de Ressincronização Cardíaca: Um Estudo de Coorte

Abstract Background: Clinical studies demonstrate that up to 40% of patients do not respond to cardiac resynchronization therapy (CRT), thus, appropriate patient selection is critical to the success of CRT in heart failure. Objective: Evaluation of mortality predictors and response to CRT in the Brazilian scenario. Methods: Retrospective cohort study including patients submitted to CRT in a tertiary hospital in southern Brazil from 2008 to 2014. Survival was assessed through a database of the State Department of Health (RS). Predictors of echocardiographic response were evaluated using Poisson regression. Survival analysis was performed by Cox regression and Kaplan Meyer curves. A two-tailed p value less than 0.05 was considered statistically significant. Results: A total of 170 patients with an average follow-up of 1011 ± 632 days were included. The total mortality was 30%. The independent predictors of mortality were age (hazard ratio [HR] of 1.05, p = 0.027), previous acute myocardial infarction (AMI) (HR of 2.17, p = 0.049) and chronic obstructive pulmonary disease (COPD) (HR of 3.13, p = 0.015). The percentage of biventricular stimulation at 6 months was identified as protective factor of mortality ([HR] 0.97, p = 0.048). The independent predictors associated with the echocardiographic response were absence of mitral insufficiency, presence of left bundle branch block and percentage of biventricular stimulation. Conclusion: Mortality in patients submitted to CRT in a tertiary hospital was independently associated with age, presence of COPD and previous AMI. The percentage of biventricular pacing evaluated 6 months after resynchronizer implantation was independently associated with improved survival and echocardiographic response.

Resumo Fundamento: Estudos Clínicos demonstram que até 40% dos pacientes não respondem à terapia de ressincronização cardíaca (TRC), assim a seleção apropriada dos pacientes é fundamental para o sucesso da TRC na insuficiência cardíaca. Objetivo: Avaliação de preditores de mortalidade e resposta à TRC no cenário brasileiro. Métodos: Estudo de coorte retrospectivo incluindo os pacientes submetidos à TRC em hospital terciário no Sul do Brasil entre 2008-2014. A sobrevida foi avaliada através de banco de dados da Secretaria Estadual de Saúde (RS). Os preditores de resposta ecocardiográfica foram avaliados utilizando método de regressão de Poisson. A análise de sobrevida foi feita por regressão de Cox e curvas de Kaplan Meyer. Um valor de p bicaudal inferior a 0,05 foi considerado estatisticamente significativo. Resultados: Foram incluídos 170 pacientes com seguimento médio de 1011 ± 632 dias. A mortalidade total foi de 30%. Os preditores independentes de mortalidade identificados foram idade (hazzard ratio [HR] de 1,05; p = 0,027), infarto agudo do miocárdio (IAM) prévio (HR de 2,17; p = 0,049) e doença pulmonar obstrutiva crônica (DPOC) (HR de 3,13; p = 0,015). O percentual de estimulação biventricular em 6 meses foi identificado com fator protetor de mortalidade ([HR] 0,97; p = 0,048). Os preditores independentes associados à reposta ecocardiográfica foram ausência de insuficiência mitral, presença de bloqueio de ramo esquerdo e percentual de estimulação biventricular. Conclusão: A mortalidade nos pacientes submetidos à TRC em hospital terciário foi independentemente associada à idade, presença de DPOC e IAM prévio. O percentual de estimulação biventricular avaliado 6 meses após o implante do ressincronizador foi independentemente associado a melhora da sobrevida e resposta ecocardiográfica.

Impacto del cambio de programación en la incidencia acumulada de choques apropiados e inapropiados en portadores de cardiodesfibrilador automático implantable / Impact of programming change on the cumulative incidence of appropriate and inappropriate shocks in patients with implantable cardioverter defibrillator

Introducción: el cardiodesfibrilador automático implantable (DAI) ha impactado positivamente en el tratamiento de la muerte súbita cardíaca. Sin embargo, los choques, apropiados o inapropiados generan efectos adversos. Definir zonas para las terapias según la patología de base y utilizando rangos de frecuencia altos e intervalos de detección prolongados ha demostrado disminuir el número de terapias sin aumentar la mortalidad. En Uruguay no existen datos sobre el impacto de estos cambios de programación en la incidencia de choques, como tampoco se han evaluado predictores de tales acontecimientos. Método: cohorte retrospectiva observacional de 191 pacientes vivos con DAI en el período comprendido entre diciembre de 1991 y abril de 2016 en el Servicio de Electrofisiología de Casa de Galicia. El implante se realizó con criterio de prevención secundaria en el 82% de los casos; edad 55±16 años, con predominio del sexo masculino (78%). El 46% tenían fracción de eyección del ventrículo izquierdo (FEVI) >40% y 37% era portador de cardiopatía isquémica. Se asoció terapia de resincronización cardíaca (TRC) en 20%. A partir de enero de 2013 la programación se ajustó a las recomendaciones actuales y se aplicó a 75 pacientes (39%). A efectos de comparar la performance de la nueva estrategia con la tradicional, se determinó la densidad de incidencia de choques apropiados e inapropiados entre los 116 pacientes programados según la estrategia convencional y los 75 con la nueva estrategia y se calculó la razón de densidades de choques apropiados e inapropiados entre ambos grupos. Resultado: con una mediana de seguimiento de tres años, la incidencia acumulada de choques apropiados fue de 30,9% (IC95% 24,4%-37,9%) y de choques inapropiados 16,8% (IC95% 11,7%-22,8%) en el grupo entero. Con la programación tradicional los choques apropiados e inapropiados fueron de 40,5% y 23,3% respectivamente versus 16,0% y 6,7% cuando se utilizó la programación actual. Los factores predictores de choques inapropiados identificados fueron los choques apropiados (OR 4,66 IC95% 1,81-12 p=0,001) y la programación tradicional (OR 6,77 IC95% 1,77-25,9 p=0,005), mientras que para los choques apropiados fue la programación tradicional (OR 3,28 IC95% 1,46-7,38 p=0,002). El uso de TRC (OR 0,036 IC95% 0,01-0,3 p=0,002) constituyó un factor protector independiente. La incidencia de choques inapropiados se reduce 27,7% con la programación actual, mientras que la incidencia de choques apropiados se incrementa 18,0%. Conclusión: la incidencia acumulada de choques apropiados e inapropiados es frecuente en la población estudiada. La programación del dispositivo de acuerdo a las recomendaciones actuales se asoció significativamente a menor ocurrencia de choques inapropiados. La programación tradicional y los choques apropiados fueron predictores independientes de choques inapropiados mientras que el uso de TRC fue predictor negativo independiente para descargas apropiadas.

Introduction: implantable cardioverter defibrillator (ICD) has positively impacted the treatment of sudden cardiac death. However, appropriate or inappropriate shocks generate multiple adverse effects of diverse severity. Defining zones for therapies considering baseline pathology and using higher frequency ranges and longer detection times has been shown to decrease the number of therapies without increasing mortality. In Uruguay, there is no data on the impact of these programming changes on the incidence of appropriate and inappropriate shocks, nor have predictors of such events been evaluated. Method: observational retrospective cohort of 191 alive patients with ICD in the period from December 1991 to April 2016, at the Electrophysiology Service of Casa de Galicia. The implants were performedwith secondary prevention criteria in 82%. Mean age 55±16 y.o., predominantly male (78%). 46% of patientes had left ventricular ejection fraction (LVEF) >40% and 37% had ischemic heart disease. Cardiac resynchronization therapy (CRT) was associated in 20%. From 1/2013 the programming was adjusted to the current recommendations including 75 patients (39%). We considered the cumulative incidence of appropriate and inappropriate shocks and their association with programming through univariate analysis and binary logistic regression for the multivariate. We determined the incidence density and the density ratios between the two groups. Result: with a median follow-up of 3 years, the cumulative incidence of appropriate shocks was 31% (95% CI 24.4-37.9) and inappropriate shocks 17% (CI 95% 11.7-22.8%). With traditional programming, appropriate and inappropriate shocks were 40.5% and 23%, while with the new programming protocol it was 16% and 6.7% respectively. The predictors of inappropriate shocks identified were: appropriate shocks (OR 4.66 CI 95% 1.81-12 p=0.001) and traditional programming (OR 6.77 CI 95% 1.77-25.9 p = 0.005); For appropriate shocks the predictor was the traditional programming (OR 3.28 CI 95% 1.46-7.38 p = 0.002). The use of CRT (OR 0.036 IC95% 0.01-0.3 p = 0.002) was an independent protective factor. The incidence of inappropriate shocks is reduced by 27% with the current protocol while the incidence of appropriate shocks increases by 18%. Conclusion: the cumulative incidence of appropriate and inappropriate shocks is frequent in the studied population. The programming of the device according to current recommendations was significantly associated with less occurrence of inappropriate shocks. Traditional programming and appropriate shocks were independent predictors of inappropriate shocks while the use of CRT was independent predictor of appropriate discharges.

Perfuração subaguda de ventrículo direito por cabo-eletrodo de choque de cardioversor-desfibrilador implantável / Subacute right ventricular perforation by shock lead of implantable cardioverter defibrillator

Relatamos o caso de paciente portador de cardiomiopatia hipertrófica, submetido a implante de cardioversor-desfibrilador implantável, que evoluiu, na primeira semana de pós-operatório, com dor torácica, síncope e choque cardiogênico. À ecocardiografia transtorácica, diagnosticou-se derrame pericárdico e perfuração do ventrículo direito pelo cabo-eletrodo de choque. Foi submetido a toracotomia de urgência e rafia do miocárdio com resolução do quadro. As possíveis razões desse desfecho são discutidas, comparativamente a outros casos na literatura

We report the case of a patient with hypertrophic cardiomyopathy, submitted to an implantable cardioverter defibrillator implant who developed chest pain, syncope, and cardiogenic shock in the first post-operative week. Pericardial effusion and right ventricular perforation by shock lead were diagnosed by transthoracic echocardiography. The patient underwent emergency thoracotomy and myocardial raffia with resolution of the condition. We discuss the possible reasons for this outcome and compare it to other cases in the literature

Complications after Surgical Procedures in Patients with Cardiac Implantable Electronic Devices: Results of a Prospective Registry / Complicações após Procedimentos Cirúrgicos em Portadores de Dispositivos Cardíacos Eletrônicos Implantáveis: Resultados de um Registro Prospectivo

Abstract Background: Complications after surgical procedures in patients with cardiac implantable electronic devices (CIED) are an emerging problem due to an increasing number of such procedures and aging of the population, which consequently increases the frequency of comorbidities. Objective: To identify the rates of postoperative complications, mortality, and hospital readmissions, and evaluate the risk factors for the occurrence of these events. Methods: Prospective and unicentric study that included all individuals undergoing CIED surgical procedures from February to August 2011. The patients were distributed by type of procedure into the following groups: initial implantations (cohort 1), generator exchange (cohort 2), and lead-related procedures (cohort 3). The outcomes were evaluated by an independent committee. Univariate and multivariate analyses assessed the risk factors, and the Kaplan-Meier method was used for survival analysis. Results: A total of 713 patients were included in the study and distributed as follows: 333 in cohort 1, 304 in cohort 2, and 76 in cohort 3. Postoperative complications were detected in 7.5%, 1.6%, and 11.8% of the patients in cohorts 1, 2, and 3, respectively (p = 0.014). During a 6-month follow-up, there were 58 (8.1%) deaths and 75 (10.5%) hospital readmissions. Predictors of hospital readmission included the use of implantable cardioverter-defibrillators (odds ratio [OR] = 4.2), functional class III­-IV (OR = 1.8), and warfarin administration (OR = 1.9). Predictors of mortality included age over 80 years (OR = 2.4), ventricular dysfunction (OR = 2.2), functional class III-IV (OR = 3.3), and warfarin administration (OR = 2.3). Conclusions: Postoperative complications, hospital readmissions, and deaths occurred frequently and were strongly related to the type of procedure performed, type of CIED, and severity of the patient's underlying heart disease.

Resumo Fundamento: Complicações após procedimentos cirúrgicos em portadores de dispositivos cardíacos eletrônicos implantáveis (DCEI) são um problema emergente devido ao aumento crescente na taxa destes procedimentos e ao envelhecimento da população, com consequente aumento de comorbidades. Objetivos: Identificar as taxas de complicações pós-operatórias, mortalidade e readmissão hospitalar, e pesquisar fatores de risco para a ocorrência desses eventos. Métodos: Registro prospectivo e unicêntrico que incluiu todos os indivíduos submetidos a procedimentos cirúrgicos em DCEI no período de fevereiro a agosto de 2011. Os pacientes foram distribuídos por tipos de procedimento nos seguintes grupos: implantes iniciais (coorte 1), troca de gerador (coorte 2) e procedimentos em cabos-eletrodos (coorte 3). Os desfechos foram avaliados por um comitê independente. Empregou-se a análise univariada e multivariada para a pesquisa de fatores de risco e o método de Kaplan-Meier para análise de sobrevida. Resultados: Foram incluídos 713 pacientes, sendo 333, 304 e 76 distribuídos nas coortes 1, 2 e 3, respectivamente. Complicações pós-operatórias foram detectadas em 7,5%, 1,6% e 11,8% dos pacientes nas coortes 1, 2 e 3, respectivamente (p = 0,014). Durante os 6 meses de seguimento, houve 58 (8,1%) óbitos e 75 (10,5%) readmissões hospitalares. Preditores de readmissão hospitalar incluíram o uso de cardioversor-desfibrilador implantável ( odds ratio [OR] = 4,2), classe funcional III-IV (OR = 1,8) e uso de warfarina (OR = 1,9). Preditores de mortalidade incluíram idade acima de 80 anos (OR = 2,4), disfunção ventricular (OR = 2,2), classe funcional III-IV (OR = 3,3) e uso de warfarina (OR = 2,3). Conclusões: Complicações pós-operatórias, readmissões hospitalares e óbitos foram frequentes. Esses eventos estiveram fortemente relacionados ao tipo de procedimento realizado, tipo de DCEI e gravidade da doença cardíaca do paciente.

Rastreio e manejo de pacientes com cabos-eletrodos de cardiodesfibriladores Riata com condutores externalizados: revisão da literatura / Screening and management of patients with Riata implantable cardioverter-defibrillator eads with externalized conductors: literature review

Os cabos-eletrodos de cardiodesfibriladores com revestimento de silicone Riata e Riata ST foramextensamente implantados entre os anos de 2003 e 2010. Sua distribuição, porém, foi interrompida após aobservação de exteriorização dos condutores por falha do isolante em diversos casos de mau funcionamento.Esses cabos-eletrodos foram classificados como classe I de recall pelo Food and Drug Administration. Diversosestudos foram realizados desde então para se determinar a incidência e a prevalência de extrusão dos condutores epara avaliar sua correlação com falha elétrica. Também tem sido estudado o melhor método de rastreio e como seconduzir os pacientes portadores desses cabos-eletrodos.

The cardioverter-defibrillator leads with Riata silicone coating and Riata ST were widely deployed between 2003 and 2010. Its distribution, however, was discontinued after observation of externalization of conductors due to insulation failure in several cases of malfunction. These leads were classified as Class I Recall by the Food and Drug Administration. Several studies have been performed since then to determine the incidence and prevalence of extrusion of the conductors and to evaluate their correlation with electrical failure. The best screening method and how to conduct patients with these leads have also been investigated.

Tempestade elétrica em portadores de cardiodesfibriladores automáticos implantáveis / Electrical storm in patients with automatic implantable cardioverter defibrillators

A tempestade elétrica em portadores de cardiodesfibriladores implantáveis é a ocorrência de pelo menos três intervenções apropriadas, resultante de taquicardia ventricular ou fibrilação ventricular, em 24 horas. É preditor de mau prognóstico e a terapia varia de medicamentos até transplante cardíaco. Este estudo teve por objetivo revisar orientações de diagnóstico e prevenção, visando ao tratamento (farmacológico, intervencionista e cirúrgico) da tempestade elétrica em portadores desses dispositivos. Compilamos publicações no Medline/PubMed e em revistas nacionais. O tratamento das condições basais e desencadeantes, como insuficiência cardíaca e insuficiência coronária, reduziu a morte súbita. A miodarona, betabloqueadores, lidocaína e magnésio são a base terapêutica. A ablação por cateter reduz arritmias e choques, estabiliza o ritmo e melhora o prognóstico. A taquicardia ventricular com substrato permite a abordagem de um circuito estável. A compreensão dos mecanismos e as melhorias no mapeamento eletrofisiológico possibilitam seu uso na fibrilação ventricular. Diferentes condições necessitam de abordagem cirúrgica, eliminando focos arritmogênicos e/ou permitindo o remodelamento,utilizando ressincronização, tratamentos para coronariopatia, valvopatias e cardiopatias congênitas, ressecção endocárdica guiada por eletrofisiologia e transplante em pacientes refratários. Atuando no sistema nervoso, aneuromodulação é alternativa. Durante anestesia peridural torácica, a denervação simpática cardíaca tem efeitos consistentes e persistentes. De modo semelhante à denervação simpática renal, pode ser um novo horizonte. Concluímos que identificar a causa é fundamental. O tratamento dos fatores causais melhora o controle e o prognóstico. Amiodarona, bloqueadores beta-adrenérgicos, lidocaína e magnésio são opções. Procedimento ablativo deve ser ponderado para taquicardia e fibrilação ventricular. Abordagem cirúrgica e neuromodulação...

Electrical storm in patients with implantable cardioverter defibrillator is the occurrence of at least three appropriate interventions resulting from tachycardia or ventricular fibrillation within 24 hours. It a predictor of poor prognosis and its treatment may vary from drug therapy to heart transplantation. Our objectivewas to review diagnostic and prevention guidelines aiming at the treatment (drug therapy, interventional and surgical treatment) of electrical storm in patients using these devices. We analyzed publications from Medline/PubMed and Brazilian medical journals. The treatment of baseline conditions and triggers, such as heart failure and coronary insufficiency, reduced sudden death. Amiodarone, betablockers, lidocaine and magnesium are the therapeutic basis. Catheter ablation reduces shock and arrhythmia, stabilizes rhythm and improves prognosis. Ventricular tachycardia with substratum allows the approach of a stable circuit. Understanding the mechanismsand improvements in electrophysiological mapping enables the use of catheter ablation in ventricular fibrillation.Different conditions require a surgical approach, eliminating arrhythmogenic cores and/or allowing cardiac remodeling, using cardiac resynchronization therapy, treatment for coronary artery disease, valve disease,congenital heart disease, electrophysiology-guided endocardial resection and heart transplantation in refractory patients. Neuromodulation is an alternative that acts on the nervous system. During thoracic epidural anesthesia, cardiac sympathetic denervation has consistent and persisting effects. Similarly, renal denervation may be anotherfuture possibility. In conclusion, identifying the cause is essential. Treatment of baseline factors improves control and prognosis. Amiodarone, betablockers, lidocaine and magnesium are pharmacological options. Catheterablation may be considered for tachycardia and ventricular fibrillation. Surgical approach and neuromodulation...

Como identificar e enfrentar a tempestade elétrica na prática clínica? / How to identify and manage electrical storm in clinical practice

O uso na prática clínica de novas formas de terapia dos portadores de cardiopatia vem aumentando a sobrevida e melhorando sua qualidade de vida ao longo dos anos. O advento dos cardioversores-defibriladores implantáveis foi um marco no tratamento dos pacientes com cardiopatias graves e mais propensos a morte súbita, com redução da taxa de mortalidade nesses pacientes. Porém, surgiram novas questões no manejo desses pacientes, especialmente no que concerne o seguimento dos portadores desses dispositivos em relação à sua otimização para redução de terapias inapropriadas, melhora de qualidade psicossocial e a conduta frente a situações emergenciais representadas por arritmias frequentes, repetitivas erefratárias, como no caso da Tempestade Elétrica. O objetivo do presente trabalho é revisar as definições, epidemiologia e especialmente a conduta frente a esse grupo de pacientes, que deve aumentar nos próximos anos, com a maior prevalência das cardiopatias, especialmente a isquêmica, e o maior número de implantes de dispositivos cardíacos eletrônicos...

The use of new forms of therapy in patients with heart disease has increased the survival and quality of life of these patients in recent years. The advent of implantable cardioverter- defibrillators was a landmark in the treatment of patients with severe heart disease, who were more prone to sudden death, and led to a reduction in mortality rates among these patients. However, new issues emerged in the management of these patients, especially concerning the follow-up of cardioverter-defibrillator patients in terms of reducing inappropriate therapies, improving their quality of life, and managing emergency situations represented by frequent, repetitive and refractory arrhythmias, such as Electrical Storm. The purpose of this paper is to revise the definitions, epidemiology, and above all, the management of this group of patients, which is expected to grow in the coming years, with the greater prevalence of heart disease, especially ischemic heart disease, and thein creased use of electronic heart implants...

Síndrome de Reel recorrente após implante de cardiodesfibrilador à esquerda e à direita / Recurrent Reel Syndrome after left and right implantation of cardioverter defibrillator

A síndrome de Reel é uma complicação rara que ocorre após o implante de dispositivos intracardíacos, sendo definida como retração e deslocamento dos cabos-eletrodos em decorrência de rotação do gerador em seu eixo sagital. Recorrências após medidas preventivas durante o reposicionamento não são comuns. Relata-se o caso de uma paciente com deslocamento recorrente de cabos-eletrodos após implante de cardiodesfibrilador a despeito de diversas medidas adotadas para prevenir novos deslocamentos e implante do dispositivo pela veia subclávia tanto esquerda como direita, com fixação do gerador à fáscia subpeitoral.

The Reel Syndrome is a rare complication that occurs after implantation of intracardiac devices, defined as lead retraction and displacement due to generator rotation on its sagittal axis. Recurrences after preventive measures during repositioning are not common. We report the case of a patient with recurrent lead displacement after defibrillator implantation in spite of several measures taken to prevent further device displacement and implantation both by left and right subclavian vein with attachment of the generator to the subpectoral fascia.

Tempestade elétrica em consulta ambulatorial: evento inusitado / Electrical storm in an outpatient visit: unusual event

Relatamos o caso de paciente com cardiopatia chagásica portador de cardiodesfibrilador implantávelque apresentou tempestade elétrica documentada em consulta de rotina. Ficou claro o caráter dramático e emergencialdo quadro, demonstrando a impossibilidade de tratamento ambulatorial da tempestade arritmogênica, o queevidenciou as limitações terapêuticas nesse cenário. Foram realizadas todas as medidas cabíveis diante da emergênciaclínica, com a utilização de estratégias para reversão e manutenção do paciente fora da crise. Fica em voga no casoem questão o impacto gerado nos âmbitos psicológico e social, tanto por parte do paciente como de seus familiarese de outros pacientes que conviveram com ele durante a internação.

We report the case of a patient with Chagas disease and implantable cardioverter defibrillator whopresented with electrical storm documented in a routine visit. The dramatic and emergency nature of the event wasclear and we realized it was not possible to treat an arrhythmogenic storm on an outpatient basis, which evidencedthe therapeutic limitations in this scenario. All possible treatment strategies were used to revert and keep thepatient out of crisis. The psychological and social impact to the patient, family members and other patients whowere in contact with him during hospitalization should be highlighted.

Perfil dos pacientes chagásicos portadores de cardioversor-desfibrilador implantável (CDI) / Profile of chagasic patients with implantable cardioverter cefibrillators (ICD)

Fundamentos: A morte súbita é responsável por 55-65% dos óbitos na doença de Chagas, e o cardioversor desfibrilador implantável (CDI) é a terapêutica mais efetiva para evitar morte súbita em pacientes com taquiarritmias ventriculares. Objetivo: Descrever o perfil clínico dos pacientes portadores de cardiopatia chagásica crônica com CDI internados em hospital de referência.Métodos: Foram avaliados 75 pacientes chagásicos, portadores de CDI, internados na Santa Casa de Misericórdia de Goiânia no período de janeiro de 2011 a dezembro de 2013, mediante revisão de prontuários. Resultados: A amostra (n=75) se constituiu de 57 (76,0%) pacientes do sexo masculino e 18 (24,0%) do sexo feminino. As internações clínicas representaram 60,0% da amostra e as de causas cirúrgicas 40,0%. Das causas clínicas, 40 (89,0%) foram de origem cardíaca: insuficiência cardíaca (IC) com 13 (32,0%) pacientes e a tempestade elétrica (TE) com 12 (30,0%) pacientes. Das 30 causas cirúrgicas, 17 (56,66%) se deveram a desgaste da bateria.Conclusão: O perfil clínico encontrado em pacientes portadores de cardiopatia chagásica crônica com CDI apresenta as seguintes características: sexo masculino, faixa etária entre 51-60 anos, presença de dispositivos de dupla-câmara, uso adequado de antiarrítmico e beta bloqueador, presença de hipertensão arterial sistêmica (HAS), fração de ejeção do ventrículo esquerdo (FEVE) entre 35-45%, internações clínicas por causas cardíacas (em especial IC e TE), e número de internações pós-implante entre zero e três.

Background: Sudden death accounts for 55-65% of the deaths from Chagas disease, and the implantable cardioverter-defibrillator (ICD) is the most effective therapy to prevent sudden death in patients with ventricular tachyarrhythmias. Objective: To describe the clinical profile of patients with chronic Chagas disease with ICD admitted to a referral hospital. Methods: 75 chagasic patients with ICD, admitted to Santa Casa de Misericórdia de Goiânia, from January 2011 to December 2013, were evaluated by means of medical record review.Results: The sample (n=75) was composed of 57 (76.0%) male patients and 18 (24.0%) female patients. Clinical admissions accounted for 60.0% of the sample, while surgical ones accounted for 40.0%. Out of all clinical admissions, 40 (89.0%) were due to heart problems: heart failure (HF), with 13 (32.0%) patients, and electrical storm (ES), with 12 (30.0%) patients. Out of the 30 surgical admissions, 17 (56.66%) were due to battery depletion.Conclusion: The clinical profile of patients with chronic Chagas disease with CDI is characterized as follows: male, aged 51-60, presence of dual-chamber devices, appropriate use of antiarrhythmic drugs and beta-blockers, presence of systemic hypertension (SH),left ventricular ejection fraction (LVEF) of 35-45%, clinical admissions due to heart problems (particularly HF and ES), and zero to three post-implantation admissions.

Efficacy of cognitive behavioral therapy in reducing psychiatric symptoms in patients with implantable cardioverter defibrillator: an integrative review

This article is a systematic review of the available literature on the benefits that cognitive behavioral therapy (CBT) offers patients with implanted cardioverter defibrillators (ICDs) and confirms its effectiveness. After receiving the device, some patients fear that it will malfunction, or they remain in a constant state of tension due to sudden electrical discharges and develop symptoms of anxiety and depression. A search with the key words “anxiety”, “depression”, “implantable cardioverter”, “cognitive behavioral therapy” and “psychotherapy” was carried out. The search was conducted in early January 2013. Sources for the search were ISI Web of Knowledge, PubMed, and PsycINFO. A total of 224 articles were retrieved: 155 from PubMed, 69 from ISI Web of Knowledge. Of these, 16 were written in a foreign language and 47 were duplicates, leaving 161 references for analysis of the abstracts. A total of 19 articles were eliminated after analysis of the abstracts, 13 were eliminated after full-text reading, and 11 articles were selected for the review. The collection of articles for literature review covered studies conducted over a period of 13 years (1998-2011), and, according to methodological design, there were 1 cross-sectional study, 1 prospective observational study, 2 clinical trials, 4 case-control studies, and 3 case studies. The criterion used for selection of the 11 articles was the effectiveness of the intervention of CBT to decrease anxiety and depression in patients with ICD, expressed as a ratio. The research indicated that CBT has been effective in the treatment of ICD patients with depressive and anxiety symptoms. Research also showed that young women represented a risk group, for which further study is needed. Because the number of references on this theme was small, further studies should be carried out.