Technical performance of a lateral flow immunoassay for detection of anti-SARS-CoV-2 IgG in the outpatient follow-up of non-severe cases and at different times after vaccination: comparison with enzyme and chemiluminescent immunoassays.

This study assessed the technical performance of a rapid lateral flow immunochromatographic assay (LFIA) for the detection of anti-SARS-CoV-2 IgG and compared LFIA results with chemiluminescent immunoassay (CLIA) results and an in-house enzyme immunoassay (EIA). To this end, a total of 216 whole blood or serum samples from three groups were analyzed: the first group was composed of 68 true negative cases corresponding to blood bank donors, healthy young volunteers, and eight pediatric patients diagnosed with other coronavirus infections. The serum samples from these participants were obtained and stored in a pre-COVID-19 period, thus they were not expected to have COVID-19. In the second group of true positive cases, we chose to replace natural cases of COVID-19 by 96 participants who were expected to have produced anti-SARS-CoV-2 IgG antibodies 30-60 days after the vaccine booster dose. The serum samples were collected on the same day that LFIA were tested either by EIA or CLIA. The third study group was composed of 52 participants (12 adults and 40 children) who did or did not have anti-SARS-CoV-2 IgG antibodies due to specific clinical scenarios. The 12 adults had been vaccinated more than seven months before LFIA testing, and the 40 children had non-severe COVID-19 diagnosed using RT-PCR during the acute phase of infection. They were referred for outpatient follow-up and during this period the serum samples were collected and tested by CLIA and LFIA. All tests were performed by the same healthcare operator and there was no variation of LFIA results when tests were performed on finger prick whole blood or serum samples, so that results were grouped for analysis. LFIA's sensitivity in detecting anti-SARS-CoV-2 IgG antibodies was 90%, specificity 97.6%, efficiency 93%, PPV 98.3%, NPV 86.6%, and likelihood ratio for a positive or a negative result were 37.5 and 0.01 respectively. There was a good agreement (Kappa index of 0.677) between LFIA results and serological (EIA or CLIA) results. In conclusion, LFIA analyzed in this study showed a good technical performance and agreement with reference serological assays (EIA or CLIA), therefore it can be recommended for use in the outpatient follow-up of non-severe cases of COVID-19 and to assess anti-SARS-CoV-2 IgG antibody production induced by vaccination and the antibodies decrease over time. However, LFIAs should be confirmed by using reference serological assays whenever possible.

Differences in children and adolescents with SARS-CoV-2 infection: a cohort study in a Brazilian tertiary referral hospital

OBJECTIVES: To compare demographic/clinical/laboratory/treatments and outcomes among children and adolescents with laboratory-confirmed coronavirus disease 2019 (COVID-19). METHODS: This was a cross-sectional study that included patients diagnosed with pediatric COVID-19 (aged <18 years) between April 11, 2020 and April 22, 2021. During this period, 102/5,951 (1.7%) of all admissions occurred in neonates, children, and adolescents. Furthermore, 3,962 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection samples were processed in patients aged <18 years, and laboratory-confirmed COVID-19 occurred in 155 (4%) inpatients and outpatients. Six/155 pediatric patients were excluded from the study. Therefore, the final group included 149 children and adolescents (n=97 inpatients and 52 outpatients) with positive SARS-CoV-2 results. RESULTS: The frequencies of sore throat, anosmia, dysgeusia, headache, myalgia, nausea, lymphopenia, pre-existing chronic conditions, immunosuppressive conditions, and autoimmune diseases were significantly reduced in children and adolescents (p<0.05). Likewise, the frequencies of enoxaparin use (p=0.037), current immunosuppressant use (p=0.008), vasoactive agents (p=0.045), arterial hypotension (p<0.001), and shock (p=0.024) were significantly lower in children than in adolescents. Logistic regression analysis showed that adolescents with laboratory-confirmed COVID-19 had increased odds ratios (ORs) for sore throat (OR 13.054; 95% confidence interval [CI] 2.750-61.977; p=0.001), nausea (OR 8.875; 95% CI 1.660-47.446; p=0.011), and lymphopenia (OR 3.575; 95% CI 1.355-9.430; p=0.010), but also had less hospitalizations (OR 0.355; 95% CI 0.138-0.916; p=0.032). The additional logistic regression analysis on patients with preexisting chronic conditions (n=108) showed that death as an outcome was significantly associated with pediatric severe acute respiratory syndrome (SARS) (OR 22.300; 95% CI 2.341-212.421; p=0.007) and multisystem inflammatory syndrome in children (MIS-C) (OR 11.261; 95% CI 1.189-106. 581; p=0.035). CONCLUSIONS: Half of the laboratory-confirmed COVID-19 cases occurred in adolescents. Individuals belonging to this age group had an acute systemic involvement of SARS-CoV-2 infection. Pediatric SARS and MIS-C were the most important factors associated with the mortality rate in pediatric chronic conditions with COVID-19.

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

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).

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).

Efficacy, Safety, and Performance of Isolated Left vs. Right Ventricular Pacing in Patients with Bradyarrhythmias: A Randomized Controlled Trial.

BACKGROUND: Considering the potential deleterious effects of right ventricular (RV) pacing, the hypothesis of this study is that isolated left ventricular (LV) pacing through the coronary sinus is safe and may provide better clinical and echocardiographic benefits to patients with bradyarrhythmias and normal ventricular function requiring heart rate correction alone. OBJECTIVE: To assess the safety, efficacy, and effects of LV pacing using an active-fixation coronary sinus lead in comparison with RV pacing, in patients eligible for conventional pacemaker (PM) implantation. METHODS: Randomized, controlled, and single-blinded clinical trial in adult patients submitted to PM implantation due to bradyarrhythmias and systolic ventricular function ≥ 0.40. Randomization (RV vs. LV) occurred before PM implantation. The main results of the study were procedural success, safety, and efficacy. Secondary results were clinical and echocardiographic changes. Chi-squared test, Fisher's exact test and Student's t-test were used, considering a significance level of 5%. RESULTS: From June 2012 to January 2014, 91 patients were included, 36 in the RV Group and 55 in the LV Group. Baseline characteristics of patients in both groups were similar. PM implantation was performed successfully and without any complications in all patients in the RV group. Of the 55 patients initially allocated into the LV group, active-fixation coronary sinus lead implantation was not possible in 20 (36.4%) patients. The most frequent complication was phrenic nerve stimulation, detected in 9 (25.7%) patients in the LV group. During the follow-up period, there were no hospitalizations due to heart failure. Reductions of more than 10% in left ventricular ejection fraction were observed in 23.5% of patients in the RV group and 20.6% of those in the LV group (p = 0.767). Tissue Doppler analysis showed that 91.2% of subjects in the RV group and 68.8% of those in the LV group had interventricular dyssynchrony (p = 0.022). CONCLUSION: The procedural success rate of LV implant was low, and the safety of the procedure was influenced mainly by the high rate of phrenic nerve stimulation in the postoperative period.

Efficacy, Safety, and Performance of Isolated Left vs. Right Ventricular Pacing in Patients with Bradyarrhythmias: A Randomized Controlled Trial / Eficácia, Segurança e Desempenho da Estimulação Ventricular Esquerda versus Direita em Pacientes com Bradiarritmias: Ensaio Clínico Randomizado

Abstract Background: Considering the potential deleterious effects of right ventricular (RV) pacing, the hypothesis of this study is that isolated left ventricular (LV) pacing through the coronary sinus is safe and may provide better clinical and echocardiographic benefits to patients with bradyarrhythmias and normal ventricular function requiring heart rate correction alone. Objective: To assess the safety, efficacy, and effects of LV pacing using an active-fixation coronary sinus lead in comparison with RV pacing, in patients eligible for conventional pacemaker (PM) implantation. Methods: Randomized, controlled, and single-blinded clinical trial in adult patients submitted to PM implantation due to bradyarrhythmias and systolic ventricular function ≥ 0.40. Randomization (RV vs. LV) occurred before PM implantation. The main results of the study were procedural success, safety, and efficacy. Secondary results were clinical and echocardiographic changes. Chi-squared test, Fisher's exact test and Student's t-test were used, considering a significance level of 5%. Results: From June 2012 to January 2014, 91 patients were included, 36 in the RV Group and 55 in the LV Group. Baseline characteristics of patients in both groups were similar. PM implantation was performed successfully and without any complications in all patients in the RV group. Of the 55 patients initially allocated into the LV group, active-fixation coronary sinus lead implantation was not possible in 20 (36.4%) patients. The most frequent complication was phrenic nerve stimulation, detected in 9 (25.7%) patients in the LV group. During the follow-up period, there were no hospitalizations due to heart failure. Reductions of more than 10% in left ventricular ejection fraction were observed in 23.5% of patients in the RV group and 20.6% of those in the LV group (p = 0.767). Tissue Doppler analysis showed that 91.2% of subjects in the RV group and 68.8% of those in the LV group had interventricular dyssynchrony (p = 0.022). Conclusion: The procedural success rate of LV implant was low, and the safety of the procedure was influenced mainly by the high rate of phrenic nerve stimulation in the postoperative period.

Resumo Fundamento: Considerando-se os potenciais efeitos deletérios da estimulação do ventrículo direito (VD), a hipótese desse estudo é que a estimulação unifocal ventricular esquerda pelo seio coronário é segura e pode proporcionar melhores benefícios clínicos e ecocardiográficos aos pacientes com bradiarritmias que apresentam função ventricular normal, necessitando apenas da correção da frequência cardíaca. Objetivos: Avaliar a segurança, a eficácia e os efeitos da estimulação do ventrículo esquerdo (VE), utilizando um cabo-eletrodo com fixação ativa, em comparação à estimulação do VD. Métodos: Estudo clínico, randomizado, simples-cego em pacientes adultos com indicação de marca-passo (MP) devido a bradiarritmias e função ventricular sistólica ≥ 0,40. A randomização aleatória (VD vs VE) ocorreu antes do procedimento. Os desfechos primários do estudo foram: o sucesso, a segurança e a eficácia do procedimento proposto. Os desfechos secundários foram: a evolução clínica e alterações ecocardiográficas. Empregou-se os testes Qui-quadrado, Exato de Fisher e t de Student, com nível de significância de 5%. Resultados: De junho de 2012 a janeiro de 2014 foram incluídos 91 pacientes, sendo 36 no grupo VD e 55 no grupo VE. As características basais dos pacientes dos dois grupos foram similares. O implante de MP foi realizado com sucesso e sem nenhuma intercorrência em todos os pacientes do grupo VD. Dos 55 pacientes inicialmente alocados para o grupo VE, o implante do cabo-eletrodo em veias coronárias não foi possível em 20 (36,4%) pacientes. Dentre os 35 pacientes que permaneceram com o cabo-eletrodo no VE, a estimulação frênica foi a complicação mais frequente e foi detectada em 9 (25,7%) pacientes. Na fase de seguimento clínico, não houve hospitalizações por insuficiência cardíaca. Reduções superiores a 10% na fração de ejeção do VE foram observadas em 23,5% dos pacientes do grupo VD e em 20,6% dos pacientes do grupo VE (p = 0,767). A análise feita pelo Doppler tecidual mostrou que 91,2% dos indivíduos do grupo VD e 68,8% dos do grupo VE apresentaram dissincronia interventricular (p = 0,022). Conclusões: A taxa de sucesso do implante no VE foi baixa e a segurança do procedimento foi influenciada, principalmente, pela alta taxa de estimulação frênica no pós-operatório.

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.

Usefulness of preoperative venography in patients with cardiac implantable electronic devices submitted to lead replacement or device upgrade procedures.

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.

Minimally Invasive Epicardial Pacemaker Implantation in Neonates with Congenital Heart Block / Implante de Marca-Passo Epicárdico por Acesso Minimamente Invasivo em Neonatos com Bloqueio Atrioventricular Congênito

Abstract Background: Few studies have characterized the surgical outcomes following epicardial pacemaker implantation in neonates with congenital complete atrioventricular block (CCAVB). Objective: This study sought to assess the long-term outcomes of a minimally invasive epicardial approach using a subxiphoid access for pacemaker implantation in neonates. Methods: Between July 2002 and February 2015, 16 consecutive neonates underwent epicardial pacemaker implantation due to CCAVB. Among these, 12 (75.0%) had congenital heart defects associated with CCAVB. The patients had a mean age of 4.7 ± 5.3 days and nine (56.3%) were female. Bipolar steroid-eluting epicardial leads were implanted in all patients through a minimally invasive subxiphoid approach and fixed on the diaphragmatic ventricular surface. The pulse generator was placed in an epigastric submuscular position. Results: All procedures were successful, with no perioperative complications or early deaths. Mean operating time was 90.2 ± 16.8 minutes. None of the patients displayed pacing or sensing dysfunction, and all parameters remained stable throughout the follow-up period of 4.1 ± 3.9 years. Three children underwent pulse generator replacement due to normal battery depletion at 4.0, 7.2, and 9.0 years of age without the need of ventricular lead replacement. There were two deaths at 12 and 325 days after pacemaker implantation due to bleeding from thrombolytic use and progressive refractory heart failure, respectively. Conclusion: Epicardial pacemaker implantation through a subxiphoid approach in neonates with CCAVB is technically feasible and associated with excellent surgical outcomes and pacing lead longevity.

Resumo Fundamento: Há poucos estudos caracterizando os desfechos cirúrgicos após implante de marca-passo em neonatos com bloqueio atrioventricular total congênito (BAVTC). Objetivos: Este estudo procurou avaliar os resultados a longo prazo de uma abordagem epicárdica minimamente invasiva com utilização de acesso subxifoide para implante de marca-passo em neonatos. Métodos: Entre julho de 2002 a fevereiro de 2015, 16 neonatos consecutivos foram submetidos a implante de marca-passo epicárdico devido a BAVTC. Entre eles, 12 (75,0%) apresentavam defeitos cardíacos congênitos associados ao BAVTC. Os pacientes tinham uma média de idade de 4,5 ± 5,3 dias e nove (56,3%) eram do sexo feminino. Cabo-eletrodo bipolar revestido com esteroide foi implantado em todos os pacientes através de uma abordagem subxifoide minimamente invasiva e fixado na superfície ventricular diafragmática. O gerador de pulsos foi alojado em uma posição epigástrica submuscular. Resultados: Todos os procedimentos foram realizados com sucesso, sem complicações intraoperatórias ou mortes. O tempo médio de duração das operações foi de 90,2 ± 16,8 minutos. Após seguimento médio de 4,1 ± 3,9 anos e máximo de 12,2 anos, não foram observadas complicações de loja do gerador de pulsos, aumento crônico do limiar de comando, fratura de cabo-eletrodo ou outros problemas relacionados ao sistema de estimulação cardíaca. Três crianças foram submetidas à troca do gerador de pulsos por depleção normal de bateria aos 4,0, 7,2 e 9,0 anos de idade, sem necessidade de troca do cabo-eletrodo ventricular. Houve duas mortes aos 12 e 325 dias após o implante do marca-passo devido a sangramento decorrente do uso de trombolítico e insuficiência cardíaca refratária progressiva, respectivamente. Conclusões: O implante de marca-passo epicárdico através de abordagem subxifoide em neonatos com BAVTC com alojamento epigástrico do gerador de pulsos é tecnicamente viável e associado a excelentes desfechos cirúrgicos e longevidade do cabo-eletrodo de estimulação.

Minimally Invasive Epicardial Pacemaker Implantation in Neonates with Congenital Heart Block.

BACKGROUND: Few studies have characterized the surgical outcomes following epicardial pacemaker implantation in neonates with congenital complete atrioventricular block (CCAVB). OBJECTIVE: This study sought to assess the long-term outcomes of a minimally invasive epicardial approach using a subxiphoid access for pacemaker implantation in neonates. METHODS: Between July 2002 and February 2015, 16 consecutive neonates underwent epicardial pacemaker implantation due to CCAVB. Among these, 12 (75.0%) had congenital heart defects associated with CCAVB. The patients had a mean age of 4.7 ± 5.3 days and nine (56.3%) were female. Bipolar steroid-eluting epicardial leads were implanted in all patients through a minimally invasive subxiphoid approach and fixed on the diaphragmatic ventricular surface. The pulse generator was placed in an epigastric submuscular position. RESULTS: All procedures were successful, with no perioperative complications or early deaths. Mean operating time was 90.2 ± 16.8 minutes. None of the patients displayed pacing or sensing dysfunction, and all parameters remained stable throughout the follow-up period of 4.1 ± 3.9 years. Three children underwent pulse generator replacement due to normal battery depletion at 4.0, 7.2, and 9.0 years of age without the need of ventricular lead replacement. There were two deaths at 12 and 325 days after pacemaker implantation due to bleeding from thrombolytic use and progressive refractory heart failure, respectively. CONCLUSION: Epicardial pacemaker implantation through a subxiphoid approach in neonates with CCAVB is technically feasible and associated with excellent surgical outcomes and pacing lead longevity.

Complications after Surgical Procedures in Patients with Cardiac Implantable Electronic Devices: Results of a Prospective Registry.

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. 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.

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.

Implante de marcapasso atrioventricular epicárdico subxifoide como estratégia para extração transvenosa de cabos-eletrodos em paciente com infecção / Epicardial atrioventricular pacemaker implantation through subxiphoid approach as a strategy for transvenous lead extraction in a patient with infection

A despeito da utilização de profilaxia antibiótica, tanto nos implantes iniciais como nos procedimentos de reoperação, as taxas de infecção relacionada aos dispositivos cardíacos eletrônicos implantáveis têm aumentadoprogressivamente, causando impacto na mortalidade e custos hospitalares. O tratamento de processos infecciososrelacionados aos dispositivos cardíacos eletrônicos implantáveis consiste na remoção completa do sistema deestimulação cardíaca, associada a terapia antimicrobiana sistêmica e reimplante de um novo dispositivo cardíaco. Neste artigo, relatamos o caso clínico de paciente com infecção na loja do gerador de pulsos sem evidênciasde infecção intravascular. O implante de marcapasso atrioventricular epicárdico subxifoide foi utilizado como estratégia para diminuir o risco de contaminação do novo sistema e facilitar a remoção transvenosa dos eletrodos antigos abandonados sob melhores condições técnicas...

Despite the use of antibiotic prophylaxis at the time of cardiac implantable electronic device implantation or reoperations, rates of cardiac implantable electronic device-related infection have increasedprogressively causing an impact on mortality and treatment costs. The treatment of cardiac implantable electronic device-related infections demands a complete removal of the infected device followed by systemic antimicrobial therapy and reimplantation of a new system. In this article, we report the case of a patient with pulse generator pocket infection without evidence of intravascular infection. Epicardial atrioventricular pacemaker implant through subxiphoid approach was used as a strategy to decrease the risk of contamination of the new system and to facilitate the removal of the abandoned transvenous leads under better technical conditions...

Extração de cabo-eletrodo endocárdico abandonado orientada pela PET-CT em portador de ressincronizador cardíaco epicárdico com suspeita de endocardite infecciosa / Extraction of an abandoned endocardial pacemaker lead guided by PET-CT in patient with epicardial cardiac resynchronization and suspected infectious endocarditis

Processos infecciosos relacionados aos dispositivos cardíacos eletrônicos implantáveis estão entre ascomplicações mais graves e de difícil tratamento. A incidência de infecções relacionadas aos dispositivos cardíacoseletrônicos implantáveis pode variar de 1% a 7%, apresentando considerável impacto na morbimortalidade.Estudos recentes têm demonstrado que a adição da tomografia por emissão de pósitrons acoplada à tomografiacomputadorizada aos critérios da Duke University modificados aumenta a sensibilidade e a especificidade dodiagnóstico de infecção relacionada aos dispositivos cardíacos eletrônicos implantáveis. Neste artigo relatamos ocaso clínico de um paciente com suspeita de endocardite relacionada a cabo-eletrodo transvenoso abandonado eressincronizador cardíaco epicárdico em uso, em que os achados da tomografia por emissão de pósitrons acopladaà tomografia computadorizada utilizando fluordesoxiglucose 18F ajudaram o correto entendimento do processo ea condução do tratamento cirúrgico...

Infections related to implantable electronic cardiac devices are among the most serious and most difficult to treat complications. The incidence of infections related to cardiac devices may vary from 1% to 7% and result in significant impact on morbidity and mortality. Recent studies have shown that positron emission computed tomography in combination with the modified Duke criteria, increases the sensitivity and specificity of the diagnosis of infections related to cardiac implantable electronic devices. In this article, we report the clinical case of a patient with suspected infectious endocarditis related to an abandoned endocardial pacemaker lead and epicardial cardiac resynchronization, whose 18F-fluoro-2-deoxyglucose positron emission tomography combinedto computed tomography findings were useful for a proper understanding of the process and to guide the surgicaltreatment...

Uso de tomografia por emissão do pósitrons acoplada a tomografia computadorizada para orientar a estratégia cirúrgica do tratamento de complicação infecciosa em portador de marcapasso / Use of positron-emissiontomography combined with a multidetection helical computed tomography to guide the surgical strategy in the treatment of pacemaker infection

Dentre as complicações relacionadas aos dispositivos cardíacos eletrônicos implantáveis, os processosinfecciosossão os de maior gravidade e de mais difícil tratamento. A taxa média de infecções relacionadas a esses dispositivoscardíacos relatada na literatura pode variar de 1% a 7% e resultam em importante impacto na morbimortalidade.Neste artigo relatamos o caso clínico de um paciente com infecção crônica relacionada a cabo-eletrodo epicárdicoabandonado, com manifestações recorrentes, em que os achados da tomografia por emissão de pósitrons acoplada atomografia computadorizada utilizando 18F-fluoro-2-deoxiglicose ajudaram o correto entendimentodo processo e acondução do tratamento cirúrgico.

Among the complications related to cardiac implantable electronic devices, infections are the mostserious and more difficult to treat. The mean rate of infections related to these cardiac devices reported in theliterature ranges from 1% to 7% and result in significant impact on morbidity and mortality. We report theclinical case of a patient with chronic infection related to abandoned epicardial pacemaker lead, with recurrentmanifestations, in which the findings of 18F-fluoro-2-deoxyglucose positron-emission tomography combinedwith a multidetection helical computed tomography were useful for a proper understanding of the process and toguide the surgical treatment.

Functional Capacity of Patients with Pacemaker Due to Isolated Congenital Atrioventricular Block / Capacidade Funcional de Portadores de Marca-Passo por Bloqueio Atrioventricular Congênito Isolado

Background: Isolated congenital atrioventricular block (CAVB) is a rare condition with multiple clinical outcomes. Ventricular remodeling can occur in approximately 10% of the patients after pacemaker (PM) implantation. Objectives: To assess the functional capacity of children and young adults with isolated CAVB and chronic pacing of the right ventricle (RV) and evaluate its correlation with predictors of ventricular remodeling. Methods: This cross-sectional study used a cohort of patients with isolated CAVB and RV pacing for over a year. The subjects underwent clinical and echocardiographic evaluation. Functional capacity was assessed using the six-minute walk test. Chi-square test, Fisher's exact test, and Pearson correlation coefficient were used, considering a significance level of 5%. Results: A total of 61 individuals were evaluated between March 2010 and December 2013, of which 67.2% were women, aged between 7 and 41 years, who were using PMs for 13.5 ± 6.3 years. The percentage of ventricular pacing was 97.9 ± 4.1%, and the duration of the paced QRS complex was 153.7 ± 19.1 ms. Majority of the subjects (95.1%) were asymptomatic and did not use any medication. The mean distance walked was 546.9 ± 76.2 meters and was strongly correlated with the predicted distance (r = 0.907, p = 0.001) but not with risk factors for ventricular remodeling. (Arq Bras Cardiol. 2014; [online].ahead print, PP.0-0) Conclusions: The functional capacity of isolated CAVB patients with chronic RV pacing was satisfactory but did not correlate with risk factors for ventricular remodeling. .

Fundamento: O bloqueio atrioventricular congênito isolado (BAVCi) é raro e tem múltiplas apresentações clínicas. O remodelamento ventricular pode ocorrer em cerca de 10% dos indivíduos após o implante de marca-passo. Objetivos: Avaliar a capacidade funcional de crianças e adultos jovens com BAVCi e estimulação crônica no ventrículo direito (VD) e pesquisar sua associação com fatores preditores de remodelamento ventricular. Métodos: Estudo transversal em coorte de indivíduos com BAVCi e estimulação no VD há mais de um ano. Os indivíduos foram submetidos a avaliação clínica e ecocardiográfica. A capacidade funcional foi avaliada pelo teste de caminhada de seis minutos. Foram empregados os testes qui-quadrado, exato de Fisher e coeficiente de correlação de Pearson, considerando o nível de significância de 5%. Resultados: De março de 2010 a dezembro de 2013, foram avaliados 61 indivíduos, 67,2% do sexo feminino, com 7-41 anos de idade e uso de MP há 13,5 ± 6,3 anos. O percentual de estimulação ventricular era 97,9 ± 4,1% e a duração do complexo QRS estimulado era de 153,7 ± 19,1 ms. A maioria (95,1%) era assintomática e não utilizava medicamentos. A distância média percorrida de 546,9 ± 76,2 m teve forte correlação com a distância predita (r = 0,907; p = 0,001) e não se associou com os fatores de risco de remodelamento estudados. Conclusões: A capacidade funcional de portadores de BAVTCi com estimulação crônica no VD foi satisfatória e não se correlacionou com os fatores de risco para remodelamento ventricular. .