Amiodarone or Implantable Cardioverter-Defibrillator in Chagas Cardiomyopathy: The CHAGASICS Randomized Clinical Trial.

Importance: Over 10 000 people with Chagas disease experience sudden cardiac death (SCD) annually, mostly caused by ventricular fibrillation. Amiodarone hydrochloride and the implantable cardioverter-defibrillator (ICD) have been empirically used to prevent SCD in patients with chronic Chagas cardiomyopathy. Objective: To test the hypothesis that ICD is more effective than amiodarone therapy for primary prevention of all-cause mortality in patients with chronic Chagas cardiomyopathy and moderate to high mortality risk, assessed by the Rassi score. Design, Setting, and Participants: CHAGASICS is an open-label, randomized clinical trial. The study enrolled patients from 13 centers in Brazil from May 30, 2014, to August 13, 2021, with the last follow-up November 8, 2021. Patients with serological findings positive for Chagas disease, a Rassi risk score of at least 10 points (intermediate to high risk), and at least 1 episode of nonsustained ventricular tachycardia were eligible to participate. Data were analyzed from May 3, 2022, to June 16, 2023. Interventions: Patients were randomized 1:1 to receive ICD or amiodarone (with a loading dose of 600 mg after randomization). Main Outcomes and Measures: The primary outcome was all-cause mortality, and secondary outcomes included SCD, hospitalization for heart failure, and necessity of a pacemaker during the entire follow-up. Results: The study was stopped prematurely for administrative reasons, with 323 patients randomized (166 in the amiodarone group and 157 in the ICD group), rather than the intended 1100 patients. Analysis was by intention to treat at a median follow-up of 3.6 (IQR, 1.8-4.4) years. Mean (SD) age was 57.4 (9.8) years, 185 patients (57.3%) were male, and the mean (SD) left ventricular ejection fraction was 37.0% (11.6%). There were 60 deaths (38.2%) in the ICD arm and 64 (38.6%) in the amiodarone group (hazard ratio [HR], 0.86 [95% CI, 0.60-1.22]; P = .40). The rates of SCD (6 [3.8%] vs 23 [13.9%]; HR, 0.25 [95% CI, 0.10-0.61]; P = .001), bradycardia requiring pacing (3 [1.9%] vs 27 [16.3%]; HR, 0.10 [95% CI, 0.03-0.34]; P < .001), and heart failure hospitalization (14 [8.9%] vs 28 [16.9%]; HR, 0.46 [95% CI, 0.24-0.87]; P = .01) were lower in the ICD group compared with the amiodarone arm. Conclusions and Relevance: In patients with chronic Chagas cardiomyopathy at moderate to high risk of mortality, ICD did not reduce the risk of all-cause mortality. However, ICD significantly reduced the risk of SCD, pacing need, and heart failure hospitalization compared with amiodarone therapy. Further studies are warranted to confirm the evidence generated by this trial. Trial Registration: ClinicalTrials.gov Identifier: NCT01722942.

Mortality risk score for patients with Chagas cardiomyopathy and pacemaker.

BACKGROUND: Prognosis of Chronic Chagasic Cardiomyopathy (CCC) patients depends on functional and clinical factors. Bradyarrhythmia requiring pacemaker is a common complication. Prognosis of these patients is poorly studied, and mortality risk factors are unknown. We aimed to identify predictors of death and to define a risk score for mortality in a large cohort of CCC patients with pacemaker. METHODS: It was an observational, unicentric and prospective study. The endpoint was all-cause mortality. Cox regression was used to identify predictors of death and to define a risk score. Bootstrapping method was used to internal score validation. RESULTS: We included 555 patients and after a mean follow-up of 3.7±1.5 years, 100 (18%) deaths occurred. Predictors of death were: right ventricular dysfunction (HR [hazard ratio] 2.24; 95%CI 1.41-3.53; P = 0.001); heart failure class III or IV (HR 2.16; 95% confidence interval [95%CI] 1.16-4.00; P = 0.014); renal disease (HR 2.14; 95%CI 1.24-3.68; P = 0.006); left ventricular end-systolic diameter > 44mm (HR 1.97; 95%CI 1.26-3.05; P = 0.003); atrial fibrillation (HR 1.94; 95%CI 1.25-2.99; P = 0.003) and cardiomegaly on X-ray (HR 1.87; 95%CI 1.10-3.17; P = 0.020). The score identified patients with: low (0-20 points), intermediate (21-30 points) and high risk (>31points). The optimism-corrected C-statistic of the predictive model was 0.751 (95% CI 0.696-0.806). Internal validation with bootstrapping revealed a calibration slope of 0.946 (95% CI 0.920-0.961), reflecting a small degree of over-optimism and C-statistic of 0.746 (95% CI 0.692-0.785). CONCLUSIONS: This study identified predictors of mortality in CCC patients with pacemaker defining a simple, validated and specific risk score.

Factors Associated with the Treatment Costs within the First Year after Pacemaker Implantation or Pulse Generator Replacement. / Fatores Associados aos Custos do Tratamento no Primeiro Ano após Implantes Iniciais ou Trocas de Geradores de Pulsos de Marca-passos Cardíacos.

BACKGROUND: The use of artificial cardiac pacemakers has grown steadily in line with the aging population. OBJECTIVES: To determine the rates of hospital readmissions and complications after pacemaker implantation or pulse generator replacement and to assess the impact of these events on annual treatment costs from the perspective of the Unified Health System (SUS). METHODS: A prospective registry, with data derived from clinical practice, collected during index hospitalization and during the first 12 months after the surgical procedure. The cost of index hospitalization, the procedure, and clinical follow-up were estimated according to the values reimbursed by SUS and analyzed at the patient level. Generalized linear models were used to study factors associated with the total annual treatment cost, adopting a significance level of 5%. RESULTS: A total of 1,223 consecutive patients underwent initial implantation (n=634) or pulse generator replacement (n=589). Seventy episodes of complication were observed in 63 patients (5.1%). The incidence of hospital readmissions within one year was 16.4% (95% CI 13.7% - 19.6%) after initial implants and 10.6% (95% CI 8.3% - 13.4%) after generator replacements. Chronic kidney disease, history of stroke, length of hospital stays, need for postoperative intensive care, complications, and hospital readmissions showed a significant impact on the total annual treatment cost. CONCLUSIONS: The results confirm the influence of age, comorbidities, postoperative complications, and hospital readmissions as factors associated with increased total annual treatment cost for patients with pacemakers.

FUNDAMENTO: O uso de marca-passos cardíacos artificiais tem crescido constantemente, acompanhando o envelhecimento populacional. OBJETIVOS: Determinar as taxas de readmissões hospitalares e complicações após implante de marca-passo ou troca de gerador de pulsos e avaliar o impacto desses eventos nos custos anuais do tratamento sob a perspectiva do Sistema Único de Saúde (SUS). MÉTODOS: Registro prospectivo, com dados derivados da prática clínica assistencial, coletados na hospitalização índice e durante os primeiros 12 meses após o procedimento cirúrgico. O custo da hospitalização índice, do procedimento e do seguimento clínico foram estimados de acordo com os valores reembolsados pelo SUS e analisados ao nível do paciente. Modelos lineares generalizados foram utilizados para estudar fatores associados ao custo total anual do tratamento, adotando-se um nível de significância de 5%. RESULTADOS: No total, 1.223 pacientes consecutivos foram submetidos a implante inicial (n= 634) ou troca do gerador de pulsos (n= 589). Foram observados 70 episódios de complicação em 63 pacientes (5,1%). A incidência de readmissões hospitalares em um ano foi de 16,4% (IC 95% 13,7% - 19,6%) após implantes iniciais e 10,6% (IC 95% 8,3% - 13,4%) após trocas de geradores. Doença renal crônica, histórico de acidente vascular encefálico, tempo de permanência hospitalar, necessidade de cuidados intensivos pós-operatórios, complicações e readmissões hospitalares mostraram um impacto significativo sobre o custo anual total do tratamento. CONCLUSÕES: Os resultados confirmam a influência da idade, comorbidades, complicações pós-operatórias e readmissões hospitalares como fatores associados ao incremento do custo total anual do tratamento de pacientes com marca-passo.

Fatores Associados aos Custos do Tratamento no Primeiro Ano após Implantes Iniciais ou Trocas de Geradores de Pulsos de Marca-passos Cardíacos / Factors Associated with the Treatment Costs within the First Year after Pacemaker Implantation or Pulse Generator Replacement

Resumo Fundamento O uso de marca-passos cardíacos artificiais tem crescido constantemente, acompanhando o envelhecimento populacional. Objetivos Determinar as taxas de readmissões hospitalares e complicações após implante de marca-passo ou troca de gerador de pulsos e avaliar o impacto desses eventos nos custos anuais do tratamento sob a perspectiva do Sistema Único de Saúde (SUS). Métodos Registro prospectivo, com dados derivados da prática clínica assistencial, coletados na hospitalização índice e durante os primeiros 12 meses após o procedimento cirúrgico. O custo da hospitalização índice, do procedimento e do seguimento clínico foram estimados de acordo com os valores reembolsados pelo SUS e analisados ao nível do paciente. Modelos lineares generalizados foram utilizados para estudar fatores associados ao custo total anual do tratamento, adotando-se um nível de significância de 5%. Resultados No total, 1.223 pacientes consecutivos foram submetidos a implante inicial (n= 634) ou troca do gerador de pulsos (n= 589). Foram observados 70 episódios de complicação em 63 pacientes (5,1%). A incidência de readmissões hospitalares em um ano foi de 16,4% (IC 95% 13,7% - 19,6%) após implantes iniciais e 10,6% (IC 95% 8,3% - 13,4%) após trocas de geradores. Doença renal crônica, histórico de acidente vascular encefálico, tempo de permanência hospitalar, necessidade de cuidados intensivos pós-operatórios, complicações e readmissões hospitalares mostraram um impacto significativo sobre o custo anual total do tratamento. Conclusões Os resultados confirmam a influência da idade, comorbidades, complicações pós-operatórias e readmissões hospitalares como fatores associados ao incremento do custo total anual do tratamento de pacientes com marca-passo.

Abstract Background The use of artificial cardiac pacemakers has grown steadily in line with the aging population. Objectives To determine the rates of hospital readmissions and complications after pacemaker implantation or pulse generator replacement and to assess the impact of these events on annual treatment costs from the perspective of the Unified Health System (SUS). Methods A prospective registry, with data derived from clinical practice, collected during index hospitalization and during the first 12 months after the surgical procedure. The cost of index hospitalization, the procedure, and clinical follow-up were estimated according to the values reimbursed by SUS and analyzed at the patient level. Generalized linear models were used to study factors associated with the total annual treatment cost, adopting a significance level of 5%. Results A total of 1,223 consecutive patients underwent initial implantation (n=634) or pulse generator replacement (n=589). Seventy episodes of complication were observed in 63 patients (5.1%). The incidence of hospital readmissions within one year was 16.4% (95% CI 13.7% - 19.6%) after initial implants and 10.6% (95% CI 8.3% - 13.4%) after generator replacements. Chronic kidney disease, history of stroke, length of hospital stays, need for postoperative intensive care, complications, and hospital readmissions showed a significant impact on the total annual treatment cost. Conclusions The results confirm the influence of age, comorbidities, postoperative complications, and hospital readmissions as factors associated with increased total annual treatment cost for patients with pacemakers.

The Six Pillars of Lifestyle Medicine in Managing Noncommunicable Diseases - The Gaps in Current Guidelines. / Os Seis Pilares da Medicina do Estilo de Vida no Manejo de Doenças Não Transmissíveis ­ As Lacunas nas Diretrizes Atuais.

BACKGROUND: Noncommunicable diseases (NCDs), also known as chronic diseases that are long-lasting, are considered the major cause of death and disability worldwide, and the six pillars of lifestyle medicine (nutrition, exercise, toxic control, stress management, restorative sleep, and social connection) play an important role in a holistic management of their prevention and treatment. In addition, medical guidelines are the most accepted documents with recommendations to manage NCDs. OBJECTIVE: The present study aims to analyze the lack of lifestyle pillars concerning the major Brazilian medical guidelines for NCDs and identify evidence in the literature that could justify their inclusion in the documents. METHOD: Brazilian guidelines were selected according to the most relevant causes of death in Brazil, given by the Mortality Information System, published by the Brazilian Ministry of Health in 2019. Journals were screened in the PUBMED library according to the disease and non-mentioned pillars of lifestyle. RESULTS: Relevant causes of deaths in Brazil are acute myocardial infarction (AMI), diabetes mellitus (DM), and chronic obstructive pulmonary diseases (COPD). Six guidelines related to these NCDs were identified, and all address aspects of lifestyle, but only one, regarding cardiovascular prevention, highlights all six pillars. Despite this, a literature search involving over 50 articles showed that there is evidence that all the pillars can help control each of these NCDs. CONCLUSION: Rarely are the six pillars of lifestyle contemplated in Brazilian guidelines for AMI, DM, and COPD. The literature review identified evidence of all lifestyle pillars to offer a holistic approach for the management and prevention of NCDs.

FUNDAMENTO: As doenças crônicas não transmissíveis (DCNT), também conhecidas como doenças crônicas de longa duração, são consideradas a principal causa de morte e incapacidade em todo o mundo, e os seis pilares da medicina do estilo de vida (nutrição, exercício, controle de tóxicos, manejo do estresse, saúde do sono e conexão social) desempenham um papel importante na gestão holística da sua prevenção e tratamento. Além disso, as diretrizes médicas são os documentos mais aceitos com recomendações para o manejo das DCNT. OBJETIVO: O presente estudo tem como objetivo analisar a ausência de pilares de estilo de vida nas principais diretrizes médicas brasileiras sobre as DCNT e identificar evidências na literatura que possam justificar sua inclusão nos documentos. MÉTODO: As diretrizes brasileiras foram selecionadas de acordo com as causas de morte mais relevantes no Brasil, informadas pelo Sistema de Informações sobre Mortalidade publicado pelo Ministério da Saúde em 2019. Os periódicos foram selecionados na biblioteca PUBMED de acordo com a doença e os pilares do estilo de vida não mencionados. RESULTADOS: Causas relevantes de mortes no Brasil são o infarto agudo do miocárdio (IAM), o diabetes mellitus (DM) e as doenças pulmonares obstrutivas crônicas (DPOC). Foram identificadas seis diretrizes relacionadas a essas DCNT e todas abordam aspectos do estilo de vida, mas apenas uma, referente à prevenção cardiovascular, destaca todos os seis pilares. Apesar disso, uma pesquisa bibliográfica envolvendo mais de 50 artigos mostrou que há evidências de que todos os pilares podem ajudar no controle de cada uma dessas DCNT. CONCLUSÃO: Raramente os seis pilares do estilo de vida são contemplados nas diretrizes brasileiras para IAM, DM e DPOC. A revisão da literatura identificou evidências de todos os pilares do estilo de vida para oferecer uma abordagem holística para a gestão e prevenção das DCNT.

Os Seis Pilares da Medicina do Estilo de Vida no Manejo de Doenças Não Transmissíveis - As Lacunas nas Diretrizes Atuais / The Six Pillars of Lifestyle Medicine in Managing Noncommunicable Diseases - The Gaps in Current Guidelines

Resumo Fundamento: As doenças crônicas não transmissíveis (DCNT), também conhecidas como doenças crônicas de longa duração, são consideradas a principal causa de morte e incapacidade em todo o mundo, e os seis pilares da medicina do estilo de vida (nutrição, exercício, controle de tóxicos, manejo do estresse, saúde do sono e conexão social) desempenham um papel importante na gestão holística da sua prevenção e tratamento. Além disso, as diretrizes médicas são os documentos mais aceitos com recomendações para o manejo das DCNT. Objetivo: O presente estudo tem como objetivo analisar a ausência de pilares de estilo de vida nas principais diretrizes médicas brasileiras sobre as DCNT e identificar evidências na literatura que possam justificar sua inclusão nos documentos. Método: As diretrizes brasileiras foram selecionadas de acordo com as causas de morte mais relevantes no Brasil, informadas pelo Sistema de Informações sobre Mortalidade publicado pelo Ministério da Saúde em 2019. Os periódicos foram selecionados na biblioteca PUBMED de acordo com a doença e os pilares do estilo de vida não mencionados. Resultados: Causas relevantes de mortes no Brasil são o infarto agudo do miocárdio (IAM), o diabetes mellitus (DM) e as doenças pulmonares obstrutivas crônicas (DPOC). Foram identificadas seis diretrizes relacionadas a essas DCNT e todas abordam aspectos do estilo de vida, mas apenas uma, referente à prevenção cardiovascular, destaca todos os seis pilares. Apesar disso, uma pesquisa bibliográfica envolvendo mais de 50 artigos mostrou que há evidências de que todos os pilares podem ajudar no controle de cada uma dessas DCNT. Conclusão: Raramente os seis pilares do estilo de vida são contemplados nas diretrizes brasileiras para IAM, DM e DPOC. A revisão da literatura identificou evidências de todos os pilares do estilo de vida para oferecer uma abordagem holística para a gestão e prevenção das DCNT.

Abstract Background: Noncommunicable diseases (NCDs), also known as chronic diseases that are long-lasting, are considered the major cause of death and disability worldwide, and the six pillars of lifestyle medicine (nutrition, exercise, toxic control, stress management, restorative sleep, and social connection) play an important role in a holistic management of their prevention and treatment. In addition, medical guidelines are the most accepted documents with recommendations to manage NCDs. Objective: The present study aims to analyze the lack of lifestyle pillars concerning the major Brazilian medical guidelines for NCDs and identify evidence in the literature that could justify their inclusion in the documents. Method: Brazilian guidelines were selected according to the most relevant causes of death in Brazil, given by the Mortality Information System, published by the Brazilian Ministry of Health in 2019. Journals were screened in the PUBMED library according to the disease and non-mentioned pillars of lifestyle. Results: Relevant causes of deaths in Brazil are acute myocardial infarction (AMI), diabetes mellitus (DM), and chronic obstructive pulmonary diseases (COPD). Six guidelines related to these NCDs were identified, and all address aspects of lifestyle, but only one, regarding cardiovascular prevention, highlights all six pillars. Despite this, a literature search involving over 50 articles showed that there is evidence that all the pillars can help control each of these NCDs. Conclusion: Rarely are the six pillars of lifestyle contemplated in Brazilian guidelines for AMI, DM, and COPD. The literature review identified evidence of all lifestyle pillars to offer a holistic approach for the management and prevention of NCDs.

Detection of Early Diffuse Myocardial Fibrosis and Inflammation in Chagas Cardiomyopathy with T1 Mapping and Extracellular Volume.

Purpose: To evaluate myocardial T1 mapping and extracellular volume (ECV) parameters in different stages of Chagas cardiomyopathy and determine whether they are predictive of disease severity and prognosis. Materials and Methods: Prospectively enrolled participants (July 2013 to September 2016) underwent cine and late gadolinium enhancement (LGE) cardiac MRI and T1 mapping with a precontrast (native) or postcontrast modified Look-Locker sequence. The native T1 and ECV values were measured among subgroups that were based on disease severity (indeterminate, Chagas cardiomyopathy with preserved ejection fraction [CCpEF], Chagas cardiomyopathy with midrange ejection fraction [CCmrEF], and Chagas cardiomyopathy with reduced ejection fraction [CCrEF]). Cox proportional hazards regression and the Akaike information criterion were used to determine predictors of major cardiovascular events (cardioverter defibrillator implant, heart transplant, or death). Results: In 107 participants (90 participants with Chagas disease [mean age ± SD, 55 years ± 11; 49 men] and 17 age- and sex-matched control participants), the left ventricular (LV) ejection fraction and the extent of focal and diffuse or interstitial fibrosis were correlated with disease severity. Participants with CCmrEF and participants with CCrEF showed significantly higher global native T1 and ECV values than participants in the indeterminate, CCpEF, and control groups (T1: 1072 msec ± 34 and 1073 msec ± 63 vs 1010 msec ± 41, 1005 msec ± 69, and 999 msec ± 46; ECV: 35.5% ± 3.6 and 35.0% ± 5.4 vs 25.3% ± 3.5, 28.2% ± 4.9, and 25.2% ± 2.2; both P < .001). Remote (LGE-negative areas) native T1 and ECV values were also higher (T1: 1056 msec ± 32 and 1071 msec ± 55 vs 1008 msec ± 41, 989 msec ± 96, and 999 msec ± 46; ECV: 30.2% ± 4.7 and 30.8% ± 7.4 vs 25.1% ± 3.5, 25.1% ± 3.7, and 25.0% ± 2.2; both P < .001). Abnormal remote ECV values (>30%) occurred in 12% of participants in the indeterminate group, which increased with disease severity. Nineteen combined outcomes were observed (median follow-up time: 43 months), and a remote native T1 value greater than 1100 msec was independently predictive of combined outcomes (hazard ratio, 12 [95% CI: 4.1, 34.2]; P < .001). Conclusion: Myocardial native T1 and ECV values were correlated with Chagas disease severity and may serve as markers of myocardial involvement in Chagas cardiomyopathy that precede LGE and LV dysfunction.Keywords: MRI, Cardiac, Heart, Imaging Sequences, Chagas Cardiomyopathy Supplemental material is available for this article. © RSNA, 2023.

Myocardial function reclassification: Echocardiographic strain patterns in patients with chronic Chagas cardiomyopathy and intraventricular dyssynchrony.

BACKGROUND: We aimed to identify, among Chronic Chagas Cardiomyopathy (CCC) patients with left ventricular dysfunction (LVD) and non-left bundle branch block (non-LBBB), subgroups with different functional and mechanical patterns of global longitudinal strain (GLS) and intraventricular dyssynchrony (IVD) at rest and after exercise stress test, and reclassify them using a new echocardiographic approach. METHODOLOGY: In this single-center cross-sectional study, 40 patients with CCC, left ventricular ejection fraction (LVEF) ≤ 35% and non-LBBB underwent rest echocardiography and then treadmill exercise stress echocardiography with GLS and IVD analysis. The sample was divided into four groups, based on GLS and IVD significant variation between rest and exercise: GLS + IVD+ (9 patients); GLS + IVD- (9 patients); GLS-IVD+ (10 patients); GLS-IVD- (10 patients). RESULTS: At rest, median LVEF was 28% (21.3%-33%) and GLS (-7% (-5%/-9.3%), were not different among groups. The average response of GLS was an increase of 0.74% over rest values, and the average response of IVD was a decrease of 6.9 ms. Group GLS-IVD+ presented more dyssynchrony at rest (p = 0.01). Left atrial (LA) volume (higher in GLS-IVD-) (p = 0.022) and TAPSE (higher in GLS + IVD+) (p = 0.015) were also different among groups at baseline. Of the 40 patients evaluated, 27 (67.5%) had very severe LVD (GLS < -8%). In addition, among these patients, 11 patients had contractile reserve after undergoing stress echocardiography. CONCLUSIONS: In patients with CCC, severe LVD and non-LBBB, the evaluation of GLS and IVD between rest and exercise was able to reclassify myocardial function and to identify subgroups with contractile reserve and significant dyssynchronopathy.

Cardiac arrhythmias and Covid-19

ABSTRACT: Cardiovascular manifestations of COVID-19 include cardiac rhythm disturbances, whose mechanisms, incidence, and most common types are not well established in this population. Intense inflammatory response and metabolic activity contribute to recurrence of pre-existing arrhythmias, and other arrhythmias can occur due to myocardial injury, acute coronary insufficiency, and electrolyte disturbances. Brady- and tachyarrhythmias, as well as conduction disorders have been described. QT interval prolongation and fatal ventricular arrhythmias (Torsades de Pointes) may result from the pathological process or adverse effect of drugs (antiarrhythmics, chloroquine / hydroxychloroquine, azithromycin and antivirals). Patients with congenital heart disease and hemodynamic repercussions, patients with signs of heart failure, pulmonary hypertension, cyanosis, hypoxemia, and those who underwent heart transplantation and immunosuppression are at greater risk. In patients with implantable cardioverter defibrillators (ICDs), the risk depends on the presence of structural heart disease. In the course of COVID-19, in-person assessment of these patients should be limited to high-risk situations, including syncope, worsening of heart failure and shock delivery by ICDs. Likewise, cardiac implantable electronic device implantation or replacement surgery should be limited to emergency and urgent cases, including symptomatic high-degree atrioventricular block, ICD for secondary prevention and pulse generator replacement due to battery drain.

Upper extremity deep venous thrombosis and pulmonary embolism after transvenous lead replacement or upgrade procedures.

BACKGROUND: Venous obstructions are frequent in patients with transvenous leads, although related clinical findings are rarely reported. After lead replacement or upgrade procedures, these lesions are even more frequent, but there is still no evidence to support this observation. AIM: To investigate the incidence and possible risk factors for upper extremity deep venous thrombosis (UEDVT) and pulmonary embolism (PE) after lead replacement or upgrade procedures. METHODS: Prospective cohort carried out between April 2013 and July 2016. Preoperative evaluation included venous ultrasound and pulmonary angiotomography. Diagnostic exams were repeated postoperatively to detect the study outcomes. Multivariate logistic regression models were used to identify prognostic factors. RESULTS: Among the 84 patients included, 44 (52.4%) were female and mean age was 59.3 ± 15.2 years. Lead malfunctioning (75.0%) was the main surgical procedure indication. Lead removal was performed in 44 (52.4%) cases. The rate of postoperative combined events was 32.6%, with 24 (28.6%) cases of UEDVT and six (7.1%) cases of PE. Clinical manifestations of deep venous thrombosis occurred in 10 (11.9%) patients. Independent prognostic factors for UEDVT were severe collateral circulation in the preoperative venography (odds ratio [OR] 4.7; 95% confidence interval [CI] 1.1-19.8; P = .037) and transvenous lead extraction (OR 27.4; 95% CI 5.8-128.8; P < .0001). CONCLUSION: Reoperations involving previously implanted transvenous leads present high rates of thromboembolic complications. Transvenous lead extraction had a significant impact on the development of UEDVT. These results show the need of further studies to evaluate the role of preventive strategies for this subgroup of patients.

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).