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.

Prevalence of Left Ventricular Dyssynchrony in Patients with Congenital Atrioventricular Block and Long-Term Pacing: A Three-Dimensional Echocardiographic Study.

BACKGROUND: Left ventricular (LV) dysfunction is the major reason for poor outcomes in patients with congenital complete atrioventricular block (CCAVB) and pacemaker. Long-term pacing has been associated with LV mechanical dyssynchrony. However, the relationship of dyssynchrony and LV dysfunction is not clear. OBJECTIVE: We sought to evaluate the prevalence of LV dyssynchrony by real time three-dimensional echocardiography (RT3DE) in patients with CCAVB and its association with LV dysfunction. In addition, we evaluated the agreement between RT3DE and tissue Doppler imaging (TDI) for detecting LV dyssynchrony. METHOD: We studied 50 patients [median age 20 years old (5 months to 62 years), 68% women] with CCAVB and pacemaker who underwent complete two-dimensional echocardiography and RT3DE. LV dyssynchrony was considered if the systolic dyssynchrony index (SDI) was ≥ 5%. Intraventricular mechanical delay was defined by TDI when differences in electromechanical activation between LV walls were > 65 msec. RESULTS: LV systolic dysfunction was present in 16 patients (32%) by two-dimensional and in 20 patients (40%) by RT3DE. There was a good correlation between LV ejection fraction by two-dimensional and RT3DE (r = 0.75; P < 0.001). Fourteen (28%) patients had intraventricular dyssynchrony by TDI, while 12 (24%) had intraventricular dyssynchrony by RT3DE. There was a good agreement between LV dyssynchrony by TDI and RT3DE (Kappa = 0.735; P < 0.001). There was a negative correlation between LV ejection fraction and SDI obtained by RT3DE (r = -0.58; P < 0.001) CONCLUSIONS: In patients with CCAVB and long-term pacing, LV dyssynchrony occurred in one-third of patients and was related to LV dysfunction. There was a good correlation between dyssynchrony obtained by RT3DE and TDI.

New karyotypes of Atlantic tree rats, genus Phyllomys (Rodentia: Echimyidae).

Phyllomys (Echimyidae, Rodentia) is a genus of Neotropical rodents with available cytogenetic data restricted to six out of 13 species, mainly based on simple staining methods, without detailed analyses. In this work, we present new karyotypes for Phyllomys lamarum (diploid number 2n = 56, fundamental number or number of autosomal arms FN = 102) and Phyllomys sp. (2n = 74, FN = 140) from the state of Minas Gerais, southeastern Brazil. We provide the first GTG- and CBG-banding patterns, silver-staining of the nucleolar organizer regions (Ag-NORs), and fluorescence in situ hybridization (FISH) with telomeric and 45S rDNA probes of Phyllomys. In addition to examining their chromosomes and phenotypic characters, we sequenced mitochondrial DNA from the specimens analyzed to confirm their taxonomic identification. The comparison of the distinctive chromosome complements of our specimens with those of other species of Phyllomys already published allowed us to conclude that chromosome data may be very useful for the taxonomy of the genus, as no two species analyzed presented the same diploid and fundamental numbers (2n and FN).

Predictors of Quality of Life, Anxiety and Acceptance in Patients with Implantable Cardioverter-Defibrillator. / Preditores de Qualidade de Vida, Ansiedade e Aceitação em Pacientes com Cardioversor-Desfibrilador Implantável.

BACKGROUND: An implantable cardioverter-defibrillator (ICD) can cause high levels of anxiety and depression, resulting in negative effects on quality of life. OBJECTIVES: To evaluate the quality of life, anxiety, and acceptance of the ICD using standardized measurement instruments and identify predictors of better responses for each of the outcomes studied. METHOD: This is a prospective cohort study with patients undergoing initial ICD implantation or reoperation to maintain the device. The study outcomes included quality of life, anxiety, and acceptance of the ICD. The change in scores (30 and 180 days) was assessed using the minimal important difference (MID). Univariate analysis and the multivariate logistic regression model were used to identify predictors of better responses, adopting a significance level of 5%. RESULTS: A total of 147 patients were included between January/2020 to June/2021, with a mean age of 55.3 ± 13.4 years and a predominance of males (72.1%). The MID for quality of life, anxiety, and ICD acceptance were observed in 33 (22.4%), 36 (24.5%) and 43 (29.3%) patients, respectively. Age equal to or greater than 60 years (OR=2.5; 95%CI=1.14-5.53; p=0.022), absence of atrial fibrillation (OR=3.8; 95%CI=1.26-11.63; p=0.017) and female gender (OR=2.2; 95%CI=1.02-4.97; p=0.045) were independent predictors of better responses to quality of life, anxiety and acceptance of the ICD, respectively. CONCLUSION: The identification of predictors for better quality of life scores, anxiety, and acceptance of the device can support the implementation of specific care for patients with a greater chance of presenting unfavorable results.

FUNDAMENTO: O cardioversor-desfibrilador implantável (CDI) pode causar níveis elevados de ansiedade e depressão, resultando em efeitos negativos na qualidade de vida. OBJETIVOS: Avaliar a qualidade de vida, a ansiedade e a aceitação do CDI por meio de instrumentos de medida padronizados e identificar preditores de melhores respostas para cada um dos desfechos estudados. MÉTODO: Coorte prospectiva com pacientes submetidos a implante inicial de CDI ou reoperação para a manutenção do dispositivo. Os desfechos do estudo incluíram: qualidade de vida, ansiedade e aceitação do CDI. A mudança nos escores (30 e 180 dias) foi avaliada por meio da diferença mínima importante (DMI). Foi utilizada a análise univariada e o modelo de regressão logística multivariada para a identificação de preditores de melhores respostas, adotando-se o nível de significância de 5%. RESULTADOS: De janeiro/2020 a junho/2021 foram incluídos 147 pacientes, com idade média de 55,3 ± 13,4 anos e predomínio do sexo masculino (72,1%). A DMI para qualidade de vida, a ansiedade e a aceitação do CDI foram observadas em 33 (22,4%), 36 (24,5%) e 43 (29,3%) pacientes, respectivamente. Idade igual ou maior que 60 anos (OR=2,5; IC 95%=1,14-5,53; p=0,022), ausência de fibrilação atrial (OR=3,8; IC 95%=1,26-11,63; p=0,017) e sexo feminino (OR=2,2; IC 95%=1,02-4,97; p=0,045) foram preditores independentes de melhores respostas para qualidade de vida, ansiedade e aceitação do CDI, respectivamente. CONCLUSÃO: A identificação de preditores para melhores escores de qualidade de vida, ansiedade e aceitação do dispositivo pode subsidiar a implementação de cuidados específicos para os pacientes com maiores chances de apresentar resultados desfavoráveis.

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.

Data-driven, cross-disciplinary collaboration: lessons learned at the largest academic health center in Latin America during the COVID-19 pandemic.

Introduction: The COVID-19 pandemic has prompted global research efforts to reduce infection impact, highlighting the potential of cross-disciplinary collaboration to enhance research quality and efficiency. Methods: At the FMUSP-HC academic health system, we implemented innovative flow management routines for collecting, organizing and analyzing demographic data, COVID-related data and biological materials from over 4,500 patients with confirmed SARS-CoV-2 infection hospitalized from 2020 to 2022. This strategy was mainly planned in three areas: organizing a database with data from the hospitalizations; setting-up a multidisciplinary taskforce to conduct follow-up assessments after discharge; and organizing a biobank. Additionally, a COVID-19 curated collection was created within the institutional digital library of academic papers to map the research output. Results: Over the course of the experience, the possible benefits and challenges of this type of research support approach were identified and discussed, leading to a set of recommended strategies to enhance collaboration within the research institution. Demographic and clinical data from COVID-19 hospitalizations were compiled in a database including adults and a minority of children and adolescents with laboratory confirmed COVID-19, covering 2020-2022, with approximately 350 fields per patient. To date, this database has been used in 16 published studies. Additionally, we assessed 700 adults 6 to 11 months after hospitalization through comprehensive, multidisciplinary in-person evaluations; this database, comprising around 2000 fields per subject, was used in 15 publications. Furthermore, thousands of blood samples collected during the acute phase and follow-up assessments remain stored for future investigations. To date, more than 3,700 aliquots have been used in ongoing research investigating various aspects of COVID-19. Lastly, the mapping of the overall research output revealed that between 2020 and 2022 our academic system produced 1,394 scientific articles on COVID-19. Discussion: Research is a crucial component of an effective epidemic response, and the preparation process should include a well-defined plan for organizing and sharing resources. The initiatives described in the present paper were successful in our aim to foster large-scale research in our institution. Although a single model may not be appropriate for all contexts, cross-disciplinary collaboration and open data sharing should make health research systems more efficient to generate the best evidence.

Quality of life and functional capacity after long-term right ventricular pacing in pediatrics and young adults with congenital atrioventricular block.

BACKGROUND: Although several studies have demonstrated deleterious consequences of chronic right ventricular (RV) pacing on ventricular function and synchronicity, its effects on health-related quality of life (HRQoL) and functional exercise capacity remain uncertain. We aimed to evaluate the effect of RV pacing on HRQoL and functional capacity of children and young adults with congenital complete atrioventricular block (CCAVB). METHODS: We included 66 consecutive subjects with RV cardiac pacemaker due to CCAVB and under clinical follow-up for more than 1 year. Multidimensional HRQoL scores were evaluated by Short Form-36 Health Survey (SF-36) and Child Health Questionnaire-Parent Form 50 (CHQ-PF50). Functional capacity was tested by a 6-minute walk distance test (6MWDT). Association analysis was performed to examine if any demographic and clinical characteristics were associated with lower HRQoL scores and shorter distances at the 6MWDT. RESULTS: Domains presenting lower HRQoL scores were vitality (64.0 ± 17.3), mental health (67.3 ± 8.0), role emotional (69.7 ± 35.8) in the SF-36 questionnaire; general health perceptions (61.3 ± 8.3), general behavior (61.9 ± 15.6), parental impact-emotional (67.7 ± 28.7) in the CHQ-PF50. Female gender (P = 0.009), left ventricular ejection fraction lower than 55% (P = 0.013), cardiovascular drugs (P = 0.003) were significantly associated with lower HRQoL scores. Average distance traveled during the 6MWDT was 539.8 ± 82.9 m. The 6MWDT showed significant association with age (P = 0.006) and cardiovascular drugs (P = 0.024). CONCLUSIONS: Chronic RV pacing did not affect the HRQoL and physical capacity of pediatrics and young subjects. Female gender, ventricular function, and cardiovascular drugs were associated with lower HRQoL scores. Older subjects walked shorter distances in the 6MWDT, as well as subjects who were taking cardiovascular drugs.

The impact of data quality monitoring of a multicenter prospective registry of cardiac implantable electronic devices.

Data quality monitoring plays a crucial role in multicenter prospective registries. By maintaining high data accuracy, completeness, and consistency, researchers can improve the overall quality and reliability of the registry data, enabling meaningful conclusions and supporting evidence-based decisions. The purpose of the present study was to evaluate data quality metrics (completeness, accuracy, and temporal plausibility) of a Multicenter Registry of Cardiac Implantable Electronic Devices (CIEDs) and to perform a direct data audit of a random sample of records to assess the agreement levels with the source documents. The CIED Registry was a prospective, multicenter, real-world observational study carried out from January 2020 to December 2022 in five designated centers across Sao Paulo, Brazil. We assessed the data quality of the CIED Registry by using two distinct approaches:•Dynamic data monitoring using features of the REDCap (Research Electronic Data Capture) software, including data reports and data quality rules•Direct data audit in which information from a random sample of 10 % of cases from the coordinating center was compared with original source documents Our findings suggest that the methodological approach applied to the CIED Registry resulted in high data completeness, accuracy, temporal plausibility, and excellent agreement levels with the source documents.

Validity and reliability of the Brazilian Portuguese version of the Florida Patient Acceptance Survey for patients with implantable cardioverter defibrillators.

Device acceptance is a crucial factor in identifying implantable cardioverter defibrillator (ICD) patients at risk for psychosocial distress and unfavorable quality of life outcomes. The purpose of this study was to examine the evidence of the validity of internal structure (construct) and reliability of the Florida Patient Acceptance Survey (FPAS) in a sample of ICD patients, comparing the psychometric indicators of the complete (FPAS-18 item) and abbreviated (FPAS-12 item) versions. The sample included 151 participants (97 males, mean age of 55.7 ± 14.1 years) who completed the cross-culturally adapted version of the FPAS instrument for the Brazilian context. The psychometric properties of both versions of the FPAS instrument were evaluated by two distinct approaches:•Exploratory and confirmatory factor analysis: used to test the internal structure of the instrument•Cronbach's Alpha and McDonald's Omega: used to determine the reliability of the instrument The two versions of the FPAS-Br instrument showed consistent evidence of internal structure validity and reliability. However, the FPAS-Br 12-item showed a better psychometric adjustment, confirmed by the analysis of the quality indicators of the models.

Timing to Intubation COVID-19 Patients: Can We Put It Off until Tomorrow?

BACKGROUND: The decision to intubate COVID-19 patients receiving non-invasive respiratory support is challenging, requiring a fine balance between early intubation and risks of invasive mechanical ventilation versus the adverse effects of delaying intubation. This present study analyzes the association between intubation day and mortality in COVID-19 patients. METHODS: We performed a unicentric retrospective cohort study considering all COVID-19 patients consecutively admitted between March 2020 and August 2020 requiring invasive mechanical ventilation. The primary outcome was all-cause mortality within 28 days after intubation, and a Cox model was used to evaluate the effect of time from onset of symptoms to intubation in mortality. RESULTS: A total of 592 (20%) patients of 3020 admitted with COVID-19 were intubated during study period, and 310 patients who were intubated deceased 28 days after intubation. Each additional day between the onset of symptoms and intubation was significantly associated with higher in-hospital death (adjusted hazard ratio, 1.018; 95% CI, 1.005-1.03). CONCLUSION: Among patients infected with SARS-CoV-2 who were intubated and mechanically ventilated, delaying intubation in the course of symptoms may be associated with higher mortality. TRIAL REGISTRATION: The study protocol was approved by the local Ethics Committee (opinion number 3.990.817; CAAE: 30417520.0.0000.0068).

Distinct Outcomes in COVID-19 Patients with Positive or Negative RT-PCR Test.

Identification of the SARS-CoV-2 virus by RT-PCR from a nasopharyngeal swab sample is a common test for diagnosing COVID-19. However, some patients present clinical, laboratorial, and radiological evidence of COVID-19 infection with negative RT-PCR result(s). Thus, we assessed whether positive results were associated with intubation and mortality. This study was conducted in a Brazilian tertiary hospital from March to August of 2020. All patients had clinical, laboratory, and radiological diagnosis of COVID-19. They were divided into two groups: positive (+) RT-PCR group, with 2292 participants, and negative (-) RT-PCR group, with 706 participants. Patients with negative RT-PCR testing and an alternative most probable diagnosis were excluded from the study. The RT-PCR(+) group presented increased risk of intensive care unit (ICU) admission, mechanical ventilation, length of hospital stay, and 28-day mortality, when compared to the RT-PCR(-) group. A positive SARS-CoV-2 RT-PCR result was independently associated with intubation and 28 day in-hospital mortality. Accordingly, we concluded that patients with a COVID-19 diagnosis based on clinical data, despite a negative RT-PCR test from nasopharyngeal samples, presented more favorable outcomes than patients with positive RT-PCR test(s).

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.

Post-acute sequelae of SARS-CoV-2 infection (PASC): a protocol for a multidisciplinary prospective observational evaluation of a cohort of patients surviving hospitalisation in Sao Paulo, Brazil.

INTRODUCTION: COVID-19 may lead to persistent and potentially incapacitating clinical manifestations (post-acute sequelae of SARS-CoV-2 infection (PASC)). Using easy-to-apply questionnaires and scales (often by telephone interviewing), several studies evaluated samples of COVID-19 inpatients from 4 weeks to several months after discharge. However, studies conducting systematic multidisciplinary assessments of PASC manifestations are scarce, with thorough in-person objective evaluations restricted to modestly sized subsamples presenting greatest disease severity. METHODS AND ANALYSES: We will conduct a prospective observational study of surviving individuals (above 18 years of age) from a cohort of over 3000 subjects with laboratory-confirmed COVID-19 who were treated as inpatients at the largest academic health centre in Sao Paulo, Brazil (Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo). All eligible subjects will be consecutively invited to undergo a 1-2-day series of multidisciplinary assessments at 2 time-points, respectively, at 6-9 months and 12-15 months after discharge. Assessment schedules will include detailed multidomain questionnaires applied by medical research staff, self-report scales, objective evaluations of cardiopulmonary functioning, physical functionality and olfactory status, standardised neurological, psychiatric and cognitive examinations, as well as diagnostic laboratory, muscle ultrasound and chest imaging exams. Remaining material from blood tests will be incorporated by a local biobank for use in future investigations on inflammatory markers, genomics, transcriptomics, peptidomics and metabolomics. ETHICS AND DISSEMINATION: All components of this programme have been approved by local research ethics committees. We aim to provide insights into the frequency and severity of chronic/post-COVID multiorgan symptoms, as well as their interrelationships and associations with acute disease features, sociodemographic variables and environmental exposures. Findings will be disseminated in peer-reviewed journals and at scientific meetings. Additionally, we aim to provide a data repository to allow future pathophysiological investigations relating clinical PASC features to biomarker data extracted from blood samples. TRIAL REGISTRATION NUMBER: RBR-8z7v5wc; Pre-results.

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).

Validity Evidence of the Brazilian Version of the Florida Shock Anxiety Scale for Patients with Implantable Cardioverter Defibrillators. / Evidências de Validade da Versão Brasileira da Florida Shock Anxiety Scale para Portadores de Cardioversor-Desfibrilador Implantável.

BACKGROUND: In spite of proven effectiveness of implantable cardioverter defibrillators (ICDs), shock therapy delivered by the device may result in increased levels of anxiety and depression, leading to deleterious effects on quality of life. OBJECTIVE: To carry out the translation, cross-cultural adaptation and validation of the Florida Shock Anxiety Scale (FSAS) scale into Brazilian Portuguese. METHODS: In this psychometric study, construct validity was performed by exploratory (EFA) and confirmatory (CFA) factor analyses, and by item response theory (IRT). The adjustment indexes of the CFA were: Robust Mean-Scaled Chi Square/df NNFI, CFI (Comparative Fit Index), GFI (Goodness Fit Index), AGFI (Adjusted Goodness Fit Index), RMSEA (Root Mean Square Error of Approximation) and RMSR (Root Mean Square of Residuals). Reliability was evaluated through Cronbach's Alpha, McDonald's Omega and Greatest Lower Bound (GLB). The analyses were carried out with the programs SPSS 23 and Factor 10.8.01. A 5 percent significance level was used. RESULTS: The final Portuguese version of the FSAS was administered to 151 ICD patients, with a mean age of 55.7 ± 14.1 years, and predominantly male. The parallel analysis indicated that the FSAS is unidimensional, with an explained variance of 64.4%. The correlations ranged from 0.31 to 0.77, factor loadings from 0.67 to 0.86, and communalities from 0.46 to 0.74. The adjustment indexes of the CFA were above the quality threshold. Satisfactory reliability evidence was provided by the FSAS. CONCLUSIONS: The FSAS-Br showed consistent validity and reliability evidence. Therefore, it can be used in ICD patients in Brazil. (Arq Bras Cardiol. 2020; 114(5):764-772).

FUNDAMENTO: A despeito da comprovada efetividade do cardioversor-desfibrilador implantável (CDI), as terapias de choque deflagradas pelo dispositivo podem causar níveis elevados de ansiedade e depressão, provocando efeitos deletérios na qualidade de vida. OBJETIVO: Realizar a tradução, adaptação transcultural e validação do instrumento Florida Shock Anxiety Scale (FSAS) para a língua portuguesa falada no Brasil. MÉTODOS: Nesse estudo psicométrico, a validade de construto foi realizada pela análise fatorial exploratória (AFE) e confirmatória (AFC) e pela Teoria de Resposta ao Item. Os índices de ajustamento da AFC foram: Robust Mean-Scaled Chi Square/df NNFI, CFI (Comparative Fit Index), GFI (Goodness Fit Index), AGFI (Adjusted Goodness Fit Index), RMSEA (Root Mean Square Error of Approximation) e RMSR (Root Mean Square of Residuals). A confiabilidade foi verificada pelo Alfa de Cronbach, Ômega de McDonald e Greatest Lower Bound. As análises foram realizadas no SPSS 23.0 e Factor 10.8.01, com nível de significância de 5%. RESULTADOS: A versão final em português do FSAS foi administrada em 151 portadores de CDI, com idade média de 55,7 ± 14,1 anos e predomínio do sexo masculino. A análise paralela indicou que o FSAS é unidimensional, com variância explicada de 64,4%. As correlações variaram de 0,31 a 0,77; as cargas fatoriais de 0,67 a 0,86 e as comunalidades de 0,46 a 0,74. Os índices de ajustamento da AFC estabeleceram-se acima dos limites de qualidade. Encontramos evidências satisfatórias de confiabilidade da escala FSAS. CONCLUSÃO: O instrumento FSAS-Br apresentou evidências consistentes de validade e confiabilidade, podendo, portanto, ser utilizado em portadores de CDI do Brasil. (Arq Bras Cardiol. 2020; 114(5):764-772).

Prevention of venous thrombosis by warfarin after permanent transvenous leads implantation in high-risk patients.

BACKGROUND: The incidence of venous lesions following transvenous cardiac device implantation is high. Previous implantation of temporary leads ipsilateral to the permanent devices, and a depressed left ventricular ejection fraction have been associated with an increased risk of venous lesions, though the effects of preventive strategies remain controversial. This randomized trial examined the effects of warfarin in the prevention of these complications in high-risk patients. METHOD: Between February 2004 and September 2007, we studied 101 adults who underwent a first cardiac device implantation, and who had a left ventricular ejection fraction < or =0.40, or a temporary pacing system ipsilateral to the permanent implant, or both. After device implantation, the patients were randomly assigned to warfarin to a target international normalized ratio of 2.0-3.5, or to placebo. Clinical and laboratory evaluations were performed regularly up to 6 months postimplant. Venous lesions were detected at 6 months by digital subtraction venography. RESULTS: Venous obstructions of various degrees were observed in 46 of the 92 patients (50.0%) who underwent venography. The frequency of venous obstructions was 60.4% in the placebo, versus 38.6% in the warfarin group (P = 0.018), corresponding to an absolute risk reduction of 22% (relative risk = 0.63; 95% confidence interval = 0.013-0.42). CONCLUSIONS: Warfarin prophylaxis lowered the frequency of venous lesions after transvenous devices implantation in high-risk patients.

Preditores de Qualidade de Vida, Ansiedade e Aceitação em Pacientes com Cardioversor-Desfibrilador Implantável / Predictors of Quality of Life, Anxiety and Acceptance in Patients with Implantable Cardioverter-Defibrillator

Resumo Fundamento O cardioversor-desfibrilador implantável (CDI) pode causar níveis elevados de ansiedade e depressão, resultando em efeitos negativos na qualidade de vida. Objetivos Avaliar a qualidade de vida, a ansiedade e a aceitação do CDI por meio de instrumentos de medida padronizados e identificar preditores de melhores respostas para cada um dos desfechos estudados. Método Coorte prospectiva com pacientes submetidos a implante inicial de CDI ou reoperação para a manutenção do dispositivo. Os desfechos do estudo incluíram: qualidade de vida, ansiedade e aceitação do CDI. A mudança nos escores (30 e 180 dias) foi avaliada por meio da diferença mínima importante (DMI). Foi utilizada a análise univariada e o modelo de regressão logística multivariada para a identificação de preditores de melhores respostas, adotando-se o nível de significância de 5%. Resultados De janeiro/2020 a junho/2021 foram incluídos 147 pacientes, com idade média de 55,3 ± 13,4 anos e predomínio do sexo masculino (72,1%). A DMI para qualidade de vida, a ansiedade e a aceitação do CDI foram observadas em 33 (22,4%), 36 (24,5%) e 43 (29,3%) pacientes, respectivamente. Idade igual ou maior que 60 anos (OR=2,5; IC 95%=1,14-5,53; p=0,022), ausência de fibrilação atrial (OR=3,8; IC 95%=1,26-11,63; p=0,017) e sexo feminino (OR=2,2; IC 95%=1,02-4,97; p=0,045) foram preditores independentes de melhores respostas para qualidade de vida, ansiedade e aceitação do CDI, respectivamente. Conclusão A identificação de preditores para melhores escores de qualidade de vida, ansiedade e aceitação do dispositivo pode subsidiar a implementação de cuidados específicos para os pacientes com maiores chances de apresentar resultados desfavoráveis.

Abstract Background An implantable cardioverter-defibrillator (ICD) can cause high levels of anxiety and depression, resulting in negative effects on quality of life. Objectives To evaluate the quality of life, anxiety, and acceptance of the ICD using standardized measurement instruments and identify predictors of better responses for each of the outcomes studied. Method This is a prospective cohort study with patients undergoing initial ICD implantation or reoperation to maintain the device. The study outcomes included quality of life, anxiety, and acceptance of the ICD. The change in scores (30 and 180 days) was assessed using the minimal important difference (MID). Univariate analysis and the multivariate logistic regression model were used to identify predictors of better responses, adopting a significance level of 5%. Results A total of 147 patients were included between January/2020 to June/2021, with a mean age of 55.3 ± 13.4 years and a predominance of males (72.1%). The MID for quality of life, anxiety, and ICD acceptance were observed in 33 (22.4%), 36 (24.5%) and 43 (29.3%) patients, respectively. Age equal to or greater than 60 years (OR=2.5; 95%CI=1.14-5.53; p=0.022), absence of atrial fibrillation (OR=3.8; 95%CI=1.26-11.63; p=0.017) and female gender (OR=2.2; 95%CI=1.02-4.97; p=0.045) were independent predictors of better responses to quality of life, anxiety and acceptance of the ICD, respectively. Conclusion The identification of predictors for better quality of life scores, anxiety, and acceptance of the device can support the implementation of specific care for patients with a greater chance of presenting unfavorable results.

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.

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.