The recording of arrhythmic events (AE) in renal transplant candidates (RTCs) undergoing dialysis is limited by conventional electrocardiography. However, continuous cardiac rhythm monitoring seems ...to be more appropriate due to automatic detection of arrhythmia, but this method has not been used.
We aimed to investigate the incidence and predictors of AE in RTCs using an implantable loop recorder (ILR).
A prospective observational study conducted from June 2009 to January 2011 included 100 consecutive ambulatory RTCs who underwent ILR and were followed-up for at least 1 year. Multivariate logistic regression was applied to define predictors of AE.
During a mean follow-up of 424 ± 127 days, AE could be detected in 98% of patients, and 92% had more than one type of arrhythmia, with most considered potentially not serious. Sustained atrial tachycardia and atrial fibrillation occurred in 7% and 13% of patients, respectively, and bradyarrhythmia and non-sustained or sustained ventricular tachycardia (VT) occurred in 25% and 57%, respectively. There were 18 deaths, of which 7 were sudden cardiac events: 3 bradyarrhythmias, 1 ventricular fibrillation, 1 myocardial infarction, and 2 undetermined. The presence of a long QTc (odds ratio OR = 7.28; 95% confidence interval CI, 2.01-26.35; p = 0.002), and the duration of the PR interval (OR = 1.05; 95% CI, 1.02-1.08; p < 0.001) were independently associated with bradyarrhythmias. Left ventricular dilatation (LVD) was independently associated with non-sustained VT (OR = 2.83; 95% CI, 1.01-7.96; p = 0.041).
In medium-term follow-up of RTCs, ILR helped detect a high incidence of AE, most of which did not have clinical relevance. The PR interval and presence of long QTc were predictive of bradyarrhythmias, whereas LVD was predictive of non-sustained VT.
The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to ...advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings.
Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems.
We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry.
This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries.
Transvenous lead extraction (TLE) of cardiac implantable electronic devices (CIED) is an uncommon procedure and requires specialized personnel and adequate facilities.
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.
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%.
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.
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).
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.
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.
Abstract Background Worsening in clinical and cardiac status has been noted after chronic right ventricular pacing, but it is uncertain whether atriobiventricular (BiVP) is preferable to atrio-right ...ventricular pacing (RVP). Conventional versus Multisite Pacing for BradyArrhythmia Therapy study (COMBAT) sought to compare BiVP versus RVP in patients with symptomatic heart failure (HF) and atrioventricular (AV) block. Methods and Results COMBAT is a prospective multicenter randomized double blind crossover study. Patients with New York Heart Association functional class (FC) II-IV, left ventricular ejection fraction (LVEF) <40%, and AV block as an indication for pacing were enrolled. All patients underwent biventricular system implantation and then were randomized to receive successively (group A) RVP-BiVP-RVP, or (group B) BiVP-RVP-BiVP. At the end of each 3-month crossover period, patients were evaluated according to Quality of Life (QoL), FC, echocardiographic parameters, 6-Minute Walk Test (6MWT), and peak oxygen consumption (VO2max ). Sixty patients were enrolled, and the mean follow-up period was 17.5 ± 10.7 months. There were significant improvements in QoL, FC, LVEF, and left ventricular end-systolic volume with BiVP compared with RVP. The effects of pacing mode on 6MWT and VO2max were not significantly different. Death occurred more frequently with RVP. Conclusion In patients with systolic HF and AV block requiring permanent ventricular pacing, BiVP is superior to RVP and should be considered the preferred pacing mode.
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.
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