In patients with advanced HF and severe systolic dysfunction: (1) a significant reduction of MSNA (at rest and during handgrip) occurred after CRT, and this behavior was significantly superior to HF patients receiving only medical therapy; (2) MSNA reduction after CRT had an inverse correlation with O2 consumption outcomes.

BackgroundThe 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.PurposeOur study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems.Methods and ResultsWe 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.ConclusionThis 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.

The femoral vein has been used as an alternative conduit to implant pacemakers in children of any weight. Such method associates endocardial pacing and good cosmetics. The aim of this study was to evaluate prospectively, since 1981, the long-term follow-up of 99 children, from newborn to 13 years old (average = 4.1 +/- 3.6 years, 56 girls), who underwent the implantation of pacemakers via the femoral vein. Atrioventricular block was present in 88% of patients, of congenital etiology in 39% and postoperative in 54%. Single chamber pacemakers were implanted in 92% of patients. During a mean follow-up of 5.3 +/- 5.0 years (maximum = 18.2 years), 5 patients died of cardiac causes, 4 of infection, 2 suddenly, and 3 of unknown causes. The 5-, 10- and 15-year actuarial survival rates were 83.7%, 75.7%, and 75.7%, respectively. Transfemoral leads were used for a mean of 48.9 +/- 44.0 months. Reasons for lead explantations were pacing failure in five patients, infection in eight, and elective in nine. The 2-, 5- and 10-year actuarial survivals of transfemoral leads were 87.6%, 73.8%, and 31.8%, respectively. The mean lead survival was 97 months. Overall, 105 reoperations were performed, 38 for battery depletion, 24 for body growth, 14 for infection or pocket revisions, and 27 for miscellaneous reasons. In conclusion, the durability and overall long-term performance of transfemoral leads were excellent.

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

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