@haoc.org.br
Cardiac Pacing
Cardiology and Cardiovascular Medicine, Critical Care and Intensive Care Medicine
Scopus Publications
Frederico Scuotto, Caio Marcos de Moraes Albertini, Stefano Garzón Dias Lemos, Rodolfo Staico, Renato Samy Assad, and Claudio Cirenza
Elsevier BV
Frederico Scuotto, Caio Marcos de Moraes Albertini, Stefano Garzón Dias Lemos, Rodolfo Staico, Renato Samy Assad, and Claudio Cirenza
Elsevier BV
Caio Marcos de Moraes Albertini, Katia Regina da Silva, Marta Fernandes Lima, Joaquim Maurício da Motta Leal Filho, Martino Martinelli Filho, and Roberto Costa
Wiley
AbstractBackgroundVenous 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.AimTo investigate the incidence and possible risk factors for upper extremity deep venous thrombosis (UEDVT) and pulmonary embolism (PE) after lead replacement or upgrade procedures.MethodsProspective 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.ResultsAmong 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).ConclusionReoperations 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.
Frederico Scuotto, Maria Fernanda Silva Jardim, Flávia Balbo Piazzon, Caio Marcos de Moraes Albertini, Renato Samy Assad, Guilherme Fenelon, and Claudio Cirenza
Elsevier BV
Elizabeth Sartori Crevelari, Katia Regina da Silva, Caio Marcos de Moraes Albertini, Marcelo Luiz Campos Vieira, Martino Martinelli Filho, and Roberto Costa
Sociedade Brasileira de Cardiologia
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.
Caio Marcos de Moraes Albertini, Katia Regina da Silva, Joaquim Maurício da Motta Leal Filho, Elizabeth Sartori Crevelari, Martino Martinelli Filho, Francisco Cesar Carnevale, and Roberto Costa
Sociedade Brasileira de Cardiologia
Background Venous obstructions are common in patients with transvenous cardiac implantable electronic devices, but they rarely cause immediate clinical problems. The main consequence of these lesions is the difficulty in obtaining venous access for additional leads implantation. Objectives We aimed to assess the prevalence and predictor factors of venous lesions in patients referred to lead reoperations, and to define the role of preoperative venography in the planning of these procedures. Methods From April 2013 to July 2016, contrast venography was performed in 100 patients referred to device upgrade, revision and lead extraction. Venous lesions were classified as non-significant (< 50%), moderate stenosis (51-70%), severe stenosis (71-99%) or occlusion (100%). Collateral circulation was classified as absent, discrete, moderate or accentuated. The surgical strategy was defined according to the result of the preoperative venography. Univariate analysis was used to investigate predictor factors related to the occurrence of these lesions, with 5% of significance level. Results Moderate venous stenosis was observed in 23%, severe in 13% and occlusions in 11%. There were no significant differences in relation to the device side or the venous segment. The usefulness of the preoperative venography to define the operative tactic was proven, and in 99% of the cases, the established surgical strategy could be performed according to plan. Conclusions The prevalence of venous obstruction is high in CIED recipients referred to reoperations. Venography is highly indicated as a preoperative examination for allowing the adequate surgical planning of procedures involving previous transvenous leads.
Arn Migowski and Regina Maria de Aquino Xavier
Sociedade Brasileira de Cardiologia
Mailing Address: Arn Migowski • Rua das Laranjeiras 374, Instituto Nacional de Cardiologia, 5o andar. Postal Code 22240-006, Laranjeiras, RJ – Brazil E-mail: arnmigowski@yahoo.com.br, arn.santos@inca.gov.br Manuscript received November 30, 2016, revised manuscript January 26, 2017, accepted January 26, 2017
Katia Regina da Silva, Caio Marcos de Moraes Albertini, Elizabeth Sartori Crevelari, Eduardo Infante Januzzi de Carvalho, Alfredo Inácio Fiorelli, Martino Martinelli Filho, and Roberto Costa
Sociedade Brasileira de Cardiologia
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.
Kátia Regina da Silva, Roberto Costa, Elizabeth Sartori Crevelari, Marianna Sobral Lacerda, Caio Marcos de Moraes Albertini, Martino Martinelli Filho, José Eduardo Santana, João Ricardo Nickenig Vissoci, Ricardo Pietrobon, and Jacson V. Barros
Public Library of Science (PLoS)
Background 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. Purpose Our 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 Results 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. Conclusion 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.