KATIA REGINA DA SILVA
Projetos de Pesquisa
Unidades Organizacionais
Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina
LIM/11 - Laboratório de Cirurgia Cardiovascular e Fisiopatologia da Circulação, Hospital das Clínicas, Faculdade de Medicina
LIM/11 - Laboratório de Cirurgia Cardiovascular e Fisiopatologia da Circulação, Hospital das Clínicas, Faculdade de Medicina
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conferenceObject Prospective study of thromboembolic events after reoperation in permanent artificial cardiac pacing(2018) ALBERTINI, C. M.; SILVA, K. R.; LEAL FILHO, J. M.; MARTINELLI FILHO, M.; COSTA, R.- Effectiveness and Safety of Transvenous Removal of Cardiac Pacing and Implantable Cardioverter-defibrillator Leads in the Real Clinical Scenario(2020) COSTA, Roberto; SILVA, Katia Regina da; CREVELARI, Elizabeth Sartori; NASCIMENTO, Wagner Tadeu Jurevicius; NAGUMO, Marcia Mitie; MARTINELLI FILHO, Martino; JATENE, Fabio BiscegliBackground: 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.
- The impact of data quality monitoring of a multicenter prospective registry of cardiac implantable electronic devices(2023) SAUCEDO, Sarah Caroline Martins; SILVA, Katia Regina; SILVA, Laisa de Arruda; CRIVELARI, Jessica Moretto; COSTA, RobertoData 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 evidencebased 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: center dot Dynamic data monitoring using features of the REDCap (Research Electronic Data Capture) software, including data reports and data quality rules center dot 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.
- Effectiveness of epicardial atrial pacing using a bipolar steroid-eluting endocardial lead with active fixation in an experimental model(2013) BUENO, Savia Christina Pereira; TAMAKI, Wagner Tetsuji; SILVA, Marcelo Fiorelli Alexandrino da; ZAMBOLIM, Cristiane Maciel; SILVA, Katia Regina da; MARTINELLI FILHO, Martino; COSTA, RobertoPURPOSE: To assess the effectiveness of bipolar epicardial atrial pacing using an active fixation bipolar endocardial lead implanted on the atrial surface in an experimental model. METHODS: A total of ten Large White adult pigs underwent pacemaker implantation under general anesthesia. Atrial pacing and sensing parameters were obtained at the procedure, immediate postoperative period and on the 7th and the 30th postoperative in unipolar and bipolar configurations. RESULTS: All procedures were successfully performed. There were no perioperative complications and no early deaths. Atrial pacing and sensing parameters for both unipolar and bipolar modes remained stable throughout the study. We observed a progressive increase in atrial thresholds, ranging from 0.49 +/- 0.35 (at implantation) to 1.86 +/- 1.31 volts (30th postoperative day), in unipolar mode. Atrial impedance measurements decreased slightly over time, ranging from 486.80 +/- 126.35 Ohms (at implantation) to 385.0 +/- 80.52 Ohms (30th postoperative day). Atrial sensing measures remained stable from the immediate postoperative period until the end of the study. CONCLUSION: The bipolar active fixation endocardial lead implanted epicardially can provide stable conditions of pacing and sensing parameters throughout the postoperative follow-up.
- Upper extremity deep venous thrombosis and pulmonary embolism after transvenous lead replacement or upgrade procedures(2020) ALBERTINI, Caio Marcos de Moraes; SILVA, Katia Regina da; LIMA, Marta Fernandes; LEAL FILHO, Joaquim Mauricio da Motta; MARTINELLI FILHO, Martino; COSTA, RobertoBackground 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.
bookPart Infecçoes de dispositivos cardiacos eletrónicos implantáveis(2018) COSTA, Roberto; ALBERTINI, Caio Marcos de Moraes; NASSIF JR., Miguel; CREVELARI, Elizabeth Sartori; SILVA, Kátia Regina da- Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration - Methodology and Case Study(2013) SILVA, Katia Regina da; COSTA, Roberto; CREVELARI, Elizabeth Sartori; LACERDA, Marianna Sobral; ALBERTINI, Caio Marcos de Moraes; MARTINELLI FILHO, Martino; SANTANA, Jose Eduardo; VISSOCI, Joao Ricardo Nickenig; PIETROBON, Ricardo; BARROS, Jacson V.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.
conferenceObject Role of the 18F-fluorodeoxyglucose positron emission tomography for diagnosis of cardiac implantable electronic devices infection: initial results of a referral center(2016) COSTA, R.; SILVA, K. R.; SIA FILHO, E. J.; SOEIRO, A.; SICILIANO, R. F.; CARVALHO, R. A.; ALVES, L. B. O.; SOARES JR., J.; MARTINELLI FILHO, M.; STRABELLI, T. V.conferenceObject Developing an adverse events reporting system to measure real-world outcomes of cardiac implantable electronic devices(2016) SILVA, K. R.; ALVES, L. B. O.; KAWAUCHI, T. S.; AMAYA, I. C. M.; MELO, G. R. G.; BARROS, J. V.; MACHADO, I.; BAGGIO, J. M.; RODRIGUES, C. G.; CARVALHO, G.; OLIVEIRA, J. C.; LIMA, C. E. B.; MARTINELLI FILHO, M.; COSTA, R.- Complications after Surgical Procedures in Patients with Cardiac Implantable Electronic Devices: Results of a Prospective Registry(2016) SILVA, Katia Regina da; ALBERTINI, Caio Marcos de Moraes; CREVELARI, Elizabeth Sartori; CARVALHO, Eduardo Infante Januzzi de; FIORELLI, Alfredo Inacio; MARTINELLI FILHO, Martino; COSTA, RobertoBackground: 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.