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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- 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.
- 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.
- Novel approach to epicardial pacemaker implantation in patients with Limited venous access(2013) COSTA, Roberto; SCANAVACCA, Mauricio; SILVA, Katia Regina da; MARTINELLI FILHO, Martino; CARRILLO, RogerBACKGROUND Limited venous access in certain patients increases the procedural risk and complexity of conventional transvenous pacemaker implantation. OBJECTIVE The purpose of this study was to determine a minimally invasive epicardial approach using pericardial reflections for dual-chamber pacemaker implantation in patients with limited venous access. METHODS Between June 2006 and November 2011, 15 patients underwent epicardial pacemaker implantation. Procedures were performed through a minimally invasive subxiphoid approach and pericardial window with subsequent fluoroscopy-assisted lead placement. Mean patient age was 46.4 +/- 15.3 years (9 male [(60.0%], 6 female [40.0%]). The new surgical approach was used in patients determined to have limited venous access due to multiple abandoned leads in 5 (33.3%), venous occlusion in 3 (20.0%), intravascular retention of lead fragments from prior extraction in 3 (20.0%), tricuspid valve vegetation currently under treatment in 2 (13.3%), and unrepaired intracardiac defects in 2 (13.3%). RESULTS All procedures were successful with no perioperative complications or early deaths. Mean operating time for isolated pacemaker implantation was 231.7 +/- 33.5 minutes. Lead placement on the superior aspect of right atrium, through the transverse sinus, was possible in 12 patients. In the remaining 3 patients, the atrial lead was implanted on the left atrium through the oblique sinus, the postcaval recess, or the left pulmonary vein recess. None of the patients displayed pacing or sensing dysfunction, and all parameters remained stable throughout the follow-up period of 36.8 +/- 25.1 months. CONCLUSION Epicardial pacemaker implantation through pericardial reflections is an effective alternative therapy for those patients requiring physiologic pacing in whom venous access is limited.
- Quality of Life and Functional Capacity after Long-Term Right Ventricular Pacing in Pediatrics and Young Adults with Congenital Atrioventricular Block(2013) SILVA, Katia Regina da; COSTA, Roberto; OLIVEIRA JR., Roberto Marcio De; LACERDA, Marianna Sobral; HUANG, Adriana I. Un; ROSSI, Marina Bertelli; CREVELARI, Elizabeth Sartori; TAMAKI, Wagner Tetsuji; MARTINELLI FILHO, Martino; PIETROBON, RicardoBackgroundAlthough 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). MethodsWe 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. ResultsDomains 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 impactemotional (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). ConclusionsChronic 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.