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 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.
- 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.
- Functional Capacity of Patients with Pacemaker Due to Isolated Congenital Atrioventricular Block(2015) OLIVEIRA JUNIOR, Roberto Marcio de; SILVA, Katia Regina da; KAWAUCHI, Tatiana Satie; ALVES, Lucas Bassolli de Oliveira; CREVELARI, Elizabeth Sartori; MARTINELLI FILHO, Martino; COSTA, RobertoBackground: Isolated congenital atrioventricular block (CAVB) is a rare condition with multiple clinical outcomes. Ventricular remodeling can occur in approximately 10% of the patients after pacemaker (PM) implantation. Objectives: To assess the functional capacity of children and young adults with isolated CAVB and chronic pacing of the right ventricle (RV) and evaluate its correlation with predictors of ventricular remodeling. Methods: This cross-sectional study used a cohort of patients with isolated CAVB and RV pacing for over a year. The subjects underwent clinical and echocardiographic evaluation. Functional capacity was assessed using the six-minute walk test. Chi-square test, Fisher's exact test, and Pearson correlation coefficient were used, considering a significance level of 5%. Results: A total of 61 individuals were evaluated between March 2010 and December 2013, of which 67.2% were women, aged between 7 and 41 years, who were using PMs for 13.5 +/- 6.3 years. The percentage of ventricular pacing was 97.9 +/- 4.1%, and the duration of the paced QRS complex was 153.7 +/- 19.1 ms. Majority of the subjects (95.1%) were asymptomatic and did not use any medication. The mean distance walked was 546.9 +/- 76.2 meters and was strongly correlated with the predicted distance (r = 0.907, p = 0.001) but not with risk factors for ventricular remodeling. Conclusions: The functional capacity of isolated CAVB patients with chronic RV pacing was satisfactory but did not correlate with risk factors for ventricular remodeling.
- Impact of the COVID-19 Pandemic on Cardiac Implantable Electronic Devices Procedures in a Tertiary Referral Center(2021) COSTA, Roberto; SILVA, Katia Regina da; SAUCEDO, Sarah Caroline Martins; SILVA, Laisa Arruda; CREVELARI, Elizabeth Sartori; NASCIMENTO, Wagner Tadeu Jurevicius; SILVEIRA, Thiago Goncalves; FIORELLI, Alfredo; MARTINELLI FILHO, Martino; JATENE, Fabio Biscegli
- Prognosis Determinants after Cardioverter-Defibrillators Implantation in Brazil Reply(2017) SILVA, Katia Regina da; ALBERTINI, Caio Marcos de Moraes; CREVELARI, Elizabeth Sartori; CARVALHO, Eduardo Infante Januzzi de; FIORELLI, Alfredo Inacio; MARTINELLI FILHO, Martino; COSTA, Roberto
- Efficacy, Safety, and Performance of Isolated Left vs. Right Ventricular Pacing in Patients with Bradyarrhythmias: A Randomized Controlled Trial(2019) CREVELARI, Elizabeth Sartori; SILVA, Katia Regina da; ALBERTINI, Caio Marcos de Moraes; VIEIRA, Marcelo Luiz Campos; MARTINELLI FILHO, Martino; COSTA, RobertoBackground: 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.
- Validity Evidence of the Brazilian Version of the Florida Shock Anxiety Scale for Patients with Implantable Cardioverter Defibrillators(2020) SILVA, Katia Regina; COSTA, Roberto; MELO, Giovanna Regina Garcia de Oliveira; REBUSTINI, Flavio; BENEDETTO, Marcos Sidney; NAGUMO, Marcia Mitie; SEARS, Samuel F.Background: In spite of proven effectiveness of implantable cardioverter defibrillators (ICDs), shock therapy delivered by the device may result in increased levels of anxiety and depression, leading to deleterious effects on quality of life. Objective: To carry out the translation, cross-cultural adaptation and validation of the Florida Shock Anxiety Scale (FSAS) scale into Brazilian Portuguese. Methods: In this psychometric study, construct validity was performed by exploratory (EFA) and confirmatory (CFA) factor analyses, and by item response theory (IRT). The adjustment indexes of the CFA were: Robust Mean-Scaled Chi Square/df NNFI, CFI (Comparative Fit Index), GFI (Goodness Fit Index), AGFI (Adjusted Goodness Fit Index), RMSEA (Root Mean Square Error of Approximation) and RMSR (Root Mean Square of Residuals). Reliability was evaluated through Cronbach's Alpha, McDonald's Omega and Greatest Lower Bound (GLB). The analyses were carried out with the programs SPSS 23 and Factor 10.8.01. A 5 percent significance level was used. Results: The final Portuguese version of the FSAS was administered to 151 ICD patients, with a mean age of 55.7 +/- 14.1 years, and predominantly male. The parallel analysis indicated that the FSAS is unidimensional, with an explained variance of 64.4%. The correlations ranged from 0.31 to 0.77, factor loadings from 0.67 to 0.86, and communalities from 0.46 to 0.74. The adjustment indexes of the CFA were above the quality threshold. Satisfactory reliability evidence was provided by the FSAS. Conclusions: The FSAS-Br showed consistent validity and reliability evidence. Therefore, it can be used in ICD patients in Brazil.
- Usefulness of Preoperative Venography in Patients with Cardiac Implantable Electronic Devices Submitted to Lead Replacement or Device Upgrade Procedures(2018) ALBERTINI, Caio Marcos de Moraes; SILVA, Katia Regina da; LEAL FILHO, Joaquim Maurfcio da Motta; CREVELARI, Elizabeth Sartori; MARTINELLI FILHO, Martino; CAMEVALE, Francisco Cesar; COSTA, RobertoBackground: 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.
- Factors Associated with the Treatment Costs within the First Year after Pacemaker Implantation or Pulse Generator Replacement(2024) ALVES, Lucas Bassoli de Oliveira; SILVA, Katia Regina; BARROS, Jacson Venancio; COLUGNATI, Fernando Antonio Basile; MARTINELLI FILHO, Martino; COSTA, RobertoBackground: 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.
- Predictors of Quality of Life, Anxiety and Acceptance in Patients with Implantable Cardioverter-Defibrillator(2024) SILVA, Laisa Arruda; SILVA, Katia Regina; SAUCEDO, Sarah Caroline Martins; COSTA, RobertoBackground: An implantable cardioverter-defibrillator (ICD) can cause high levels of anxiety and depression, resulting in negative effects on quality of life. Objectives: To evaluate the quality of life, anxiety, and acceptance of the ICD using standardized measurement instruments and identify predictors of better responses for each of the outcomes studied. Method: This is a prospective cohort study with patients undergoing initial ICD implantation or reoperation to maintain the device. The study outcomes included quality of life, anxiety, and acceptance of the ICD. The change in scores (30 and 180 days) was assessed using the minimal important difference (MID). Univariate analysis and the multivariate logistic regression model were used to identify predictors of better responses, adopting a significance level of 5%. Results: A total of 147 patients were included between January/2020 to June/2021, with a mean age of 55.3 +/- 13.4 years and a predominance of males (72.1%). The MID for quality of life, anxiety, and ICD acceptance were observed in 33 (22.4%), 36 (24.5%) and 43 (29.3%) patients, respectively. Age equal to or greater than 60 years (OR=2.5; 95%CI=1.14-5.53; p=0.022), absence of atrial fibrillation (OR=3.8; 95%CI=1.26-11.63; p=0.017) and female gender (OR=2.2; 95%CI=1.02-4.97; p=0.045) were independent predictors of better responses to quality of life, anxiety and acceptance of the ICD, respectively. Conclusion: The identification of predictors for better quality of life scores, anxiety, and acceptance of the device can support the implementation of specific care for patients with a greater chance of presenting unfavorable results.