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1.
Braz. j. oral sci ; 21: e226252, jan.-dez. 2022. ilus
Article in English | LILACS, BBO | ID: biblio-1366526

ABSTRACT

Universal health coverage is a global target included in the United Nations Sustainable Development Goals agenda for 2030. Healthcare in Brazil has universal coverage through the Unified Health System (SUS), which guarantees health as basic right to the Brazilian population. Considering the principles of SUS, public oral healthcare management is a huge challenge. Aim: To identify good management practices for quality care adopted by local public oral healthcare managers and teams around Brazil. Methods: This study was registered with PROSPERO (CRD42017051639). Five databases (PubMed, Embase, Web of Science, Scopus and Lilacs) as well as the reference lists and citations of the included publications were searched according to PRISMA guidelines. Results:A total of 30,895 references were initially found, which were evaluated according to the defined eligibility criteria. Twenty qualitative studies, eight surveys and two mixed-model studies were selected. The practices (codes) were organized into three main groups (families), and the Frequency of the Effect Size (FES) of each code was calculated. Among the 20 codes identified, the most relevant ones were: Diagnosis and Health Planning (FES=80%) and Family Health Strategy(FES=66,7). The Intensity of the Effect Size of each study was also calculated to demonstrate the individual contribution of each study to the conclusions. Conclusion: The evidence emerging from this review showed that healthcare diagnosis, planning, and performance based on the family health strategy principles were the most relevant practices adopted by public oral healthcare managers in Brazil. The widespread adoption of these practices could lead to improved oral healthcare provision and management in Brazil


Subject(s)
Humans , Unified Health System , Dental Care , Health Management , Health Policy , Brazil
2.
Rev. bras. cir. cardiovasc ; 35(4): 437-444, July-Aug. 2020. tab, graf
Article in English | LILACS, SES-SP | ID: biblio-1137309

ABSTRACT

Abstract Objective: The preparation of parents of children who should undergo cardiac surgery requires special treatment such as the explanations about the event. This study aims to compare the effects of standardized nursing guidelines with routine institutional orientation on the anxiety of parents of children undergoing cardiac surgery. Methods: Randomized clinical trial. The sample consisted of parents of children who underwent cardiac surgery from December 2010 to April 2011. Twenty-two parents were randomized to the intervention group (IG) and received the standard nursing guidelines and 22 participated in the control group (CG) and received the routine guidelines from the institution. Anxiety was assessed by the State-Trait Anxiety Inventory (STAI) applied in the preoperative period, between 12 and 20 hours before surgery and before receiving standard or institutional guidelines and 48 hours after surgery. The analysis of variance (ANOVA) for repeated measures was performed to evaluate the differences between the variations in STAI scores between the groups during the studied period. The level of significance was 0.05. Results: There were no significant differences in baseline anxiety scores between groups with regard to trait anxiety as well as state anxiety: STAI-trait (CG 42.6±4.9 vs. IG 41.4±6.0, P=0.48); STAI-state (CG 42.3±5.7 vs. IG 45.6±8.3, P=0.18). Likewise, the variation in score after 48 hours was similar between groups (STAI-trait P=0.77; STAI-state P=0.61). Conclusion: There were no significant differences in the parents' anxiety levels when comparing the two types of guidelines: the standard nursing and the institutional orientation.


Subject(s)
Humans , Anxiety , Cardiac Surgical Procedures , Parents , Practice Guidelines as Topic , Preoperative Period
3.
Arq. bras. cardiol ; 114(3): 446-455, mar. 2020. tab, graf
Article in Portuguese | LILACS | ID: biblio-1088884

ABSTRACT

Resumo Fundamento Registros multicêntricos representativos do mundo real podem fornecer informações importantes, mas existem poucos estudos descrevendo como implementar estas ferramentas. Objetivo Descrever o processo de implementação de um banco de dados em infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCST) em um hospital de referência e sua aplicação para outros centros com uma plataforma online . Métodos Nossa instituição implementou em 2009 um Registro de Infarto Agudo do Miocárdio (RIAM), com a inclusão prospectiva e consecutiva de todos os pacientes com diagnóstico de IAMCST que internaram na instituição. No período de março de 2014 a abril de 2016 foi realizada a migração para o sistema online com o software REDCap e expansão do registro para outros centros. A plataforma REDCap é um software de uso gratuito disponibilizado pela Universidade Vanderbilt a instituições interessadas em pesquisa, mediante cadastramento prévio. Resultados Foram realizadas as seguintes etapas do aprimoramento e expansão do registro: 1. Padronização das variáveis; 2. Implementação do software REDCap ( Research Electronic Data Capture ) institucional; 3. Desenvolvimento de formulários de coleta de dados ( Case Report Form - CRF); 4. Expansão do registro para outros centros de referência utilizando o software REDCap; 5. Treinamento da equipe e dos centros participantes pelo POP (Procedimento Operacional Padrão). Conclusões A descrição da metodologia utilizada para implementar e expandir o RIAM pode auxiliar outros centros e pesquisadores a realizar estudos semelhantes, compartilhar informações entre instituições, o desenvolvimento de novas tecnologias em saúde e auxiliar nas políticas públicas em doenças cardiovasculares. (Arq Bras Cardiol. 2020; 114(3):446-455)


Abstract Background Multicenter registries representing the real world can be a significant source of information, but few studies exist describing the methodology to implement these tools. Objective To describe the process of implementing a database of ST-segment elevation acute myocardial infarction (STEMI) at a reference hospital, and the application of this process to other centers by means of an online platform. Methods In 2009, our institution implemented an Registry of Acute Myocardial Infarction (RIAM), with the prospective and consecutive inclusion of every patient admitted to the institution who received a diagnosis of STEMI. From March 2014 to April 2016, the registries were uploaded to a web-based system using the REDCap software and the registry was expanded to other centers. Upon subscription, the REDCap platform is a noncommercial software made available by Vanderbilt University to institutions interested in research. Results The following steps were taken to improve and expand the registry: 1. Standardization of variables; 2. Implementation of institutional REDCap (Research Electronic Data Capture); 3. Development of data collection forms (Case Report Form - CRF); 4. Expansion of registry to other reference centers using the REDCap software; 5. Training of teams and participating centers following an SOP (Standard Operating Procedure). Conclusion The description of the methodology used to implement and expand the RIAM may help other centers and researchers to conduct similar studies, share information between institutions, develop new health technologies, and assist public policies regarding cardiovascular diseases. (Arq Bras Cardiol. 2020; 114(3):446-455)


Subject(s)
Humans , Myocardial Infarction , Registries , Prospective Studies , Hospitalization
4.
Rev. bras. cir. cardiovasc ; 34(4): 504-506, July-Aug. 2019.
Article in English | LILACS | ID: biblio-1020507
5.
Rev. Assoc. Med. Bras. (1992) ; 65(6): 818-824, June 2019. tab, graf
Article in English | LILACS | ID: biblio-1012977

ABSTRACT

SUMMARY BACKGROUND: The use of the 3D printer in complex cardiac surgery planning. OBJECTIVES: To analyze the use and benefits of 3D printing in heart valve surgery through a systematic review of the literature. METHODS: This systematic review was reported following the Preferred Reporting Items for Systematic Review and registered in the Prospero (International Prospective Register of Systematic Reviews) database under the number CRD42017059034. We used the following databases: PubMed, EMBASE, Scopus, Web of Science and Lilacs. We included articles about the keywords "Heart Valves", "Heart Valve Prosthesis Implantation", "Heart Valve Prosthesis", "Printing, Three-Dimensional", and related entry terms. Two reviewers independently conducted data extraction and a third reviewer solved disagreements. All tables used for data extraction are available at a separate website. We used the Cochrane Collaboration tool to assess the risk of bias of the studies included. RESULTS: We identified 301 articles and 13 case reports and case series that met the inclusion criteria. Our studies included 34 patients aged from 3 months to 94 years. CONCLUSIONS: Up to the present time, there are no studies including a considerable number of patients. A 3D-printed model produced based on the patient enables the surgeon to plan the surgical procedure and choose the best material, size, format, and thickness to be used. This planning leads to reduced surgery time, exposure, and consequently, lower risk of infection.


RESUMO INTRODUÇÃO: A impressora 3D é utilizada como coadjuvante no planejamento de cirurgias de cardiopatias complexas. OBJETIVOS: Analisar o uso e os benefícios da impressão 3D em cirurgias de válvula cardíaca por meio de revisão sistemática da literatura. MÉTODOS: Esta revisão sistemática foi conduzida de acordo com os itens do Preferred Reporting for Systematic Reviews e registrada no banco de dados Prospero (Registro Prospectivo Internacional de Revisão Sistemática) sob o número CRD42017059034. Foram utilizados os seguintes bancos de dados: PubMed, Embase, Scopus, Web of Science e Lilacs. Incluídos artigos com os termos de busca "Heart Valves", "Heart Valve Prosthesis Implantation", "Heart Valve Prosthesis", "Printing, Three-Dimensional" e termos relacionados. Dois revisores independentes conduziram a extração dos dados e um terceiro (revisor) solucionou as discordâncias. Todas as tabelas usadas para a extração de dados estão disponibilizadas em site próprio. A ferramenta Cochraine Collaboration foi utilizada para avaliar o risco de viés na inclusão de estudos. RESULTADOS: Identificados 301 artigos e 13 relatos de casos e séries de casos que atenderam aos critérios de inclusão. A amostra envolveu 34 pacientes, com idade de 3 meses a 94 anos. CONCLUSÃO: Até o presente momento, não há estudos que contemplem um número considerável de pacientes. A impressão de um modelo 3D produzida a partir do protótipo do paciente permitirá ao cirurgião planejar a cirurgia, bem como escolher o melhor material, tamanho, formato e espessura da válvula a ser utilizada. Esse planejamento reduz o tempo de cirurgia, a exposição e, consequentemente, a redução do risco de infecção.


Subject(s)
Humans , Male , Female , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/methods , Printing, Three-Dimensional/instrumentation , Reproducibility of Results , Treatment Outcome , Heart Valve Prosthesis Implantation/instrumentation
6.
Rev. bras. cir. cardiovasc ; 34(2): 142-148, Mar.-Apr. 2019. tab
Article in English | LILACS | ID: biblio-990566

ABSTRACT

Abstract Introduction: Coronary artery bypass grafting (CABG) is the most frequently performed heart surgery in Brazil. Recent international guidelines recommend that national societies establish a database on the practice and results of CABG. In anticipation of the recommendation, the BYPASS Registry was introduced in 2015. Objective: To analyze the profile, risk factors and outcomes of patients undergoing CABG in Brazil, as well as to examine the predominant surgical strategy, based on the data included in the BYPASS Registry. Methods: A cross-sectional study of 2292 patients undergoing CABG surgery and cataloged in the BYPASS Registry up to November 2018. Demographic data, clinical presentation, operative variables, and postoperative hospital outcomes were analyzed. Results: Patients referred to CABG in Brazil are predominantly male (71%), with prior myocardial infarction in 41.1% of cases, diabetes in 42.5%, and ejection fraction lower than 40% in 9.7%. The Heart Team indicated surgery in 32.9% of the cases. Most of the patients underwent cardiopulmonary bypass (87%), and cardioplegia was the strategy of myocardial protection chosen in 95.2% of the cases. The left internal thoracic artery was used as a graft in 91% of the cases; the right internal thoracic artery, in 5.6%; and the radial artery in 1.1%. The saphenous vein graft was used in 84.1% of the patients, being the only graft employed in 7.7% of the patients. The median number of coronary vessels treated was 3. Operative mortality was 2.8%, and the incidence of cerebrovascular accident was 1.2%. Conclusion: CABG data in Brazil provided by the BYPASS Registry analysis are representative of our national reality and practice. This database constitutes an important reference for indications and comparisons of therapeutic procedures, as well as to propose subsequent models to improve patient safety and the quality of surgical practice in the country.


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Registries/statistics & numerical data , Coronary Artery Bypass/methods , Coronary Artery Bypass/statistics & numerical data , Brazil , Coronary Artery Bypass/adverse effects , Cross-Sectional Studies , Treatment Outcome , Hospital Mortality , Intraoperative Complications
7.
São Paulo med. j ; 136(6): 501-504, Nov.-Dec. 2018.
Article in English | LILACS | ID: biblio-991689

ABSTRACT

ABSTRACT BACKGROUND: Central blood pressure is a factor that may predict cardiovascular events. However, its use in clinical practice is not well consolidated. Therefore, the aim of our study will be to summarize the use of central hemodynamic parameters to predict cardiovascular-related outcomes and all-cause mortality. DESIGN AND SETTING: Protocol for systematic review of longitudinal observational studies conducted in healthcare institutions, as presented in the studies included. METHODS: We will perform a systematic search in the electronic databases MEDLINE (via PubMed), EMBASE and LILACS (via Virtual Health Library (VHL)), using health descriptors terms for elderly people and for hemodynamic indices of central blood pressure. We will include articles that evaluated hemodynamic indices and at least one of the following outcomes: all-cause mortality, total cardiovascular death, total non-cardiovascular death, myocardial infarction, stroke, coronary artery restenosis after percutaneous coronary intervention, revascularization and aortic syndromes. Two independent reviewers will conduct analysis on the abstracts selected and on the full-text articles. Two reviewers will independently perform data extraction and evaluate the methodological quality of the articles selected, and a third reviewer will evaluate any divergences. The methodological quality of the studies will be assessed in accordance with the ROBINS-I tool (Risk Of Bias In Non-randomized Studies of Interventions). RESULTS AND CONCLUSIONS: Through this systematic review, we intend to summarize evidence that supports the use of central hemodynamic parameters for central blood pressure to diagnose and perform prognostics on arterial hypertension in elderly patients within clinical practice and predict future cardiovascular events in this population. REGISTRATION: Prospero - CRD42018085264.


Subject(s)
Humans , Aged , Systematic Reviews as Topic , Hemodynamics , Hypertension/diagnosis , Myocardial Infarction/prevention & control , Evidence-Based Medicine , Arterial Pressure
8.
Rev. bras. cir. cardiovasc ; 32(2): 71-76, Mar.-Apr. 2017. tab
Article in English | LILACS | ID: biblio-843479

ABSTRACT

Abstract Objective: To report the early results of the BYPASS project - the Brazilian registrY of adult Patient undergoing cArdiovaScular Surgery - a national, observational, prospective, and longitudinal follow-up registry, aiming to chart a profile of patients undergoing cardiovascular surgery in Brazil, assessing the data harvested from the initial 1,722 patients. Methods: Data collection involved institutions throughout the whole country, comprising 17 centers in 4 regions: Southeast (8), Northeast (5), South (3), and Center-West (1). The study population consists of patients over 18 years of age, and the types of operations recorded were: coronary artery bypass graft (CABG), mitral valve, aortic valve (either conventional or transcatheter), surgical correction of atrial fibrillation, cardiac transplantation, mechanical circulatory support and congenital heart diseases in adults. Results: 83.1% of patients came from the public health system (SUS), 9.6% from the supplemental (private insurance) healthcare systems; and 7.3% from private (out-of -pocket) clinic. Male patients comprised 66%, 30% were diabetics, 46% had dyslipidemia, 28% previously sustained a myocardial infarction, and 9.4% underwent prior cardiovascular surgery. Patients underwent coronary artery bypass surgery were 54.1% and 31.5% to valve surgery, either isolated or combined. The overall postoperative mortality up to the 7th postoperative day was 4%; for CABG was 2.6%, and for valve operations, 4.4%. Conclusion: This first report outlines the consecution of the Brazilian surgical cardiac database, intended to serve primarily as a tool for providing information for clinical improvement and patient safety and constitute a basis for production of research protocols.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Cardiovascular Surgical Procedures/statistics & numerical data , Registries/statistics & numerical data , Multicenter Studies as Topic/statistics & numerical data , Databases, Factual/statistics & numerical data , Cardiovascular Surgical Procedures/mortality , Brazil/epidemiology , Coronary Artery Bypass/mortality , Coronary Artery Bypass/statistics & numerical data , Prospective Studies , Treatment Outcome , Coronary Disease/surgery , Coronary Disease/mortality , Heart Valves/surgery
9.
Arq. bras. cardiol ; 102(6): 539-548, 06/2014. tab, graf
Article in English | LILACS | ID: lil-712919

ABSTRACT

Background: The applicability of international risk scores in heart surgery (HS) is not well defined in centers outside of North America and Europe. Objective: To evaluate the capacity of the Parsonnet Bernstein 2000 (BP) and EuroSCORE (ES) in predicting in-hospital mortality (IHM) in patients undergoing HS at a reference hospital in Brazil and to identify risk predictors (RP). Methods: Retrospective cohort study of 1,065 patients, with 60.3% patients underwent coronary artery bypass grafting (CABG), 32.7%, valve surgery and 7.0%, CABG combined with valve surgery. Additive and logistic scores models, the area under the ROC (Receiver Operating Characteristic) curve (AUC) and the standardized mortality ratio (SMR) were calculated. Multivariate logistic regression was performed to identify the RP. Results: Overall mortality was 7.8%. The baseline characteristics of the patients were significantly different in relation to BP and ES. AUCs of the logistic and additive BP were 0.72 (95% CI, from 0.66 to 0.78 p = 0.74), and of ES they were 0.73 (95% CI; 0.67 to 0.79 p = 0.80). The calculation of the SMR in BP was 1.59 (95% CI; 1.27 to 1.99) and in ES, 1.43 (95% CI; 1.14 to 1.79). Seven RP of IHM were identified: age, serum creatinine > 2.26 mg/dL, active endocarditis, systolic pulmonary arterial pressure > 60 mmHg, one or more previous HS, CABG combined with valve surgery and diabetes mellitus. Conclusion: Local scores, based on the real situation of local populations, must be developed for better assessment of risk in cardiac surgery. .


Fundamento: A aplicabilidade de escores de risco (ER) internacionais em cirurgia cardíaca (CC) ainda não está bem definida em centros fora da América do Norte e Europa. Objetivo: Avaliar a capacidade do Berstein Parsonnet 2000 (BP) e do EuroSCORE (ES) em predizer mortalidade intra-hospitalar (MIH) em pacientes submetidos a CC em hospital de referência do Brasil e identificar os preditores de risco (PR). Métodos: Coorte retrospectiva de 1.065 pacientes. Foram incluídos dados de cirurgias realizadas entre janeiro de 2007 e julho de 2008, quando 60,3% dos pacientes realizaram CRM, 32,7%, cirurgia valvar, e 7,0%, CRM combinada com cirurgia valvar. Foram calculados os modelos aditivos e logísticos dos escores, a área sob a curva ROC (AUC) e a razão de mortalidade padronizada (RMP). Regressão logística multivariada foi realizada para identificar os PR. Resultados: A MIH da amostra foi de 7,8%. As características basais dos pacientes da amostra foram significativamente diferentes em relação ao BP e ao ES. As AUCs do BP aditivo e logístico foram 0,72 (IC95%; 0,66-0,78 p = 0,74) e as do ES foram 0,73 (IC95% 0,67-0,79 p = 0,80). O cálculo da RMP no BP foi 1,59 (IC95%; 1,27-1,99) e no ES foi 1,43 (IC95%; 1,14-1,79). Sete PR de MIH foram identificados: idade, creatinina sérica > 2,26 mg/dL, endocardite ativa, pressão arterial pulmonar > 60 mmHg, uma ou mais CC, CRM combinada com cirurgia valvar e diabetes melito. Conclusão: Ambos os ER mostraram-se inadequados na avaliação pré-operatória de pacientes submetidos a CC, reforçando a necessidade de se desenvolverem ER baseados na realidade local. .


Subject(s)
Aged , Female , Humans , Male , Middle Aged , Coronary Artery Bypass/mortality , Hospital Mortality , Heart Valve Diseases/surgery , Risk Assessment/methods , Brazil , Logistic Models , Postoperative Complications , Reference Values , Reproducibility of Results , Retrospective Studies , Risk Factors , Sensitivity and Specificity
10.
Arq. bras. cardiol ; 99(6): 1075-1081, dez. 2012. ilus, tab
Article in Portuguese | LILACS | ID: lil-662376

ABSTRACT

FUNDAMENTO: Um programa de coaching em pesquisa tem foco em desenvolvimento de habilidades e raciocínio científico. Para os profissionais da saúde, pode ser útil para o incremento no número e na qualidade de projetos e artigos. OBJETIVO: Avaliar os resultados iniciais e a metodologia de implantação do Research and Innovation Coaching Program do grupo Research on Research da Duke University na Sociedade Brasileira de Cardiologia. MÉTODOS: O programa trabalha em duas bases: o treinamento e o coaching. O treinamento é realizado online e aborda conteúdos sobre ideia de pesquisa, busca na literatura, escrita científica e estatística. Após o treinamento, o coaching favorece o estabelecimento de colaboração entre pesquisadores e centros mediante uma rede de contatos. O presente estudo descreve a implementação e os resultados iniciais dos anos 2011-2012. RESULTADOS: Em 2011, 24 centros receberam o treinamento, que consistiu em reuniões online, estudo e prática dos conteúdos abordados. Em janeiro de 2012, foi implementado um novo formato que teve como objetivo atingir mais pesquisadores. Em seis meses foram alocados 52 pesquisadores. No total, 20 artigos foram publicados e mais 49 artigos foram redigidos e aguardam submissão e/ou publicação. De forma adicional, foram elaboradas cinco propostas de financiamento de pesquisa. CONCLUSÃO: O número de artigos e as propostas de financiamento atingiram os objetivos inicialmente propostos. Contudo, os principais resultados desse tipo de iniciativa devem ser medidos em longo prazo, pois a consolidação da produção nacional de pesquisa de alta qualidade é um círculo virtuoso que se autoalimenta e expande com o tempo.


BACKGROUND: Research coaching program focuses on the development of abilities and scientific reasoning. For health professionals, it may be useful to increase both the number and quality of projects and manuscripts. OBJECTIVE: To evaluate the initial results and implementation methodology of the Research and Innovation Coaching Program of the Research on Research group of Duke University in the Brazilian Society of Cardiology. METHODS: The program works on two bases: training and coaching. Training is done online and addresses contents on research ideas, literature search, scientific writing and statistics. After training, coaching favors the establishment of a collaboration between researchers and centers by means of a network of contacts. The present study describes the implementation and initial results in reference to the years 2011-2012. RESULTS: In 2011, 24 centers received training, which consisted of online meetings, study and practice of the contents addressed. In January 2012, a new format was implemented with the objective of reaching more researchers. In six months, 52 researchers were allocated. In all, 20 manuscripts were published and 49 more were written and await submission and/or publication. Additionally, five research funding proposals have been elaborated. CONCLUSION: The number of manuscripts and funding proposals achieved the objectives initially proposed. However, the main results of this type of initiative should be measured in the long term, because the consolidation of the national production of high-quality research is a virtuous cycle that feeds itself back and expands over time. (Arq Bras Cardiol 2012;99(6):1075-1081).


Subject(s)
Humans , Biomedical Research/education , Education/methods , Research Personnel/education , Writing , Brazil , Cardiology , Education, Distance/methods , Program Evaluation , Reproducibility of Results , Research Design/standards , Societies, Medical , Universities
11.
Rev. bras. cir. cardiovasc ; 25(3): 311-321, jul.-set. 2010. ilus, tab
Article in Portuguese | LILACS | ID: lil-564996

ABSTRACT

OBJETIVO: Avaliar a segurança, viabilidade e efeitos iniciais, clínicos e sobre a perfusão miocárdica, da administração intramiocárdica, transtorácica, de VEGF 165 plasmidial em pacientes com doença arterial coronariana avançada e angina refratária, não passíveis de revascularização percutânea e cirúrgica. MÉTODOS: Ensaio clínico fase I/II. Treze pacientes cardiopatas isquêmicos com angina refratária apesar de tratamento medicamentoso máximo por no mínimo seis meses, não passíveis de revascularização cirúrgica ou por cateter foram submetidos a injeções intramiocárdicas de 2000µg VEGF 165 plasmidial. Os pacientes foram avaliados por cintilografia miocárdica, teste ergométrico, questionário de qualidade de vida (Minnesota) e determinação das classes de insuficiência cardíaca (NYHA) e angina (CCS). RESULTADOS: Não houve óbitos ou reintervenções. Durante o período de tratamento medicamentoso máximo, não se observou diferenças em cintilografias miocárdicas, testes ergométricos e questionários de qualidade de vida, ainda, houve tendência a piora das classes NYHA (P=0,05) e CCS (P=0,05). Três meses após intervenção, observou-se melhora dos escores cintilográficos SSS (18,38±7,51 vs. 15,31±7,29, P=0,003) e SRS (11,92±7,49 vs. 8,53±6,68, P=0,002), porém não na proporção da extensão da área de miocárdio isquêmico (23,38±13,12 por cento vs. 20,08±13,88 por cento, P=0,1). Houve tendência a melhora dos METs nas ergometrias (7,66±4,47 vs. 10,29±4,36, P=0,08), melhora do escore de qualidade de vida (48,23±18,35 vs. 30,15±20,13; P=0,02) e das classes NYHA (3,15±0,38 vs. 1,77±0,83, P=0,001) e CCS (3,08±0,64 vs. 1,77±0,83, P=0,001), no mesmo período. CONCLUSÕES: A terapia demonstrou-se segura e viável nesta série de pacientes. Os resultados iniciais tendem a demonstrar melhora na gravidade da angina e redução da intensidade da isquemia miocárdica.


OBJECTIVE: Safety, feasibility and early myocardial angiogenic effects evaluation of transthoracic intramyocardial phVEGF165 administration for refractory angina in no option patients. METHODS: Cohort study, in which 13 patients with refractory angina under optimized clinical treatment where included, after cineangiograms had been evaluated and found unfeasible by surgeon and interventional cardiologist. Intramyocardial injections of 5mL solution containing plasmidial VEGF165 where done over the ischemic area of myocardium identified by previous SPECT/Sestamibi scan. Evaluations included a SPECT scan, stress test, Minnesotta QOL questionnaire and NYHA functional class and CCS angina class determinations. RESULTS: There were no deaths or new interventions during the study period. There were no significant variations in SPECT scans, QOL scores and stress tests results during medical treatment in the included patients. After the 3rd post operative month, there was improvement in SPECT segmental scores, SSS (18.38±7.51 vs. 15.31±7.29, P=0.003) and SRS (11.92±7.49 vs. 8.53±6.68, P=0.002). The ischemic area extension, however, had non-significant variation (23.38±13.12 percent vs. 20.08±13.88 percent, P=0.1). Stress tests METs varied from 7.66±4.47 pre to 10.29±4.36 METs post-op (P=0.08). QOL score improved from 48.23±18.35 pre to 30.15±20.13 post-op points (P=0.02). NYHA class was 3.15±0.38 pre vs. 1.77±0.83 post-op (P=0.001) and angina CCS class, 3.08±0.64 vs. 1.77±0.83 (P=0.001). CONCLUSIONS: Intramyocardial VEGF165 therapy for refractory angina, in this small trial of no option patients, resulted feasible and safe. Early clinical and scintilographic data showed improvements in symptoms and myocardial perfusion, with regression of ischemia severity in treated areas.


Subject(s)
Female , Humans , Male , Middle Aged , Angina Pectoris/therapy , Angiogenesis Inducing Agents/administration & dosage , Genetic Therapy/methods , Myocardial Ischemia/therapy , Vascular Endothelial Growth Factor A/administration & dosage , Vascular Endothelial Growth Factor A/genetics , Angiogenesis Inducing Agents/adverse effects , Plasmids/administration & dosage , Severity of Illness Index , Treatment Outcome , Vascular Endothelial Growth Factor A/adverse effects
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