Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase I safety study (the TABMMI study).

AIMS: To assess the hypothesis that fluoroscopically-guided helical needle transendocardial delivery of autologous bone marrow (ABM) mononuclear cells (MNCs) in chronic post myocardial infarction patients is safe and improves ejection fraction (EF). METHODS AND RESULTS: Twenty ischaemic heart failure patients with an EF ≤40% were enrolled. ABMMNCs were prepared, counted for CD34+ and CD133+ content, and delivered percutaneously to the heart at 5 to 10 peri-infarct sites. Two-dimensional (2D) transthoracic echocardiography, EF measurements, Holter, and exercise tolerance time (ETT) were performed at baseline, one week (wk), and 6, 12, and 24 months (mo). 96±29 million ABMMNCs were injected into 8.5±2.6 peri-infarct sites over 42±17 minutes (n=20). There were no adverse events associated with the catheter-based cell transplantation procedure or significant increases in ventricular events on Holter. EF improved over baseline from 34.9±4.3% to 41.9±5.1% at 12 mo to 42.2±7.1% (p=0.00005) at 24 mo. ETT improvements were statistically significant from 246±113 sec to 373±183 sec at 12 mo and 371±181 sec at 24 mo (p=0.006). CONCLUSIONS: ABMMNCs delivered with the helical needle transendocardial catheter was safe in this uncontrolled open label study. Increased EF and ETT support the safety of the procedure and technologies involved and warrant additional investigation.

Transendocardial autologous bone marrow in chronic myocardial infarction using a helical needle catheter: 1-year follow-up in an open-label, nonrandomized, single-center pilot study (the TABMMI study).

BACKGROUND: Cell therapy has shown benefit in preclinical and clinical studies, although debate continues on the mechanism of action and the most appropriate methods for performing such therapies. We assessed the hypothesis that helical needle transendocardial (TE) delivery of autologous bone marrow (ABM) mononuclear cells around regions of hypo- or akinesia in patients after chronic myocardial infarction (MI) would be safe and possibly improve ejection fraction (EF). METHODS AND RESULTS: Ten stable post-MI patients with an EF <40% were enrolled. Autologous bone marrow cells were aspirated from the iliac crest and delivered percutaneously with a TE helical needle catheter. A total of 86 x 10(6) cells were injected into 7.1 +/- 3.1 sites around the infarct to target the peri-infarct zones. Two-dimensional echocardiographic left ventricle EF measurements, 24-hour Holter, and exercise tolerance testing were performed at baseline, day of procedure, 1 and 12 weeks, and 6 and 12 months. There were no adverse events associated with the catheter-based cell transplantation procedure. At 6 and 12 months, all patients showed an improvement in left ventricle EF over baseline (35.2 +/- 4.6 to 40.8 +/- 4.5, P = .003 at 6 months; 35.2 +/- 4.6 to 42.3 +/- 5.1, P = .0001 at 12 months). CONCLUSIONS: Autologous bone marrow cells delivered with the helical needle TE catheter was safe in this small uncontrolled study in patients with chronic MI. Increased EF and other positive data trends support continued development of this therapeutic strategy in larger controlled trials.

Incidence of high blood pressure in a group of tannery workers in Brazil.

The aim of this study was to measure the incidence of high blood pressure (HBP) in a medium-size tannery in Botucatu, São Paulo State, southeast Brazil. A previous study at this tannery showed a high prevalence of arterial hypertension. A positive correlation was found between cumulated work time and arterial pressure. We followed a cohort of workers for seven years. At the end of this period, HBP incidence rate was calculated as 0.0964.year(-1). This was considered high compared to other occupational groups.

Incidence of high blood pressure in a group of tannery workers in Brazil

O objetivo deste estudo foi medir a incidência de hipertensão arterial sistêmica em um curtume de médio porte em Botucatu, São Paulo, Sudeste do Brasil, onde havia sido observada, em estudo prévio, uma correlação positiva entre tempo de trabalho e níveis pressóricos, bem como uma alta prevalência de hipertensão. Para tanto, uma coorte de trabalhadores desse curtume foi acompanhada durante sete anos. Ao final do seguimento, estimou-se a taxa de incidência de hipertensão arterial como 0,0964.ano-1, valor considerado elevado se comparado com o encontrado em outros grupos profissionais.

Condições de trabalho em oficinas de reparação de veículos automotores de Botucatu (São Paulo); nota prévia / Working conditions in the automobile repair shops in Botucatu, São Paulo, Brazil: preliminary report

Este estudo avalia qualitativamente as exposições ocupacionais a ruído e a substâncias químicas, condições de movimentação de cargas e o cumprimento de algumas normas regulamentadoras, em 1997. Identificaram-se 68 empresas (catálogo telefônico e outras indicações), coletando-se informações através de observação e aplicação de questionário. Treze empresas não estavam inscritas no Cadastro Geral de Contribuintes nem na Prefeitura Municipal. O efetivo total encontrado foi de 418 trabalhadores, 13 com idades entre 15 e 17 anos. Ruído: moderado em 41% das empresas e intenso em 16%. Movimentação manual de cargas: moderada em 35% das empresas e intensa em 15%. Normas Regulamentadoras: Comissão Interna de Prevenção de Acidentes (CIPA) - existente em uma das quatro empresas que deveriam possuí-la; Programa de Controle Médico de Saúde Ocupacional (PCMSO) e Programa de Prevenção de Riscos Ambientais (PPRA) - realizados numa única empresa; condições sanitárias e de conforto precárias em 78% das empresas; 96% das empresas possuíam pelo menos um tipo de equipamento de proteção (EPI). Uso de produtos químicos: relacionados 26 diferentes produtos majoritariamente utilizados em funilaria e pintura; hábito de limpeza de peças com gasolina, thinners e querosene; higiene corporal precária em 75% das empresas (mãos, braços e vestuário sujos de óleo e ou graxa). Tais resultados revelam necessidade de desenvolvimento de estratégias de intervenção/prevenção para esse grupo de micro e pequenas empresas.

This study qualitatively evaluates occupational exposure to noise and chemicals, heavy load handling conditions, and observance of work regulations. Sixty-eight shops were identified from the telephone directory and other sources. Information was collected by observation and by questionnaire. Thirteen shops were not registered. Of a total of 418 workers, 13 had ages between 15 and 17 years. Noise: moderate in 41% and marked in 16% of the locations. Heavy load handling conditions were moderate in 35% and marked in 15% of the shops evaluated. Work regulations: The Accident Prevention Committee (CIPA) was established in one of the four shops requiring them; Medical Control and Occupational Health Programs was organized in only one location. Conditions of sanitation and comfort were unsuitable in 78% of the shops; 96% of the locations had at least one type of personal protection. Use of chemical products: 26 products were used in automotive bodywork and painting; routine cleaning of parts with gasoline, thinners and kerosene in all shops; workers' hygiene was unsuitable in 75% of the locations (hands, arms and clothes were oily and greasy). These results indicate the need for the development of intervention/prevention strategies for these small businesses.

Validade das informaçöes ocupaçäo e causa básica em declaraçöes de óbito de Botucatu, Säo Paulo / Validity of information on occupation and principal cause on death certificates in Botucatu, Säo Paulo

Estuda a validade das informaçöes sobre ocupaçäo habitual e causa básica em declaraçöes de óbito (DO) de moradores de Botucatu falecidos nesta cidade. Analisou-se a concordância dessas informaçöes com seus padröes-ouro, estabelecidos por intermédio de entrevistas com familiares de 552 falecidos em 1997 e análise de documentaçäo médica. O coeficiente Kappa para a concordância entre a informaçäo sobre ocupaçäo e o padräo-ouro foi 0,31 (IC 95 por cento 0,29-0,34). Para a concordância entre causa básica declarada e o padräo-ouro, o coeficiente Kappa foi de 0,76 (IC 95 por cento 0,75-0,77). Conclui-se que, embor a validade da informaçäo sobre a causa básica do óbito seja boa, a validade da informaçäo sobre a ocupaçäo habitual é bastante precária. Isto impossibilita a utilizaçäo dessas informaçöes em estudos epidemiológicos locais. Tal constataçäo alerta para a necessidade de previamente verificar a fidedignidade de informaçöes ocupacionais provenientes de declaraçöes de óbito em estudos de saúde do trabalhador. Outra implicaçäo desse achado é enfatizar a necessidade de investir-se n melhoria da qualidade dessas informaçöes.