Análise comparativa de exposição do operador à radiação entre as técnicas radial, femoral e radial com dispositivo protetor em procedimentos de cardiologia intervencionista
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2016-01-26
Autores
Bienert, Igor Ribeiro de Castro [UNESP]
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Universidade Estadual Paulista (Unesp)
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Introdução: A cardiologia intervencionista requer necessariamente um acesso vascular invasivo, sendo esta via de acesso uma escolha do médico operador. Nesta escolha interfere o tipo de procedimento, impacto ao paciente, risco ao profissional e experiência técnica. O acesso via artéria femoral é o mais difundido globalmente e a técnica de acesso pela artéria radial tem sido progressivamente adotada devido ao maior conforto para o paciente, menores taxas de complicações e em alguns cenários, de mortalidade. Um dos focos de interesse crescente é a exposição à radiação ionizante e medidas para minimizar o risco ao paciente e ao profissional. Escassa é a literatura disponível na área e conflitantes são seus resultados. Objetivo: Avaliar os níveis de radiação recebidos pelo médico operador de acordo com as diferentes técnicas de acesso, bem como mapear áreas de escape de radiação. Após essa etapa, o estudo visou desenvolver e validar dispositivo de radioproteção dedicado à técnica radial (TRIPTable) voltado à redução da radiação ao médico operador, comparando o seu impacto à técnica femoral e radial padrão no cenário de pacientes portadores de síndrome coronária aguda randomicamente alocados para cateterismo com intenção de tratamento percutâneo. Métodos: A fase inicial pré-clínica do estudo foi constituída de avaliação em ambiente controlado dos níveis de radiação em pontos pré-especificados de um operador simulado com phantom de água. A fase clínica do estudo foi um ensaio clínico prospectivo, randomizado, unicêntrico, comparativo entre três grupos denominados técnica femoral, técnica radial e técnica radial com dispositivo radioprotetor TRIPTable, recrutados no Hospital das Clínicas de Marília (Marília/SP) e randomizados na proporção 1:1:1 (108 pacientes - 36 por grupo) avaliando a radiação recebida pelo operador em três diferentes pontos (gônadas, tireoide e olhos). Os resultados foram comparados com o grupo controle de 108 pacientes provenientes de coorte randomizada externa entre técnica radial e femoral 1:1, utilizando critérios similares, porém com operadores cegos aos objetivos de avaliação de radiação visando detecção de vieses de técnica (efeito Hawthorne) e validação de resultados. Resultados: Não houve diferença entre o estudo e a coorte externa ou entre os grupos do estudo quanto a características clínicas, desfechos dos procedimentos ou parâmetros de exposição radiológica ao paciente. Os resultados indicam maior radiação recebida pelo operador com a técnica radial (12,5 mSv), seguida da femoral (10,1 mSv) e TRIPTable (6,8 mSv). Em relação aos locais de exposição, o território de gônadas teve maior sensibilidade radiológica com uso da técnica radial (p=0,001). Com uso da técnica femoral não houve diferença entre os três territórios (p=0,398), porém na análise ad hoc o território de gônadas foi mais sensível quando comparado à exposição aos olhos (p=0,016) e limítrofe em comparação à tireoide (p=0,056). No grupo do dispositivo TRIPTable não houve diferença significativa entre qualquer um dos territórios analisados (p=0,180). Conclusões: O estudo indica equivalência entre os resultados do procedimento entre os grupos e quanto à exposição radiológica ao paciente. Contudo, demonstrou maior impacto radiológico para o operador que utilizou a técnica radial, em comparação à técnica femoral e à técnica radial com uso do dispositivo TRIPTable. O uso do dispositivo reduziu o impacto radiológico comparado ainda à técnica femoral. Tais diferenças derivaram primordialmente da variação em território de gônadas. Os achados demonstram um campo de exposição radiológica heterogêneo ao corpo do operador, benefício do dispositivo testado e oportunidade de novas formas de desenvolvimento de medidas de radioproteção. Registros: UTN/OMS - U1111-1158-8591 Plataforma Brasil - CAAE 32767514.0.1001.5413 Clinical Trials - NCT 02200783.
Background: Interventional cardiology requires an invasive vascular access, a choice of medical operator. This choice is affected by type of procedure, patient impact, professional risk and technical experience. Interventional procedures via radial technique have progressively increased due to improved patient comfort, lower complication rates, and reduced mortality in some scenarios. One area of interest is radiation exposure and ways to minimizing it. Most studies focusing on patient radiation risk demonstrated conflicting results, and there is no consensus for increased exposure with any technique. Objective: The aim of this study was to evaluate radiological exposure under controlled radial and femoral access simulation tests, mapping radiation paths. After this stage, the study developed a radiological protection device for the transradial technique (TRIPTable), comparing its impact as compared to standard femoral and radial techniques in the setting of patients with acute coronary syndrome randomly assigned for catheterization with intent to percutaneous treatment. Methods: Radiation exposure was simulated under controlled conditions for femoral and radial techniques using a pressurized ionization chamber and water phantom. Different measurement points were defined according to standard positions to simulate radiation received by the operator in the gonads, thyroid, and eyes at different angles during real procedures. The clinical phase of the study is a prospective clinical trial, single-center, randomized, and comparing three groups (femoral technique, radial technique, and radial technique with radioprotective device), admitted in the Emergency Department of Hospital das Clinicas de Marilia (Marilia / SP – Brazil). Patients were randomized in a 1:1:1 proportion (108 patients - 36 per group) evaluating the radiation received by the operator measured by dosimetry at three different points (gonads, thyroid and eyes). As it is impossible to blind operators to study techniques, the results were compared to an external control cohort of patients including 108 individuals with similar inclusion and exclusion criteria, randomized for radial and femoral technique, but with blinded operators to radiation objectives, aiming technical bias detection (Hawthorne effect) and validation of results. Results: There was no difference between groups regarding clinical characteristics, procedures or patient radiation exposure outcomes. The results indicate higher radiation received by the operator with the radial technique (12.5 mSv) as compared to femoral technique (10.1 mSv) and TRIPTable technique (6.8 mSv). Regarding exposure locations, the gonad region had a higher radiation sensitivity with radial technique (p=0.001). With femoral technique there was no difference between the three territories (p=0.398) but the ad hoc analysis indicated higher radiosensibility in gonads when compared to eyes exposure (p=0.016) and borderline compared to thyroid exposure (p=0.056). In the TRIPTable device group there was no significant difference between any of the territories analyzed (p=0.180). Conclusions: The study indicates no difference of radiation exposure to the patients between the groups. However, there was a greater radiologic impact to the operator who used the radial technique, compared to the femoral technique and TRIPTable device technique. The device reduced the radiological impact even compared to the femoral technique. Such differences derived primarily from variation in gonads exposure. The findings demonstrate a heterogeneous radiation exposure to the operator body, device benefit and an opportunity to develop new ways to improve radiation protection. Registration: UTN/OMS - U1111-1158-8591 Plataforma Brasil - CAAE 32767514.0.1001.5413 Clinical Trials - NCT 02200783.
Background: Interventional cardiology requires an invasive vascular access, a choice of medical operator. This choice is affected by type of procedure, patient impact, professional risk and technical experience. Interventional procedures via radial technique have progressively increased due to improved patient comfort, lower complication rates, and reduced mortality in some scenarios. One area of interest is radiation exposure and ways to minimizing it. Most studies focusing on patient radiation risk demonstrated conflicting results, and there is no consensus for increased exposure with any technique. Objective: The aim of this study was to evaluate radiological exposure under controlled radial and femoral access simulation tests, mapping radiation paths. After this stage, the study developed a radiological protection device for the transradial technique (TRIPTable), comparing its impact as compared to standard femoral and radial techniques in the setting of patients with acute coronary syndrome randomly assigned for catheterization with intent to percutaneous treatment. Methods: Radiation exposure was simulated under controlled conditions for femoral and radial techniques using a pressurized ionization chamber and water phantom. Different measurement points were defined according to standard positions to simulate radiation received by the operator in the gonads, thyroid, and eyes at different angles during real procedures. The clinical phase of the study is a prospective clinical trial, single-center, randomized, and comparing three groups (femoral technique, radial technique, and radial technique with radioprotective device), admitted in the Emergency Department of Hospital das Clinicas de Marilia (Marilia / SP – Brazil). Patients were randomized in a 1:1:1 proportion (108 patients - 36 per group) evaluating the radiation received by the operator measured by dosimetry at three different points (gonads, thyroid and eyes). As it is impossible to blind operators to study techniques, the results were compared to an external control cohort of patients including 108 individuals with similar inclusion and exclusion criteria, randomized for radial and femoral technique, but with blinded operators to radiation objectives, aiming technical bias detection (Hawthorne effect) and validation of results. Results: There was no difference between groups regarding clinical characteristics, procedures or patient radiation exposure outcomes. The results indicate higher radiation received by the operator with the radial technique (12.5 mSv) as compared to femoral technique (10.1 mSv) and TRIPTable technique (6.8 mSv). Regarding exposure locations, the gonad region had a higher radiation sensitivity with radial technique (p=0.001). With femoral technique there was no difference between the three territories (p=0.398) but the ad hoc analysis indicated higher radiosensibility in gonads when compared to eyes exposure (p=0.016) and borderline compared to thyroid exposure (p=0.056). In the TRIPTable device group there was no significant difference between any of the territories analyzed (p=0.180). Conclusions: The study indicates no difference of radiation exposure to the patients between the groups. However, there was a greater radiologic impact to the operator who used the radial technique, compared to the femoral technique and TRIPTable device technique. The device reduced the radiological impact even compared to the femoral technique. Such differences derived primarily from variation in gonads exposure. The findings demonstrate a heterogeneous radiation exposure to the operator body, device benefit and an opportunity to develop new ways to improve radiation protection. Registration: UTN/OMS - U1111-1158-8591 Plataforma Brasil - CAAE 32767514.0.1001.5413 Clinical Trials - NCT 02200783.
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Palavras-chave
Radiação ionizante, Cateterismo cardíaco, Artéria femoral, Artéria radial, Ionizing radiation, Cardiac catheterization, Radial artery, Femoral artery