Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know

OBJECTIVES: This study compared radiofrequency ablation versus conventional surgery in patients who had not undergone previous treatment for bilateral great saphenous vein insufficiency, with each patient serving as his own control. METHOD: This was a randomized controlled trial that included 18 patients and was carried out between November 2013 and May 2015. Each of the lower limbs of each patient was randomly assigned to undergo either radiofrequency ablation or conventional surgery. Clinical features (hyperpigmentation, hematoma, aesthetics, pain, skin burn, nerve injury, and thrombophlebitis) were evaluated at one week, one month, and six months postoperatively. Hemodynamic assessments (presence of resection or occlusion of the great saphenous vein and recurrent reflux in the sapheno-femoral junction and in the great saphenous vein) were performed at one month, six months, and 12 months postoperatively. The independent observer (a physician not involved in the original operation), patient, and duplex ultrasonographer were not made aware of the treatment done in each case. Clinicaltrials.gov: NCT02588911. RESULTS: Among the clinical variables analyzed, only the aesthetic evaluation by the physicians was significant, with radiofrequency ablation being considered better than conventional surgery (average, 0.91 points higher: standard deviation: 0.31; 95% confidence interval: -1.51, -0.30; p=0.003). However, in our study, we observed primary success rates of 80% for radiofrequency ablation and 100% for conventional surgery. CONCLUSIONS: If the physician is not required to inform the patient as to the technique being performed, the patient will not be able to identify the technique based on the signs and symptoms. Our study revealed that both techniques led to high levels of patient satisfaction, but our results favor the choice of conventional surgery over radiofrequency ablation, as patients who underwent conventional surgery had better hemodynamic assessments.

Carbon dioxide contrast medium for endovascular treatment of ilio-femoral occlusive disease

OBJECTIVES:Compare the use of carbon dioxide contrast medium with iodine contrast medium for the endovascular treatment of ilio-femoral occlusive disease in patients without contraindications to iodine.MATERIALS AND METHODS:From August 2012 to August 2014, 21 consecutive patients with ilio-femoral occlusive disease who were eligible for endovascular treatment and lacked contraindications to either iodine contrast or carbon dioxide were randomized into the carbon dioxide or iodine groups and subjected to ilio-femoral angioplasty.We analyzed the feasibility of the procedures, the surgical and clinical outcomes, the procedure lengths, the endovascular material costs, the contrast costs and the quality of the angiographic images in each group.RESULTS:No conversions to open surgery and no contrast media related complications were noted in either group. A post-operative femoral pulse was present in 88.9% of the iodine group and 80% of the carbon dioxide group. No differences in procedure length, endovascular material cost or renal function variation were noted between the groups. Four patients in the carbon dioxide group required iodine supplementation to complete the procedure. Contrast media expenses were reduced in the carbon dioxide group. Regarding angiographic image quality, 82% of the carbon dioxide images were graded as either good or fair by observers.CONCLUSIONS:The use of carbon dioxide contrast medium is a good option for ilio-femoral angioplasty in patients without contraindications to iodine and is not characterized by differences in endovascular material costs, procedure duration and surgical outcomes. In addition, carbon dioxide has lower contrast expenses compared with iodine.

Public private partnership in vascular surgery / Parceria público-privada em cirurgia vascular

Objective To describe and analyze the results of a public-private partnership between the Ministry of Health and a private hospital in a project of assistance and scientific research in the field of endovascular surgery. Methods: The flows, costs and clinical outcomes of patients treated in a the public-private partnership between April 2012 and July 2013 were analyzed. All patients underwent surgery and stayed at least one day at the intensive care unit of the private hospital. They also participated in a research protocol to compare two intravenous contrast media used in endovascular surgery (iodinated contrast and carbon dioxide). Results A total of 62 endovascular procedures were performed in 57 patients from the public healthcare system. Hospital and endovascular supplies expenses were significantly higher as compared to the amount paid by the Unified Health System (SUS - Sistema Único de Saúde) in two out of three disease groups studied. Among outpatients, the average interval between appointment and surgery was 15 days and, in hospitalized patients 7 days. All procedures were successful with no conversion to open surgery. The new contrast medium studied - carbon dioxide – was effective and cheaper. Conclusion The waiting time for patients between indication and accomplishment of surgery was significantly reduced. Public-private partnerships can speed up care of patients from public health services, and generate and improve scientific knowledge. .

Objetivo Descrever e analisar os resultados de parceria público-privada entre o Ministério da Saúde e um hospital privado em projeto de assistência e pesquisa científica na área de cirurgia endovascular. Métodos: Foram analisados fluxos, custos e resultados clínicos dos pacientes atendidos numa parceria público-privada entre abril de 2012 e julho de 2013. Todos os pacientes foram operados, ficaram pelo menos um dia na unidade de terapia intensiva do hospital privado e participaram de um protocolo de pesquisa para comparação entre dois contrastes endovenosos para cirurgia endovascular (contraste iodado e dióxido de carbono). Resultados Foram realizados 62 procedimentos endovasculares em 57 pacientes provenientes do sistema público. Os gastos hospitalares e com material endovascular mostraram-se significativamente maiores em relação ao que é pago pelo Sistema Único de Saúde (SUS) em dois dos três grupos de doenças estudados. Entre os pacientes ambulatoriais, o intervalo médio entre a consulta e a cirurgia foi de 15 dias e, nos internados, 7 dias. Todos os procedimentos foram bem sucedidos, sem conversão para cirurgia aberta. O novo contraste estudado, o dióxido de carbono, mostrou-se eficaz e mais barato. Conclusão O tempo de espera dos pacientes entre indicação cirúrgica e sua realização foi significativamente reduzido. Parcerias público-privadas podem trazer agilidade no atendimento dos pacientes do SUS, permitindo também geração de conhecimento científico. .