Análise da relação custo-efetividade do dispositivo de oclusão vascular AngioSealTM comparado à compressão manual e/ou mecânica após intervenções endovasculares

Abstract

Background: Vascular occlusion devices were developed to enable immediate sheath removal and minimize puncture site complications in patients undergoing endovascular interventions. Some studies, however, have shown no reduction of these complications. This study was aimed at assessing the cost-effectiveness of immediate femoral sheath removal and occlusion with the AngioSeal TM vascular occlusion device vs occlusion by manual and/or mechanical compression after endovascular interventions. Methods: Patients undergoing endovascular interventions from September 2006 to January 2009 were studied to evaluate technique outcomes, complications and costs due to the use of devices and treatment of puncture site complications. The sample was divided into the vascular closure device group (VCD Group), with 95 patients submitted to extra-cardiac interventions, and the manual and/or mechanical compression group (MC Group) with 312 patients undergoing percutaneous coronary interventions. Results: Successful hemostasis without major complications was obtained in 96.8% of the patients in the VCD Group and in 98.1% of the patients in the MC Group (P = 0.47). The individual cost of the treatment due to compression technique complications (R$ 3,600.00) was greater than the cost of the closure device (R$ 1,000.00) even when more than one device was used. However, when the total cost was analyzed per group, the relative cost per patient of the VCD Group (R$ 1,010.53) was higher than the cost of the MC Group (R$ 69.23) (P < 0.0001). Conclusions: Manual and/or mechanical compression occlusion is as effective as the use of vascular occlusion devices, but with a significantly lower cost.

Avaliação técnica do dispositivo de fechamento vascular Exoseal-Cordis®

“…the percentage of patients for whom complete hemostasis is achieved with just one device, varies from 87% to 96% and does not differ significantly from the results for manual compression. 11 In our study, there were no failures in the group in which the device was used, which c an be explained by the small sample size.…”

“…21 Analyzing this debate in our setting (in Brazil), Gioppato et al conducted a study that investigated the total cost, summing the amounts spent on treatment of complications (pseudoaneurysms treated with Doppler-guided thrombin injections) that only occurred in the group treated using manual compression. 11 The authors came to the conclusion that, despite the per-individual cost of treatment of complications related to hemostasis by compression being considerably higher, when costs were analyzed by group, the total cost for the VCD group was significantly greater than the cost for the group subjected to manual compression.…”