RESUMO
Catheter-based interventions have become a less invasive alternative to conventional surgical techniques for a wide array of cardiovascular diseases but often create large arteriotomies. A completely percutaneous technique is attractive as it may reduce the overall complication rate and procedure time. Currently, large bore arteriotomy closure relies on suture-based techniques. Access-site complications are not uncommon and often seem related to closure device failure. The MANTA VCD is a novel collagen-based closure device that specifically targets arteriotomies between 10 and 22 Fr. This technical report discusses the MANTA design concept, practical instructions for use and preliminary clinical experience.
Assuntos
Procedimentos Endovasculares/instrumentação , Hemostasia Cirúrgica/instrumentação , Implantes Absorvíveis , Idoso , Idoso de 80 Anos ou mais , Animais , Bovinos , Colágeno , Procedimentos Endovasculares/métodos , Procedimentos Endovasculares/estatística & dados numéricos , Feminino , Hemostasia Cirúrgica/métodos , Hemostasia Cirúrgica/estatística & dados numéricos , Humanos , Masculino , Procedimentos Cirúrgicos sem SuturaRESUMO
BACKGROUND: Stent placement in saphenous vein bypass grafts is associated with a high incidence of myonecrosis usually resulting from embolization of thrombus and friable atheroma. Embolic protection devices reduce the incidence of adverse events after vein graft stenting. However, first-generation balloon occlusion systems are still associated with a 10% incidence of periprocedural adverse events. We report the first experience with a new second-generation balloon occlusion embolic protection device, the TriActiv Balloon Protected Flush Extraction System. METHODS: Ninety-six lesions in 78 saphenous vein grafts were treated in 74 patients. The primary end point was major adverse cardiovascular events at 30 days. RESULTS: Device success was achieved in 92% of patients, and atheromatous debris was recovered in 69% of analyzed aspirates. By 30 days, major adverse cardiovascular events, which were limited to non-Q-wave myocardial infarctions, occurred in 16.2%. Per protocol analysis in patients with device success revealed a rate of adverse events of only 5.7%. CONCLUSIONS: The initial experience with the TriActiv Balloon Protected Flush Extraction System demonstrated a high success rate and recovery of embolic debris with an acceptable rate of adverse events. A large randomized trial will compare this device to other embolic protection systems.
