BACKGROUND The use of pre-closure suture-based devices represents a widely access-site hemostasis technique in percutaneous transfemoral transcatheter-aortic-valvereplacement(TF-TAVR);yet this technique is associated ...BACKGROUND The use of pre-closure suture-based devices represents a widely access-site hemostasis technique in percutaneous transfemoral transcatheter-aortic-valvereplacement(TF-TAVR);yet this technique is associated with the risk of a device failure that may result in clinically relevant residual bleeding.Thus,a bailout intervention is needed.So far,the best management of pre-closure device failure has not been recognized.AIM To report the first clinical results obtained using a novel bailout hemostasis technique for patients with double suture-based vascular closure device failure in the setting of TF-TAVR.METHODS We developed a“pledget-assisted hemostasis”technique to manage residual access-site bleeding.This consists of the insertion of a surgical,non-absorbable,polytetrafluoroethylene pledget over the sutures of the two ProGlide(Abbott Vascular,CA,United States).The ProGlide’s knot-pushers are used to push down the pledget and the hand-made slipknot to seal the femoral artery leak.This technique was used as a bailout strategy in patients undergoing TF-TAVR with a systematic double pre-closure technique.Post-procedural access-site angiography was systematically performed.In-hospital complications were systematically detected and classified according to Valve Academic Research Consortium-2 criteria.RESULTS Out of 136 consecutive patients who underwent TF-TAVR,15 patients(mean age 80.0±7.2 years,66.7%female)with access-site bleeding after double pre-closure technique failure were treated by pledget-assisted hemostasis.In the majority of patients,16F sheath was used(n=12;80%).In 2 cases(13%),a peripheral balloon was also inflated in the iliac artery to limit blood loss during pledget preparation.Angiography-confirmed hemostasis(primary efficacy endpoint)was achieved in all patients.After the procedure,1 patient required blood transfusion(2 units),and no other bleeding or major ischemic complication was noticed.CONCLUSION The“pledget assisted hemostasis”might be considered as a possible bailout technique to treat patients with residual access site bleeding.Further studies are needed to compare this approach with other bail-out techniques.展开更多
文摘BACKGROUND The use of pre-closure suture-based devices represents a widely access-site hemostasis technique in percutaneous transfemoral transcatheter-aortic-valvereplacement(TF-TAVR);yet this technique is associated with the risk of a device failure that may result in clinically relevant residual bleeding.Thus,a bailout intervention is needed.So far,the best management of pre-closure device failure has not been recognized.AIM To report the first clinical results obtained using a novel bailout hemostasis technique for patients with double suture-based vascular closure device failure in the setting of TF-TAVR.METHODS We developed a“pledget-assisted hemostasis”technique to manage residual access-site bleeding.This consists of the insertion of a surgical,non-absorbable,polytetrafluoroethylene pledget over the sutures of the two ProGlide(Abbott Vascular,CA,United States).The ProGlide’s knot-pushers are used to push down the pledget and the hand-made slipknot to seal the femoral artery leak.This technique was used as a bailout strategy in patients undergoing TF-TAVR with a systematic double pre-closure technique.Post-procedural access-site angiography was systematically performed.In-hospital complications were systematically detected and classified according to Valve Academic Research Consortium-2 criteria.RESULTS Out of 136 consecutive patients who underwent TF-TAVR,15 patients(mean age 80.0±7.2 years,66.7%female)with access-site bleeding after double pre-closure technique failure were treated by pledget-assisted hemostasis.In the majority of patients,16F sheath was used(n=12;80%).In 2 cases(13%),a peripheral balloon was also inflated in the iliac artery to limit blood loss during pledget preparation.Angiography-confirmed hemostasis(primary efficacy endpoint)was achieved in all patients.After the procedure,1 patient required blood transfusion(2 units),and no other bleeding or major ischemic complication was noticed.CONCLUSION The“pledget assisted hemostasis”might be considered as a possible bailout technique to treat patients with residual access site bleeding.Further studies are needed to compare this approach with other bail-out techniques.
