Pledget-assisted hemostasis to fix residual access-site bleedings after double pre-closure technique

BACKGROUND: The use of pre-closure suture-based devices represents a widely access-site hemostasis technique in percutaneous transfemoral transcatheter-aortic-valve-replacement (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.