E-121 Single center experience with a novel FDA-approved percutaneous femoral artery closure device (CELT ACD®) in neurovascular procedures. (22nd July 2019) - Htun, W
Abstract : Purpose: Celt ACD® (Vasorum Ltd. Dublin, Ireland) is a unique percutaneously applied vascular closure device that achieves hemostasis through the delivery of a stainless steel (316 LVM) plug which is anchored on both sides of the arterial wall. The extendable wings of the implant provide an immediate vascular closure. We studied the safety and efficacy profile of the Celt in our neurodiagnostic and interventional cases. Patients and method: After obtaining a local IRB approval, Celt was used in all consecutive neurodiagnostic and interventional cases from 2018 to 2019. Patients presented with or without a systemic thrombolytic agent or a dual antiplatelet therapy. A 5, 6 and 7 F Celt system was available for closure. The 7 F device can be used for a femoral sheath size up to 9 F. Recorded data were analyzed for an immediate failure to close the access site, early or delayed migration of the implant, pain or delayed neuropathy, infection, early or delayed hematomas and other unforeseeable complications at the puncture site. Results: Celt was applied in 271 neuro-endovascular procedures in a total of 204 patients (M: F ratio 1.4: 1; age range 24 - 93 years). Majority of subjects (72%) presented either on systemic thrombolytic agents (tPA or Heparin) or were placed on a dual antiplatelet agent prior to the procedure. The closure device was used for a right femoral artery access in 76.4%, left femoral artery in 19.9%, right femoral vein in 1.48% and left femoral vein in 2.2% of the cases. The most common implant used was a 5 F system (55.7%), followed by a 6 F (26.19%) and a 7 F (18.08%) system. Three (1.4%) major complications and 18 (8.8)% minor complications were observed. We encountered in our early learning stage a failed attempted placement of Celt in one venous and one arterial access each (0.98%) that remained asymptomatic. In one of these cases the Celt implant was accidentally deployed without properly attaching to the arterial wall. The device was dislodged into the popliteal artery without any flow restriction and the patient remained asymptomatic. Other adverse events were a complete and symptomatic occlusion of right external iliac artery, 1 patient presented with a delayed peripheral neuropathy. No early or delayed hematomas were observed whenever a proper device placement was achieved. On follow-up angiograms, several months following the placement, Celt implants were found in 18 cases adjacent to the arterial wall within the soft tissue. The extravascular migration remained asymptomatic and has previously been observed with other closure devices and may be related to arterial pulsation. Conclusion: Based on our experience Celt is very easy to use and an exceptionally safe and effective percutaneous closure device. Disclosures: W. Htun: None. N. Patel: None. R. Rabinovich: None. S. Newman: None. A. Wakhloo: None.