Technical success and short-term results from mechanical thrombectomy for lower extremity iliofemoral deep vein thrombosis using a computer aided mechanical aspiration thrombectomy device

Abstract

Background: The symptoms of deep vein thrombosis (DVT) include severe pain and swelling, and the complications can include post-thrombotic syndrome and recurrent venous thromboembolism. Aspiration thrombectomy (AT) treats arterial and venous disease by removing acute thrombus without reliance on thrombolytic agents but also has the potential to remove fresh blood. Intelligent aspiration is designed to minimize blood loss during AT by aspirating continuously in the thrombus but only intermittently when in a patent vascular segment with active flow. The Indigo System with Lightning 12 intelligent aspiration (Penumbra, Inc, Alameda, Calif) uses an automatic valve controlled by a proprietary computer algorithm to optimize thrombus removal and minimize blood loss. This computer-aided mechanical AT (CMAT) system was used for 16 consecutive patients.

Methods: The present retrospective review included 16 patients who had undergone CMAT for iliofemoral acute DVT from July 2020 to June 2021. The primary outcome was >70% thrombus removal as determined by multiplanar venography. The secondary outcomes included single-session therapy, blood loss during aspiration, the need for postprocedure blood transfusion, thrombolytic use, symptom resolution before discharge, and periprocedural complications.

Results: Sixteen patients (mean age, 58.6 years; range, 31-80 years; 75.0% women) had undergone CMAT with the Lightning 12 system. All the patients had presented with pain and swelling of 2 to 16 days in duration. No patient had presented with phlegmasia. Access was obtained via the popliteal (n = 11), posterior tibial (n = 3), small saphenous (n = 1), or soleal (n = 1) vein. Thrombus reduction of ≥70% was achieved for all 16 patients (100%). Single-session therapy was successful for 15 patients (93.8%). Eight patients (50%) had received stents. All patients had experienced symptom resolution before discharge. The median blood loss was 155.0 mL (interquartile range, 95.0-187.5), and no patient had required a postprocedure transfusion. One patient had undergone angioplasty after thrombectomy, and one patient (6.2%) had received adjunctive tissue plasminogen activator therapy. No patient had developed postoperative acute kidney failure. No periprocedural complications occurred. At 1 to 8 months of follow-up, 15 of the 16 patients (93.8%) had patency of the treated iliofemoral area, and 14 (87.5%) had no recurrent symptoms.

Conclusions: These results suggest that CMAT using the Lightning 12 system is safe for clot removal for patients with acute iliofemoral DVT with a high rate of single-session technical success and symptom resolution. In the present case series, the Lightning 12 system was also associated with low blood loss, and no patient had required a blood transfusion.

Keywords: Aspiration thrombectomy; Catheter-directed thrombolysis; Lower extremity deep vein thrombosis; Venous thromboembolism.