The Effect of Balloon-Assisted Pharmacomechanical Catheter-Directed Thrombolysis on the Patency and Post-Thrombotic Syndrome in Patients with Acute Iliofemoral Deep Vein Thrombosis: is It Really Necessary or Not?

Background: The objective of this study was to describe the contribution and advantage of balloon-dilatation of iliac and femoral veins following pharmacomechanical catheter-directed thrombolysis (PCDT) on the development of post-thrombotic syndrome (PTS). Methods: From October 2018 and January 2022, 85 patients with acute total occlusion of the iliac and femoral veins were treated with PCDT. The cohort was divided into 2 groups depending on the utilization of concomitant balloon dilatation of iliac and femoral veins (Group 1, n = 34, 40.0%) or not (Group 2, n = 51, 60.0%) during the PCDT. All patients underwent duplex ultra-sound scanning for evaluating the patency of iliac veins and recanalization rates at 3, 6, and 12 months postoperatively. The Villalta score was used to score the severity of PTS at 12 months postoperatively. Results: Patients who underwent balloon-assisted PCDT (group 1) exhibited significantly higher primary patency rates in common iliac vein (CIV) (recanalization 84.3 +/- 14.6%, P = 0.003), external iliac vein (EIV) (recanalization 82.8 +/- 17.2, P = 0.003) and common femoral vein (CFV) (recanalization 88.1 +/- 12.1%, P = 0.038) compared with the group 2 at the end of 12 months follow-up. Only 2 patients underwent venous stenting in follow-up due to severe venous claudication, however, 13 patients were required iliac vein stenting due to severe PTS proved with a high Villalta score at 12-month follow-up. The d-dimer level at 1-year follow-up had also significantly lower in Group 1 due to higher rates of patency and lower thrombosis burden. The most common bleeding events were hematuria (n = 4) or oozing in the puncture site (n = 4). Conclusions: This study showed that balloon-assisted PCDT reduces the risk of PTS, is more successful in common iliac vein recanalization, reduces the need for the venous stent, and even lowers the D-dimer levels of the patients compared to routine PCDT alone.