Successful iliac vein and inferior vena cava stenting ameliorates venous claudication and improves venous outflow, calf muscle pump function, and clinical status in post-thrombotic syndrome

Abstract

Objectives: Stent therapy has been proposed as an effective treatment of chronic iliofemoral (I-F) and inferior vena cava (IVC) thrombosis. The purpose of this study was to determine the effects of technically successful stenting in consecutive patients with advanced CVD (CEAP3-6 +/- venous claudication) for chronic obliteration of the I-F (+/-IVC) trunks, on the venous hemodynamics of the limb, the walking capacity, and the clinical status of CVD. These patients had previously failed to improve with conservative treatment entailing compression and/or wound care for at least 12 months.

Methods: The presence of venous claudication was assessed by > or =3 independent examiners. The CEAP clinical classification was used to determine the severity of CVD. Outflow obstruction [Outflow Fraction at 1- and 4-second (OF1 and OF4) in %], venous reflux [Venous Filling Index (VFI) in mL/100 mL/s], calf muscle pump function [Ejection Fraction (EF) in %] and hypertension [Residual Venous Fraction (RVF) in %], were examined before and after successful venous stenting in 16 patients (23 limbs), 6 females, 10 males, median age 42 years; range, 31-77 yearas, left/right limbs 14/9, using strain gauge plethysmography; 7/16 of these had thrombosis extending to the IVC. Contralateral limbs to those stented without prior I-F +/- IVC thrombosis, nor infrainguinal clots on duplex, were used as control limbs (n = 9). Excluded were patients with stent occlusion or stenoses, peripheral arterial disease (ABI <1.0), symptomatic cardiac disease, unrelated causes of walking impairment, and malignancy. Preinterventional data (< or =30 days) were compared with those after endovascular therapy (8.4 months; interquartile range [IQR], 3-11.8 months). Nonparametric analysis was applied.

Results: Compared with the control group, limbs with I-F +/- IVC thrombosis before stenting had reduced venous outflow (OF4) and calf muscle pump function (EF), worse CEAP clinical class, and increased RVF (all, P < 0.05). At 8.4 months (IQR, 3-11.8 months) after successful I-F (+/-IVC) stenting, venous outflow (OF1, OF4) and calf muscle pump function (EF) had both improved (P < 0.001) and the RVF had decreased (P < 0.001), at the expense of venous reflux, which had increased further (increase of median VFI by 24%; P = 0.002); the CEAP status had also improved (P < 0.05) from a median class C3 (range, C3-C6; IQR, C3-C5) [distribution, C6: 6; C4: 4; C3: 13] before intervention to C2 (range, C2-C6; IQR, C2-C4.5) [distribution, C6: 1; C5: 5; C4: 4; C2: 13] after intervention. At this follow up (8.4 months median), venous outflow (OF1, OF4), calf muscle pump function (EF), and RVF of the stented limbs did not differ significantly from those of the control; significantly worse (P < 0.025) were the amount of venous reflux (VFI), and the CEAP clinical class, despite the improvement with stenting. Incapacitating venous claudication noted in 62.5% (10 of 16, 95% CI, 35.8%-89.1%) of patients (15 of 23 limbs; 65.2%, 95% CI, 44.2%-86.3%) before stenting was eliminated in all after stenting (P < 0.001).

Conclusions: Successful I-F (+/-IVC) stenting in limbs with venous outflow obstruction and complicated CVD (C3-C6) ameliorates venous claudication, normalizes outflow, and enhances calf muscle pump function, compounded by a significant clinical improvement of CVD. The significant increase in the amount of venous reflux of the stented limbs indicates that elastic or inelastic compression support of the successfully stented limbs would be pivotal in preventing disease progression.

FIGURE 1. A, Ultrasound guided access to the femoral vein just below its confluence with the profunda femoris vein. Post-thrombotic changes in the common femoral vein (arrow), occlusion of external and common iliac veins (two arrow heads), and large collaterals via the internal iliac vein are noted. B, A stiff angled glide wire (Terumo Medical Corporation, Somerset, NJ) and the introducer are in place. C, Three 14-mm-wide (one ×60 mm, one ×40 mm long) Smart stents (Cordis Corporation, Miami, FL) have been deployed from the bifurcation of the inferior vena cava to the mid common femoral vein. The common and external iliac veins and the common femoral vein have been predilated with a 14 mm × 4 cm high-pressure balloon. Stents also dilated postdeployment with the same balloon. The upper stent-end just enters the IVC but does not override the opposite side (arrow). D, Completion venography performed from the sheath just below the stented area. Pressure measurements revealed no gradient between the inferior vena cava and the common femoral vein. Note the short distance from the distal end of the stent (arrow) to the entry point of the introducer (arrow).

FIGURE 2. Anatomic location and extent of iliofemoral (±inferior vena cava) venous stenting, and type of stents (Gianturco, Smart, Wallstent) used in the recanalization of chronic thrombosis. Stenting extended to the veins listed and included the intervening venous segments. IVC, inferior vena cava; CIV, common iliac vein; EIV, external iliac vein; CFV, common femoral vein

FIGURE 3. Venous hemodynamics, including venous outflow (outflow fraction at 1 and 4 seconds; A, B), calf muscle pump function (ejection fraction; C), amount of venous reflux (venous filling index; D) and venous hypertension (residual volume fraction; E), and the CEAP clinical class (F) in 23 limbs with chronic iliofemoral (I-F) ± inferior vena cava (IVC) thrombosis (DVT) and 9 control limbs, before (≤30 days) and after (median, 8.4; interquartile range, 3–11.8 months) successful I-F (±IVC) venous stenting. Data are median and interquartile range.