Dr. Jimenez's 2021 publication

Adjunctive techniques to minimize thrombotic complications following treatment with Varithena of truncal and tributary veins¹

Objective

To assess the effect of intraoperative improved techniques during treatment for patients with symptomatic varicose veins and their impact on extension of thrombus into deep veins.

Patients

(n= 99; single center)

Symptomatic varicose veins patients (C2-C6) associated with either saphenofemoral or saphenopopliteal vein reflux
129 limbs in 99 patients were treated
Veins treated included: great saphenous vein (n=89), anterior accessory saphenous vein (n=15), small saphenous vein (n=14), and tributary veins (n=56)

Methods

Retrospective review between April 2018 and August 2020

The following adjunctive techniques were performed when delivering treatment:

Preoperative duplex ultrasound at the time of operation. Large perforator veins were localized and mapped before injection of microfoam
Limb elevation to greater than 45°
Injection of 10 mL of sterile saline before microfoam infusion to displace blood from the vein
Attempted limitation of microfoam volume to 5 mL or less (if possible). The mean volume of microfoam used per session was 7.6 ± 3.3 mL
Compression of the axial vein 5 cm caudal to the saphenofemoral or saphenopopliteal junctions and compression of perforator veins during microfoam injection
Dorsiflexion and plantar flexion of the ipsilateral foot and ankle for 20 repetitions after microfoam injection

Key results

Immediate closure rate was 95% with 81% overall symptomatic relief at last follow-up
– The mean follow up was 113.5 days for the entire patient population
Two limbs (1.5%) required postoperative anticoagulation for thrombus extension into the deep venous system (common femoral vein n=1, popliteal vein n=1) postoperatively. Both resolved with anticoagulation
One asymptomatic limb developed a femoral vein deep venous thrombosis (DVT) and resolved following 3 months of anticoagulation
One symptomatic late DVT was noted 4 months post-procedure*
No pulmonary emboli were noted, and no neurologic or visual adverse events were reported

Conclusion

The rate of non-occlusive extension of thrombus into the deep system following treatment was 1.5%, markedly lower than incidence in thermal ablation reported in current peer reviewed literature
With the use of these adjunctive techniques, this study demonstrated minimal deep venous thrombotic adverse events following microfoam ablation and lower ATE’s than reported in early Phase III clinical trials

Comparison of Adverse Thrombotic Events (ATE’s) Across Studies

Study	Common femoral or popliteal extension	Other deep venous thrombosis	% of total ATE's in study	Symptomatic	Patients with ATE's anticoagulated
VANISH-1²	5.5%	3.3%	8.8%	22%	Not stated
VANISH-2³	3.9%	6.6%	10.5%	33%	50%
Jimenez, et al	1.5%	1.5%	3.0%	0.78%	100%

Study limitations

Non-randomized, retrospective review

Short period of follow up

References

* Femoropopliteal DVT occurred 4 months after microfoam injection following a long-haul airplane flight. She was later found to be heterozygous for Factor V Leiden.

1. Jimenez JC, et al. Adjunctive techniques to minimize thrombotic complications following microfoam sclerotherapy of saphenous trunks and tributaries. J Vasc Surg Venous Lymphat Disord. 2021 Jul;9(4):904-909. Epub 2020 Nov 26. PMID: 33248297.
2. King JT, O’Byrne M, Vasquez M, Wright D; VANISH-1 Investigator Group. Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance. Eur J Vasc Endovasc Surg. 2015 Dec;50(6):784-93. Epub 2015 Sep 16. PMID: 26384639.
3. Todd KL 3rd, Wright DI; VANISH-2 Investigator Group. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence. Phlebology. 2014 Oct;29(9):608-18. Epub 2013 Jul 17. PMID: 23864535.