Stenting of Obstructions Effective in Treating Deep Venous Reflux

[okarol]

Stenting of Obstructions Effective in Treating Deep Venous Reflux
         
Key Points:

    * Stenting obstructions in deep reflux disease improves symptoms
    * Treatment directed at reflux itself not necessary
    * Stenting recommended as primary therapy for deep venous reflux

By Alison Palkhivala
Tuesday, December 22, 2009

Stenting to treat obstructions in patients with chronic venous insufficiency (CVI) dramatically reduces the symptoms of deep reflux disease, even though the reflux itself remains untreated, according to research published December 14, 2009, ahead of print in the Journal of Vascular Surgery.

Seshadri Raju, MD, from the University of Mississippi Medical Center (Flowood, MS) and colleagues treated venous obstructions in 528 limbs with chronic deep reflux in 504 patients using intravascular ultrasound (IVUS)-guided iliac vein stent placement. The limb obstructions consisted of deep venous reflux alone (n = 172) or in combination with untreated superficial or perforator reflux (n = 356). Iliac vein stenting was the sole corrective procedure performed.

Retrospective Analysis

At 30 days, there was no mortality, and morbidity was minor. At 5-year follow-up, cumulative secondary stent patency was 88%. Just over half of the treated limbs had healed active ulcers and substantial improvements in swelling. Over three-quarters of the limbs were free from ulcer recurrence and dermatitis and patients reported substantial reductions in pain (table 1). Quality of life was significantly improved, and reflux parameters did not deteriorate after stenting.

Table 1. Five-Year Outcomes of Symptoms of Reflux Following Stenting

Outcome
   

Cumulative Rate

Limbs with healed active ulcers
   

54%

Freedom of ulcer recurrence in legs with healed ulcers
   

88%

Freedom for leg dermatitis
   

81%

Substantial improvement in pain
   

78%

Substantial improvement in swelling
   

55%

Outcomes Were a Surprise

"Traditionally, the treatment of patients with chronic venous disease is to correct reflux," Dr. Raju told TCTMD in a telephone interview. "In superficial veins, reflux is easy to correct, but correction of deep reflux has always been very difficult. It requires open surgery.”

Dr. Raju explained that his group started using stents in some of these patients “because we know in addition to reflux there’s an obstructive component. Our idea was that we would correct the obstruction [with a stent], and then we’d come back and correct the reflux to get better correction of the pathology. … To our surprise, many of these patients got nearly total symptom relief [with stenting alone], so it was not necessary to correct the reflux.”

According to Dr. Raju, his team uses Wallstents (Boston Scientific, Natick, MA), which are approved by the FDA for numerous indications, including, venous stenting in hemodialysis patients. “They have an astonishing patency in primary disease – better than 99%.,” he said. “It is somewhat less in post-thrombotic cases but even then [it is very good]. Stents seem to do so much better in the venous system compared to the arterial system. You don’t get as much instant restenosis, the patency rate is higher, [and] complications appear to be milder."

New Treatment Paradigm

“Our treatment paradigm has changed,” said Dr. Raju. "Putting in a stent is simpler and easier than open surgery. So, it’s what we do. Reflux open surgery has pretty much gone out as a treatment option in our center because the results of stenting are so good."

William A. Gray, MD, of Columbia University Medical Center (New York, NY) told TCTMD in an e-mail communication that this study is important because previously, "it was not clear that there was this degree of iliac vein disease contributing to deep venous reflux, and that it could be addressed so effectively with endovascular therapy." He agreed that stenting should become the primary treatment for deep reflux disease, "assuming that these results can be replicated in a broader experience (i.e., in multiple centers with multiple operators). For patients with deep venous reflux identified in the lower extremities, a determination of iliac venous issues should be undertaken, since there appears to be a probable effective treatment."

Study Details

Patients ranged in age from 15 to 87. Procedures took place over an 11-year period. Obstruction was ultimately diagnosed by IVUS, as venography and other functional tests had poor diagnostic sensitivity to detect obstruction. The etiology of the obstruction was nonthrombotic in 37% of limbs, post-thrombotic in 54%, and combined in 9%.

Deep venous reflux was present in all limbs and was associated with superficial and/or perforator reflux in 69%. In 59% of limbs, reflux was severe, with a reflux multisegment score of 3 or greater, and 42% of limbs had axial reflux.

Source:

   1.  Raju S, Darcey R, Neglén P. Unexpected major role for venous stenting in deep reflux disease. J Vasc Surg. 2009;Epub ahead of print.

Disclosures:

    * Drs. Raju and Gray report no relevant conflicts of interest.

http://www.tctmd.com/show.aspx?id=88132