Deep vein thrombosis treatment (DVT) with Trellis-8 Infusion System breaks up thrombosis in most patients much quicker than using a drug alone, according to a study published in the March issue of the Journal of Vascular and Interventional Radiology, and presented at the Society of Interventional Radiology's annual meeting this week in Washington, D.C.
Using imaging, the Trellis device, developed by Bacchus Vascular of Santa Clara, Calif., combines the use of clot-busting drugs with a drug dispersion device to break up the clot, providing interventional radiologists with physical assistance to break up the clot faster. Because the device disperses the drug throughout the clot, it allows the clot-dissolving drug to work much more quickly—and often less drug is used, which may lead to a decrease in the risk of bleeding, according to the researchers.
A registry of 532 patients with upper and lower extremity DVT was examined. Of 565 limbs treated, the vein was reopened in all cases, and the treatment worked on acute or chronic clots. Sixty-eight percent of the patients’ thrombi were in the iliac vein, 19 percent in the smaller femoropoliteal veins, and 13 percent in the subclavian vein.
According to a clinical series derived from registry data, thrombus was acute in 28 percent, acute on chronic in 44 percent, 11 percent subacute, 12 percent subacute on chronic and chronic in 6 percent, per the SIR clot-age classification guidelines. Combined Grades II and III lysis ( > 50 to 100 percent thrombus removal) were established in 96.8 percent of acute onset of symptoms, 93.6 percent in acute on chronic, 96.7 percent in subacute, 89.2 percent in subacute on chronic and 90.9 percent with chronic onset of symptoms, with venous patency achieved in all cases.
The researchers reported there were no adverse events in the acute procedural follow-up period. Venous angioplasty, and/or stenting, was also used in the study in conjunction with the Trellis procedure to treat underlying problems depending on individual patient needs, such as a narrow area in the vein that would make a person susceptible to future clots.
“It [Trellis] gets the clot out right away, restoring blood flow in the vein while the patient’s blood becomes sufficiently thinned by anticoagulation medication to prevent blood clots in the future. Patients experience dramatic relief of pain, swelling and skin discoloration in just a few hours,” said Gerard J. O’Sullivan, MD, interventional radiologist. Presently, this is the largest commercial data registry by a manufacturer to assess the effectiveness and safety of this type of treatment for DVT, he said.
“This is a very significant advance in DVT treatment, which hasn’t changed in more than 40 years,” added O’Sullivan. “With the aid of the Trellis device, this interventional radiology procedure could really change the way DVT patients are treated and should become a standard of care,” he said.
“All acute DVT patients should be sent to the interventional radiology department for a consult. We can help their physicians determine the best course of action. If the vein is completely or severely blocked, immediate treatment is needed. Not all partial clots will require treatment, but if the area is still swollen after five to seven days, patients should ask for an appointment with an interventional physician at the hospital,” O’Sullivan said.