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Isolated Thrombolysis Using Trellis Device Safe and Efficacious for Treating Deep Vein Thrombosis: Presented at SIR

By Crina Frincu-Mallos, PhD

WASHINGTON, DC -- March 18, 2008 -- Deep vein thrombosis (DVT) treatment with the Trellis device breaks up a blood clot faster than using a drug alone, researchers reported here in a presentation March 16 at the Society of Interventional Radiology (SIR) 33rd Annual Scientific Meeting.

The Trellis-8 Peripheral Infusion System disperses a clot-lysis drug throughout the clot at 500 to 3000 rpm, allowing the drug to act much more quickly than the current catheter-directed thrombolysis (CDT) technique.

"Thrombolytic therapy for DVT should result in the immediate restoration of venous patency, inline flow, and the resolution of the patient's symptoms," said lead author Gerard J. O'Sullivan, MD, Interventional Radiologist, Section of Interventional Radiology, Department of Radiology, University College Hospital, Galway, Ireland.

Dr. O'Sullivan and colleagues from St. Joseph Hospital, Orange County, California, examined interventions in 827 limbs in 771 patients, performed using isolated thrombolysis technique with the Trellis device.

Data was collected on patients treated between February 2005 and February 2008 at 362 international sites. In terms of age, patients treated were 54 ± 30 years old, with equal numbers of males and females.

"The majority of patients treated (94.7%) had venous problems, and these are the types of patients the device is designed for," explained Dr. O'Sullivan.

In terms of the clinical presentation of the clot, 248 limbs (30%) had acute thrombus, and 360 (44%) were acute or chronic. In 78.8% of the patients, the thrombus was located in the iliac vein.

"The more acute the thrombus, the better results we get," said Dr. O'Sullivan. "The vast majority of cases were treated in less than 2 hours, with the Trellis-use time around 22 minutes."

Combined grade 2 and 3 lysis was achieved in 97% of the cases; venous patency was established in all cases.

"We have observed no bleeding at all -- the reason being that the balloon isolates the thrombolysis site; moreover, the remains of the thrombus are sucked up, so there is very little going [into the system]," noted Dr. O'Sullivan. There was no change in the fibrinogen levels, which are monitored throughout the process.

Adjunctive therapies were carried out in 76% of the patients, due to underlying chronic obstruction of the clot. A total of 351 patients were treated with percutaneous transluminal angioplasty (PTA) alone, 211 with PTA and stent, while 104 patients were treated using catheter-directed thrombolysis (CDT). Tissue plasminogen activator was the lytic delivered in 93% of cases.

Dr. O'Sullivan and colleagues suggested a randomised trial with long-term follow-up.

[Presentation title: An Endovascular Approach to Deep Venous Thrombosis Utilizing Isolated Thrombolysis and Adjunctive Measures. Abstract 4]

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