Promising Foam Treatment

Preliminary results from a phase II trial showed that select patients treated for varicose veins with a new type of injectable foam have had no visual, cardiac, or neurological side effects. Sclerosant foams have been in use for 11 years now for the treatment of spider and small varicose veins. The foams are made by combining an irritant or sclerosant with air. The irritant causes the wall of the vein to scar, preventing what is known as reflux.

Feeling No Pain

The newest foam, made with carbon dioxide, is called Varisolve®, and is considered an innovation since it doesn't cause burning or pain, as do other sclerosants.

Leg veins contain valves designed to keep blood from flowing backward as it reenters the heart. When varicose veins are formed due to weakened valves, especially in the great saphenous vein (GSV), the one that travels up the inside of the leg, they cause this backward flow which then causes blood to collect within the veins of the leg. This backward flow then causes pressure to be exerted on the veins, making them swell and twist.

Less Invasive

The newest technique for treating this phenomenon involves blocking the GSV, which helps to avoid this backflow, also known as reflux. Of these blocking techniques, Varisolve foam injection offers a less invasive option as opposed to surgery or intravenous procedures that employ lasers or radiofrequency ablation.

In theory, air-based foams carry a risk to patients because the air is not soluble within the blood. However, the author of the trial, John D. Regan, M.D., clinical director of the Interventional Section in the Department of Radiology at Wake Forest University Baptist Medical Center, believes the risk is infinitesimal, since the main component of Varisolve, carbon-dioxide, creates smaller bubbles and greater solubility.

Those patients with a right-to-left heart shunt, a common defect occurring in about 1/4 of the population, have a higher risk of having foam bubbles enter the shunt and travel to the brain or heart without first having been filtered through the lungs. These were the chosen participants in this trial and they are given continuous transcranial Doppler ultrasound monitoring of their brains from prior to the procedure all the way through to the post-procedure stage. Magnetic resonance imaging (MRI) of the brain is also administered as were vision tests, neurological exams, and blood tests that monitor cardiac changes.

A tiny catheter is placed in the GSV and the Varisolve foam is then injected into the vein. Pressure is place on the vein in the groin area to help keep the foam within the leg. Then more foam is injected, a compression dressing and stocking placed on the patient's leg, and presto: the patient can get up and walk right away.

While 90% of the 28 patients treated developed tiny bubbles in their blood, there were no signs that this in any way impaired the health of the participants. The study will be continued until 50 patients have undergone the treatment and been assessed.