Pilot study demonstrates new device is effective in preventing blockages in older bypassed veins during angioplasty

November 14, 2001

A pilot study undertaken by cardiologists at Thomas Jefferson University Hospital, Philadelphia, and four other hospitals nationwide, shows that a novel self-expanding cylindrical filter used during angioplasty helps to eliminate floating pieces of plaque during stent placement in vein bypasses.

The procedure offers hope for people whose bypassed vein grafts are more than five years old (considered aged vein grafts) and have an extensive buildup of plaque. "In many of these individuals, the plaque becomes dislodged during the stent procedure and crumbles into small pieces," said Michael Savage, M.D., associate professor of Medicine, Jefferson Medical College of Thomas Jefferson University.

"Plaque fragments are carried by blood flow down the vein and can close the artery downstream. As a result, these patients may suffer a heart attack during angioplasty." Dr. Savage is also director, Cardiac Catheterization Laboratory at Thomas Jefferson University Hospital, one of the hospitals participating in the study.

Known as the CAPTIVE Feasibility Study, the results will be presented Wednesday, Nov. 14, at the American Heart Association's Scientific Sessions 2001 conference in Anaheim.

The CAPTIVE Feasibility Study involved 29 patients from five hospitals who were candidates for angioplasty in a bypassed vein and underwent the procedure using a self-expanding filter, the MedNova Cardioshield. In addition to Thomas Jefferson University Hospital, the hospitals taking part in the study were Lenox Hill Hospital in New York City; Mayo Clinic, Rochester, Minn.; North Ohio Heart Center, Elyria, Ohio; and Emory University Hospital, Atlanta.

The cardioshield filter is contained on a thin guidewire and is delivered into a vein covered by a thin sheath during the angioplasty procedure. When the sheath is pulled back, the filter pops open (similar to the concept of a paper umbrella). There are tiny holes at the lower end of the filter which serve to permit continuous blood flow. The filter travels down the vein collecting microscopic pieces of plaque that were dislodged during the stent placement. When the plaque is collected, a slightly larger retrieval catheter is delivered into the vein to cover the basket filter and take the filter out.

Of the 29 high risk patients who participated in the pilot study, whose ages ranged from 44 to 88, 26 were men and three were women. There was plaque material retrieved in 77 percent of the patients. The device worked as designed and was delivered, deployed and retrieved in all 29 patients without incident.

As a next step, Dr. Savage said: "Given the relatively low complication rates observed in this high-risk population, a prospective randomized trial is warranted to establish the clinical efficacy of this device." MedNova is located in Galway, Ireland.

For information about treatment for cardiac disease including coronary interventional procedures or to make an appointment with a Jefferson cardiologist, call 1-800-JEFF-NOW.
Contact: Nan Myers or Phyllis Fisher at 215-955-6300. After Hours: 215-955-6060. E-mail: nan.myers@mail.tju.edu

Editors: This information is embargoed for release Nov. 14, 2001 at 8 p.m. ET (5 p.m. PT) at the American Heart Association's Scientific Sessions 2001 conference in Anaheim.

Thomas Jefferson University

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