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PACEMAKER: Spring 2006

Heart Health Pioneers

Michael Sondergard

Two men with blocked kidney arteries receive promising new stent filtering device

Ken Fogle says the decision was easy.

William Keettel found it much more difficult.

In the end, both men made the same decision and agreed to become the first patients in Iowa to undergo kidney artery stent placements using a new “filter” device to improve procedure results.

Fogel, from Hamilton, Illinois, and Keettel, from Iowa City, Iowa, have atherosclerotic renal artery stenosis (a narrowing or obstruction in the kidney arteries). While the condition is a treatable cause of high blood pressure, it creates a high risk of heart attack, stroke, heart failure, kidney failure, and death.

UI Heart and Vascular Center cardiologists believe a special miniature filter called AngioguardTM may help reduce the risks associated with renal artery stenting. Angioguard uses a tiny protective basket to catch particles of plaque released during the stenting procedure. Once the stent is implanted, the basket is collapsed and pulled back through the delivery catheter, thereby removing plaque from the body.

Renal artery stenting is a prime focus of the national Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study, which is funded by the National Institutes of Health. UI Hospitals and Clinics is the only center in Iowa enrolling patients in the clinical trial.

James Rossen, M.D., UI professor of internal medicine and a co-principal investigator of the UI portion of the study, says physicians have been trying to understand this disease for many years. Each treatment has positive and negative aspects.

“But as a whole, we don't know whether a stent or medication is better for the patient,” Rossen says. “This will be the definitive study for this disease.”

So far, the results are encouraging. Fogle and Keettel both underwent the procedure in October 2005, and both reported subsequent decreases in blood pressure.

“It’s been really good,” Fogle says. “I feel fantastic.”

Keettel says his blood pressure dropped 30 points.

“It was really quite incredible,” he says. “It’s made an enormous difference in how I feel. My wife says I have more spring in my step, that I’m a lot peppier.”

During the study, participants are randomized to one of two groups. One group will receive medication alone to control blood pressure and other risk factors. The other will be treated with medication and placement of a stent in the narrowed kidney artery.

Participants are being followed for the duration of the six-year study to determine which treatment better reduces the rate of heart attacks, heart failure, strokes, and kidney failure.

William Lawton, M.D., a hypertension specialist and co-principal investigator of the UI portion of the study with Rossen, says medication has historically been used to control high blood pressure and associated problems.

“With advances in technology, balloon angioplasty and stents—treatments used to open a narrowed artery—have been used increasingly, but without evidence that they reduce the risk of heart and kidney problems,” he says. “This study will examine whether inserting a stent, or metal scaffold, that props the artery open leads to better patient outcomes.”

About renal artery stenosis

Stenosis or narrowing of the renal (kidney) arteries is one of the major correctable causes of high blood pressure. In patients who have accelerated high blood pressure, the prevalence of stenosed renal arteries is much higher. Physicians have tried to identify patients who could benefit from intervention, but this remains a challenge as patients may have renal artery stenosis but another cause for hypertension or kidney dysfunction. Renal artery stenosis is more common in patients with atherosclerosis in other locations such as known carotid artery disease; coronary artery disease (such as angina pectoris, prior heart attack, or prior coronary artery stent or bypass surgery); or leg artery circulation problems.

How to join the study

For information about the CORAL study, call UI Heart and Vascular Center at 319-356-3413, or go online to www.coralclinicaltrial.org.

Pioneers

First in Iowa
UI Heart and Vascular Center cardiologist James Rossen, M.D. performed Iowa's first kidney artery stent placement using a new "filter" device to catch particles of plaque. Ken Fogle was one of the first patients to undergo the procedure.

Last modification date: Wed Apr 9 12:51:33 2008
URL: http://www.uihealthcare.com /news/pacemaker/2006/spring/hearthealthpioneers.html