Date: 5/5/2011

Patients have Access to National Heart Trial

Merrillville resident Shirley Isolampi is recovering quickly after a minimally invasive procedure to clear a coronary artery blockage.

Cardiologists at Community Hospital are first in northwest Indiana to offer patients access to a national clinical trial of a device that targets calcified coronary artery plaque buildup. Called the ORBIT II Trial, researchers will study the effectiveness and safety involved with the use of Diamondback 360º System in treating blocked coronary arteries.

Community Hospital in Munster also was first in Indiana to use the Diamondback 360º™ Orbital Atherectomy System in the treatment of peripheral arterial disease or PAD. Physicians use the device to “sand away” hardened plaque - a calcified material that builds up on the inside walls of blood vessels - in a minimally-invasive procedure to treat blocked arteries in the lower limbs or peripherals (PAD), enabling patients to walk without pain.

The ORBIT II Trial will help to determine whether the Diamondback device is a safe and effective treatment option for patients with coronary artery disease (CAD). CAD is the most common form of heart disease in the United States, affecting more than 16 million people. CAD accounts for more deaths than any other major cause of death in the U.S., claiming more lives than cancer, chronic lower respiratory diseases and accidents combined.

ORBIT II Trial principal investigator and cardiologist Arvind Gandhi, M.D. says angioplasty and stenting can become more complicated and difficult with the other devices and techniques currently available for calcification in the coronary arteries.

“Use of the Diamondback 360º is a minimally invasive procedure that may save time and reduce the patient’s risk for complications in comparison to bypass graft surgery,” Gandhi said. “The study will help us determine if the Diamondback 360º will become the treatment of choice when unblocking calcified coronary arteries.”

“I’m so thankful to Dr. Gandhi and glad I was able to be proactive and take care of the blockage before I suffered a heart attack or worse,” said heart patient Shirley Isolampi of Merrillville, who was the first patient to be enrolled in the study. “I said, ‘Let’s git ‘er done!’ like the cable guy says. I have a family history of heart disease, so I felt a need to stay close to my situation.”

I’m thankful that this new procedure was available to me, Isolampi said. The Diamondback grinds down the calcium built up and it evaporates and exits the body through the bloodstream. I’m very pleased with the results and Dr. Gandhi said he was too.

CAD is treated with coronary artery bypass graft (CABG) surgery in more than 400,000 people each year in the U.S. In this open chest surgery, a segment of a healthy blood vessel from another part of the body is used to make a detour around the blocked part of the coronary artery. Hospital stays last 4 to 6 days or longer.

Minimally invasive treatment with percutaneous coronary intervention (PCI) accounts for more than 1,300,000 procedures each year. PCI is a procedure in which a catheter is threaded through the blood vessels and is used to deliver a device to the heart to treat the artery blockage. Patients can frequently return home the same day as the PCI procedure or may need to stay in the hospital overnight. The most common PCI treatments are:

Balloon Angioplasty: a tiny balloon on the tip of a catheter is inserted into the artery blockage and inflated, pressing the plaque of the blockage against the artery wall and opening up the artery.

Stenting: a wire mesh tube is inserted and expanded within the blockage to keep the vessel open.

Atherectomy (including Diamondback 360º): uses a small, diamond-coated crown designed to sand away hardened plaque without damaging the good arterial tissue.

Once underway, Isolampi says she was awake and watched almost everything. Dr. Gandhi placed a stent after using Diamondback 360º to clear the calcium deposits in my coronary artery, she said. I didn’t feel a thing and everyone made me feel comfortable — no anxiety or anxiousness.

“Community Hospital nurses are wonderful and provided very, very good care and follow up,” Isolampi said. “We’re lucky to have the excellent care available at Community Hospital so close to home. It is a top-notch hospital.”

For more information about the cardiovascular programs and services available at Community Hospital in Munster, visit our web site at