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Soluble stents may offer alternative to bypass surgery

At work: A student at the Advanced Experimental Thermofluid Engineering Research Lab at Virginia Tech, where researchers are working to design stents that are more compatible with the body

Aruna Harjani (The Jakarta Post)
Jakarta
Wed, January 7, 2015

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Soluble stents may offer alternative to bypass surgery

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span class="inline inline-center">At work: A student at the Advanced Experimental Thermofluid Engineering Research Lab at Virginia Tech, where researchers are working to design stents that are more compatible with the body. US CDC/Virginia Tech

A buffed gym fanatic '€” was wheeled into the intensive care unit at a hospital in India. The 26-year-old man was brought in by ambulance because of massive chest pains, says Shahid A. Merchant, the cardiologist called in to consult.

Tests showed the main arteries were 95 percent blocked from smoking and overexertion. In what he says was a first, Merchant used a non-surgical solution '€” a bio-degradable, soluble scaffold '€” on a 26-year-old '€” saving the man from incision bypass surgery.

'€œWhat I have realized then heart disease is a problem in the Asian community particularly in this part of the world,'€ Merchant, who practices in India, said recently at the Asia-Pacific Cardiology conference in Jakarta. '€œGenetically we are predisposed to the blockage of the heart arteries and a high incidence of diabetes, high cholesterol, high blood pressure due to greasy, salty, fatty food, and obesity.'€

Patients might develop cardiac blockages for a variety of reasons: heart attacks, high cholesterol, high blood pressure or diabetes.

Usually, blockages below 70 percent are treated with medication and lifestyle changes; while more severe cases can be treated mechanically, by non-surgical techniques like angioplasty, or by insertion of metal stents, which remain in the body.

'€œThe only issue with the metal stents is that they stay in your body all your life, with the help of blood thinner medications like aspirin and Plavix,'€ Merchant said.

Courtesy Cordis Johnson and Johnson Medical.
Courtesy Cordis Johnson and Johnson Medical.

The surgeon said that he wanted a simpler solution than metal stents, which are useful only for a year. He worked with a pharmaceutical company to design stents that would dissolve over time.

Merchant started researching non-surgical techniques in French and American laboratories in 1988.

'€œFor 11 years, I experimented on animals. I am an innovator and developer for this technology, which has only been known to the world in 1999'€.

Approval to use soluble scaffolds or stents was given in 2013.

'€œFor 25 years, I have been working on research on how to treat heart disease without an open heart surgery. I innovated the technique by using medicated stents, made of Cobalt chromium and which has a polymer and a drug,'€ he says.

Merchant describes how a soluble scaffold is used. '€œA critical blockage is opened up with a balloon. A stent is mounted on the balloon, which is inflated at high pressure so the stent gets embedded on the arterial wall. Once the medicated stent is attached on the arterial wall, the balloon is deflated and removed so the stent will remain in its place and with the medication, the blockage will open up'€.

The stent melts after a year and the normal lining of the heart develops normal collagen and smooth muscle '€œas if God has given a new piece of coronary artery'€, Merchant said, adding that the success rate of soluble stents has been 98 percent, he says.

Patient who undergo the treatment can stop taking the blood thinner tablets after a year.

Merchant uses an IVUS system '€” a catheter with a camera '€” to check inside a patient'€™s heart before inserting the stents.

A soluble stent is 60 microns thick, as compared to the 40 microns of a metal stent. '€œYou need to be an expert to use a 60-micron soluble stent,'€ Merchant says. A surgeon has to handle 20,000 cases before he is allowed to use the soluble stent, he adds.

Currently, only surgeons in a few cities such as London, Mumbai, New York and Tokyo have adapted the technique.

The advantages of soluble stents over cardiac bypass surgery is that there are no incisions and no need for general anesthesia or blood transfusions. Only an overnight hospital stay is required and patients can watch the procedure on screen.

'€œBlockages actually start from two years of age,'€ Merchant says. '€œAs the years go by it increases depending on the lifestyle'€.

Old-school: A traditional non-soluble stent. AP
Old-school: A traditional non-soluble stent. AP

According to Surya Dharma, a cardiologist practicing at Mitra Kelapa Gading Hospital, doctors here have started using ABSORB II technology, which he says is the same product as a soluble stent and has the same features and functions.

'€œThere is nothing new about the technology, since it has been discovered a few years ago. We have used the stents in hundreds of patients at Harapan Kita,'€ Surya said.

Another cardiologist, Doni Ferman from Harapan Kita Hospital'€™s National Cardiovascular Center, echoed Surya.

'€œYes, we have been using absorbable stents for two years,'€ Doni said. '€œWe'€™re using these stents for coronary intervention, not for peripheral intervention, he said, referring to arteries in the body, leg, kidney or brain.

However, Doni was cautious. '€œI believe it'€™s too premature to say this stent can replace bypass surgery because we need much more data to answer that opinion'€.

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