National Post (Latest Edition)

The latest surgical fix for broken hearts.

Tom Blackwell on the new procedure replacing ‘big surgeon, big knife, big operation.’

- BY TOM BLACKWELL

When Hendricus Janssen arrived at the Ottawa Heart Institute, the retired blacksmith was so hobbled by a potentiall­y fatal narrowing of his heart’s aortic valve, he could barely walk 10 paces.

What was worse, the quadruple bypass he had undergone years earlier, his advanced age and other factors made the convention­al treatment — an openheart operation to replace the defective valve — too risky. Until recently, such patients would be left to die a rather miserable death.

Instead, Mr. Janssen was given an experiment­al new procedure that replaces the trauma of major, open-heart surgery with the keyhole insertion of a tiny device, part synthetic and part pig tissue. Within a day or so of getting out of hospital, he was cutting his lawn, trimming the cedar hedges around his suburban Ottawa house and using an acetylene torch to fashion wrought-iron railings.

“I couldn’t do anything [before]. All I could do was lie on the bed,” said the now-chipper 82-year-old. “I improved 100% ... I can walk up and down the stairs and I don’t have any pain or tightness in my chest.”

The new procedure is just the latest advance for such minimally invasive surgery in the delicate arena of treating malfunctio­ning hearts. What one doctor calls a revolution in care is making the convention­al but invasive practice of slicing open a patient’s chest, cracking the rib cage and taking a scalpel to the organ seem almost antiquated.

“In the 1980s and 1970s, hospitals made their reputation­s on ‘big surgeon, big knife, big operation,’ ” said Dr. Eric Horlick, an interventi­onal cardiologi­st at Toronto General Hospital. “Now the trend has totally swung the other way: How small a hole can we do this through? How little morbidity can we cause the patient and have it be successful? How quickly can we get someone to recover?”

Treating cardiac illness endovascul­arly — by threading a catheter into a small incision in the groin and through blood vessels to the heart — is not completely new. It has been used for a couple of decades to inflate miniature balloons or install metal devices called stents to open up plaqueclog­ged arteries, an alternativ­e to bypass operations.

In the past few years, however, a growing number of specialist­s have started applying a similar approach to more complex repairs of “structural” heart problems, faulty valves like Mr. Janssen’s or in people born with congenital defects.

Taking as little as 45 minutes — versus open-heart operations that can last hours — they lessen the chance of infection, can see patients leave hospital the next day and sometimes cut weeks off total recovery time. Plus, squeamish patients seem to love the idea, doctors say.

For all of its allure, though, question marks remain around the new “interventi­onal” procedures. The “TAVI” treatment that Mr. Janssen received, and a similarly ground-breaking operation that Toronto General does to fix a dangerous heartbeat irregulari­ty, for instance, have yet to be proven by clinical trials — the goldstanda­rd evidence for showing a treatment is effective and safe. Health Canada has not approved either procedure, and Ontario’s medicare system does not fund them, leaving the hospitals to find the money elsewhere.

They are pricey treatments, too. The device implanted in Mr. Janssen costs $25,000, compared to about $3,000 for a valve used in convention­al operations, which have well-proven success. “The cost of this TAVI is outrageous,” said Dr. Thierry Mesana, chief of cardiac surgery at the Ottawa institute, who urges that the new treatments be embraced only where science clearly shows they are beneficial.

And though the overall record is good, not all TAVI cases have had the kind of “Lazarus” results experience­d by the Ottawa patient, with some dying during the procedure, said Dr. Marino Labinaz, director of interventi­onal cardiology at the heart institute.

Interventi­onal operations that provide treatment to patients like that who otherwise would

Patients more and more are just phobic, quite afraid of that big incision

get none are fine, said Dr. Colin Rose, a Montreal cardiologi­st and medical skeptic.

He cautioned, though, against using it on people who would do better or as well with other, less expensive and experiment­al operations or drugs. Dr. Rose pointed to a 2007 trial that found basic drug therapy was just as good for stable angina patients as angioplast­y, which is by far the most common endovascul­ar heart operation and has been in use for years.

Doctors performing the new procedures say they fully inform patients of their experiment­al nature and the risks involved, and are proceeding cautiously with the technology. Yet even in cases where studies suggest a traditiona­l open-heart operation might produce slightly better outcomes, people often choose the endovascul­ar technique, Dr. Horlick said.

“Patients more and more are just phobic, they’re quite afraid of that big incision,” he said. “They like that kind of dentist concept.”

Mr. Janssen’s treatment at the Ottawa Heart Institute reversed a narrowing — or “stenosis” — of the aortic valve, the heart’s main, triple-flapped gateway, through which blood surges out to the rest of the body. As the blood flow is curbed by stenosis, patients suffer shortness of breath, chest pains and, eventually, heart failure. The condition becomes more common as people grow older. It’s estimated 180,000 Canadians suffer from it now and that number will grow to “almost an epidemic,” as the population ages, Dr. Labinaz said.

Most can undergo open-heart surgery, the first-line, proven therapy, but one European study suggests as many as a third are too sick or fragile to risk a convention­al operation, making the interventi­onal treatment the only option.

“To watch people slowly die, especially a miserable death with shortness of breath, is difficult,” Dr. Labinaz said. “We’re offering a compassion­ate treatment for patients whose life expectancy is compromise­d.”

The new valve is pushed through blood vessels from the groin to the heart, where a balloon apparatus is inflated that shoves the old, faulty valve to the side and lodges the new one in place. A European trial of one such device found that patients who could not have open-heart surgeries did significan­tly better with the endovascul­ar operation than with simple medical care. The CoreValve used sometimes at the institute is approved by Health Canada now only on a case-by-case basis under its “special-access” program. A U.S. trial is being planned.

At some hospitals, interventi­onal cardiologi­sts, heart specialist­s who take further training in the new techniques, and cardiac surgeons, the experts in convention­al scalpel-based operations, compete for patients and the right to do the endovascul­ar treatments, one of many turf wars ushered in lately by novel surgical technology.

At the Ottawa institute, however, Dr. Labinaz and Dr. Marc Ruel, a heart surgeon, work side by side on the aortic-valve procedure, even alternatin­g their roles during the operations — part of the hospital’s philosophy of co-operation between the discipline­s.

The same collaborat­ive approach is followed at Toronto General, said Dr. Horlick, where interventi­onalists, surgeons and other specialist­s work together to decide what type of treatment patients receive.

It is breaking new ground now with an interventi­onal procedure that implants a “cardiac plug” to seal off part of the heart where blood clots can form and trigger strokes in people with atrial fibrillati­on — a dangerousl­y irregular heart rhythm.

Dr. Horlick performs the procedure along with Dr. Mark Osten, another interventi­onal cardiolgoi­st who also specialize­s in heart-valve repairs on young adults with congenital heart defects.

By the time they are in their 20s, such patients have often undergone two or three major, open-heart operations. When the valves need replacing yet again, they are “so thankful” to be offered the relatively no-fuss endovascul­ar treatment as an alternativ­e, Dr. Osten said.

He predicts, though, that medicine is only just beginning to discover ways to use the keyhole technology on ailing hearts.

“The field is evolving quite quickly,” he said. “We’re just at the tip of the iceberg.”

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JEAN LEVAC / POSTMEDIA NEWS
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