The latest surgical fix for broken hearts.
Tom Blackwell on the new procedure replacing ‘big surgeon, big knife, big operation.’
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.”