It is considered the last frontier of heart care.
Many patients suffer from such severely clogged arteries that physicians rarely dare trying to open them with the minimally invasive technique of angioplasty.
Such cases have been considered too risky, complex, time-consuming and of questionable benefit for a procedure that involves carefully guiding a wire through an artery and past a fatty deposit to inflate a tiny balloon to restore blood flow.
Not so anymore.
A small but growing number of doctors in Buffalo and elsewhere are taking on the unconquered territory of heart problems known as chronic total occlusions, or CTOs, in certain patients.
They have been aided by new devices and new approaches, as well as experience elsewhere in the world and initial studies that suggest angioplasty can improve symptoms like chest pain and, perhaps, prolong life.
Advocates say the procedure offers a minimally invasive alternative to potentially tens of thousands of patients including individuals who want an alternative to surgery, others who are considered too risky for bypass operations, and still others whose surgically repaired arteries have reclogged.
“It’s a challenging procedure and, historically, had low success rates, so people avoided doing it. But this will be the standard of care in 10 years,” said Dr. Henry Meltser, an interventional cardiologist who started performing angioplasty on these difficult cases last year at the Catholic Health Heart Center at Mercy Hospital.
At Kaleida Health, Dr. Kishor Phadke has performed the procedure on a few selected patients over the years, but there is no formal program at the hospital system.
He said the opening last year of the Gates Vascular Institute on the Buffalo Niagara Medical Campus has created the opportunity to bring together the medical team and resources needed to do the demanding procedures on a regular basis.
“To do CTOs, you need an entire institution to dedicate the time and have the mindset,” he said.
Think of a blockage in an artery like a house.
Traditional angioplasty approaches the clog through the front door in the direction of the flow of blood.
Doctors insert a thin, flexible catheter into the artery of the groin or arm and thread it through blood vessels to the clog. A wire is inserted into the catheter and manipulated across and beyond the blockage.
The wire acts as a guide over which a tiny deflated balloon at the tip of the catheter can be positioned past the blockage and inflated to restore blood flow. In some patients, the medical team also will implant a metal mesh tube to keep the artery propped open.
But in chronic total occlusions, the blockage is so hard it’s as though the front door is bolted shut, so doctors need to learn other routes. For instance, one technically difficult approach is to manipulate the catheter through helper arteries against the flow of blood to the back door of the clog.
“Nobody thought you could get through these smaller channels,” Meltser said.
“But the Japanese over the years overcame the challenge and showed that you can. Now we have two doors, and that significantly increases your success rate.”
Advances in equipment also have helped doctors tackle these severe blockages.
BridgePoint Medical, which was bought last year by Boston Scientific Corp., developed the first devices approved by the Food and Drug Administration specifically for dealing with these severe blockages. The catheters and guide wire went on the market in 2011.
A second opinion
For Charles Will, 62, the procedure was exactly what he had hoped for.
The Buffalo native suffered a heart attack in Sarasota, Fla., where he had moved in 1988, and doctors there recommended heart bypass surgery.
Will’s father told him to get a second opinion in Buffalo, so against doctors orders, he flew back here.
The first physician he saw said the location and extent of the blockage made it too risky for him to attempt angioplasty, but he steered him to Meltser, who found a way last year to open the long and rock-hard blockage with a minimally invasive approach.
“It was worth a shot. They didn’t need to bust open my chest. I went in at 6 a.m. one day and was out at noon the next day,” said Will, who is returning to the area to serve as business manager of the River Oaks Golf Course on Grand Island.
Although chronic total occlusions appear in about 30 percent of patients with blocked arteries, few get angioplasty because of the difficulty of getting through their blockage and the high chance of complications. As such, few cardiologists are experienced in the procedure, and success at opening these severe blockages is heavily influenced by the training and experience of the doctors who do the procedure.
The success rate for restoring blood flow with angioplasty in a patient with a severe blockage ranges from 50 percent to 88 percent of cases, which is lower than the 98 percent success rate for typical blockages, according to a recent medical journal review. The best rates came from medical centers with the most experienced operators.
Current guidelines call for angioplasty for these severe blockages in patients with appropriate medical conditions and done with an experienced operator.
“You need a dedicated team, and you need to know multiple techniques. It took me a year of hard learning – courses and doing the procedure,” Meltser said.
Another reason for the slow adoption of angioplasty for chronic total occlusions is the debate in medicine over the current state of research into its benefits, especially whether angioplasty for these blockages is better at prolonging life than other treatments.
“There’s no question it relieves symptoms. We can only surmise whether it improves survival, but the evidence is tantalizing,” Phadke said.
Patients like Will offer personal testimonies.
“I feel 15 years younger,” he said.
But individual success stories are not enough in science.
Skepticism about the procedure remains because of the lack so far of a randomized controlled study – the gold standard in research – in which angioplasty for these blockages is compared with medical therapy or bypass surgery.
What’s known about angioplasty’s effect on symptoms and survival in patients with chronic total occlusions comes from smaller observational studies. This type of study looks for differences in outcomes of treatments but doesn’t make sure the patients getting the various therapies being compared are similar enough to weed out potential external influences.
Although interest in angioplasty for the severe blockages is growing with improved success rates, “the current body of evidence is not sufficient to clearly determine the magnitude of benefits and to identify which patients are most likely to improve,” according to an article last month in the American Heart Journal.
Criticism of the available research misses the point, said Dr. Jeffrey Moses, an advocate for angioplasty in select cases.
“There is a lot of medicine we don’t know 100 percent about,” said Moses, director of cardiovascular interventions at New York Presbyterian Hospital/Columbia University Medical Center. “In the interim, we have to treat patients.”
“Common sense has to prevail in the absence of perfect data,” he said. “If you have a lot of studies that indicate this procedure may be a benefit, does that mean patients don’t deserve it?”