The New Young at Heart

Fall/Winter 2009

One of the most long-awaited advances in modern cardiac medicine has arrived, and dozens of high risk, mostly elderly heart patients at Massachusetts General Hospital are benefitting from it. It is a procedure that involves inserting a new state-of-the-art artificial valve in the hearts of patients with defective aortic valves that are restricting blood flow, a life-threatening condition called aortic stenosis. Mass General is one of more than two dozen sites across the country — and the first in New England — that participated in a recently-completed clinical trial to test the effectiveness of the non-invasive valve replacement method.

Robert Shaw was one of the first Mass General patients to undergo the procedure. When MGH interventional cardiologist Igor Palacios, MD, diagnosed him with aortic stenosis, doctor and patient agreed that Mr. Shaw had so many existing health problems that open-heart surgery to insert a new valve would have posed too great a risk to the 75-year-old resident of Narragansett, RI. Mr. Shaw had already undergone two heart bypass surgeries as well as chemotherapy and surgery for metastasized colon cancer.

So Dr. Palacios suggested his patient enroll in the new study; and in 2008, Mr. Shaw received his new valve, delivered to his heart through a catheter in his leg by a diverse team led by Dr. Palacios, director of the MGH Heart Center’s Structural Heart Disease Program.

“Because of my previous surgeries, it didn’t seem like a good idea to open me up again,” Mr. Shaw recalls. Now, a year later, his wife Anne says his last checkup showed “his aortic valve was working beautifully and his overall heart health is definitely improved.” And the couple has the hard facts to prove it: after years of scaling back travel plans because of Mr. Shaw’s poor health, the couple flew to Germany in June for an activity-filled two-week vacation.

For high risk patients like Mr. Shaw with severe aortic stenosis, open heart surgery to replace 
the defective heart valve could lead to severe debilitation, complications and prolonged hospital stays, and in many cases, death. Patients are deemed high risk if they face a 10- to 15-percent risk of death in standard surgery; most have had prior open-heart surgery or other serious health problems, including lung disease, kidney disease, prior strokes or peripheral artery disease. Until now, those patients have foregone surgery or opted for it, and faced the risks.

But the new procedure offers a welcome lifeline for those patients. In the PARTNER trial (which stands for the Placement of Aortic Transcatheter Valves), high risk patients are randomly selected for the non-invasive procedure involving inserting the new state-of-the-art valve via a catheter laced through the leg or chest; or for open-heart surgery in which the same valve is inserted. A second arm of the study involves performing the non-invasive method on inoperable patients — those whose risk of death or major morbidity (organ failure) is more than 50 percent. Most patients in both trial arms are in their mid- to high-80s; the oldest patient was 98.

In all, the trial, which ended in August, enrolled 1,050 patients across the U.S. and Canada. The procedure is expected to win approval from the Federal Drug Administration for widespread clinical use in high risk and inoperable patients.

“Many patients who come to us have been evaluated elsewhere, have been told they are too high risk for surgery, and come here because they don’t have any other options,” says Jonathan Passeri, MD, a cardiologist at MGH and instructor in Medicine at Harvard Medical School. He is a member of the multi-disciplinary team that performs the new procedure.

So how are patients faring? Although the official data isn’t published yet, informally the participating centers and Mass General — which performed about 16 of the procedures — have reported terrific outcomes. Since the trial began in 2008 with 25 participating sites, its early success prompted additional hospitals to participate, and now several more sites are taking part.

“Technically, the procedure is very successful,” says Dr. Passeri. “As the technique and technology have advanced during the process, outcomes have gotten better and better, and all of us are very pleased with initial results. Certainly, what we’re witnessing supports what we all expected — that the procedure will be a good option for people with high or prohibitive risks for surgery.”

The narrowing of the heart valve that occurs in aortic stenosis obstructs blood flow from the heart into the aorta and onward to the rest of the body. This condition usually results in an abnormal heart sound, called a heart murmur, which doctors can hear with a stethoscope. When the aortic valve is obstructed, a patient’s heart needs to work harder to pump blood to the body. Eventually, this excessive work causes heart muscle to thicken. Aortic stenosis is most common among the elderly, although some babies are born with a defective aortic valve.

For low-risk or moderate-risk patients, standard valve replacement surgery has been done for years, and with good outcomes. But standard surgery for the sickest patients often results in “very prolonged hospitalizations with multiple complications,” says Dr. Passeri. “If they survive the operation, they are often in hospital for months, then in rehabilitation facilities for months, and have a very impaired quality of life because surgery takes such a toll on them.”

In comparison, recovery from the new non-invasive procedure is much faster. Patients typically spend a week or less in the hospital, which is in line with the lengths of stay of moderate- and low-risk patients who undergo surgery. One female patient — who turned 90 the day before she underwent the non-invasive procedure — was in such great shape 48 hours later that the medical staff felt she was ready for discharge. Just to be safe, the staff kept her for an extra day before letting her go.

But several members of the trial team can’t seem to shake one case that didn’t have such a happy ending. The patient was a 92 year-old man who was randomized to standard surgery and later died. “He spent a long time in the hospital after the surgery, had many complications, was in and out of rehab and really suffered,” recalls Dr. Passeri. “If we had been past the trial stage when he came to us, and had the freedom to use the device as opposed to randomizing patients, we believe he would still be with us today.”

But the overall success of the new procedure likely will mean it’s just a matter of time until it wins FDA approval. The trial will soon move into a second phase for low-risk elderly patients and for younger patients with moderate risk. This phase also includes the use of a smaller catheter, which will enable more patients to undergo the procedure.

In the scope of cardiac disease, the new procedure “is very big,” says Dr. Passeri. “Aortic stenosis is the most commonly acquired valve disease in the industrialized world. It is the most common reason that valve replacement surgery is done. Moreover, it’s a disease of the elderly, so the prevalence of this disease is going up as people are living longer and the population is aging.”

Adds Dr. Palacios, “The scope and impact of this study is going to be enormous. It represents a paradigm shift in treating valvular disease [disease of any one of the four heart valves], which for many years has been predominantly surgical treatment. This shows that we are heading to less-invasive techniques for treating valve disease. So this is going to have a major impact
on cardiology.”

Sidebar: The first patient

When Joseph Riley visited his cardiologist, Mass General’s Kenneth Rosenfield, MD, in the summer of 2008, Dr. Rosenfield told the 88-year-old patient he had severe aortic stenosis and needed an aortic valve replacement. But, the doctor added, Joe “wouldn’t survive another surgery,” recalls Paul Riley, his son.

Indeed, in the months leading up to that visit, Joe, who lives alone (his wife died four years ago) in Stoughton, Mass., had been experiencing severe shortness of breath as a result of his condition and was confined to his house so he could be connected to an oxygen supply. He had other health problems, and a previous heart bypass surgery at age 74.

Dr. Rosenfield, a senior interventional cardiologist and head of MGH Vascular Medicine and Intervention, told Joe he was likely a “perfect candidate” for the inoperable group of the PARTNER trial, and MGH cardiac surgeon Arvind Agnihotri, MD, evaluated him and found him eligible. In June 2008, Joe Riley became the first MGH patient to undergo the non-invasive procedure.

“I knew from the moment I saw him in the recovery room that it was a success,” recalls Paul. “His cheeks were rosy and he was already looking better and breathing better than he had in a long time.” Indeed, Joe’s past year has been “fantastic,” says Paul. During one follow-up visit to see Igor Palacios, MD — who performed the procedure — “Dad walked the equivalent of two-and-a-half football fields in a six-minute-walk test.”

Joe’s turnaround has even surprised the PARTNER team. “We can’t believe how well he’s done. He’s one of our best success stories,” says Dr. Palacios.

More than a year later, Joe is still living independently. “I don’t think he would be here today had he not had the procedure,” says Paul.

Sidebar: How it works — and what it costs

In the procedure, doctors insert the valve, produced by Edwards Lifesciences, into a balloon-delivery system and then thread it through the patient’s circulatory system from the leg or the chest. Once in place, the balloon expands and the new valve is placed inside the patient’s own diseased heart valve, effectively expanding the space through which blood flows. All this is done on a beating heart, without the need for cardiopulmonary bypass, a technique that temporarily takes over the function of the heart and lungs during surgery while maintaining the circulation of blood and the oxygen in the body.

The study is also tracking the procedure’s cost. For it to become a viable option in the long-term, the procedure must be cheaper than standard surgery, and today it’s not. Typically, a multi-disciplinary team of about 20 people participates in each valve replacement — more than the number in open-heart surgery. Each valve costs $18,000, though with FDA approval, competition will force down the price tag. As the valve technology and delivery method are increasingly refined, eventually, patients may not require general anesthesia and the procedure will become faster and more routine — which could all work to reduce costs.

Already, the length of hospital stays has dropped dramatically, though that needs to be weighed against the fact that the procedure is keeping alive more people who would otherwise have died — translating into a higher volume of heart patients overall.