Hank Madaloni is no stranger to battles. In World War II, he fought in Europe under Gen. George S. Patton’s command, seeing action in the Battle of the Bulge in Belgium and then moving to the front lines in Munich in 1945 when Russia advanced to stake its claim to Eastern Germany.

Today, the 78-year-old from La Verne, Calif., is in the midst of an ongoing battle for his life. He has survived not one but two heart attacks—as well as two subsequent heart bypass surgeries. And he has conquered colon and bladder cancer as well.

Still, Madaloni is an eternal optimist. If you ask him, he’ll tell you that he fully expects to live to see his 100th birthday, in 2023. He has yet to be proven wrong.

Madaloni’s plans for a centennial birthday celebration were nearly derailed in 1999, however, by a kind of physiological bombshell. A few years earlier, his physicians had found a small area of weakness in his aorta, the main blood vessel coming from the heart. Because of its small size, they were relatively unconcerned, and decided simply to keep an eye on it. Over time, however, it grew precipitously—what had previously been just a tiny blemish became a 26-inch danger zone.

Abdominal aneurysms rupture in about 15,000 people each year, causing uncontrollable hemorrhaging; they are the 13th leading cause of death in the United States. Hank Madaloni’s aneurysm was no different—and hence a real danger to his life.

A quick anatomy lesson goes a long way towards explaining why the abdomen is a particularly dangerous spot for this aortic abnormality to occur. After the aorta leaves the heart, it makes a quick U-turn and dips down into the abdomen; from there, it supplies blood to all the organs and the legs. When an abdominal aortic aneurysm, or AAA, forms in this area, it puts that supply route in serious peril.

The most common site of an AAA is below the renal arteries, which are the vessels that provide blood to the kidneys. Some sort of weakening or damage occurs to the arterial wall; most often that damage begins to spread and grow larger. In fact, the larger an aneurysm becomes, the more quickly it grows. Finally, like a balloon with too much air inside it, the aneurysm wall will burst or rupture—and that can prove deadly. Consequently, the goal in treating aneurysms is to detect them as early as possible, and to shore up any weak spots before they rupture.


Walking On Eggshells

When Hank Madaloni’s disturbingly large aneurysm was detected, his community-based specialists were alarmed. Because of his history of heart attacks, the sort of major surgery normally required to defuse an AAA was risky. He was warned that one false move—literally—could cause the aneurysm to burst. Indeed, Madaloni recalls, all the doctors could recommend was for him to “get his house in order” and not exert himself in any way. Madaloni, normally a very active man, was reduced to sitting around the house, “waiting for the bomb to go off,” he says. For the first time in his medically complicated life, he began to think that the end was near.

Then Madaloni was referred to USC University Hospital vascular surgeons Fred A. Weaver, M.D., and Douglas B. Hood, M.D. Their take on the situation was considerably less apocalyptic. “The first thing Dr. Hood did after examining me was to tell me that it was OK to return to my daily activities and routine, and start living life again,” Madaloni recalls.

They also told him about a new procedure that could repair his aneurysm without requiring them to open his abdomen. Called endovascular abdominal aortic aneurysm repair, this minimally invasive procedure requires only two small incisions in the groin area for the insertion of a small, flexible device called a stent-graft into the artery to strengthen the affected area.

Despite the fact that he would be one of the first patients to undergo the procedure at USC University Hospital, Madaloni was all for the procedure. But first, he wanted to have a little fun. “I wanted to go to Las Vegas,” Madaloni laughs. “Dr. Hood told me to go and have a good time, and then he would do the surgery.”


An Open Option

Weaver, who serves as director of vascular surgery at USC University Hospital, and chief of the division of vascular surgery at the Keck School of Medicine of the University of Southern California, has been actively involved in abdominal aortic aneurysm repair since the 1980s. He is a firm believer in the importance of repairing an aneurysm, rather than letting it grow and possibly rupture.

“If an aneurysm does rupture,” notes Weaver, “the chances the patient will die are 50 to 70 percent. Those are pretty grim statistics.”

Until recently, the only option was to do an open surgical repair. Weaver, who has been performing these surgeries for years, says they do offer patients with aneurysms the opportunity to defuse their internal time bomb.

“We treat aneurysms based on size,” he explains. “Abdominal aortic aneurysms less than 4 centimeters are rarely, if ever, treated as they do not pose as great a rupture risk. However, if this aneurysm grows to more than 5 or 6 centimeters, then it should be fixed.”

The open operation involves making a large incision from just below the breastbone to the top of the pubic bone. The weakened portion of the vessel is then excluded, or shut off, from the rest of the aorta and replaced by a synthetic graft, which is sewn into place. Patients who undergo this surgery typically spend one or two nights in the intensive care unit and remain in the hospital an additional five to seven days.

Certainly, it is a very effective treatment. “The open operation does an excellent job,” Weaver admits. “However, it is a highly invasive procedure that requires a longer hospital stay and extended recovery time at home—sometimes two to three months. There can also be some significant morbidity associated with the procedure, including a possible heart attack or lung failure.”

That is why Weaver and Hood, an assistant professor of surgery at the Keck School of Medicine and director of the endovascular therapy program at USC University Hospital, have been working to refocus the entire USC vascular surgery program toward a less invasive approach to vascular problems. “Open operations will always be necessary,” notes Weaver, “but at a referral institution it is imperative to have the skills to offer both open and minimally invasive approaches to treating vascular problems.”


The Cure Within

The idea of using endovascular surgery—a minimally invasive way to get within the vasculature to repair defects—for an abdominal aortic aneurysm was first developed in the 1980s by an Argentine physician, Juan C. Parodi, M.D., who perfected his technique using homemade devices. “He did the first human subjects and reported them in the early 1990s at the national vascular surgery meetings,” recalls Weaver. “This set up an incredible flurry of activity by various biomedical companies to create new endovascular devices to treat abdominal aortic aneurysms.”

These devices, called stent-grafts, first became commercially available soon after Parodi’s studies were made public. In essence, a stent-graft acts like a sleeve inside the aneurysm, taking the pressure off the weakened vessel walls and giving blood a stable, sturdy pathway through which to flow. This prevents the aneurysms from ballooning out further, even allowing them to recover their elasticity. And they are designed to offer a number of significant advantages to patients and physicians.

Early clinical experience suggests that stent-grafting reduces major morbidity. It can be performed in less time than is required for open surgery and it reduces the amount of time a patient needs to be hospitalized. And patients thus far seem to be able to return to their normal activities more quickly postoperatively.

According to Hood, the “new era of stent-grafting” was formally launched in September 1999 when the U.S. Food and Drug Administration (FDA) approved two endovascular devices for AAA repair. Both devices are used at USC, he says. The surgeon decides which to employ in a particular case based on specific characteristics of the patient and the aneurysm, taking into consideration each of the grafts’ specific advantages.

The ANCURE Endograft System, manufactured by Guidant Endo-Vascular Technologies, Inc., is made from a polyester cloth similar to the grafts employed in the open surgery traditionally used to treat AAA. This graft, however, is inserted via a catheter, and has specially designed metal attachments that the company says act like the sutures used to sew a conventional graft; the attachments help to ensure that once the graft is in place, it will stay in place.

The other approved device is the AneuRx Stent Graft System from Medtronic AVE. The AneuRx is a woven polyester tube covered by a metal web. It, too, is delivered via a catheter positioned within the aneurysm; when the stent comes into contact with blood, it automatically expands to a preset size, and the delivery catheter can be withdrawn.

According to the FDA, the ANCURE Endografts were tested on 421 AAA patients at 22 medical centers around the country, and compared to 111 AAA patients treated through open abdominal surgery. The endografts were inserted successfully in 91 percent of the patients, and those patients had fewer major complications and shorter hospital stays than those undergoing standard open abdominal surgery—indeed, hospital stays were reduced from a median of six days to a median of two days, according to the company. The AneuRx Stent Graft was used to treat 416 AAA patients at 13 medical centers in the U.S., and compared to 66 AAA patients who underwent the open surgery. In this case, the stent was inserted successfully 98 percent of the time, and also was associated with fewer adverse reactions and a quicker discharge from the hospital.

As required by the FDA, both companies are continuing to conduct studies on the long-term safety and effectiveness of their devices.

That, says Weaver, is a very important thing. “Any minimally invasive procedure that is introduced must be as good if not better than the traditional open operation,” he notes. “This is crucial for our patients.”


Saving Hank Madaloni

It certainly was crucial for Hank Madaloni. After his trip to Las Vegas, a renewed Madaloni was ready to become one of the first patients to undergo this minimally invasive procedure at USC University Hospital.

Endovascular stent-grafting may be significantly less invasive than open surgery, but it requires a more extensive preoperative evaluation than does surgical repair. The physicians on the case need to consider the best way to access the site of the aneurysm, where the device should be implanted, and how to customize the stent to properly fit the individual patient. That is why each patient undergoing the procedure—including Madaloni—first is given both a CT scan and an angiogram.

The procedure itself generally lasts between two and three hours, and can be done either with local or general anesthesia. Madaloni was awake throughout his procedure, and says he felt no discomfort at all.

The surgical team made two small (2-3-inch) incisions in his upper thigh. Using a fluoroscope for visual guidance, they threaded a small, flexible delivery catheter through the iliac artery to the abdominal aneurysm’s lair. Once the catheter was properly positioned, the stent-graft was fit snugly into place. The catheter was then withdrawn and removed.

“I heard the surgical team let out a big cheer when the stent-graft was successfully put into place,” Madaloni recalls. “Everyone was smiling. It was a nice feeling.” That night, Madaloni was able to eat a meal and felt only some postoperative pain at the site of his incisions. He was discharged from the hospital two days later and was driving within a week.


On the Road Again

One month after the surgery, Madaloni had a CT scan that showed the stent-graft working well; he will continue to get such scans every six months. The surgeons are watching for possible problems: Some blood might leak out of the stent-graft into the aneurysm, or there can be some stenosis—a narrowing of the artery. And it is possible that the stent-graft may kink when the aneurysm shrinks over time. Keeping a close eye simply makes good sense.

“Leaking blood from the stent is called an endoleak, and these are present in 10 to 20 percent of patients one year after the endovascular procedure,” Hood notes. “If we detect a leak, we may be able to repair it via a catheter-based approach by either fixing the stent-graft itself or placing an additional device into the patient. CT and ultrasound images will help us detect any problems of this sort.”

And, of course, because stent-grafting for abdominal aortic aneurysms is such a new technology, the long-term safety and effectiveness of the technique has not yet been established. Cautions Weaver, “Just because a procedure is minimally invasive does not mean it is necessarily better. Any new procedure needs to be scientifically verified. Yet I am convinced that the devices we are putting in now with this endovascular approach can stand up to the open operation.”

The open surgical procedure helps 95 percent of patients over the long term, Weaver notes, “which is basically a cure.” For endovascular grafting to succeed, he says, it would have to measure up to those numbers. “We won’t have these long-term findings for another five or 10 years,” he explains. “So there are some questions remaining. Still, I think the concept is a valid one, and clearly the short-term results are very good.”

Certainly, Madaloni’s short-term results are very good. After the CT scan showed the stent working well just a month after his procedure, Madaloni and a friend took off in a fully equipped travel van for a cross-country trip. Over the next two months, they traveled to Massachusetts, stopping in Arizona, New Hampshire, Maine and Madaloni’s native Buffalo, New York, where they visited relatives.