ATLANTA, Ga. ( Ivanhoe Newswire) - It can strike with virtually no symptoms or pain. If it ruptures, it can kill nine out of 10 people who develop it. Now, a surgeon has developed a device to help save people with this condition who have run out of options.
In the last five years, Bill Cardwell has encountered more challenges than he could ever face on the golf course. First it was serious heart problems, then a ticking time bomb bulging in his belly that could burst at any time.
"Absolutely it was just tick, tick, tick, tick, it's hard to not think about it," Bill Cardwell told Ivanhoe.
An abdominal aortic aneurysm is caused by a weakening in the lining of the body's main artery that carries blood from the heart to the rest of the body. If this kind of aneurysm ruptures, the risk of death is up to 90 percent. Bill needed help fast, but his heart condition and the location of the aneurysm meant he could not have surgery or get a traditional endograft to repair the problem.
"If we put a standard endograft in we would have covered his kidney arteries so he would have no blood flow to his kidneys and he would lose his kidneys. Essentially, there's really no other option," Joseph J. Ricotta II, M.D., MS, FACS, a director of vascular surgery at Emory University School of Medicine, said.
Doctor Ricotta developed a lifesaving endovascular graft customized to fit a patient's anatomy.
The small windows in the "fenestrated" stent graft allow major vessels to connect to the repaired aneurysm, allowing normal blood flow to the kidneys and other vital organs. Five months after his procedure, Bill is back on the green with a new appreciation for life and golf.
"You have to have the right attitude, now just go have fun," Bill said.
Doctor Ricotta's fenestrated graft can be used in emergency situations for patients with complex aneurysms that have ruptured or may be about to rupture. Some of the major risk factors of these potentially deadly aneurysms are smoking and high blood pressure.
BACKGROUND: An aneurysm is an abnormal bulge in the wall of an artery. Normally, the walls of arteries are thick and muscular, allowing them to withstand a large amount of pressure. Occasionally, a weak area develops in the wall of an artery. This allows the pressure within the artery to push outwards, creating a bulge or ballooned area called an "aneurysm." An abdominal aortic aneurysm is when the large blood vessel that supplies blood to the abdomen, pelvis, and legs becomes abnormally large or balloons outward. (SOURCE: www.webmd.com, www.ncbi.nlm.nih.gov/pubmedhealth)
SYMPTOMS: Abdominal aortic aneurysms often grow slowly and usually without symptoms, making them difficult to detect. As an aortic aneurysm enlarges, some people may notice:
A pulsating feeling near the navel
Tenderness or pain in the abdomen, back, or chest – severe, sudden, persistent, or constant. The pain may radiate to the groin, buttocks, or legs.
THINGS YOU DIDN'T KNOW: An abdominal aortic aneurysm can develop in anyone, but is most often seen in males over 60 who have one or more risk factors. The larger the aneurysm, the more likely it is to rupture and break open. (SOURCE: www.ncbi.nlm.nih.gov/pubmedhealth)
TREATMENT: If bleeding occurs inside the body from an aortic aneurysm, the abdominal aortic aneurysm has opened and needs repair. Surgery is usually recommended for patients who have aneurysms bigger than 2 inches (5.5 cm) across and aneurysms that are growing quickly. The goal is to perform surgery before complications or symptoms develop. In a traditional (open) repair, a large cut is made in the abdomen. The abnormal vessel is replaced with a graft made of man-made material, such as Dacron. (SOURCE: www.ncbi.nlm.nih.gov/pubmedhealth)
LATEST BREAKTHROUGHS: Another form of surgery is endovascular stent grafting. An endovascular stent graft is a tube composed of fabric supported by a metal mesh called a stent. The graft is stronger than the weakened artery and it allows your blood to pass through it without pushing on the bulge. This procedure can be done without making a large cut in the abdomen, making recovery time faster. Endovascular repair is rarely done for a leaking or bleeding aneurysm. However, it is the safest approach when the patient is suffering from other medical conditions.
Dr. Joseph Ricotta, an Assistant Professor of Surgery and Director of Clinical Research at Emory University in Atlanta, Georgia, talks about a new device that is saving lives when potentially deadly aneurysms are ready to rupture.
Can you tell me about Mr. Cardwell?
Dr. Ricotta: Mr. Cardwell is a tough case. He is a relatively young man with a big aneurysm. The aneurysm had been growing over the last 1 or 2 years before I saw him. It has reached a size where the risk of rupture was considerable. Because of his medical comorbidities, particularly his bad heart which pumps at only about 15% of normal, he was not considered a candidate for traditional open surgical repair because his heart was too weak and he probably would not have survived open surgery.
What is happening with an aneurysm? What happens inside the vessel?
Dr. Ricotta: Aneurysm is a ballooning or an outpouching of the aorta. The aorta is the main blood vessel that leaves the heart and goes down the body and gives branches to basically every organ in the body. All of the blood vessels in your body come off of the aorta. When you have a weakening of the lining of the aorta, it can balloon out and create a bulge or an aneurysm. The risk of an aneurysm is that it could burst or rupture and if it burst or ruptured, the patient would essentially bleed.
What is the traditional procedure?
Dr. Ricotta: There are different types of aneurysms depending on the location. You have aneurysms in the chest or the thoracic aorta which are called thoracic aneurysms. You have aneurysms in the abdominal aorta, which are called abdominal aortic aneurysms and you have aneurysms in both, which are called thoracoabdominal aortic aneurysms and those are the most complex types of aneurysms. Then there is an abdominal aortic aneurysm which is called an infrarenal aneurysm where it is below the renal arteries or the kidney arteries and those aneurysms are commonly treated a tube of metal and fabric that is inserted through the groin arteries, like a sleeve inside the aorta and you put it just below the kidney arteries. In Mr. Cardwell's case, his aneurysm was extending to include the kidney arteries and so this was not an option for him. He was not a candidate for the traditional open surgery because his heart function was so poor and he was not a candidate for the standard common endograft procedure because there was no room below his kidneys to put the graft and we would have to cover his kidneys with the graft.
Traditionally, what would be the option for a patient with that particular kind of problem?
Dr. Ricotta: Essentially, there is really no other option. He is not a candidate for the endograft. He is a prohibitive candidate for open surgery and so unfortunately, lots of patients that I see are told by their doctors that there is nothing that can be done for them and that they essentially just need to live their lives and one day probably, most likely, their aneurysm will just rupture.
What is this new technology you have developed?
Dr. Ricotta: Fenestrated endografts or fenestrated branch endografts are again using the same concept of a graft or tube of metal and fabric that is inserted through the groins into the aorta. What we create are little holes or fenestrations in the graft, so that we could permit blood flow to the kidney arteries, or the intestinal arteries. We line up those holes with the kidney arteries and then through those holes we put additional stents in to preserve blood flow to those kidney arteries.
How does it work?
Dr. Ricotta: Essentially the endograft is a tube of metal and fabric. You would have little holes or fenestrations that you would line up. Then through those holes you would put additional stents to preserve blood flow to those vessels and that is where the word branch comes in. The fenestration means a hole and then the branches that come out of the main aortic tube. You would have a main aortic tube in the aorta with branches coming out through the holes into those kidney arteries or intestinal arteries.
Is there a chance of leakage?
Dr. Ricotta: You plan the procedure based on the patient's CAT scan and you want a minimum of about 15 mm or 1.5 cm of seal of normal aorta. Essentially the way I do it, is I look at the CAT scan and I figure out where I am going to get the seal. That it is a durable, as you say, full-proof procedure where there is no leakage, or where the leakage will be minimal. Whatever arteries will need to be covered, that is how we decide to put fenestrations for those arteries.
Is this considered an experimental procedure?
Dr. Ricotta: It is not and I have an IDE with the FDA. We make these grafts under compassionate use.
Are they custom fit to the patient?
Dr. Ricotta: These fenestrated grafts have to be custom made to the specific anatomy of each patient and we take the patient's CAT scan, make specific measurements. Every patient's anatomy and blood vessels and aorta are different. Based on their anatomy and the CAT scan measurements, we know exactly where to make the holes for their kidney arteries and their intestinal arteries. This is particularly useful in cases where the patient presents in an emergency situation either with a ruptured complex aneurysm that cannot be treated with a standard endograft or where patients are too sick to have open surgery, where in order to save the patient's life; this is really their only option. We have done several cases where patients have come in with either ruptured aneurysms or symptomatic aneurysms that are emergency cases where we have been able to make the measurements on the CAT scans, create our holes in our endograft and treat them with a fenestrated endograft and save their life.
And this is a compassionate use situation, FDA-wise?
Dr. Ricotta: Yes.We are very careful about the selection process. These are only applied in patients or to patients who are absolutely high risk for surgery and cannot tolerate open surgery or have no other endovascular option with standard, off the shelf, commercially available endograft.
What does it mean for these patients?
Dr. Ricotta: It really gives them a second chance. It gives them new hope. Many of these patients that I see, have seen several physicians who have basically told them that unfortunately, there is nothing that can be done for their aneurysm because of their medical comorbidities. It really gives me a lot of satisfaction to be able to repair these aneurysms using this minimally invasive technique. I think that is particularly evident in Mr. Cardwell's case where he is a young man but he has a poor heart. Now, he has resumed his normal lifestyle and has a second lease on life, so to speak.
Will this prevent any kind of a rupture in the area where the vessel was weakened?
Dr. Ricotta: The aneurysm is entirely excluded. Patients will need to come back for surveillance followups and we need to make sure, based on ultrasound or CAT scans, that everything is in good position. The long-term, at least the mid-term to long-term data is excellent with these grafts. I would point out that the results across the board with fenestrated grafts compared with open surgery for people with very complex aneurysms, such as thoracoabdominal aneurysms, are night and day. The risk of mortality with open surgery is somewhere in the 10 percent to 12 percent range, just the procedure alone. The risk of mortality with a fenestrated graft is 1 perecent to 2 percent. The risk of paralysis with open surgery is again around 10 percent to 12 percent and the risk of paralysis with a fenestrated graft is around 2 percent to 3 percent. The risk of kidney failure being on dialysis with open surgery is somewhere in the 5 percent to 7 percent range and with endovascular repair is in the 1 percent to 2 percent range. The results across the board are much better with the endovascular minimally invasive approach, but more importantly, these are patients who really have no other option.
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