Find care now
If you are experiencing a medical emergency, please call 911 or seek care at an emergency room.
A MedStar Health Research Institute study shows significant promise for treating complex aortic aneurysms with a minimally invasive procedure.
The aorta is the largest artery in the body, carrying blood from the heart to all the organs throughout the circulatory system. When the aorta bulges and becomes aneurysmal, it can have life-threatening consequences. Research at MedStar Health Research Institute demonstrates that a personalized, minimally invasive technique to repair aortic aneurysms can help save lives.
Due to damage or weakness, the aorta can bulge and dissect, allowing blood to leak between the layers of the artery’s walls or rupture and cause internal bleeding, which can often be fatal.
About 200,000 people in the U.S. are diagnosed with an aortic aneurysm each year, and almost 10,000 died from aortic aneurysms or aortic dissections in 2019. A ruptured aortic aneurysm is the tenth leading cause of death in men older than 55 and the country’s fifteenth most common cause of death overall.
Some of these patients can be too old or frail for surgery which precludes them from being offered surgical repair. Fortunately, with advances in technology and dedicated clinical research, we have offered these patients a minimally invasive approach to treat these complex aortic aneurysms. Our research focuses on an innovative therapy that is helping improve and save the lives of patients with complex aortic aneurysms for which there previously has been no effective minimally invasive treatment.
What is a complex aortic aneurysm?
Aortic aneurysms are bulges of the aorta and are broadly categorized by where they occur. Thoracic aortic aneurysms (TAAs) are found in the chest and while their etiology is multifactorial, a major risk factor is high blood pressure, smoking or stress.
An aneurysm in the abdomen arising below the artery to the kidneys is an abdominal aortic aneurysm (AAA). Complex AAAs (such as thoracoabdominal aortic aneurysms, TAAA) occur in the aortic segment, involving the arteries to the liver, intestine and/or kidneys. Infection, injury, and hardened arteries (atherosclerosis) are the most common causes of AAA, which occur most commonly in patients over age 65.
Risk factors and symptoms of AAAs.
According to the U.S. Centers for Disease Control and Prevention, about 75% of AAAs occur in patients with a history of smoking. The U.S. Preventative Services Taskforce recommends that all men age 65-75 get an ultrasound to check for signs of AAA if they have ever smoked, even if they have no symptoms—which is the case with most cases of AAA. Similar recommendations have been made for women with a history of smoking by the Society of Vascular Surgery (SVS) in their guidelines.
An AAA rupture or dissection can lead to sudden death. If symptoms occur, they can include pain in the abdomen, pelvis, or groin or deep, throbbing pain in the back or side. It can often present as syncope.
Other risk factors include high blood cholesterol, high blood pressure, and hardened arteries. Some disorders inherited from your family can also increase your risk, like Marfan Syndrome and Ehlers-Danlos Syndrome, multisystem disorders that can make the body’s soft tissues fragile. A family history of aortic aneurysms also increases the risk.
To check for an AAA, your doctor may use imaging tests such as an Ultrasound, echocardiogram, computed tomography (CT) scan, or MRI to look inside your body. Suppose the aneurysm is small, and your risk is low; your doctor may suggest regular checkups and medications to help lower blood pressure and cholesterol, like beta blockers, statins, etc., to halt the progression of the aneurysmal disease.
Limitations with current treatment options.
Surgery may be recommended for patients whose AAA is larger than 5-5.5cm, are growing rapidly, or have ominous morphology or imaging features concerning impending rupture. Traditional open surgery involves removing the damaged portion of the aorta and replacing it with a graft, a thin fabric tube that is sewn into place. Recovery from this procedure can take several weeks or longer.
A 2021 study demonstrated a high mortality rate among patients who had open surgery to repair a complex aortic aneurysm. Nearly 7% of study participants died within 30 days after surgery, many due to complications with underlying heart, kidney, or lung disease.
Complex AAA has long been difficult to repair for some patients with multiple medical problems who will likely do poorly from an open repair and have unique anatomic challenges that preclude them from conventional endovascular repair. These patients are left with few treatment options and a “ticking time bomb” that could rupture and lead to sudden death.
The clinical trial we are conducting is approved by the FDA, allowing me to modify the Cook Alpha Thoracic Endovascular Graft to tailor it to my patient’s individual anatomy, and hence offer my patients a life-saving treatment.
Successful treatment for TAAs with a smaller device.
For some patients, particularly those with underlying severe medical diseases or unique, challenging anatomies, endovascular repair is a safer option than open surgery. Through a small 2-3mm incision in the groin, the surgeon inserts a flexible tube into an artery and guides it to the aorta. A graft is placed inside the aneurysm, re-routing blood through this stent graft instead of the aneurysmal aorta, preventing rupture or dissection.
In 2016, the U.S. Food and Drug Administration approved the Cook Alpha for use in patients with TAA who are candidates for endovascular surgery. Studies demonstrated that this smaller low-profile device helped reduce the number of deaths 30 days after surgery to repair TAA to zero.
This minimally invasive graft procedure for aneurysms in the chest has proven very effective, demonstrating a 98% technical success rate.
Advancement to treat complex AAAs using PMEG F/B-EVAR device.
Endovascular technology has successfully treated thoracic and abdominal aortic aneurysms, so we wanted to learn if it could have similar benefits for patients with complex AAA, those “ticking time bombs” for whom there are few other options. Therefore, the fenestrated and branched endovascular (F/B-EVAR) technology is being used for the high-risk patients through this trial to offer them a treatment tailored to their anatomy.
While patients are being prepared for surgery, the surgeon measures and maps the abdominal aorta and its branches that route blood to the liver, intestines, and kidneys. Special computer software allows me to make extremely precise measurements of each patient’s blood vessels and create a stent graft that mirrors the patient’s anatomy and maintains blood flow. This is called a physician-modified endograft (PMEG). This is done through an Investigational Device Exemption (IDE), an FDA-approved clinical trial called the FEVAR study.
By the time the patient is ready for surgery, the graft is prepared to be implanted. The surgeon accesses the arteries through a small incision and places the stent graft to repair the aorta and its branches, maintaining blood flow and supporting the vessel. There is no other commercially available technology that can repair complex aortic aneurysms in this way.
The minimally invasive precision of this procedure allows us to treat patients we otherwise could not due to the high rate of complications from traditional surgery. Additional benefits of endovascular surgery include shorter recovery times, less discomfort, smaller incisions, and less stress on the heart and lungs.
Our study examines the safety and effectiveness of the PMEG device (FEVAR) to repair complex aortic aneurysms because we want this treatment to be available to everyone who could benefit.
Treatment, follow-up, and enrollment.
We are currently enrolling patients in our ongoing research. Trial participants receive treatment for their complex aortic aneurysm using the PMEG device, and our study team carefully monitors their progress, and regression of their aneurysm sac. We keep a close follow-up for at least five years. We also use a questionnaire to measure patients’ quality of life at regular intervals for five years after surgery.
Participants must be over age 18, with complex aortic aneurysms, and at high risk of death or complications from open surgery. There are several other criteria to be involved, so if you’re interested in enrolling, discuss this trial with your doctor.
Referring physicians and prospective participants may email javairiah.fatima@medstar.net or call (202) 877-0812 or (507) 250-5160 for more information.
Fantastic results at the forefront of treatment.
With one of only 11 Investigational Device Exemptions issued by the U.S. Food and Drug Administration, Dr. Fatima at MedStar Health Research Institute is permitted to study new ways to safely use medical devices like the PMEG as part of the FEVAR clinical trial. Collectively, the institutions that have studied this device for the treatment of AAA have performed over 2,500 procedures so far.
Despite the high-risk nature of patients offered this treatment, the death rate has been an astounding low at less than 2%. The implanted stents are durable, and blood flow rates (patency) are greater than 95%. It is not an exaggeration to call these results “fantastic.”
Our work investigating impactful treatments puts us at the forefront of academic and investigational work and benefits our patients daily.
The research infrastructure and resources at MedStar Health Research Institute allow us to provide leading-edge treatment options for our patients in Washington, DC, and lead at the vanguard of medical innovation.
