Dipankar Mukherjee, MD, the lead investigator for Inova’s clinical trial on the device, discusses how the recently FDA-approved ALTO™ device is transforming treatment of abdominal aortic aneurysms (AAA).
With the commercial release of the ALTO™ Abdominal Stent Graft System, Inova’s vascular surgeons are helping to ensure the best possible outcomes for patients with abdominal aortic aneurysms (AAA). This recently FDA-approved stent graft device has expanded the number of patients who can be offered minimally invasive endovascular repair. Until now, some patients were not able to be treated using other endovascular stent devices.
An AAA occurs when a portion of the abdominal aorta widens abnormally due to a weakening of the vessel wall. This condition may result in life-threatening internal bleeding if it ruptures, making this condition among the leading causes of death in the United States. According to the CDC, AAAs are more prevalent among men and people age 65 and older, with 75 percent of patients reporting a history of smoking. Patients do not typically have symptoms, although pain in the back, side, buttocks, groin or legs is sometimes reported. Common causes of AAAs are a family history and are a result of risk factors such as hardened arteries, high cholesterol and high blood pressure. Some infections and injuries can also cause AAA.
Both the Society for Vascular Surgery and the U.S. Preventative Services Task Force recommend a one-time AAA screening using ultrasound imaging for men age 65 years or older, particularly those with a history of smoking or a family history of AAA. An indication for routine screening in women is not as strong but can be considered if the same risk factors are present.
Implantation of the ALTO device, completed for the first time at Inova Heart and Vascular Institute in early August of this year, was the first implant surgery performed in the Washington, DC region and one of the first centers in the U.S. to offer this procedure for AAA patients. The new device differs from traditional approaches used for endovascular repair through the use of a conformable liquid polymer which allows for the graft design to be a durable, customizable and anatomically adaptive aortic seal.
Inova’s aneurysm program is one of three programs in the state of Virginia. In the recently released U.S. News and World Report 2020-2021 ratings, Inova’s AAA repair program was rated as “high performing” for the fourth consecutive year. In addition, Inova received an “A” safety rating from the LeapFrog Group, a national organization committed to improving healthcare quality and safety for consumers. In the category of high-risk surgery, LeapFrog identified Inova as the only hospital in the Washington, DC-Baltimore area that “fully meets the standards” for open aortic procedures.
“We have an outstanding faculty and a supportive team that offers open and endovascular aneurysm repair. The ALTO program keeps us at the forefront of clinical care and research in the management of aneurysmal disease,” said Richard Neville, MD, Associate Director of Inova Heart and Vascular Institute, System Director of Vascular Services, and Vice-Chairman of the Department of Surgery.
Dipankar Mukherjee, MD, Chief of Vascular Surgery for Inova Fairfax Hospital, discusses the innovative ALTO implant procedure and how the graft device is transforming abdominal aortic aneurysm care.
Q&A with Dr. Dipankar Mukherjee
- What range of services does Inova offer to diagnose and treat AAA?
Inova offers the entire gamut of treatment options for AAA, from diagnosis to all available treatment options and subsequent follow-up care. The treatment options include endovascular aortic repair (EVAR) as well as open surgical repair when that may be more appropriate. We have available the latest in endovascular stent graft repair technology by virtue of participating in clinical trials evaluating the next generation of ever-improving endovascular stents. We are able to offer the best repair using the optimal stent based on patient’s specific aneurysm anatomy.
- In what instances would you advise a patient to consider the ALTO implant?
The ALTO implant uses polymer sealing technology to obtain the proximal seal to eliminate pressurization of the AAA sac. This is a unique concept as far as EVAR is concerned. This may prove to be a more durable treatment for the long term. There is modest early evidence to suggest that such may be the case. This implant has the ability to treat more patients with AAA, including those with short neck of the aneurysm.
- In general, what is the success rate for AAA repair?
The success rate for AAA repair is excellent. We are able to accomplish minimally invasive repair most often without the need for even a groin incision. Patients are usually discharged from the hospital the next day. They are closely followed in the office with ultrasound examinations of the repair, and with CT angiography if there are any concerns. The mortality and morbidity of endovascular repair is superior when compared to open repair. The quality of life following endovascular repair is also superior.
- What has been the success rate in the clinical trials that led to approval of this device? How does that compare to other devices and techniques used to treat AAA?
In the ELEVATE trial, treatment success was 96.7 percent at one year. Type I endoleak rate was 1.4 percent with 100 percent freedom from type III endoleak, device migration, device fracture, stent occlusion or AAA rupture. Devices related secondary intervention rate was 2.7 percent.
Learn more about Inova’s world-class heart and vascular care at inovaheart.org.