Paradigm Shift Enhances Effectiveness of Complex Aortic Aneurysm Repair

Minimally invasive endovascular repair makes for safer and more effective repair of complex aortic aneurysms, especially those that include the arteries branching to the brain, arms, intestines and kidneys.
Image of a stent

Photo above: An artistic take on the image of a branched endograft to illustrate the essence of this device, which has transformed complex aortic aneurysm repair. (Based on the original photo taken by Matt Wright.)

Surgeons at UMass Memorial Health’s Center for Complex Aortic Disease are advancing both fenestrated and branched forms of endovascular aortic repair (EVAR) techniques. These involve only two groin needle punctures, rather than open surgical repair, making the procedures safer and recovery faster for patients.

By the time patients meet Andres Schanzer, MD, FACS, they have been through cardiac work-ups with their own cardiologists and vascular surgeons already. They know the size and complexity of their abdominal aortic aneurysm, and they are acutely aware of the risk of rupture. They come to UMass Memorial Medical Center in Worcester looking for new treatment possibilities and the potential to improve and extend their lives. They come looking for hope.

“Many of my patients have been living with this for several years before I see them, and they may have been told there’s no repair strategy available for them,” said Schanzer, Chief of the Division of Vascular and Endovascular Surgery and Director of the Center for Complex Aortic Disease at UMass Memorial Medical Center, one of 10 U.S. sites using custom-made endografts for complex fenestrated/branched endovascular aortic aneurysm repairs. He is also Director of the UMass Memorial Health Heart and Vascular Center and a Professor at UMass Chan Medical School.

“In many of these cases, endovascular repair may be a good option. It provides a minimally invasive alternative to an open repair, with faster recovery and less pain. It’s the most transformational technology we’ve had in vascular surgery in decades, and it’s a tremendous benefit when there’s a more complex aneurysm present.”

The Center for Complex Aortic Disease is one of the busiest in the nation when it comes to minimally invasive endovascular aortic repair (EVAR), a procedure that has fundamentally altered treatment for thoracic and abdominal aortic aneurysms. Many of the center’s patients, who come from across the U.S. as well as from other nations, would not be able to tolerate the traditional open surgical repair because of comorbidities, advanced age, or location or complexity of the aneurysm.

“Open thoracoabdominal repair is the most invasive surgery you can do to a human,” Schanzer said. After making a midline transabdominal or retroperitoneal incision to access and then clamp the aorta and iliac arteries, the surgeon replaces the section of the artery that has the aneurysm with a tubular or bifurcated prosthetic graft. Most aortic aneurysms develop below the renal arteries and become increasingly complex when they involve blood supply to the kidneys and the intestines, a situation that requires the fenestrated endovascular aortic repair (FEVAR) procedure.

A minimally invasive alternative

During a minimally invasive repair of an aortic aneurysm, an expandable stent graft is delivered to the area of the aneurysm through blood vessels using wires and catheters. When it’s in place, the surgeon expands the stent graft into position, leaving the aneurysm intact while constructing the device. At UMass Memorial, a new fiber-optic imaging technology is used to enhance visibility and reduce the amount of radiation exposure to patients and the clinical team.

“Endovascular repair is a complete paradigm shift in how quickly people can be treated and recover. I’ve never seen a technology move a field forward so rapidly,” Schanzer said. “We can do the procedure through small needle punctures. We introduce the device into the artery and then essentially build the device inside the patient’s blood vessels.”

The minimally invasive FEVAR technique makes for safer and more effective repair of complex aortic aneurysms that include the arteries branching to the kidneys and intestines. The stent graft is designed to accommodate more complex aortic anatomy. Small holes in the endograft are configured at the exact location of the branch arteries to accommodate the addition of smaller stent grafts to those arteries. The fenestrated endograft must align with the patient’s particular anatomy.

Schanzer has completed more than 450 FEVAR procedures, a number that puts him among the top three U.S. surgeons who perform the procedures. Vascular surgeon Jessica Simons, MD, MPH, DFSVS, has partnered with him in many of those procedures. In addition to her role in the Center for Complex Aortic Disease, Simons is Associate Professor of Surgery and Program Director, Vascular Surgery Residency, UMass Chan Medical School.   

In August 2022, Schanzer and his team became the first in the world to repair a diseased aortic arch using a retrograde three-vessel device custom-made for a patient’s anatomy. A prototype of the device was first manufactured and deployed in a 3D printed model of the patient’s aorta to establish technical feasibility.

“The configuration for this device was the first of its kind to use three branches to the arteries supplying the arms and brain in such a way that all could be accessed from a single groin puncture,” Schanzer said, adding that the patient recovered well and went home after a short hospital stay.

Faster recovery for patients

The fact that endovascular repairs are so much less invasive means that the speed of treatment increases and the recovery period decreases. Even a complex FEVAR procedure involves only three to five hours of surgery and one to three days of recovery in the hospital’s cardiovascular unit.  

“I tell my patients they’ll be back to normal in one to three weeks,” he said. In comparison, patients who have an open repair spend three to seven days in intensive care, 10 to 20 days on the cardiovascular floor, and some time in a rehabilitation facility. Their recovery at home typically continues for a minimum of six months. 

Schanzer said he and his team achieve technical success — that is, placing the device, maintaining the patient’s stability and stopping blood flow to the aneurysm — in 97% of FEVAR cases. Mortality rate within 30 days of the procedure is less than 4%.

“Given the complexity of the procedures and the multiple comorbidities of our patients, that is excellent,” Schanzer said. Conventional open repairs have mortality rates ranging from 5 to 20%.

Patient-centered, team-based approach

To meet the needs of patients who are undergoing these complex endovascular procedures, every member of the center’s team must have expertise beyond what is usually expected in their professional areas. That begins with Lindsey Carr, an administrative assistant and patient care coordinator who helps patients get to the hospital, schedule scans and navigate insurance challenges. Nurse practitioners on the team provide essential clinical care and ensure that patients understand the risks and benefits of the procedures. Devon Robichaud, MSN, ACNP, Clinical Coordinator, sees patients in person or remotely before their surgeries, follows them post-surgery throughout their lives, and manages issues that can arise at any time during the process. Like Robichaud, Shauneen Valliere, NP, Research Coordinator, provides clinical care, and she also ensures that the center follows the latest FDA regulations.

Support of the clinical team continues throughout the patient experience. Vascular anesthesiologists, who specialize in these types of procedures, place essential lumbar drains to remove excess cerebrospinal fluid and prevent paralysis. The cardiovascular ICU is staffed with nurses who are experienced in taking care of these complex patients.

The team also takes a collaborative approach to working with patients and families, as well as with referring physicians and surgeons. Standard practice at the center is to invite physicians to observe their patient’s procedure and keep them apprised of the patient’s journey — which is lifelong. Patients must commit to having follow-up imaging on an annual basis.

Schanzer said it’s essential for patients to have their care fully understood by their local physicians. That ensures that the information about their procedure, recovery and ongoing progress is readily available to the referring provider when the patient returns home.

“We tell our referring physicians about everything — clinical visits, our concerns, any complications that arise, follow-up needs,” said Robichaud.

Leadership in the Aortic Research Consortium

UMass Memorial’s Center for Complex Aortic Disease is one of 10 sites participating in a physician-sponsored investigational device exemption study. Each site functioned independently until coming together as the U.S. F/BEVAR Aortic Research Consortium in 2018. The consortium is evaluating custom-made and physician-modified FDA-approved devices for treatment of patients with complex abdominal or thoracoabdominal aneurysms. Schanzer serves as Medical Director. Together, the 10 sites have completed more than 2,500 cases, making it the largest trial of its kind in the world.

“Having such a large data set helps as we examine the issues we encounter. For example, the best types of device designs, different types of anatomical challenges, rates of recovery, need for reinterventions, etc.,” Schanzer said. “A single site doesn’t have enough data to draw conclusions on these types of issues. Now the data we are drawing from is orders of magnitude greater.”

He believes the consortium and its large dataset of fenestrated and branched EVAR procedures will be essential in advancing endovascular repair to greater efficacy.

“The consortium will provide the infrastructure and the agile regulatory pathway to enable large-scale testing of emerging technologies,” he said, adding that the amount of data will facilitate more randomized trials to study the technology and bring it to new heights. “We can push the field much further by all working together.”

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