Cardiac Surgeons at AHN Allegheny General First in Pennsylvania to Implant New Device for the Treatment of Aortic Arch Disease

Procedure Performed in May as Part of Latest Clinical Trial Sponsored by Artivion

PITTSBURGH - Cardiac surgeons at Allegheny Health Network's (AHN) Allegheny General Hospital (AGH) today announced they are the first in Pennsylvania to implant the investigational Arcevo™ LSA hybrid stent graft device as part of a clinical trial, ARTIZEN sponsored by Artivion, evaluating its safety and effectiveness in patients with certain aortic arch conditions, specifically aortic arch dissections (aortic tears) and aneurysms.

Aortic dissection can be a life-threatening medical emergency, which occurs when there is a tear in the inner layer of the aorta, the body's main artery. Blood travels through this tear, forcing the inner and middle layers of the artery wall to split apart, or dissect. Aortic aneurysms occur when there is damage to the aortic wall, causing all aortic layers to grow, which can lead to rupture.

Scott M. Halbreiner, MD, cardiac surgeon and medical director of AHN's aortic disease program, serves as the local principal investigator and successfully completed the first implant in May.

"The stent graft's innovative design, which takes into account the complexity of this procedure as well as the anatomical location of the repair, may offer significant advancement in the field of aortic disease," said Dr. Halbreiner. "This design in particular includes a stent intended to restabilize not just the site of the aortic tear, but the left subclavian artery branch."

Most commonly, dissections take place at the aorta's upper descending archway between the heart and main artery - this specific entry point is under the most stress, with frequent and forceful blood flow coming from the heart. Patients with this type of aortic dissection can present with a severe, sudden-onset ripping or tearing sensation in the chest.

The treatment for aortic arch disease is typically an open-heart procedure that involves surgically removing the diseased portion of the aorta and replacing it with a stent graft that restores appropriate blood flow.

As part of this procedure, cardiac surgeons also need to bypass the left subclavian artery (LSA) with a second graft and then connect it to the aortic graft. This allows for continued blood flow to the brain, spinal cord and left arm, which otherwise would be compromised by the aortic arch repair.

However, the bypass of the LSA has historically been a challenge due to its anatomic location deep in the chest, said Dr. Halbreiner.

The Arcevo LSA is a self-expanding aortic stent graft with an integrated stented LSA branch, all preloaded onto a system that's deployed into the transected aorta and LSA during an aortic repair procedure. Essentially, this device is designed to stabilize the damaged aorta and LSA in one stented device with two "arm branches", compared to using separate grafts and connecting them via sutures.

The new device was designed to facilitate easier stent placement for surgeons while also minimizing bleeding and reducing the risk of injury to the nerves around the LSA, as well as the artery itself. As a result, surgeons may anticipate shorter operative times and shorter post-op length of stay for patients.

As part of this clinical trial, participants will be followed for up to five years, with a focus on 1-year outcomes, monitoring for all-cause mortality, unanticipated aortic reoperation, and left LSA blockage, among other potential complications.

The ARTIZEN trial is an investigational, prospective, multicenter, non-randomized clinical trial that includes 132 participants in the U.S. and Europe, all of whom have experienced aortic dissection or aneurysm in the aortic arch.

In May 2025, AHN AGH also announced it was the first in the state and among the first nationwide to successfully implant a new stent device, also from Artivion, that was clinically-proven via its innovative design to significantly reduce the incidence of aorta tears recurring, a common complication.

For more information on the AHN Cardiovascular Institute, visit ahn.org

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