Safety and Efficacy of 16F Sheath Access in the First Segment of the Axillary Artery for Fenestrated/Branched Endovascular Aortic Repair

The human aorta is the body's main highway, a thick, elastic tube that carries oxygen-rich blood from the heart to the rest of the body. When a section of this highway weakens and bulges, it forms an aneurysm, a dangerous swelling that can rupture if not treated. For decades, the standard fix was open surgery, a massive operation where doctors cut through the chest or abdomen to replace the damaged section with a synthetic tube. While effective, this approach carries significant risks, especially for older patients or those with other health issues. In recent years, a less invasive alternative has emerged: endovascular repair. Instead of a large incision, surgeons thread a flexible, fabric-covered tube, known as a stent graft, through the blood vessels from the groin up to the site of the problem. This device acts as a new inner lining, reinforcing the weak wall from the inside.

However, treating aneurysms in the thoracoabdominal region—the area where the chest meets the belly—presents a unique puzzle. This section of the aorta supplies blood to vital organs like the kidneys and the intestines through several smaller branches. A simple tube cannot simply cover this area without blocking those essential off-ramps. To solve this, engineers developed fenestrated and branched devices, which have custom-made holes or side tubes that align perfectly with the organ arteries, allowing blood to flow through to them while the main graft seals the aneurysm. Placing these complex devices often requires the surgeon to work from both the groin and an arm, threading wires and catheters from the top down to guide the graft into place. The challenge lies in finding a safe entry point in the arm that is large enough to accommodate the thick delivery tubes but small enough to avoid damaging the limb.

A team of researchers at Shanghai Ninth People's Hospital set out to test a specific solution to this access problem. They focused on the first segment of the axillary artery, the large vessel that runs under the collarbone and down the arm. While this artery is a common choice for upper-body access, it is often too small to handle the very large tubes needed for these complex repairs without risking injury. The researchers wanted to see if they could safely use an open surgical approach to expose this specific part of the artery, allowing them to insert a large tube, perform the repair, and then close the vessel securely. Their goal was to determine if this method offered a safe and reliable way to treat the most difficult aortic aneurysms without the high trauma of a full open-chest surgery.

The study involved 78 patients who underwent this procedure between 2017 and 2024. These individuals suffered from complex aortic diseases, with the vast majority having thoracoabdominal aneurysms classified as Type IV, meaning the swelling extended from the chest down into the abdomen. The patients were generally older, with a median age of 73, and many had other health conditions like high blood pressure or a history of smoking. Before the operation, the medical team used detailed imaging scans to measure the size of the axillary artery in each patient. They found that in most cases, the artery was wide enough to accommodate the large equipment, with nearly four out of five patients having a vessel diameter greater than 8 millimeters.

The surgical procedure itself was a carefully choreographed sequence of steps. Under general anesthesia, the surgeons made a horizontal incision just below the collarbone. They carefully moved aside the chest muscles to expose the first segment of the axillary artery. Once the artery was isolated, they placed a special stitch around it, like a drawstring bag, to control bleeding later. After making a small puncture, they guided a wire down into the aorta and then slid a 16 French sheath—a tube roughly the width of a thick marker—into place. This large opening allowed them to maneuver the complex stent graft and the smaller catheters needed to connect the device to the kidney and intestinal arteries. The entire process, from the first cut to the final closure, took a median of 255 minutes.

The results of the study were encouraging. The procedure was technically successful in almost every case, with a 97 percent clinical success rate within 30 days. The surgeons were able to place the stent grafts and secure the connections to the vital organ arteries in nearly all patients. Crucially, the method proved safe regarding the access site itself. In every single case, the surgeons were able to close the artery using the pre-placed stitch, tightening it to stop the bleeding without needing to place a stent inside the artery or perform a secondary repair. There were no cases of permanent damage to the spinal cord, a serious risk in these types of surgeries, and no patients required a covered stent to fix a tear in the axillary artery.

While the approach was largely successful, the researchers did observe some complications, though most were manageable. About six percent of patients developed a hematoma, a collection of blood under the skin at the incision site, which resolved with conservative care. Ten percent experienced temporary numbness or tingling in the arm, likely due to the proximity of nerves during the dissection, but all of these patients recovered fully without permanent nerve damage. One patient suffered a stroke, and a few experienced temporary kidney issues or heart failure, which are known risks associated with major aortic repairs regardless of the access method. Only one patient died within 30 days of the procedure. The study noted that the success of the access depended heavily on the size of the artery; if the vessel is too narrow relative to the size of the tube, the risk of injury increases significantly.

The researchers concluded that using an open surgical approach to access the first segment of the axillary artery is a safe and effective strategy for these complex repairs. It provides a stable, large opening that allows surgeons to deliver the necessary equipment and navigate the intricate anatomy of the aortic branches. By exposing the artery directly, the team could control the vessel precisely, avoiding the uncertainties of blind puncture techniques and ensuring that the large tubes could be inserted and removed without causing catastrophic damage. This method bridges the gap between the need for large-bore access and the desire to avoid the trauma of traditional open-chest surgery.

The study does have limitations, primarily because it was conducted at a single hospital and did not compare this method directly against other access techniques in a controlled group. The sample size was relatively small, and the follow-up period was not long enough to rule out very late complications. However, the data provides strong evidence that for patients with the right anatomy, this approach offers a reliable path to treating some of the most challenging aortic aneurysms. It demonstrates that with careful planning and precise surgical technique, the upper arm can serve as a safe gateway for life-saving endovascular repairs, offering a viable alternative for patients who might otherwise face higher risks with other methods.