SAN DIEGO — A new technology platform for treating abdominal aortic aneurysms that mimics a hand-sewn anastomosis appears safe and effective, results from a phase I multicenter trial showed.
The Aptus Endovascular AAA Repair System (Aptus Endosystems Inc.) is a three-piece modular device with an unsupported main body and two fully supported limbs in a 5.3-mm outside diameter (16 Fr) delivery system.
“This system represents a new endovascular capability: the ability to attach one object to another with a device independent of the objects being attached,” Dr. David H. Deaton reported at the Vascular Annual Meeting. “In our minds it's a faithful reproduction of transmural, interrupted suture and it gives the operator a new level of control.”
With this technology, helical staples with a 4-mm depth are delivered through an independent stapling system. The location and number of staples are controlled by the operator and provide for endograft fixation and sealing that can be customized to the anatomical challenges of each patient.
“This helical incorporation of tissue holds both graft to aorta and aorta to graft, which has the potential to eliminate neck dilation,” said Dr. Deaton, chief of endovascular surgery at Georgetown University Hospital, Washington, and one of the study investigators.
In a study conducted at five centers in the United States, Dr. Deaton and his associates enrolled 21 patients with a proximal aortic neck length of 12 mm and an iliac landing zone of 10 mm. He reported on 6-month safety and feasibility data in all patients and 1-year follow-up in 14 patients. Secondary end points included freedom from endoleaks, rupture, migration, and device integrity. The mean age of patients was 75 years and 95% were men. The mean diameter of their aneurysms was 56 mm.
Dr. Deaton reported that the endograft was successfully deployed with the Aptus system in all patients without conversion. A median of 4 staples per patient was used, with a range of 2–10. Significant reduction of aneurysm size occurred in 43% of the patients at 6 months and 69% of patients at 1 year. No aneurysm enlargement was seen during either time period.
Two proximal cuffs and one limb extension were used as adjunctive devices at implantation, and three secondary interventions were performed in two patients for limb thrombosis. There were four type II endoleaks at 6 months and one type II endoleak at 1 year, but there were no type I, II, or IV endoleaks. There were no adverse events, device integrity failures, or migration.
“One of the real benefits of an independent fixation system is [that it allows] a significant reduction in the caliber of graft delivery catheters,” Dr. Deaton said. “It also allows you to reposition the proximal stent without an advanced delivery catheter.”
Dr. Deaton is a consultant to Aptus Endosystems Inc. and serves on the company's advisory board.