William Jordan Presents Three-Year EndoAnchor Registry Study Data
DECEMBER 2018
William D. Jordan, Jr., MD, chief of the Emory Division of Vascular Surgery and Endovascular Therapy, presented three-year data from the ANCHOR registry study of Medtronic's Heli-FX EndoAnchor system at the 45th Annual Symposium of Vascular and Endovascular Issues in New York, otherwise known as the VEITHsymposium. The data showed that the system effectively treated patients with complex anatomy, including hostile aortic necks, requiring intervention for an abdominal aortic aneurysm (AAA). Dr. Jordan and Jean-Paul de Vries, MD, of St. Antonius Hospital in Nieuwegein, the Netherlands, are co-principal investigators of the study.
The ANCHOR registry is a prospective, multicenter study involving sites in the USA and Europe, and is evaluating the real-world use of EndoAnchors in patients. The EndoAnchor is a spiral-shaped, metallic implant that is intended to provide fixation and sealing between endovascular aortic grafts that have exhibited migration or endoleak and the native artery. The registry aims to enroll 2,000 patients, with the three-year data so far including 800 patients treated for AAA with Heli-FX EndoAnchors in combination with an approved graft.
Hostile aortic necks have anatomic characteristics that make treatment for AAA difficult, including short neck length, large neck diameter, extreme neck angulation, and abundant mural thrombus or calcium within the neck.
The majority of patients enrolled received EndoAnchor implants prophylactically, while a smaller group received them following a previously failed endovascular aortic repair (EVAR). The data Dr. Jordan presented included a subset of patients from these groups who were eligible for clinical and imaging follow-up at three years. All patients had short, hostile neck anatomies, with median neck lengths of 11.2 mm in the prophylactic group, and 10.2 mm in the therapeutic revision group.
The three-year results indicated low rates of Type 1a endoleaks for both groups, positive sac stability and regression despite the hostile anatomy characteristics, high rates of freedom from secondary procedures to treat Type Ia endoleaks, and very low rates of aneurysm-related mortality. Endoleaks happen when blood leaks back into an aneurysm sac following an EVAR procedure, with Type Ia occurring when there is a gap between the graft and the vessel wall at seal zones.
"Hostile aortic necks are frequently seen in clinical practice and have historically presented challenges for physicians treating patients through an endovascular approach," says Dr. Jordan. "With these data, we are continuing to validate that by using Heli-FX in these challenging cases, we have the ability to successfully treat this critical patient population and expand applicability of EVAR to those with complex aortic anatomies."
