Clinical Ramifications of an Extended Proximal Seal Zone with a Novel Endograft System: First Report of 108 Consecutive Cases
M. Burress Welborn, III1, Huey B. McDaniel2, Ronny C. Johnson1, Ronald E. Kennedy2, Andrew Knott1, Gerhard H. Mundinger2, Fred S. Stucky1, George D. Van Cleve2, Kenneth Ouriel3
1Valley Vascular Consultants, Huntsville, AL;2St. Dominic's Cardiovascular Surgical Associates, Jackson, MS;3Syntactx, New York, NY
Background: The AFX Endograft with ActiveSeal™ technology features highly conformable STRATA fabric enabling increased conformability within an irregularly shaped aortic neck, with the potential to extend the zone of sealing beyond the aortic neck. This study comprises the first report of the early clinical experience with the device in a consecutive series of patients with infrarenal abdominal aortic aneurysms (AAA).
Methods: A retrospective review of the baseline characteristics, imaging findings, clinical data, and outcome of consecutive AAA patients treated with the AFX device (Endologix, Irvine, CA) at two US centers was performed by independent monitors. Computed tomographic (CT) imaging measurements in the overall study population were site-reported. An independent core laboratory assessed aortic neck characteristics and fabric apposition from 3D reformatted CT datasets in an Imaging Cohort subset of the study population. The anatomic neck was defined as the proximal aortic neck where the aortic diameter remained within 10% of its infrarenal reference. Median follow-up was 4 (0-14) months overall and 6 (1-14 months) in the Imaging Cohort. Values are expressed as mean ± SD or median and range.
Results: Among the 108 patients, 103 (95.4%) were treated electively and 5 (4.6%) were treated urgently for rupture; 80 (74.1%) were male and 28 (25.9%) female with a median age of 70 (56-83) years. An average of 2.3±0.7 AFX components was implanted per patient; no proximal neck bare stents were employed. There were no perioperative deaths in elective procedures and 2 deaths in patients with ruptured AAA (40%). Major adverse events occurred in 4 elective cases (3.9%) and 2 ruptured cases (40%). Over short-term follow-up, two type 1 endoleaks (one 1a, 0.9%; one 1b, 0.9%) and one type 3 endoleak (0.9%) were observed. Type 2 endoleaks were evident on completion angiography in 18 patients (16.7%), all but one of which resolved spontaneously by the first post-procedure CT study. There were two type 2 endoleaks observed on follow-up CT studies (1.9%); one of which was not evident at the implant procedure. There were 4 aneurysm-related reinterventions; 3 in elective cases (2.9%) performed for an iatrogenic iliac arteriovenous fistula, renal stenting for partial ostial coverage, and a type III endoleak. No patient experienced endograft migration, limb occlusion, rupture or open surgical conversion. In the Imaging Cohort (37 patients), 360-degree fabric-to-wall apposition continued over a mean length of 25±17 mm and extended an average of 5 mm distal to the end of the anatomic neck. Fabric apposition length exceeded the anatomic neck length in 20 (54%) of the patients in the Imaging Cohort.
Conclusions: Satisfactory short-term outcome was achieved in an initial series of patients treated with a new endograft and fabric with the potential to improve proximal neck sealing. Circumferential fabric apposition continued beyond the anatomic neck in approximately one-half of the cases, and there was a low rate of endoleaks and device-related complications. Definitive results, however, await the availability of longer term follow-up data.
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