Five Year Outcomes of Endosuture Aneurysm Repair (ESAR) in Patients with Short Neck Abdominal Aortic Aneurysm from the ANCHOR Registry
Frank R Arko, III1, Benjamin J Pearce2, John P Henretta3, Giovanni Torsello4, Jean M Panneton5, Yun Peng6, H. Edward Garrett, Jr.7
1Carolinas Medical Center, Charlotte, NC;2University of Alabama at Birmingham, Birmingham, AL;3Mission Hospital, Asheville, NC;4St. Franziskus Hospital, Munster, Germany5Sentara Norfolk General Hospital, Norfolk, VA;6Medtronic, Santa Rosa, CA;7University of Tennessee, Memphis, TN
Background: Hostile aortic neck anatomies such as proximal short necks are known to put patients at an increased risk for Type IA endoleaks, migration, and need for reinterventions. The Heli-FX EndoAnchor System (Medtronic, Santa Rosa, CA) was designed to improve the fixation and seal of aortic stent grafts. Endosuture aneurysm repair (ESAR) utilizing EndoAnchors with the Endurant stent graft has been shown to be safe and effective for the treatment of patients with short necks in the short term. This study reports the five-year patient outcomes of the ANCHOR short neck cohort to assess the durability of their ESAR repair.
Methods: Seventy patients from the ANCHOR Registry (Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry) had an infrarenal neck length greater than 4 mm and less than 10 mm and were selected for this sub-group analysis. At five years, this short neck cohort had clinical and imaging follow up compliance rates of 85% (28/33) and 70% (23/33), respectively.
Results: The short neck cohort had a mean age of 71.3±8.1 years and was 27.1% (19/70) female. The cohort’s proximal neck length was 6.9 ± 1.6 mm, the proximal neck was 25.7 ± 4.0 mm, and the maximum aneurysm diameter was 57.7 ± 12.7 mm. Kaplan Meier rates of freedom from all-cause mortality (ACM) was 68.5 ± 6.2%, aneurysm-related mortality (ARM) was 90.1 ± 4.5%, any endovascular or surgical secondary procedure was 76.9 ± 7.2%, and rupture was 95.6 ± 3.2% (Table 1). There were no stent graft migrations through five years. Through five years, three subjects had surgical conversions to treat aneurysm rupture (two) and aneurysm enlargement/Type II endoleak (one). There were a total of nine Type IA endoleaks detected, of which two resolved spontaneously by the next follow-up visit, and the remainder required secondary interventions. After five years, 68.2% (15/22) of subjects had sac regression, 13.6% (3/22) had stable sacs, and 18.2% (4/22) had increased sac diameter as compared to their one-month measurements.
Conclusions: Following ESAR treatment utilizing Heli-FX EndoAnchors with Endurant, the five-year outcomes of the short neck cohort from the ANCHOR registry showed no migrations, low rate of ruptures, and positive sac regression. Overall, this five-year analysis suggests ESAR is a durable solution for patients with short proximal necks although a larger study with longer follow up is necessary.
Table 1: Kaplan Meier Survival Analyses through Five Years
|Five Year Freedom from Rate1||No. at risk2|
|0-30 days||31-365 days||366-731 days||732-1096 days||1097-1461 days||1462-1826 days|
|ACM||68.5 ± 6.2%||70||66||62||56||46||41|
|ARM||90.1 ± 4.5%||70||66||62||56||46||41|
|Secondary procedures3||76.9 ± 7.2%||70||63||59||53||43||36|
|Rupture||95.6 ± 3.2%||70||66||62||56||46||41|
|1Estimate made at end of time interval 2Number of subjects at risk at the beginning of interval 3Secondary procedures include both secondary endovascular procedure and surgical procedures|
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