EndoAnchor Treatment of Type Ia Endoleaks After Endovascular Infrarenal Aortic Aneurysm Repair
William D Jordan, Jr.1, Kenneth Ouriel2, Manish Mehta3, Frank R Arko4, John P Henretta5, Benjamin J Pearce1, Jean Paul PM de Vries6
1University of Alabama at Birmingham, Birmingham, AL;2Syntactx, New York, NY;3Vascular Group, PLLC, Albany, NY;4Carolinas Medical Center, Charlotte, NC;5Mission Hospital, Asheville, NC;6St. Antonius Hospital, Nieuwegein, Netherlands
Type Ia endoleaks continue to occur immediately after endograft deployment or remote from the initial procedure in patients undergoing endovascular aneurysm repair (EVAR). EndoAnchors have been employed to treat the endoleak in such patients and the current series reports the outcome of therapy in the Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (ANCHOR).
Over a 29 month period ending in July 2014, 201 patients were enrolled in ANCHOR and treated with EndoAnchors for immediate type Ia endoleaks following endograft deployment (PRIMARY arm; N=109, 54.2%) or type Ia endoleaks remote from EVAR (REVISION arm, N=92, 45.8%). Patients were followed for clinical outcomes over a mean of 15±6 months after EndoAnchor implantation. Computed tomographic (CT) images were reviewed by an independent core laboratory in 145 patients (72.1%) preoperatively and 109 (54.2%) postoperatively (108 with contrast). Continuous variables were assessed with the Student’s t test and dichotomous variables with Fisher’s exact test. Bonferroni corrections were used for multiple comparisons.
Aneurysms averaged 60±16mm in maximum diameter, with infrarenal neck length 16±12mm, infrarenal neck diameter 28±6mm, infrarenal angulation 37±17 degrees. Aortic necks were shorter than 10mm in length in 42.7% and shorter than 5mm in 17.5% of patients. An average of 6±2 and 7±3 EndoAnchors was implanted in the PRIMARY and REVISION cases, respectively (P=.003), with successful deployment and absence of type Ia endoleak on completion angiography in 190/201 patients (94.5%).
Over mean follow-up of 15±6 months, all-cause mortality was 2/200 (1.0%), with aneurysm-related reinterventions in 21 patients (10.4%). There were 12 patients (6.0%) with endograft-related reinterventions and 11 patients (5.5%) with EndoAnchor-related reinterventions; all for type Ia endoleaks. There were no ruptures or open surgical conversions. Core laboratory analysis identified endoleaks in 14/108 patients (13.0%) with postoperative contrast CT studies; 4/60 in PRIMARY cases (6.7%) and 10/48 in REVISIONS (20.8%, P=.043). The endoleak was evident on the first postoperative CT scan in all but one of these cases. Short neck predicted EndoAnchor failure; 18±13mm versus 8±5mm in those with and without postoperative type Ia endoleaks, respectively (P<.001). Neck length 5mm) was evident in 39.1% of patients with 12-month CT scans; sac enlargement (>5mm) developed in 3.7% of patients.
CONCLUSIONS: EndoAnchors are successful in remediating type Ia endoleaks in 87.0% of cases. Success was more frequent in patients treated for endoleaks that were detected and treated at the time of initial EVAR compared with those identified and treated in follow-up. EndoAnchors should be considered as a potentially effective treatment option when type Ia endoleak is encountered during or after EVAR.
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