ITalian Excluder Registry and results of Gore Excluder endograft for the treatment of elective infrarenal abdominal aortic aneurysms.
BACKGROUND
To report the midterm results of elective endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAAs) in a multicenter, clinical unsponsored registry using the Gore Excluder endograft.


METHODS
This study is a retrospective analysis of a multicenter, prospective registry that involved nine centers in Italy. Periodic clinical and radiographic follow-up with computed tomography scans were performed at 1, 6, and 12 months after the procedure, and on a yearly basis thereafter.


RESULTS
A total of 872 patients underwent elective EVAR. Primary technical success was 97.5%, and hospital mortality was 1.0% (9/872). At least 816 (93.6%) patients underwent a follow-up control. Freedom from all-cause death was estimated to be 97.9% at 1 year, 93.4% at 3 years, and 88.5% at 5 years. Aneurysm-related mortality was 1.6% (n = 13) with only two late AAA-related deaths observed at 21 and 36 months. Significant predictors of all-cause mortality included age (P < .001) and AAA maximum diameter (P = .027). Overall conversion rate was 2.3% (n = 19). Mean elapsed time from initial intervention to surgical conversion was 23 ± 18 months (range, 0-52 months). Late rupture was detected in four (0.5%) cases: two of these patients died after conversion. The rate of any reintervention was 9.4% (n = 77); most of them were required within the first 24 months. The leading cause of reintervention was endoleak (n = 41; 5.0%). Limb thrombosis occurred in nine (1.1%) cases. Freedom from reintervention at 1, 3, and 5 years of follow-up were 98.6%, 94.6%, and 86.5%.


CONCLUSIONS
The ITalian Gore Excluder Registry is the largest clinical unsponsored registry using a single device, with the longest follow-up period so far. The present experience confirms the effectiveness of EVAR using the Gore Excluder with low rates of mortality, migration, reintervention, and limb thrombosis.
Vascular Surgery, Department of Heart and Vessels, Careggi University Hospital, University of Florence School of Medicine, Florence, Italy.
Carlo
C
Pratesi
Section of Vascular Surgery, Department of Surgery and Morphological Sciences, Circolo University Hospital, University of Insubria, Varese, Italy. Electronic address: gabriele.piffaretti@uninsubria.it.
Gabriele
G
Piffaretti
Vascular Surgery, Department of Heart and Vessels, Careggi University Hospital, University of Florence School of Medicine, Florence, Italy.
Giovanni
G
Pratesi
Section of Vascular Surgery, Department of Surgery and Morphological Sciences, Circolo University Hospital, University of Insubria, Varese, Italy.
Patrizio
P
Castelli
D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D017558:Elective Surgical Procedures; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000401:mortality / Q000601:surgery; D012042:Registries; D012086:Reoperation; D012189:Retrospective Studies; D015607:Stents; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome