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Long-term outcomes of the Endurant TM endograft in patients undergoing endovascular abdominal aortic aneurysm repair.

INTRODUCTION: To investigate the long-term outcomes after endovascular aneurysm repair (EVAR), in a real-world setting using the EndurantTM endograft (EG).

METHODS: 184 EVAR candidates treated with the EndurantTM family EGs in a single vascular center were prospectively enrolled from January 2009 to December 2016. Kaplan-Meir estimates of long-term standardized primary and secondary outcome measures were performed Per protocol, subgroup comparison analysis was performed in 3 groups: patients treated within instructions for use (in-IFU) vs patients treated outside-IFU, EVAR in patients receiving Endurant proximal diameter 32 or 36 mm EG vs those receiving <32 mm diameter EG and EVAR with various EndurantTM EG versions.

RESULTS: The mean follow-up was 75.09 ± 37.9 months (range: 4.1-172 months). The median age of the patients was 72.96 ± 7.03 years (range: 55-88 years). 177 patients were males (96.2%). Compliance with IFU was followed in 107 patients (58.2%). Overall survival was 69.5 and 48% at 5 and 8 years respectively. Of the 102 all-cause deaths, seven (6.9%) were aneurysm related. Six of these post-implant deaths occurred in patients presented with aneurysm rupture from type Ia or/and type Ib endoleak. At 5/8/and 10 years of observation, freedom from aneurysm rupture, open surgical conversion (OSC), type I/III endoleak, any type of endoleak, aneurysm-related secondary intervention probabilities and neck-related events, were as follows: 98.1/95/and 89.4%, 95.1/91.2/and 85.7%, 93.6/87.3/and 83.9%, 83.4/74/and 70.9%, 89.8/76.7/and 72% and 96.3/90%/and 87.6% respectively. Corresponding clinical success was 90/77.4/and 68.4%. Patients treated outside-IFU had significantly higher risk of aneurysm rupture, OSC probability, occurrence of type I/III endoleak, and chance of reinterventions and lower clinical success probabilities compared to the in-IFU counterparts at 5 and 8 years. This statistical difference remained when type Ia endoleak or endoleak of any type was considered independently. Additionally, it was stronger in patients having extreme anatomical boundaries (>1 hostile anatomical condition), when aneurysm related death, aneurysm rupture and clinical success at 5 years were considered. Overall proximal migration and limb occlusion was recorded in 1.1 and 4,9% of the patients. Overall re-intervention rate was 17.4%. Increase in aneurysm sac diameter was observed in 12.5% of patients and was not related to IFU status. The EndurantTM version or the proximal EG diameter had no significant association with the chance of any complication or adverse event.

CONCLUSIONS: The data confirmed the durability of the Endurant EG, achieving promising long-term outcomes in a real-world setting. However, its positive performance must be interpreted with caution in patients treated off-label especially those with extreme anatomical boundaries. In this cohort, some of EVAR advantages might be lost in the late future. Further similar studies are warranted.

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