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S6: Plenary Session 6

SS15 - Transatlantic Multicenter Study on the Use of a Modified Preloaded Delivery System for Fenestrated Endovascular Aortic Repair (MPDS-FEVAR Study)

Friday, June 16, 2023
10:00 AM – 10:11 AM ET
Objectives: Analyze the outcomes of endovascular complex abdominal (C-AAA) and thoraco-abdominal aortic aneurysm (TAAA) repair using the COOK® fenestrated device with the modified preloaded delivery system with a biport handle and preloaded catheters (MPDS). The device allows catheterization and stenting of the preloaded fenestrations and target vessels from the ipsilateral main graft delivery system (Figure 1).

Methods: A multicenter retrospective single arm cohort study (NCT05141123) was performed, including all consecutive patients with C-AAA and TAAAs treated with the MPDS fenestrated device (COOK®). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the SVS reporting standards, were collected at discharge, 30-day, 6 months and annually thereafter.

Results: Overall, 712 patients from 16 centers in Europe and the USA were included. Mean age was 72.5 (± 8.2) and 83% were male. All patients presented electively, 35.4% (n=252) were TAAAs and 64.6% (n=460) were C-AAA. Main indications for use were: routine use (36.1%), caudal oriented renal arteries (12.1%), stenosed access vessels (9.2%) and unilateral iliac occlusion (2.1%). Overall, 2755 target vessels were included (mean 3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MDPS, (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F (±4), and in 41 patients (6.7%) the sheath size was ≤8F.
Technical success was 96.1%, and in 93.2% of cases the target vessels were successfully canulated using the MDPS. Mean procedural time was 228min (±95), contrast volume was 119ml (±76), fluoroscopy time was 68.9min (±31) and median radiation entry dose 2630 mGy (IQR: 838-5251). Median blood-loss was 300ml (IQR: 200-500). Thirty-day mortality was 4.8% (n=34). Access complications occurred in 6.7% (n=48) and thirty-day-reintervention in 7% (n=50;18 branch related). Follow-up >30 days was available for 628 (88%) patients, with a median follow-up of 19 months (IQR: 8-39). Branch related endoleaks (type Ic/IIIc) were observed in 14 patients (2.2%) and aneurysm growth >5mm was observed in 58 (9.2%). Freedom-from-reintervention at 12 and 24 months was 87.1% (SE:1.5%) and 79.2% (SE:2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE:0.3%) and 96.8% (SE:0.4%), respectively, and was 97.9% (SE:0.4%) and 95.3% (SE:0.8%) for arteries stented from below using the MDPS, respectively.

Conclusions: The MDPS is safe and effective. Overall benefits include reduction of contralateral sheath size in the treatment of complex anatomies with favourable results.