Endovascular Abdominal Aortic Aneurysm Repair with Large Diameter Devices (35/36 mm) is Associated with Acceptable Risk of Device Failure
Abhisekh Mohapatra, MD1, Jonathan Bath, MD2, Eric S. Hager, MD1, Karim M. Salem, MD1, Michael C. Madigan, MD1, Rabih A. Chaer, MD1, Michel S. Makaroun, MD1, Michael J. Singh, MD1.
1University of Pittsburgh Medical Center, Pittsburgh, PA, USA, 2University of Cincinnati, Cincinnati, OH, USA.
Objectives: Endovascular abdominal aortic aneurysm repair (EVAR) using smaller diameter (<28 mm) devices is associated with infrequent device migration and type Ia endoleaks. Large diameter (35 and 36 mm) devices are typically reserved for patients treated emergently or with limited open surgical options. We sought to determine whether these devices were associated with a high incidence of type Ia endoleaks, device migration, aneurysm-related mortality, or need for early re-intervention.
Methods: We conducted a retrospective multi-center review of patients that underwent EVAR using a 36 mm Zenith (Cook Medical), 36 mm Endurant (Medtronic) or 35 mm Excluder (Gore) device between 2009 and 2016. Baseline characteristics, preoperative, intraoperative, and postoperative data were collected including CT angiograms and duplex ultrasound examinations. The primary outcome was type Ia endoleak; secondary outcomes included re-interventions, device migration (>10mm), and aneurysm-related mortality at mid-term.
Results: 939 EVARs were performed in the study period, of which 64 (6.8%) had large diameter devices. Five patients with fenestrated grafts and four without follow-up were excluded. In the 55 patients, mean follow-up duration was 16.8 months with longest follow-up of 57 months. The mean preoperative aneurysm diameter was 61 mm (range 44-96 mm). The proximal landing zone had mean diameter 31.1 mm (30.6-31.6) and length 21.8 mm (18.7-24.8). Device-specific instructions for use were met in 78% of cases. Nine cases (16.4%) were performed urgently and eight (14.6%) for rupture. The main body was oversized by a mean of 16.1%. Two proximal cuffs were placed to address intraoperative type Ia endoleaks. 3 patients (5.5%) required re-intervention within 1 year. There was one late type Ia endoleak at 3.7 years, and one aneurysm-related mortality (aortic rupture secondary to type III endoleak) at 1.1 years. Excluding patients presenting with rupture, overall survival was 87.2% at 1 year and 74.3% at 2 years. No cases of device migration were observed.
Conclusions: Large diameter EVAR devices are associated with acceptable risks of device failure as determined by rate of type Ia endoleak, device migration, or rupture. Early and mid-term results demonstrate that large devices are safe and effective when used in elective and emergent cases. Long-term follow-up is needed to determine if aneurysm-related mortality, device failure or re-intervention rates are increased at 5 years.
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