Introduction: Endovascular abdominal aortic aneurysm repair (EVAR) has shown considerable improvements in clinical safety and effectiveness for the treatment of abdominal aortic aneurysms (AAAs) since its initial introduction. Today, EVAR is well established and, in many cases, the preferred option because it has an early survival benefit, compared to open surgical repair (OSR). However, long term data beyond five years in a real world scenario have not been widely published and the question remains of how EVAR devices perform in the long term.
Objectives: Patients in the ENGAGE Registry had positive outcomes reported through five years of follow up. The ENGAGE Registry was extended to the 10 year follow up. This analysis reports the preliminary results of the ENGAGE Extension Registry through eight years after the index procedure.
Methods: The ENGAGE Registry was a multicentre, postmarket, non-interventional, non-randomised, single arm registry designed to collect prospectively global real world safety and clinical performance data on the Endurant Stent Graft System. In total, 1 263 patients at 79 sites initially enrolled in the ENGAGE Registry and were followed for five years. In 2015, the initiative was made to extend follow up in the ENGAGE Registry to 10 years (known as the ENGAGE Registry Extension). Forty-nine of the original sites agreed to participate in this ENGAGE Registry Extension, with a total of 390 subjects enrolled. Data were collected on stent graft migration, stent graft occlusion, stent graft stenosis, endoleaks, all-cause mortality, aneurysm-related mortality, rupture, AAA sac diameter changes, conversion to open repair, secondary procedures and adverse device related events. The clinical follow-up was 94% and the imaging compliance was 83% at 8 years.
Results: Baseline characteristics and patient risk factors of the ENGAGE Registry Extension cohort were typical of this population. Mean age was 70.4 ± 7.3 years (n = 390) and 92.3% were male (n = 360). The mean maximum diameter of the aneurysm was 59.7 ± 11.2 mm (n = 383), the mean proximal neck diameter was 23.6 ± 3.4mm (n = 387), the mean length of non-aneurysmal aortic neck was 28.0 ± 12.4 mm (n = 385), and the mean infrarenal neck angle was 28.2 ± 22.5 degrees (n = 382) upon initial treatment (Table 1). At the eight year follow up, the all cause mortality rate was 9.3% (n = 35/377) and aneurysm related mortality, as determined by an independent adjudication committee, was 0.3% (n = 1/372). There was a 73.8% freedom from aneurysm related re-interventions (Fig. 1) and a 75.8% freedom from all secondary endovascular procedures. At eight years AAA sac diameter increased (> 5 mm) in 12.0% (n = 30/251) of the patients and AAA sac diameter decreased (> 5 mm) in 63.3% (n = 159/251) of the patients. The migration rate at the eight year follow up was 1.6% (n = 2/127), with no main body migration observed in the first five years. There were no conversions to open surgery through seven years, while two conversions (0.5%, n = 2/372) occurred within the eight year window.
Conclusions: In this analysis, eight year data from the ENGAGE Registry Extension demonstrated long term clinical safety and effectiveness of the Endurant Stent Graft System and underlines again the importance of continued surveillance. The ENGAGE Registry was extended to 10 years and patients will continued to be followed.
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