JM Verhagen, professor and chief of Vascular Surgery, Erasmus University Medical Center in Rotterdam, the Netherlands, presented new data on the Endurant abdominal aortic aneurysm stent graft on the opening day of the VEITHsymposium (17–21 November, New York, USA).
Patients with challenging anatomy have historically been associated with limited eligibility for endovascular repair and higher rates of adverse events. Verhagen’s presentation focused on results across a range of patient anatomies.
“Analysis of the patient cohort from the four-year global ENGAGE registry included several anatomically challenging sub-groups: short, highly angulated, and calcium/thrombus burdened abdominal aortic aneurysm necks. These mid-term outcomes offer clinical insight into the treatment of aneurysm neck anatomies relevant and applicable to current clinical practice and real world settings,” said Verhagen.
At four-years, no significant differences were found between the short neck (>=10-<15mm) and standard neck (>=15mm) cohorts in terms of type Ia endoleak rate and aneurysm diameter increase. Low rates of aneurysm rupture and conversion to open surgery were demonstrated through four-year follow-up, and there was no significant difference between the cohorts in terms of secondary endovascular procedures. Freedom from aneurysm-related mortality at four-years was 99.2% for the short neck cohort and 98.3% for the standard length necks.
The Endurant stent graft system is approved outside of the USA for use in patients with aneurysm neck lengths of >=10mm and <=60 degrees infra-renal angulation and >=15mm with <=75 degrees infra-renal angulation. In the USA, the Endurant stent graft system is indicated for necks >=10mm and <=60 degrees infra-renal angulation.
The Endurant system received the CE mark in June 2008, and since then the global ENGAGE registry has enrolled more than 1,200 patients at 79 sites across six continents. US Food and Drug Administration (FDA) approval was received in December 2010. With ten-year follow-up planned for all patients, the ENGAGE registry represents the most robust post-market registry ever initiated.
Marc RHM van Sambeek, Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands, will report on the four-year full cohort analysis from the global ENGAGE registry at the VEITHsymposium on 21 November.