Objectives: to assess the early morbidity and mortality of a new treatment, the endovascular repair of abdominal aortic aneurysms, during its introduction into clinical practice.
Design: a prospective voluntary registry collecting demographic and risk factor data, details of aneurysm morphology, procedure performed, immediate and 30-day outcomes.
Setting: thirty-one U.K. centres performing endovascular repair submitted data.
Results: six hundred and eleven cases were registered in three years of data collection (January 1996 to December 1998). Four per cent of patients received an aortic tube device, 60% an aorto-bi-iliac device and 36% an aorto-uni-iliac device and a crossover graft (AUIC). Conversion to open repair was required in 5% of cases, with more conversions in the AUIC group (OR 2.9 (95% CI: 1.3-6.4)p=0.01). Post procedure complications occurred in 25% of cases. Unfit patients had significantly more complications than fit patients (35% vs 20% for fit patients (OR 1.8 (95% CI: 1.2-2.7)p=0.007)). At 30 days aneurysms were excluded in 90% of cases. Endoleaks were more common in larger aneurysms (2% if aneurysms were <6 cm in diameter vs 10% if >6 cm, OR 5.6 (95% CI: 2.1-14.9)p=0.0006). The overall mortality was 7% but was significantly higher for AUIC devices, (4% for combined aortic tube and bi-iliac devices (AT/BI) vs 12%, OR 2.6 (95% CI: 1.2-5.9 p=0.018)), and unfit patients (4% for fit patients vs 18%, OR 4.3 (95% CI: 2.0-9.5)p<0.001).
Conclusions: endovascular repair is feasible with short-term outcomes comparable to those of conventional surgical repair. In unfit patients the possible benefit in life expectancy gain must be balanced against the morbidity and mortality of the procedure.