科研之友
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摘要
Background: Long-term concerns about the durability of endovascular aortic aneurysm repair (EVAR) remain after the publication of controlled trials. Increased expertise in endograft technology, case selection and postoperative reintervention has created a need for reappraisal of the longer-term efficacy of EVAR using contemporary data.
Methods: Patients undergoing infrarenal EVAR between 2004 and 2010 were studied prospectively. Morphological compliance with manufacturers' instructions for use (IFU) was established using three-dimensional computed tomography. The primary outcome measures were all-cause and aneurysm-related mortality, postoperative rupture, reintervention and sac expansion. These adverse events were reported using KaplanMeier survival analysis, with comparison within, or outside IFU by the log rank test.
Results: Some 478 patients of median age 76 years had a median aneurysm diameter of 62.9 mm. Median follow-up was 44 (range 1194) months; 198 (41.4 per cent) were compliant with IFU. The 30-day mortality rate was 2.1 per cent (10 of 478 patients): nine (2.0 per cent) of 455 patients who had elective and one (4 per cent) of 23 patients who had non-elective surgery. Aneurysm-related mortality was 0.897 deaths per 100 person-years, and all-cause mortality was 8.558 deaths per 100 person-years, with significantly lower survival outside IFU (P = 0.012). Two patients had a late rupture (0.138 per 100 person-years), of whom one died. There were 6.120 reinterventions per 100 person-years, with no difference for aneurysms treated outside IFU (P = 0.136). Primary sac expansion occurred in 6.721 per 100 person-years and secondary sac expansion in 4.142 per 100 person-years.
Conclusion: In this series EVAR had a lower aneurysm-related mortality rate than demonstrated in early controlled trials, and with lower sac expansion rates than reported from image repositories. Data from earlier studies should be applied to current practice with caution.
- 出版日期2012-12
