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The Journal of Cardiovascular Surgery 2002 June;43(3):359-67


lingua: Inglese

Endovascular abdominal aortic aneurysm (AAA) repair since the FDA approval. Are we going too far?

Adelman M. A., Rockman C. B., Lamparello P. J., Jacobowitz G. R., Tuerff S., Gagne P. J., Nalbandian M., Weisswasser J., Landis R., Rosen R. J., Riles T. S.

From the Departments of Vascular Surgery and *Interventional Radiology New York University Medical Center, New York, USA


Back­ground. ­Since the FDA ­approval of endo­vas­cular ­devices for abdominal aortic aneurysm (AAA) ­repair, cli­ni­cians ­have ­been ­relaxing the ­strict inclu­sion cri­teria of the clin­ical ­trials. We ­have ­reviewed our expe­ri­ence ­during and ­after the clin­ical ­trials to ­examine ­changes in ­patient selec­tion, tech­nical ­aspects of the pro­ce­dure, and out­come.
­Methods. A ­review of a pros­pec­tively com­piled data­base of all endo­vas­cular AAA ­repairs per­formed at our insti­tu­tion was per­formed.
­Results. Endo­vas­cular AAA ­repair was ­attempted in 130 ­patients: 46 (35.4%) as a ­part of clin­ical ­trials (­Group I), and 84 (64.6%) ­since the FDA ­approval of the ­devices (Group II). Sig­nif­i­cant dif­fer­ences in ­patient selec­tion ­included: a ­higher pro­por­tion of ­short (<15 mm) prox­imal ­necks in ­Group II (28.6 vs 0.0%, p<0.001), and a ­higher pro­por­tion of ­iliac occlu­sive dis­ease in ­Group II (48.8 vs 15.4%, p=0.001). Addi­tional ­trends sug­gested ­that ­Group II ­AAA’s ­were ­more com­plex, ­including ­increased prox­imal ­neck angu­la­tion, ­increased prox­imal cal­cifi­ca­tion, ­increased pres­ence of prox­imal ­thrombus, and ­increased ­iliac tor­tu­osity. Sig­nif­i­cant dif­fer­ences in tech­nical ­aspects of the pro­ce­dure ­included ­increased ­usage of ­iliac angio­plasty (46.4 vs 13.3%, p<0.001), ­iliac ­stenting (31 vs 8.9%, p<0.01), and con­duit ­access to the ­external ­iliac ­artery (10.7 vs 0%, p=0.03) in ­Group II. Anal­ysis of out­come ­revealed a ­decreased inci­dence of the fol­lowing in ­Group II ­cases: con­ver­sions to ­open ­repair (2.4 vs 10.9%), ­lower ­extremity ­ischemia (3.6 vs 13.0%), and ­graft ­limb occlu­sion (2.4 vs 8.7%). ­Other ­major per­i­op­er­a­tive com­pli­ca­tions did not ­differ sig­nif­i­cantly ­between the 2 ­groups. How­ever, ­although the ­overall ­rate of any endo­leak ­noted in the post­op­er­a­tive ­course was ­decreased in ­Group II ­cases (26.2 vs 32.6%), the inci­dence of prox­imal or ­distal attach­ment ­site ­leaks has ­increased (11.9 vs 4.3%, p=0.14). ­Although ­this com­par­ison did not ­reach sta­tis­tical sig­nif­i­cance, the mag­ni­tude of the ­increase is con­cerning.
Con­clu­sions. ­Although we ­have ­been ­able to ­offer endo­vas­cular AAA ­repair to a ­larger ­number of ­patients ­since FDA ­approval, endo­vas­cular man­age­ment of increas­ingly com­plex prox­imal ­necks and ­increased ­iliac ­artery dis­ease ­appears to ­have ­increased the inci­dence of attach­ment ­site endo­leaks. ­Although ­many of ­these ­leaks ­have ­been suc­cess­fully man­aged ­with adjunc­tive endo­vas­cular pro­ce­dures, ­their ­increasing inci­dence is wor­ri­some and sug­gests ­that we may ­need to re-eval­uate cur­rent inclu­sion cri­teria for ­using ­this tech­nology. ­Although dif­fi­cult ­access ­issues ­have ­been han­dled ­with adjunc­tive pro­ce­dures, the pres­ence of a ­short, angu­lated prox­imal ­neck may be dif­fi­cult to over­come, and may not be ­well ­suited for endo­vas­cular ­repair ­with the cur­rently avail­able ­devices.

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