OBJECTIVE: We performed a device-specific comparison of long-term outcomes following endovascular abdominal aortic aneurysm repair (EVAR) to determine the effect(s) of device type on early and late clinical outcomes. In addition, the impact of performing EVAR both within and outside of specific instructions for use (IFU) for each device was examined. METHODS: Between January 8, 1999 and December 31, 2005, 565 patients underwent EVAR utilizing one of three commercially available stent graft devices. Study outcomes included perioperative (< or =30 days) mortality, intraoperative technical complications and need for adjunctive procedures, aneurysm rupture, aneurysm-related mortality, conversion to open repair, reintervention, development and/or resolution of endoleak, device related adverse events (migration, thrombosis, or kinking), and a combined endpoint of any graft-related adverse event (GRAE). Study outcomes were correlated by aneurysm morphology that was within or outside of the recommended device IFU. chi2 and Kaplan Meier methods were used for analysis. RESULTS: Grafts implanted included 177 Cook Zenith (CZ, 31%), 111 Gore Excluder (GE, 20%), and 277 Medtronic AneuRx (MA, 49%); 39.3% of grafts were placed outside of at least one IFU parameter. Mean follow-up was 30 +/- 21 months and was shorter for CZ (20 months CZ vs 35 and 31 months for GE and MA, respectively; P < .001). Overall actuarial 5-year freedom from aneurysm-related death, reintervention, and GRAE was similar among devices. CZ had a lower number of graft migration events (0 CZ vs 1 GE and 9 MA); however, there was no difference between devices on actuarial analysis. Combined GRAE was lowest for CZ (29% CZ, 35% GE, and 43% MA; P = .01). Graft placement outside of IFU was associated with similar 5-year freedom from aneurysm-related death, migration, and reintervention (P > .05), but a lower freedom from GRAE (74% outside IFU vs 86% within IFU; P = .021), likely related to a higher incidence of graft thrombosis (2.3% outside IFU vs 0.3% within IFU; P = .026). The differences in outcome for grafts placed within vs outside IFU were not device-specific. CONCLUSION: EVAR performed with three commercially available devices provided similar clinically relevant outcomes at 5 years, although no graft migration occurred with a suprarenal fixation device. As anticipated, application outside of anatomically specific IFU variables had an incremental negative effect on late results, indicating that adherence to such IFU guidelines is appropriate clinical practice.
OBJECTIVE: We performed a device-specific comparison of long-term outcomes following endovascular abdominal aortic aneurysm repair (EVAR) to determine the effect(s) of device type on early and late clinical outcomes. In addition, the impact of performing EVAR both within and outside of specific instructions for use (IFU) for each device was examined. METHODS: Between January 8, 1999 and December 31, 2005, 565 patients underwent EVAR utilizing one of three commercially available stent graft devices. Study outcomes included perioperative (< or =30 days) mortality, intraoperative technical complications and need for adjunctive procedures, aneurysm rupture, aneurysm-related mortality, conversion to open repair, reintervention, development and/or resolution of endoleak, device related adverse events (migration, thrombosis, or kinking), and a combined endpoint of any graft-related adverse event (GRAE). Study outcomes were correlated by aneurysm morphology that was within or outside of the recommended device IFU. chi2 and Kaplan Meier methods were used for analysis. RESULTS: Grafts implanted included 177 Cook Zenith (CZ, 31%), 111 Gore Excluder (GE, 20%), and 277 Medtronic AneuRx (MA, 49%); 39.3% of grafts were placed outside of at least one IFU parameter. Mean follow-up was 30 +/- 21 months and was shorter for CZ (20 months CZ vs 35 and 31 months for GE and MA, respectively; P < .001). Overall actuarial 5-year freedom from aneurysm-related death, reintervention, and GRAE was similar among devices. CZ had a lower number of graft migration events (0 CZ vs 1 GE and 9 MA); however, there was no difference between devices on actuarial analysis. Combined GRAE was lowest for CZ (29% CZ, 35% GE, and 43% MA; P = .01). Graft placement outside of IFU was associated with similar 5-year freedom from aneurysm-related death, migration, and reintervention (P > .05), but a lower freedom from GRAE (74% outside IFU vs 86% within IFU; P = .021), likely related to a higher incidence of graft thrombosis (2.3% outside IFU vs 0.3% within IFU; P = .026). The differences in outcome for grafts placed within vs outside IFU were not device-specific. CONCLUSION: EVAR performed with three commercially available devices provided similar clinically relevant outcomes at 5 years, although no graft migration occurred with a suprarenal fixation device. As anticipated, application outside of anatomically specific IFU variables had an incremental negative effect on late results, indicating that adherence to such IFU guidelines is appropriate clinical practice.
Authors: Salvatore T Scali; Michael M McNally; Robert J Feezor; Catherine K Chang; Alyson L Waterman; Scott A Berceli; Thomas S Huber; Adam W Beck Journal: J Vasc Surg Date: 2014-03-27 Impact factor: 4.268
Authors: Jade S Hiramoto; Catherine K Chang; Linda M Reilly; Darren B Schneider; Joseph H Rapp; Timothy A M Chuter Journal: J Vasc Surg Date: 2009-02-23 Impact factor: 4.268
Authors: Robert W Chang; Philip Goodney; Lue-Yen Tucker; Steven Okuhn; Hong Hua; Ann Rhoades; Nayan Sivamurthy; Bradley Hill Journal: J Vasc Surg Date: 2013-05-14 Impact factor: 4.268