Food and Drug Administration-approved endovascular repair devices for abdominal aortic aneurysms: a review.
ABSTRACT Endovascular treatment of infrarenal abdominal aortic aneurysm (AAA) offers a less invasive alternative to conventional open repair. Currently, only four devices are Food and Drug Administration (FDA)-approved for use in endovascular aneurysm repair (EVAR) of AAA in the United States. All four devices are associated with a high technical success rate and less morbidity than open surgical repair. Each device has its inherent design advantages and disadvantages that must be matched with patient and AAA characteristics. This review will discuss and compare the technology and procedural outcomes data of the current FDA-approved EVAR devices.
- Journal of Endovascular Surgery 06/1998; 5(2):189-91.
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ABSTRACT: Percutaneous treatment of an abdominal aortic aneurysm (AAA) is feasible, but is associated with a unique set of risks. A comparison of Excluder endograft deployment with femoral artery cutdown (FAC) versus percutaneous femoral access (PFA) for treatment of infrarenal AAA was undertaken. A single-institution, controlled, retrospective review was carried out in patients who underwent either bilateral FAC or bilateral PFA for endovascular repair of infrarenal AAA with the Gore bifurcated Excluder endograft between March 1999 and November 2003. To November 2000, 35 patients underwent bilateral FAC; since then, 47 patients have undergone bilateral PFA. All have been followed up for at least 30 days. Mean AAA size was 5.7 cm in the FAC group and 6.0 cm in the PFA group. During hospitalization there were six access-related complications in the FAC group; three required early surgical intervention. In the PFA group nine perioperative access-related complications occurred, all consisting of either hemorrhage or arterial occlusion; seven required additional intervention, and were recognized and ameliorated while the patient was still in the operating room. At 30-day follow-up there were no additional access-related complications in the PFA group. There were eight other access-related complications in eight additional patients who underwent FAC. In patients undergoing bilateral PFA total operative time was shorter (PFA 139 minutes vs FAC 169 minutes; P =.002), total in-room anesthesia time was less (PFA 201 minutes vs FAC 225 minutes; P <.008), and use of general anesthesia was reduced (P <.001). No significant differences were observed between groups with respect to estimated blood loss (PFA 459 mL vs FAC 389 mL; P =.851). Complete percutaneous treatment of AAA may have some advantages over open femoral artery access, but it is not free from risk. Percutaneous treatment of AAA can be completed successfully in most patients, but should be performed at an institution where conversion to an open procedure can be completed expeditiously if necessary.Journal of Vascular Surgery 07/2004; 40(1):12-6. · 2.88 Impact Factor
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ABSTRACT: Aneurysm sac shrinkage after endovascular aneurysm repair (EAR) provides objective evidence of successful aneurysm exclusion and absence of endotension. Attainment of this outcome parameter may be device-dependent. In this study, 169 patients underwent EAR with an AneuRx (n = 118) or Zenith (n = 51) endograft at a single institution. A prospectively maintained database was examined for significant changes in aneurysm sac diameter (> or = 5 mm) on the basis of computed tomography (CT) measurements at 6 and 12 months follow-up. Significant aneurysm sac shrinkage (> or = 5 mm) occurred in 73.1 % (19/26) vs. 43.1% (28/65) of patients in the Zenith and AneuRx groups, respectively, at 12 months (p = 0.03). At 6 months follow-up, sac shrinkage rates were 51.4% (19/37) vs. 25.8% (16/62) in the Zenith and AneuRx groups, respectively (p = 0.04). Mean reduction of sac diameter at 12 months was -7.6 +/- 1.6 mm vs. -3.5 +/- 0.8 mm in the Zenith and AneuRx groups, respectively (p = 0.01). There was a trend toward fewer Type I and III endoleaks at 1 month in the Zenith group (0 vs. 8.3%) that did not achieve statistical significance (p = 0.067). The presence of any endoleak (> or = 1 month) was associated with reduced 12 month shrink rates from 47.1% (25/51) to 28% (4/14) in the AneuRx group (p = 0.35) and from 77.3% (17/22) to 50% (2/4) in the Zenith group (p = 0.25). Patients treated with the Zenith endograft demonstrated a significantly higher rate and amount of aneurysm sac shrinkage than patients treated with an AneuRx device. Endoleaks appeared to negatively influence shrink rates with both endografts.Annals of Vascular Surgery 01/2003; 17(1):49-53. · 0.99 Impact Factor