Elsevier

Annals of Vascular Surgery

Volume 22, Issue 2, March–April 2008, Pages 221-226
Annals of Vascular Surgery

Clinical Research
A Single-Institution Experience with the AneuRx Stent Graft for Endovascular Repair of Abdominal Aortic Aneurysm

https://doi.org/10.1016/j.avsg.2008.01.001Get rights and content

We report our experience of endovascular repair of infrarenal abdominal aortic aneurysms (EVAR) using the modular AneuRx Stent Graft System. We retrospectively reviewed the outcomes of 113 patients who underwent EVAR with the AneuRx system performed at our institution between October 1999 and August 2003. The mean age of this group was 72.5 years, with 71% (n = 80) over the age of 70 years and 95% (n = 107) males. Aneurysm diameter ranged 4.0-9.0 cm, with 33% (n = 37) >6.0 cm. The average duration of late follow-up was 32.6 ± 24.8 months (median = 37). Successful deployment of the modular AneuRx system was noted in all patients. There were no immediate operative conversions, deaths within 24 hr of operation, or type I or III endoleaks observed at the completion of the procedure. Thirty-day mortality was 3.5% (n = 4). Acute deployment-related complications occurred in 10% (n = 13) of patients and included misdeployment, operative bleeding, arterial perforation/dissection, and access site complications. Acute systemic complications were present in nine patients, predominantly renal and cardiac complications. An endoleak noted at any time occurred in 25% of patients, with 40% of those requiring a secondary intervention. Two patients suffered late aneurysm rupture due to a type I endoleak and graft infection. Kaplan-Meier analysis revealed 5-year freedom from secondary intervention of 72.4%; freedom from aneurysm-related death of 93.9%; and probability of survival based on all-cause mortality of 60.1%. Endovascular treatment with the modular AneuRx Stent Graft System is safe and effective, producing acceptable rates of disease-free survival and mid-term clinical outcome.

Introduction

The less invasive nature of endovascular aortic aneurysm repair (EVAR) has made it an attractive option for the treatment of abdominal aortic aneurysms (AAAs), yet questions remain regarding the long-term clinical efficacy of this approach.1, 2 Since the approval of commercial endovascular grafts for the treatment of aortic aneurysms in 1998, the number aneurysms treated by EVAR in the United States has increased substantially. Several single-center reports have noted that 65-70% of infrarenal AAAx are currently managed by EVAR,3 and in New York State in 2002 the number of AAAs repaired by endovascular procedures outnumbered those repaired by open surgical techniques.4 Significantly, level I evidence recently generated through the Endovascular Aneurysm Repair versus Open Repair in Patients with Abdominal Aortic Aneurysm (EVAR) and the Dutch Randomized Endovascular Aneurysm Management (DREAM) clinical trials using a wide variety of devices has now confirmed that endovascular therapy is associated with a reduction in aneurysm-related deaths compared to open surgery. This mortality benefit, in addition to reduced perioperative morbidity, decreased lengths of stay in both hospital and intensive care unit settings, and reduced blood loss and transfusion requirements, has provided further support to the advantages of EVAR over open repair.5, 6, 7 Thus, while problems remain, including increased cost and the need for reintervention, EVAR appears to provide both an effective and a durable option for treatment of AAA both in clinical trials and in “real-world” settings.

Of the currently available endovascular grafts, the AneuRx Stent Graft System (Medtronic, Santa Rosa, CA) was the first to be commercially approved by the U.S. Food and Drug Administration (FDA). In January 2005, Medtronic reported data from pivotal clinical trials that included a 5-year freedom from aneurysm rupture of 96.7% and a freedom from aneurysm-related death of 91.3%. While commendable, clinical trial data may not necessarily reflect outcomes for those patients treated outside of the relatively restrictive inclusion and exclusion criteria and the requisite scrutiny of an industry-sponsored investigation. In this regard, several centers have highlighted concerns regarding the AneuRx system, including an increased incidence of clinically significant device migration. Notably, in December 2003 the FDA issued a public health notification, which stated that “the risk of late AAA-related mortality associated with AneuRx may exceed that associated with open surgery [and] the overall AAA-associated mortality from the AneuRx Stent Graft is likely to cross-over and exceed the AAA-associated mortality from open surgery at some point in time.”8 Given the uncertainties in clinical performance raised by these reports, use of the AneuRx device decreased significantly at our institution after an initial experience with over 100 implants. In this study, we reviewed our experience with patients initially treated with the AneuRx device in order to assess the effectiveness and durability of this endograft with a particular emphasis on aneurysm-related death, need for reintervention, and all-cause mortality.

Section snippets

Patient Population

We retrospectively reviewed all patients who underwent endovascular treatment of aortoiliac aneurysms with an AneuRx device between October 1999 and August 2003 at Emory University Hospital and the Atlanta Veterans Affairs Medical Center. The Emory University Institutional Review Board approved this study. Information pertaining to preoperative imaging, operative procedure, perioperative and postoperative complications, and follow-up data was gathered from hospital medical records, radiology

Results

From October 1999 to August 2003, 113 patients were treated for aortoiliac aneurysms with the AneuRx stent graft. Mean patient age was 73.8 ± 7.5 years, with 71% (n = 80) over the age of 70 years. The study population consisted largely of male patients (n = 107, 95%). Preoperative aneurysm diameter ranged 4.0-9.0 cm (5.7 ± 0.9), with 33% (n = 37) of aneurysms >6.0 cm. The technical success rate was 100%, without perioperative mortality within 24 hr of device implantation or a type I/III

Discussion

After EVAR, patients are subjected to rigorous radiographic and clinical follow-up to detect potential mid-term and late complications, which may include aneurysm rupture or expansion, endoleak, device infection, limb thrombosis, or device migration. Positional stability of the device is essential for durability and freedom from secondary procedures. Short proximal10 and distal11 fixation lengths, aortic neck dilation, and endograft oversizing12 have been implicated as risk factors for

References (25)

Cited by (8)

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Supported by a research grant from Medtronic, Inc.

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