Clinical ResearchA Single-Institution Experience with the AneuRx Stent Graft for Endovascular Repair of Abdominal Aortic Aneurysm
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)
Randomized EVAR trials and the advent of level I evidence: a paradigm shift in the management of large abdominal aortic aneurysms?
Semin Vasc Surg
(2006)- et al.
Reporting standard for endovascular aortic aneurysm repair
J Vasc Surg
(2002) - et al.
Stent graft migration after endovascular aneurysm repair: importance of proximal fixation
J Vasc Surg
(2003) - et al.
The importance of iliac fixation in prevention of stent graft migration
J Vasc Surg
(2006) - et al.
Endograft migration one to four years after endovascular abdominal aortic aneurysm repair with the AneuRx device: a cautionary note
J Vasc Surg
(2002) - et al.
Mid- and long-term device migration after endovascular abdominal aortic aneurysm repair: a comparison of AneuRx and Zenith endografts
J Vasc Surg
(2005) - et al.
Aortic neck dilation after endovascular abdominal aortic aneurysm repair: should oversizing be blamed?
Ann Vasc Surg
(2006) - et al.
AneuRx device migration: incidence, risk factors, and consequences
Ann Vasc Surg
(2005) - et al.
Aortic neck attachment failure and the AneuRx graft: incidence, treatment options, and early results
Ann Vasc Surg
(2005) - et al.
Midterm follow-up of a single-center experience of endovascular repair of abdominal aortic aneurysms with use of the Talent stent-graft
J Vasc Interv Radiol
(2006)
Short-term (30-day) outcome of endovascular treatment of abdominal aortic aneurysm: results from the prospective Registry of Endovascular Treatment of Abdominal Aortic Aneurysm (RETA)
Eur J Vasc Endovasc Surg
Endovascular abdominal aortic aneurysm repair: long-term outcome measures in patients at high-risk for open surgery
J Vasc Surg
Cited by (8)
Closure of an unusual morphology patent ductus arteriosus with a covered stent in a dog
2020, Journal of Veterinary CardiologyCitation Excerpt :CS placement is an interventional procedure currently used in human medicine for simultaneous management of coarctation of the aorta and PDA, for coarctation of the aorta alone, treatment of aortic pseudoaneurism or aneurism, right ventricular percutaneous stenting before percutaneous valve implantation, and in some cases of pulmonary artery stenosis or caval vein obstruction [12–14]. Different types of CSs to treat aortic coarctation have been used and include Jostent grafts, CP stents, and AneuRx [15,16]. The CP stent is especially designed for the treatment of vascular obstructions associated with congenital heart diseases and can be dilated to large diameters of 20 mm or beyond [17].
Aneurysm-related mortality rates in the US AneuRx clinical trial
2010, Journal of the American College of SurgeonsCitation Excerpt :Other reported experiences with AneuRx grafts are consistent with the increase in risk of aneurysm-related death with the passage of time. In 2 studies that were much smaller than ours, aneurysm-related deaths occurred in 6% of patients after 5 years in a series reported by Smith and colleagues,36 and 7% at 5 years (10% at 9 years) in a series reported by van Herwaarden and associates.37 A study by Lederle and coworkers38 demonstrated greater early mortality associated with AneuRx compared with open procedure mortality (hazard ratio 0.7; 95% CI 0.6 to 4.7); early mortality associated with the Cook Zenith and Gore Excluder stent grafts was less than that associated with open surgery.
Endovascular abdominal aortic aneurysm repair: Part I
2009, Annals of Vascular SurgerySyndecan-4 mediates macrophage uptake of group V secretory phospholipase A<inf>2</inf>-modified LDL
2009, Journal of Lipid ResearchCitation Excerpt :It is also possible that other pathophysiological conditions known to affect HSPG levels and/or sulfation of GAG chains, such as insulin resistance and diabetes (40, 41), may alter the interaction of macrophages with GV-LDL. A potential role for syndecan-4 in atherogenic processes is substantiated by several studies showing expression of this molecule by macrophages and in the vasculature, and evidence that this molecule is strongly upregulated under acute injury and chronic pro-atherogenic conditions (42–44). In conclusion, our data point to a physiologic modification of LDL that triggers an increased uptake by macrophages through a syndecan-4-dependent pathway.
Occurrence and outcomes of type 3 endoleaks in endovascular aortic repair within the Vascular Quality Initiative database
2020, BMJ Surgery, Interventions, and Health TechnologiesThe evolution of stent grafts for endovascular repair of abdominal aortic aneurysms: how design changes affect clinical outcomes
2019, Expert Review of Medical Devices
Supported by a research grant from Medtronic, Inc.