Anatomic feasibility of off-the-shelf fenestrated stent grafts to treat juxtarenal and pararenal abdominal aortic aneurysms (original) (raw)
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Ventana Fenestrated Stent-Graft System for Endovascular Repair of Juxtarenal Aortic Aneurysms
Journal of Endovascular Therapy, 2012
To describe the initial use of an off-the-shelf fenestrated stent-graft system for endovascular repair of juxtarenal abdominal aortic aneurysms. Technique: The off-the-shelf Ventana fenestrated stent-graft system consists of a 25-mm IntuiTrak self-expanding bifurcated stent-graft implanted at the aortic bifurcation. A Ventana self-expanding fenestrated proximal extension stent-graft is overlapped with the bifurcated body distally and sealed proximally in the visceral segment with a 4-cm-long scallop below and around the SMA and celiac artery, obviating the need for an infrarenal neck. Movable, non-reinforced, 3-mm fenestrations for the renal arteries can be expanded to 10 mm. The 22-F delivery system includes 6.5-F guide sheaths pre-inserted through the stent-graft fenestrations so that the renal arteries are cannulated before the fenestrated stent-graft is deployed. The Xpand renal stent-grafts, with a proximal segment intended for flaring in the aorta, are delivered on 5-F or 6-F balloon catheters through the 6.5-F guide sheaths. The technique is illustrated in 2 patients (76 and 77 years of age) with significant comorbidities and juxtarenal aortic aneurysms measuring 5.9 and 7.4 mm, respectively, who were enrolled in an ongoing prospective trial (www.ClinicalTrials.gov identifier NCT01348828) of this new device. Patient 1 had a 28-mm fenestrated stent-graft system with the aligned fenestration configuration deployed, while the stent-graft in Patient 2 was 32 mm in diameter and had offset fenestrations to accommodate the renal artery geometry. Mean fluoroscopy times were 27 and 35 minutes, and the contrast volumes were 72 and 67 mL. Total procedure times were 84 and 71 minutes. The aneurysms were effectively excluded in uneventful procedures, with no migration, endoleak, or renal dysfunction at 6-month follow-up. Conclusion: There exists an unmet clinical need for a broadly applicable endovascular option for repair of more complex juxtarenal or pararenal aortic aneurysms. These cases suggest that endovascular repair of such aneurysms using the Ventana fully integrated offthe-shelf stent-graft system is safe and feasible.
Journal of Vascular Surgery, 2013
Objective: This study assessed preliminary results of the Ventana Fenestrated System (Endologix, Irvine, Calif) as an off-theshelf integrated device for juxtarenal aortic aneurysm (JAA) or pararenal aortic aneurysm (PAA) endovascular repair. Methods: From November 2010 to April 2012, seven centers enrolled 31 patients with JAAs or PAAs in an international clinical trial of the Ventana Fenestrated System. Clinical and laboratory evaluations were done predischarge and at 1 month, with continuing follow-up through 5 years. Core laboratory computed tomography imaging assessments were performed at 1 month and at each subsequent follow-up. Results: Patients (mean age, 73 years; 90% male) presented with mean aneurysm sac diameter of 6.0 cm. One patient with a short, reversed tapered infra-superior mesenteric artery (SMA) neck was enrolled under a protocol waiver. Among the 31 patients, one of five Ventana device models was used to preserve main renal arteries, the SMA, and celiac arteries; 20 patients (65%) received the same Ventana device (aligned fenestrations, 28-mm diameter). Median fluoroscopy and procedure times were 49 and 197 minutes, respectively; median hospital length of stay was 3.0 days. The 1-month clinical success rate was 94% (29 of 31), with no perioperative mortality. One intervention on day 26 was done to resolve limb kink/occlusion. A type IA endoleak and renal occlusion secondary to procedural device damage led to a reintervention on day 52 and dialysis at 5 months. During follow-up to 23 months, three non-aneurysm-related deaths occurred. No aneurysm rupture or conversion to open repair has occurred. One late migration with endoleak and covered renal stent fracture/occlusion occurred at 8 months in the patient with a short, reverse tapered infra-SMA neck performed under a protocol waiver, which was managed successfully with bilateral renal bypasses and endovascular repair of the endoleak. Another patient underwent late endovascular interventions to resolve bilateral renal stenosis. Conclusions: The multicenter experience of the Ventana Fenestrated System supports its safety and early-term to midterm effectiveness for the endovascular repair of JAAs and PAAs. This off-the-shelf integrated system permits endovascular treatment of JAAs or PAAs; however, further expanded clinical experience and longer-term follow-up are needed to more fully assess this device system.
Endovascular management of juxtarenal aneurysms with fenestrated endovascular grafting
2004
Purpose: To evaluate the technical feasibility and short-term results of juxtarenal aneurysm repair with an endovascular graft that incorporated the visceral aortic segment with graft material. Methods: Patients were studied prospectively after the implantation of an endovascular device with graft material extending proximal to the renal arteries, variably incorporating the superior mesenteric and celiac arteries. All patients were deemed to be high risk with respect to open surgical repair and had compromised proximal neck anatomy. Proximal neck lengths were <10 mm, or <15 mm with a challenging morphology (funnel shape or extensive thrombus). Fenestrations within the graft material were customized to accommodate visceral and renal vessels on the basis of computerized tomography (CT), angiography, or intravascular ultrasound data. Selected visceral ostia were protected with balloon-expandable stents after partial endograft deployment. All patients were evaluated with CT and kidney, ureters, and bladder x-ray at discharge and at 1, 6, and 12 months. Visceral duplex scan studies were performed at 1, 6, and 12 months. Results: A total of 22 patients were enrolled in the study. Sixteen patients had short proximal necks (3-10 mm), and six had compromised necks of 10 to 15 mm in length. Endograft design included bifurcated (20) and tube (2) systems. All prostheses were implanted successfully without the acute loss of any visceral arteries. A total of 58 visceral vessels were incorporated (mean, 2.6 per patient) and most commonly included both renal arteries and the superior mesenteric artery. The mean follow-up was 6 months. There were no deaths within 30 days and no aneurysm-related deaths during the follow-up period. Two early (<30 days) and two late secondary interventions were performed, inclusive of two visceral artery stenoses detected with duplex scanning. The 30-day endoleak rate was 4.5%. The aneurysm sac decreased greater than 5 mm in 53 % of patients at 6 months and three of four patients at 12 months. Three patients developed renal insufficiency, only one of which required temporary hemodialysis. Conclusions: The placement of an endovascular prosthesis with graft material that incorporates the visceral arteries is technically feasible. The occurrence of endoleaks appears to be relatively low. The increased sealing and fixation zones in this patient population should limit the late development of proximal endoleak or migration; however, this situation will require more patients and extended follow-up. (J Vasc Surg 2004;39:279-87.) From the Department of Vascular Surgery, Cleveland Clinic Foundation.
Fenestrated endovascular repair for juxtarenal aortic aneurysm
British Journal of Surgery, 2008
Background The outcome of fenestrated endovascular aneurysm repair (F-EVAR) was evaluated. Methods Between February 2003 and December 2006, 45 patients (median age 73 (range 53–85) years) underwent primary (41) or secondary (four) F-EVAR for an abdominal aortic aneurysm with infrarenal neck anatomy unsuitable for a standard stent-graft. Median aneurysm diameter was 68 (range 55–100) mm and median infrarenal aortic neck length was 6 (range 0–13) mm. Customized fenestrated Zenith® stent-grafts were employed in all procedures, incorporating fenestrations to preserve flow into renal (80), superior mesenteric (35) and coeliac (two) arteries. Eighty-two target vessels were stented (61 bare metal, 21 covered). Results All aneurysms were isolated successfully, with preservation of the target vessels. One accessory renal artery was lost. One patient died after 5 days from myocardial infarction, and another at 3 months from multiorgan failure secondary to atheroembolism. At median follow-up o...
Fenestrated endovascular repair for juxtarenal aortic pathology
Journal of Vascular Surgery, 2009
Objective: To evaluate the outcomes after fenestrated endovascular aortic repair (f-EVAR) in a tertiary European referral center. Methods: All patients treated with commercially available custom-made f-EVAR between September 2002 and June 2007 were prospectively enrolled in a computerized database including co-morbidities and aneurysm morphology. Patients were retrospectively analyzed. Follow-up consisted of clinical examinations and computed tomography (CT) scanning. Results: A total of 54 patients were included in this study. Median age was 72 (interquartile range [IQR] 68-76) years and 85% were men. Median preoperative aneurysm diameter was 60 (53-66) mm. One hundred thirty-four vessels were targeted (43 scallops, 91 fenestrations) and 96 stents were placed (69 bare, 27 covered). Target vessel catheterization was achieved in 98% of cases. Two patients (3.7%) died within 30 days, 1 from trash embolization and multiorgan failure and 1 from retroperitoneal bleeding caused by a renal artery perforation. Three type I endoleaks occurred intraoperatively, two sealed pre-discharge and one was treated with a Palmaz stent (Cordis, Miami Lakes, Fla) on postoperative day 4. Thirteen patients had type II endoleaks, and 2 required treatment. The median clinical follow-up was 25 (12-32) months with median CT follow-up of 22 (4-26) months. Aneurysm diameter decreased >5 mm in 47%, was unchanged in 50%, and increased >5 mm in 3% of patients at 1 year. There were three type II endoleaks at 1-year follow-up, one of which was successfully treated after 19 months due to aneurysm growth. Ninety-six percent of target vessels remained patent during the study period and all occlusions occurred within the first year of follow-up. Five target vessels occluded (2 renal arteries [RAs] and 3 superior mesenteric arteries [SMAs]) without symptoms during follow-up and successful reinterventions were done on 2 stenosed RAs. Three patients suffered creatinine increase but none needed dialysis. One late aneurysm-related death occurred due to massive bleeding during redo surgery for infection.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, 2015
To evaluate the anatomic suitability of the Zenith pivot branch (p-branch) fenestrated device in ruptured abdominal aortic aneurysms (rAAA). Contrast-enhanced computed tomography (CT) images of 206 patients (mean age 75±8 years; 175 men) with rAAA were evaluated in a dedicated 3-dimensional vascular workstation. All aneurysms found unsuitable for standard infrarenal repair were evaluated for Zenith p-branch suitability according to the Investigational Device Exemption protocol for both device configurations (A, pivot fenestrations at the same level; B, right renal fenestration located more cranially). The suitability of the p-branch (A or B configuration) for short neck aneurysms (<15 mm; n=89) was 49%; of the 26 different combinations of exclusion criteria, a mismatch between a renal artery takeoff and the positioning of the corresponding fenestration was the most common. For juxta- and pararenal aneurysms (neck length <10 mm; n=66), suitability was 48%. Suitability assessed ...
Journal of Vascular Surgery, 2009
Objective: Para-anastomotic aortic aneurysms and progressive aneurysmal degeneration of the aorta after previous open aortic reconstruction pose a challenging clinical scenario. Due to the proximity to the visceral arteries, endovascular exclusion is typically not an option. However, the development of fenestrated and branched endografts has provided a less invasive means of repair. We sought to evaluate our experience using fenestrated endografts in the management of juxtarenal aortic aneurysms after previous open aortic reconstruction. Methods: This is an analysis of patients who have undergone fenestrated endovascular repair specifically for juxtarenal aneurysms in the setting of previous infrarenal open aortic surgery. Patients were treated with customized Cook (William A. Cook Australia, Ltd, Brisbane, Australia) endografts manufactured based on preoperative 3-dimensional (3-D) imaging. All patients underwent repair under the direction of a single surgeon. Results: Eighteen patients were treated from March 2004 to November 2008. All patients had a previous open aortic reconstruction, and 3 patients had two prior reconstructions. The mean time since the last operation was 8.5 years (range, 1-15 years). Mean patient age was 72-years-old (range, 57-80 years). All patients were considered high risk for open surgery due to pre-existing medical co-morbidities and/or the redo nature of their surgery. . Thirty-day and 1-year mortality was 0 and 11%, respectively. Perioperative complications occurred in 2 patients. One patient developed a congestive heart failure exacerbation and myocardial infarction, and the other patient a groin wound infection. Mean follow-up time was 23 months and cumulative primary patency was 95% (53/56 vessels), with no follow-up interventions. Conclusion: Endovascular treatment of juxtarenal aneurysms after prior aortic reconstruction is a viable alternative to open repair with high success and low reintervention rates. These devices will broaden the available treatment modalities for these conditions, and will likely significantly decrease the complication rate of treatment in these high-risk patients. ( J Vasc Surg 2009;49:1387-94.)
Early Experience with Fenestrated Stent Grafts for Treatment of Juxtarenal Aortic Aneurysm
Annals of Vascular Diseases, 2013
E ndovascular abdominal aortic aneurysm repair (EVAR) has been performed in more than 20000 cases in Japan since Zenith (Cook Medical Inc., Bloomington, Indiana, USA) stent-graft device was approved for clinical use on July 11, 2006. 1) The safe and minimal invasiveness of the technique has promoted its widespread use across the entire country. 2) However, the commercial EVAR devices currently available in Japan require that the aortic proximal neck be placed at least 10 mm in length below the lower renal artery, which precludes the application of EVAR in short-necked and juxtarenal aortic aneurysms (JAAs). Open repair with aortic clamping above the renal arteries is the gold standard for treatment of JAAs. Technological advances have led to the development of fenestrated stent-grafts with the branched technique for the treatment of JAAs. 3,4) On October 25, 2005, the Zenith Fenestrated AAA Endovascular Graft (Cook Medical Inc., USA) received the first Conformité Européenne (CE) mark in Europe. On April 4, 2012, the Food and Drug Administration (FDA) approved the device for commercial use in the United States. The device is