Fenestrated and branched endograft repair of juxtarenal aneurysms after previous open aortic reconstruction (original) (raw)
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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 Vascular Surgery, 2008
increase in open juxtarenal aortic aneurysm (JAA) repairs. Fenestrated endograft technology for JAA is developing rapidly, but only limited outcomes are known. The aim of this study was to review our open JAA experience in an era of fenestrated endograft technology, identify factors associated with increased surgical risk, determine early and midterm outcome, and provide a basis for comparison for future endovascular procedures. Methods: Data from 126 consecutive patients who underwent elective JAA repair requiring suprarenal aortic clamping from 2001 to 2006 were analyzed retrospectively. Electronic medical chart reviews were used to record 30-day complication rates. Multivariate analyses were performed to identify risk factors associated with surgical morbidity. Mail-out questionnaires and telephone surveys were conducted to determine long-term follow-up. Results: Ninety-eight males and 28 females (median age 74 years; range 55 to 93) were included in the study. Preoperative risk factors included: coronary artery disease (CAD) 58%, pulmonary disease 41%, renal insufficiency (serum creatinine [Cr] > 1.5mg/dL) 17%, and diabetes 9%. Fifteen patients underwent concomitant renal artery revascularization. Mean operative time was 319 minutes (range 91 to 648). Thirty-day mortality was 1/126 (0.8%). Median hospital length of stay was 7 days (range 3 to 85); median intensive care unit length of stay was 2 days (1 to 64). Complications included renal insufficiency (Cr increase > 0.5 mg/dL) in 22 (18%), cardiac in 17 (13%), and pulmonary in 14 (11%). Five patients required temporary hemodialysis; only one after hospital dismissal. Mean follow-up was 48 months (range 9-80). On multivariate analysis, age > 78 years (P ؍ .001), male gender (P ؍ .04), hypertension (P ,)10.؍ previous myocardial infarction (P ؍ .047), and diabetes (P )900.؍ were predictive of cardiac complications. Renal artery revascularization (P ؍ .01) and prior MI (P ؍ .04) were multivariate predictors of pulmonary complications. Both prolonged operative (>351 minutes, P ؍ .02) and renal ischemia (>23 minutes, P )400.؍ times predicted postoperative renal insufficiency. One, 3, and 5-year cumulative survival rates were 93.9%, 78.3%, and 63.8%, respectively and were not significantly different than an age-and gender-matched sample of the US population (P ؍ .16). Mortality was not predicted by any specific risk factors. Conclusions: Open surgical repair of JAA is associated with low mortality and remains the gold standard. Although 18% had renal complications, only one patient had permanent renal failure. Patients with a combination of physiologic and anatomic risk factors identified on multivariate analysis may benefit from fenestrated endograft repair. ( J Vasc Surg 2008;47:695-701.)
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.
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
European Journal of Vascular and Endovascular Surgery, 2009
The authors stated that selective fenestrated endovascular repair appeared to have a lower peri-operative mortality rate than traditional open surgery for juxtarenal abdominal aortic aneurysm. However, the available evidence was poor quality. In view of the lack of properly controlled data, poor reporting of review methods and lack of information on study validity, these conclusions may not be reliable. Searching PubMed and EMBASE were searched for studies published in English from 2001 to 2008. Search terms were reported. Relevant medical journals were handsearched. Reference lists of eligible studies were checked. Study selection Studies that reported outcomes of more than 10 cases of juxtarenal aortic aneurysm following f-EVR or open surgical repair were eligible for inclusion. Outcomes of interest were 30-day mortality, renal impairment, target vessel patency, length of stay and secondary re-intervention rate. Studies of ruptured abdominal aortic aneurysm were excluded. Mean age of participants was 73.7 years in the f-EVR group and 71.8 years in the open surgery group. Most participants were male. All f-EVR studies used Zenith fenestrated endografts. Indications for secondary re-intervention in the review included endoleak, vessel stenosis, bleeding and embolism. Most studies were set in single specialist centres and had relatively short follow-up; the longest duration of follow-up reported in the review was one year. The authors stated neither how the papers were selected for the review nor how many reviewers performed the selection. Assessment of study quality The authors did not state that they assessed validity. Data extraction Event rates and 95% confidence intervals (CIs) were extracted from each study for each outcome. The authors did not state how many reviewers performed the data extraction. Methods of synthesis Summary event rates for each type of intervention were calculated, with 95% CIs. Comparative relative risks (RR) of the two groups were calculated. Fisher's exact test was used to assess heterogeneity within groups (for outcomes) and assess heterogeneity between groups for selected demographic and clinical variables, using contingency tables. Results of the review Twenty studies were included (n=1,532, range 13 to 247) reported on eight series of f-EVR (n=368) and 12 series of open surgery (n=1164). Six studies were prospective, 12 were retrospective, one was a case-control study and one was of unreported design. Thirty-day mortality after f-EVR was 1.4% (95% CI 0.4 to 3.1; eight studies) and after open repair was 3.6% (95% CI 2.7 to 4.9; 12 studies), indicating a significantly increased risk in the open repair group (RR 1.03, 95% CI 1.01 to 1.04). Transient renal impairment after f-EVR was 14.9% (95% CI 11.5 to 18.7; eight studies) and after open repair was 20%
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.
Journal of Vascular Surgery, 2014
The objective of this study was to evaluate the anatomic feasibility of two off-the-shelf fenestrated stent graft designs to treat juxtarenal and pararenal abdominal aortic aneurysms (AAAs). Methods: Digital computed tomography angiograms were analyzed in 520 consecutive patients treated by open or fenestrated endovascular repair for complex AAAs (2000-2012). The anatomic feasibility of two off-the-shelf fenestrated designs, Endologix Ventana (Endologix Inc, Irvine, Calif) and Cook p-Branch (Cook Medical, Brisbane, Australia), was analyzed with the instructions for use (IFU) proposed by investigational protocols. Results: There were 390 patients (75%) with juxtarenal and pararenal AAAs considered potential candidates for one of the two devices. Proximal seal (>15 mm) was achieved in all patients with the p-Branch and in 61% of the patients with the Ventana stent graft (P < .0001). The ability to incorporate visceral arteries was greater with the Ventana (90% vs 61%) compared with the p-Branch design (P < .0001). Less than a third of patients met strict IFU criteria with Ventana (27%) or p-Branch (33%; P < .05). By liberal IFU criteria, 42% of patients were candidates for Ventana and 49% for p-Branch (P < .03). Overall, 63% of the patients with juxtarenal and pararenal AAAs were candidates for endovascular repair with one of the two devices. Conclusions: The p-Branch design has greater anatomic feasibility and achieves proximal seal in all patients with juxtarenal and pararenal AAAs but is not able to incorporate visceral arteries in 40% of patients. The Ventana design allows incorporation of the visceral arteries in 90% of patients but fails to provide sufficient seal in 40%. Nearly 40% of juxtarenal and pararenal AAAs do not meet anatomic criteria for endovascular repair with one of the two devices, justifying the need for additional designs.