Sizing Fenestrated Aortic Stent-grafts (original) (raw)
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Initial experience with a new fenestrated stent graft
Journal of Vascular Surgery, 2011
Objectives: The Anaconda fenestrated stent graft (Vascutek, Inchinnan, United Kingdom) is a new device that can easily be repositioned during deployment. This study evaluated its feasibility for treating abdominal aortic aneurysms with inadequate infrarenal sealing zones. Methods: Patients undergoing stent graft placement at two institutions in the United Kingdom were recruited. Results: A total of 12 visceral vessels were accommodated with 8 fenestrations for renal arteries and 4 superior mesenteric artery valleys/scallops in 4 patients. One type Ib endoleak was identified at the 1-month follow-up and successfully treated. Conclusions: The Anaconda fenestrated stent graft device can be used for the repair of abdominal aortic aneurysms with hostile anatomy and has acceptable immediate and short-term results.
Journal of Endovascular Therapy, 2013
urpose: To report the bench-top evaluation and initial clinical use of an instrument for onsite fenestration of aortic stent-grafts. Methods: A stainless steel thermal cautery instrument was designed to create circular stentgraft fenestrations from 3 to 10 mm in diameter. Three operators independently benchtested the instrument on thoracic stent-graft samples to evaluate size, shape, location, and quality of fenestrations created. For clinical use, on-site fenestration was performed 2 days before the endovascular procedure in a sterile room without access to supplemental oxygen. A fenestrator 1 or 2 mm smaller in diameter than the target vessel was used; the edges of the fenestrations were strengthened using flexible radiopaque nitinol wire. The aortic stent-graft was then re-sheathed and sterilized for added safety. Eighteen patients (17 men; mean age 51 years, range 18-80) with a variety of thoracic and juxtarenal pathologies were treated using Zenith TX2, Valiant Captivia, Zenith AAA, and Endurant stent-grafts modified in this manner. Results: After successful bench testing, the instrument was used to create 34 fenestrations in aortic stent-grafts deployed in the 18 patients. Size and location of fenestrations obtained were as desired. Subsequent catheterization of the fenestration/target vessel and covered stent deployment were successfully achieved in 31 (91%) fenestrations; 2 fenestrations had type III endoleaks and 1 fenestration was unused. There was no perioperative mortality, stroke, embolization, vessel dissection, renal failure, or graft infection. Follow-up to 1 year in the majority of patients has revealed no new fenestration-related problems. Conclusion: This simple-to-use instrument makes on-site creation of aortic stent-graft fenestrations easy, accurate, and precise. The instrument is inexpensive, robust, and easily sterilized.
Fenestrated Aortic Stent Grafts
Seminars in Interventional Radiology, 2007
Fenestrated stent grafts have been developed to offer an endovascular treatment option to those patients with abdominal aortic aneurysms whose infrarenal necks are anatomically unsuitable for endovascular repair with standard infrarenal devices. The ability to have customized fenestrations that will preserve flow to essential visceral arteries allows proximal seal and fixation to be achieved at and above the renal level. This article discusses patient selection, stent-graft design, and the importance of accurate planning. Deployment techniques along with complications and their avoidance are considered. The published midterm results are reviewed and appear to justify the continued use and evaluation of this technique as an alternative to open surgical repair in high-risk patients with infrarenal necks unsuitable for standard endovascular repair.
Institutional experience with the Zenith Fenestrated aortic stent graft
Journal of vascular surgery, 2018
The Zenith Fenestrated (ZFEN; Cook Medical, Bloomington, Ind) aortic stent graft system was approved for commercial use by the Food and Drug Administration in April 2012. We report our single-center experience of 100 consecutive patients treated with the ZFEN platform from October 2012 to March 2017. A retrospective review of our prospectively maintained fenestrated endovascular aneurysm repair (FEVAR) database at a tertiary care academic institution located in the Midwest United States was performed for descriptive analysis. All continuous variables are reported as a mean ± standard deviation and compared using two-sided Student t-tests. Categorical variables were compared using two-sided Fisher exact tests. All but one of the procedures were elective in nature. Overall intraoperative characteristics included a mean blood loss (estimated blood loss) of 388 ± 385 mL, fluoroscopy time of 63 ± 30 minutes, radiation dose of 437 ± 272 rad, contrast material volume of 99 ± 36 mL, and ope...
Early Experience with Fenestrated Stent Grafts for Treatment
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
Journal of Vascular Surgery, 2019
Objective: Physician-modified fenestrated stent grafts (PMSGs) are a useful option for urgent or semiurgent treatment of complex abdominal aortic aneurysms (CAAAs). The aim of this study was to describe in-hospital outcomes of custommade fenestrated stent grafts (CMSGs) and PMSGs for the treatment of CAAAs and thoracoabdominal aortic aneurysms (TAAAs). Methods: In this single-center, retrospective study, all consecutives patients with CAAAs or TAAAs undergoing endovascular repair using Zenith CMSGs (Cook Medical, Bloomington, Ind) or PMSGs between January 2012 and November 2017 were included. End points were intraoperative adverse events, in-hospital mortality, postoperative complications, reinterventions, target vessel patency, and endoleaks. Results: Ninety-seven patients were included (CMSGs, n ¼ 69; PMSGs, n ¼ 28). The PMSG group included more patients assigned to American Society of Anesthesiologists class 4 (n ¼ 14 [50%] vs n ¼ 16 [23%]; P ¼ .006) and more TAAAs (n ¼ 17 [61%] vs n ¼ 10 [15%]; P < .0001). Intraoperative adverse events were recorded in eight (11%) patients in the CMSG group vs six (21%) patients in the PMSG group. No intraoperative death or open conversion occurred. In-hospital mortality rates were of 4% (n ¼ 3) in the CMSG group and 14% in the PMSG group (n ¼ 4). Chronic renal failure was an independent preoperative risk factor of postoperative death or complications (odds ratio, 4.88; 95% confidence interval, 1.65-14.43; P ¼ .004). Rates of postoperative complications were 22% (n ¼ 15) and 25% (n ¼ 7) in the CMSG and PMSG groups. Spinal cord ischemia rates were 4% (n ¼ 3) and 7% (n ¼ 2) in the CMSG and PMSG groups. Reintervention rates were 16% (n ¼ 11) in the CMSG group and 32% (n ¼ 9) in the PMSG group. At discharge, target vessel patency rate in CMSGs was 98% (n ¼ 207/210). All target vessels (n ¼ 98) were patent in the PMSG group. Endoleaks at discharge were observed in 24% of the CMSG group (n ¼ 16) vs 8% of the PMSG group (n ¼ 2). Conclusions: Our study showed clinically relevant differences of several important in-hospital outcomes in the CMSG and PMSG groups. Larger cohorts and longer follow-up are needed to allow direct comparison. PMSGs may offer acceptable in-hospital results in patients requiring urgent interventions when CMSGs are not available or possible.
ANZ Journal of Surgery, 2009
Background: This study aimed to investigate the diagnostic value of computed tomography virtual intravascular endoscopy (VIE) in the follow-up of patients with abdominal aortic aneurysm (AAA) treated with fenestrated stent grafts. Methods: A total of 19 patients (17 males and 2 females; mean age: 75 years) with AAA undergoing fenestrated stent grafts were retrospectively studied. Pre-and postfenestration computed tomography data were reconstructed for the generation of VIE images of aortic ostia and fenestrated stents and compared with two-dimensional axial and multiplanar reformation (MPR) images. Serum creatinine was measured pre and post fenestration to evaluate the renal function. Results: The mean intra-aortic length measured by VIE, two-dimensional axial and MPR were 4.7, 4.4 and 4.6 mm, respectively, for the right renal stent; 5.0, 4.9 and 5.0 mm, respectively, for the left renal stent; and 5.9, 6.0 and 6.0 mm, respectively, for the superior mesenteric artery stent. Comparisons of these measurements did not show significant difference (P > 0.05). The mean diameters of renal artery ostia measured on VIE visualization pre and post fenestration were 9.2 ¥ 8.3 and 10 ¥ 8.9 mm for the right renal ostium; 8.3 ¥ 7.1 and 9.9 ¥ 8.9 mm for the left renal ostium, with significant changes observed (P < 0.01). No renal dysfunction was observed in this group. Conclusion: VIE is a valuable visualization tool in the follow-up of fenestrated stent graft repair of AAA by providing intraluminal appearance of fenestrated stents and measuring the length of stent protrusion.
Initial Experience with Fenestrated Physician-Modified Stent Grafts Using 3D Aortic Templates
Journal of Clinical Medicine
The goal of this study was to describe the surgical results of physician-modified endografts (PMEG) utilizing a 3D aortic template in a center with no prior experience in complex endovascular aortic repairs. Forty-three patients underwent physician-modified graft stent implantation using a 3D aortic model. The inclusion criteria were juxtarenal and suprarenal aortic aneurysms, type IV thoracoabdominal aneurysms, and type IA endoleak after endovascular aortic repair. In asymptomatic patients, the diameter threshold for aneurysm repair was 5.5 cm in males and 5.0 cm in females. 3D aortic templates were prepared from the patient’s computed tomography angiography scans and sterilized before use in the operating suite. Forty-three stent grafts were modified with the use of a 3D printing template. A total of 162 reinforced fenestrations (37 celiac, 43 right renal, 39 left renal, 43 superior mesenteric) with a mean of 3.8 per patient were performed. All PMEGs had a posterior reducing-diame...
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.
European Journal of Vascular and Endovascular Surgery, 2018
This study evaluates the outcomes of BeGraft stents used as bridging stents during fenestrated endovascular aortic aneurysms repair. To date, none of the balloon expandable covered stents which are currently commercially available in Europe have been specifically designed and evaluated for that purpose. Objectives: To evaluate the outcomes of the second generation BeGraft balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent grafts during fenestrated endovascular aortic repair (FEVAR) of complex aneurysms. Design: This was a single centre prospective study including all consecutive patients treated by FEVAR performed with second generation BeGraft stent grafts as bridging stents. Methods: Demographics of patients, diameter and length of the bridging stent grafts, technical success, reinterventions, occlusions, post-operative events, and imaging (Cone Beam CT and/or CTscan, and contrast enhanced ultrasound) were prospectively collected in an electronic database. Duplex ultrasound was performed before discharge and at 6 month follow-up. At 1 year, patients were evaluated clinically and by imaging (CT and ultrasound). Results: Between November 2015 and September 2016, 39 consecutive patients (one woman) were treated with custom made fenestrated endografts (2e5 fenestrations) for complex aneurysms or type 1 endoleak after EVAR, using a variety of bridging stents including the BeGraft. All 101 BeGraft stent grafts were successfully delivered and deployed. There was no in hospital mortality. Early fenestration patency rate was 99% (96/97); the sole target vessel post-operative occlusion was secondary to a dissection of the renal artery distal to the stent. Complementary stenting was unsuccessful in recovering renal artery patency; bilateral renal stent occlusion was observed in the same patient on a CT scan performed 2 months after the procedure. He required post-operative dialysis. No additional renal impairment was observed. During follow-up (median 13 months [11e15]), all fenestrations stented with BeGraft stent grafts remained patent (95/97, 98%). One type 1b endoleak was detected and treated (2.6%). Conclusions: BeGraft stent grafts used as bridging stents during FEVAR are associated with favourable outcomes at 1 year follow-up. Long-term follow-up is required to confirm these promising results.