Now available in Baton Rouge, the Zenith Fenestrated Graft offers an effective, minimally invasive treatment for abdominal aortic aneurysms. The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single -Center Study is a clinical trial approved by US FDA to study the safety and. The Zenith fenestrated endovascular (ZFEN) stent graft is a modular system that consists of a proximal body.
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Endovascular abdominal aortic aneurysm repair EVAR provides an attractive alternative to traditional open techniques.
Endovascular repair is frequently limited by aortic aneurysm neck angulation, the absence of an adequate infrarenal neck, and fenesstrated need for internal iliac preservation. Several devices have been created to incorporate visceral artery segments as well as preserve the internal iliac artery, thus broadening the patient population suited for endovascular repair.
This article will provide a review of the current literature regarding fenestrated devices, branch devices, off-the-shelf devices, and physician-modified devices. It will also highlight the iliac branch stent grafts currently on trial for internal iliac artery preservation.
Data thus far have suggested that these devices will be both a safe and effective option for anatomically challenging abdominal aortic aneurysms. Upon completion of this article, the reader will be able to identify the current devices being used in the treatment of anatomically-challenging abdominal aortic aneurysms. Physicians should claim only the credit commensurate with the extent of their participation in the activity. It has been well documented that endovascular repair of abdominal aortic aneurysms EVAR offers many advantages over open abdominal aortic aneurysm AAA repair.
This article will review the current products available for hostile aortic anatomy including fenestrated stent grafts, off-the-shelf stent grafts, physician-modified devices, and branch grafts. This article will also address internal iliac preservation with a discussion of the internal iliac artery branch graft devices currently on trial.
The modular system comprises a proximal body graft, a distal bifurcated graft, and one iliac limb. The graft components are made of woven polyester fabric sewn to self-expanding Cook-Z stents. Fixation is achieved via barbs that are located on the bare suprarenal stent of the proximal body graft.
Fenestrations are available in small, large, or scallop cutouts of the proximal margin configurations. Stenting is recommended for small fenestrations, optional for scallops, and is not recommended for large fenestrations Cook Medical, Bloomington, IN. The Zenith fenestrated endovascular ZFEN stent graft is a modular system that consists of a proximal body graft, a distal bifurcated graft, and one iliac limb.
The safety and efficacy of the device has been established in many countries, and two manuscripts summarizing the intermediate and long-term results of a multicenter prospective trial in the United States have been published.
Zenith® Fenestrated AAA Endovascular Graft Proximal Body Grafts | Cook Medical
At month follow-up, there were no aneurysm ruptures, conversions to an open procedure, or aneurysm-related deaths. Aneurysm size decreased in Type 2 endoleaks were identified in There were eight renal events, namely, four renal artery stenoses, two renal artery occlusions, and two renal infarcts. There was one case of graft migration, one case of renal artery stent fracture, and one case of fixation barb separation in which only the migrated graft required a secondary intervention.
The study concluded that the trials intermediate data were similar to other previous single-center studies, and that the fenestrated endograft was a safe and effective option for juxtarenal AAA repair. There was one perioperative death related to bowel ischemia leading to an early mortality rate of 1. Major adverse events included death in five patients, congestive heart failure, bowel ischemia, myocardial infarction, stroke, and bowel obstruction; only four of these complications were attributed to the actual procedure.
There was no observed difference in rates of occlusion or stenosis in bare-metal versus covered stents, though other studies have reported higher patency rates for covered stents. The trial concluded that the Zenith fenestrated stent graft is both safe and effective as well as durable for use in the United States. The system consists of an aortic endograft and two separate iliac limbs. The proximal end of the main body consists of two separate nitinol ring stents and four pairs of nitinol hooks that aid in sealing.
The main body itself does not contain any stents, allowing for flexibility in fenestration placement. Furthermore, the design is unique in that it can be fully repositioned after deployment.
The device also offers a magnetically assisted limb cannulation system that can decrease contralateral limb cannulation time. The stent graft is custom designed for each patient.
Four studies to date have assessed the efficacy of the fenestrated Anaconda stent feneetrated. The initial study by Bungay et al in evaluated four patients in whom there were no perioperative deaths or differences in preoperative and postoperative serum creatinine levels. At 1-month follow-up, all target vessels remained patent; however, one of the four patients did have a type 1b endoleak requiring balloon angioplasty of the right iliac graft component. Two endoleaks were identified and addressed intraoperatively, four type 2 endoleaks were noted on discharge, and one type fenestratted endoleak was identified at the most recent follow-up.
Though this feature does have its advantages, it was felt that repositioning led to embolization of zennith material and renal failure in one patient. Three patients underwent this hybrid procedure without any intraoperative or postoperative endoleaks, stent migration, dislocation, or stenosis.
Off-the-shelf devices are stent grafts that are available for immediate fenrstrated and are designed to accommodate the majority of the general population with a finite number of configurations and a modular design.
Current waiting time for individualized, customized devices ranges from 3 to 4 weeks. Since not all patients are able to wait for a customized graft, trials have sought out to investigate the feasibility, safety, and efficacy of off-the-shelf devices.
The Ventana device study, however, has been placed on fenestrahed by Endologix and the FDA given difficulties with the durability and patency of the renal artery stent graft components. The Ventana fenestrated system VFS fenestrwted designed to treat zenithh with juxtarenal and pararenal aortic aneurysms. The stent grafts consist of a self-expanding cobalt-chromium alloy endostent with a multilayer expanded polytetrafluoroethylene ePTFE graft.
Zenith® Fenestrated AAA Endovascular Graft Proximal Body | Cook Medical
There is a large scallop that permits flow to the celiac and superior mesenteric arteries SMAsas well as fenestrations with precannulated sheaths that aid in renal artery stenting see Fig. The Endologix Ventana fenestrated system consists of two scallops for the fenestratwd mesenteric artery and celiac artery as zenitj as two fenestrations for the renal arteries. A prospective multicenter trial involving fenestratec patients was conducted between November and April to demonstrate early and mid-term results of the Ventana system for juxtarenal and pararenal aortic aneurysms.
All patients were treated with one of five Ventana stent graft models. The study concluded that the Ventana device showed promising early to mid-term data; however, future studies with longer-term follow-up were needed to verify its safety, efficacy, and durability. The Zenith pivot branch device Cook Medical, Bloomington, IN is an off-the-shelf device that integrates polyethylene terephthalate fabric with a proximal stainless steel uncovered barbed supraceliac stent and several nitinol z-stents that include a scallop for the celiac artery, a strut-free fenestration for the SMAs, and two renal pivot fenestrations see Fig.
The graft can be produced with two variations fenestrxted renal artery fenestration placement. One device has both renal arteries originating at the same level, while the other device has the left renal artery originating slightly lower than the right renal artery.
The graft can be used either as fenestratwd single component when building up from a prior aortic repair or as a proximal component in combination with other Zenith devices. The Zenith pivot branch device includes a scallop for the celiac artery, a strut-free fenestration for the SMAs, and two renal pivot fenestrations.
2016 Zenith Fenestrated® clinical update
Kitagawa et al published the early clinical outcomes of 16 patients enrolled in a physician-sponsored investigation device exemption study. The patients underwent repair with the off-the-shelf Zenith p-Branch device between August and September for juxtarenal aneurysms. Two of the patients were repaired for rupture. The authors reported no aortic-related deaths, aneurysm ruptures, or open surgical conversions. One patient did require additional placement of a nitinol stent in the setting of lower extremity fehestrated in the perioperative period.
The only late complication reported was a renal stent occlusion at 3 months, and it was successfully treated with ballooning and distal nitinol stent placement. The study concluded that although early clinical data were favorable, strict attention would be required for proper patient selection and assessment of the proximal landing zone as well as configuration of the aorta near branch points. Mendes et al recently evaluated the anatomic feasibility of both the Endologix Ventana Endologix, Irvine, CA and Cook p-Branch Cook Zenoth, Brisbane, Australia devices in an unselected population of patients with juxtarenal and pararenal aneurysms.
Between July and September85 patients were identified as type 4 thoracoabdominal aortic aneurysms including pararenal and juxtarenal aneurysms. Often, patients that require this type of device do not have any other endovascular option or do not have the time required for a custom graft to be manufactured. Starnes conducted a retrospective, nonrandomized, single-institution study assessing the safety fenfstrated physician modification of the already FDA-approved Zenith Flex aortic stent graft Cook Inc.
Forty-seven patients were treated with physician-modified fenestratsd over a 3-year period — for juxtarenal aneurysms. This included one type 1 endoleak that required repair and five type 2 endoleaks only, of which one required intervention.
There was one in-hospital mortality related to aspiration and two deaths in the follow-up period, including one patient at day who died of endograft migration and SMA occlusion. Based on these promising results, the same group performed an investigator-sponsored investigational device study IDE with the approval of the FDA. The study involved 26 patients who underwent 63 fenestrations 48 renal arteries and 15 SMAs over a study period of 16 months — for juxtarenal aneurysms.
The outcome of the study assessed major adverse events and treatment success rates. Similar to their prior data, at 30 days there were only four type 2 endoleaks Major adverse events occurred in At 1-year follow-up, there were no major adverse device events and only one minor adverse device events a type 3 endoleak that was successfully treated endovascularly. The primary efficacy end point was achieved in Zwnith study concluded that the PMEG technique is valid, safe, and effective; however, fenestrsted has yet to be determined with no reported longer-term follow-up.
Ricotta and Tsilimparis looked at surgeon-modified fenestrated-branched grafts sm-FBSGs in high-risk patients presenting with symptomatic or ruptured complex abdominal as well as thoracoabdominal aortic aneurysms.
The study involved 12 patients, 7 symptomatic and 5 ruptured, of which 4 aneurysms were pararenal and 8 were thoracoabdominal—there were a total of 35 branch interventions. Aneurysm exclusion was successful in all cases. Two deaths did occur secondary to contained ruptures and one type 2 endoleak is being observed.
Branched devices consist of side arms that can be oriented axially or at an angle. The branches are primarily intended to be used with self-expanding stents grafts. The zenitg may be external to the graft, internal to the graft, or a combination of both. Branches are typically accessed from the axillary artery through preloaded wires to allow for quick and easier sheath cannulation.
They utilized an external helical branch, which demonstrated an excellent patency rate. The authors reported several advantages to the helical side-arm branch, including the minimization of distance between target vessel and branch origin as well as lessening the angulation between the vessel and self-expanding stent graft.
Several studies have demonstrated promising early results, though longer-term data are pending. There are currently two iliac branch devices on trial in the United States for the preservation of internal iliac artery flow in the setting of common iliac artery aneurysms.
Preservation of this flow plays an important role in the prevention of buttock claudication, gluteal necrosis, ischemic colitis, and sexual dysfunction. The trial is investigating the safety and effectiveness of the device for use in both aortoiliac and iliac artery aneurysms.
Trial of the Gore Excluder Iliac Branch Endoprosthesis opened in October and is a prospective, nonrandomized, multicenter, single-arm study looking at the safety and efficacy of the device for use in both common iliac artery aneurysms and aortoiliac aneurysms see Fig. The Gore Excluder Iliac Branch Endoprosthesis femestrated for preservation of flow to the internal iliac artery. In conclusion, endovascular aortic stent grafting is a valuable alternative to traditional open aortic aneurysm repair.
With recent advances in fenestrated and branched stent graft zrnith, endovascular approaches are becoming options to treat patients with anatomies previously considered ineligible for stenting. The only current FDA-approved fenestrated stent graft in the United States is the Zenith fenestrated device, for which multicenter prospective trials have validated the efficacy, safety, and durability of the graft.
Off-the-shelf stent grafts are currently being evaluated. Physician-modified stent grafts have also shown promising early results.