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Technical Innovation |
1
Radiology Associates, Oregon Imaging, Physicians and Surgeons Center, South
Building, Ste. 330, 1200 Hilyard St., Eugene, OR 97401.
2
Department of Radiology, Tuality Hospital, 335 S.E. 8th Ave., Hillsboro, OR
97123.
3
Department of Radiology, Good Samaritan Hospital, 1055 N.W. 22nd Ave.,
Portland, OR 97401.
4
Department of Radiology, Southwest Washington Medical Center, P.O. Box 1600,
Vancouver, WA 98668.
5
Department of Surgery, Good Samaritan Hospital, Portland, OR 97401
Received May 15, 2001;
accepted after revision September 20, 2001.
Address correspondence to S. F. Quinn.
Introduction
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An 85-year-old man presented with bilateral common iliac artery aneurysms with saccular configurations. The dominant aneurysm on the left measured 3.5 cm in diameter, and the dominant aneurysm on the right measured 2.5 cm in diameter. Because of the patient's advanced age and comorbid diseases, a stent-graft procedure was performed instead of a conventional surgical bypass. The patient signed the appropriate institutional review board consent form.
The main body of the stent-graft device was made using three Gianturco stents (Cook, Bloomington, IN) supported longitudinally with wire struts and covered with radially expanded polytetrafluoroethylene (Fig. 1). The proximal stent, which would be deployed in the abdominal aorta, was connected to a second stent, which would be deployed in the right external iliac artery. A third stent served as the shorter contralateral iliac limb into which the left iliac limb of the stent-graft would be deployed. The contralateral iliac limb stent-graft device was constructed with two Gianturco stents connected with wire struts. The graft material was predilated with balloon catheters as has been described by other researchers [5].
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Using conscious sedation, we performed bilateral common femoral artery punctures. The right internal iliac artery was embolized with coils. A 14-French sheath was advanced to the suprarenal abdominal aorta from the right common femoral artery puncture. A 12-French sheath was advanced into the distal abdominal aorta through the left common femoral artery puncture. The bifurcated component was deployed through the 14-French sheath by pushing the stent-graft device and withdrawing the sheath. A 30-mm-diameter 5-cm-long tracheobronchial stent was then deployed in the proximal segment of the stent-graft to secure it and to provide more wall apposition for the proximal portion of the stent-graft.
The contralateral limb of the bifurcated component was then selected from the left common femoral artery access site. An iliac stent-graft device was deployed through the 12-French sheath. Both iliac limbs were then supported with Wallstents (Boston Scientific, Watertown, MA). Completion angiography showed partial filling of the left common iliac artery aneurysm on the late phase images (Figs. 2A and 2B). Both sheaths were then pulled out, and hemostasis was achieved with manual compression. The patient was discharged from the hospital the next day.
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Follow-up CT angiography performed 7 weeks after the procedure showed complete exclusion of all the aneurysms (Figs. 2C and 2D). The patient has been followed clinically and has undergone CT angiography for 3.5 years. The aneurysms have remained excluded, and we have seen no iliac outflow abnormalities. The dominant aneurysms initially decreased slightly by 2 mm on the right and 3 mm on the left but have subsequently stabilized in size.
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The goal of developing a percutaneous stent-graft device is a difficult one. The two commercially available devices in the United States, the Ancure (Guidant, Santa Clara, CA) [2] and the AneuRx (Medtronic, Santa Rosa, CA) [4] require 25- and 22-French sheaths, respectively. These devices require surgical exposure and closure. Pavcnik et al. [6] solved this problem in dogs by delivery of a short cylindric proximal aortic component. This aortic component has slips that then accommodate the iliac limbs that are delivered sequentially. Those researchers believe that this idea can be extrapolated to humans and would allow the procedure to be performed percutaneously. Another concept, called the "slim graft," uses a guidewire to hold the graft material in a particular intravascular position and then secondarily supports it with endovascular stents [7]. If this technique is proven to work in humans, it may be performed percutaneously.
Our transluminally placed stent-graft device used the longitudinally supported endoskeleton to hold the graft material in position so that it could be secondarily supported with stents. The secondarily placed stents could be relatively high profile. The end result was that the profile of the system could be lowered. This stent-graft device will allow a percutaneous approach in some patients, or it could be used with a suture-mediated closure device if the closure device is placed before dilating to 14-French. The stent-graft device would also allow patients, particularly women with small and or tortuous iliac arteries, to undergo endovascular treatment of aneurysms.
What are the upper limits for the size of stent-grafts that can be used and still have the procedure performed percutaneously? That answer is unknown. Shawl et al. [8] described using 20-French (n = 41) and 18-French (n = 66) bypass cannulas in 107 patients and then using manual compression for hemostasis. In the first 41 patients, one patient required surgical repair of the femoral artery, three had femoral neuropathy, and 14 required blood transfusions. In the second group of 66 patients, there was one pseudoaneurysm, and six of the patients required blood transfusions. This data suggests that hemostasis can be achieved after placement of large femoral devices, but the complication rate from this study may be higher than the rate that many physicians would accept.
It is our belief that larger puncture sites will all ultimately be managed with some sort of suture-mediated device. Howell et al. [9] recently described their experience using the Perclose device (Perclose, Redwood City, CA) in 144 patients who had 16-French sheaths placed in the common femoral arteries as part of stent-graft procedures. The success rate for closing the access sites was 94.4%. Follow-up duplex sonography was available in 144 patients at 1 month, in 100 patients at 6 months, and in 59 patients at 1 year; there were no hematomas, infections, pseudoaneurysms, fistulas, or drops in ankle brachial indexes.
This system has disadvantages. It does require that a large sheath be maneuvered through the stent-graft device that is not securely anchored proximally until a second uncovered stent is deployed across the proximal fixation site. This maneuvering could potentially cause the stent-graft device to be moved proximally. Additional maneuvers are required to support the iliac limbs. As with all stentgraft designs, long-term graft and stent durability is unknown. The integrity of radially expanded polytetrafluoroethylene over time is uncertain. This design requires suturing of the radially expanded polytetrafluoroethylene to the stents and at the aortoiliac limb junctions. These areas could be susceptible to disruption over time. Additionally, there will be problems, including endoleaks, with this device as with all stent-graft designs.
In summary, this report describes using a low-profile bifurcated stent-graft device that was placed percutaneously. Although the results of this case are encouraging, further research with this stent-graft device will be needed to determine its clinical efficacy.
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  C. A. Nienaber, R. Erbel, and H. Ince Nihil nocere on the rocky road to endovascular stent-graft treatment J. Thorac. Cardiovasc. Surg., March 1, 2004; 127(3): 620 - 621. [Full Text] [PDF]
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