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(Radiology. 2001;220:533-539.)
© RSNA, 2001

Technical Developments

Aortic Dissection: Percutaneous Management with a Separating Stent-Graft—Preliminary Results1

Sung-Gwon Kang, MD, Do Yun Lee, MD, Munehiro Maeda, MD, Eun Sang Kim, BS, Donghoon Choi, MD, Byung-Ok Kim, MD, Hyun Ki Yoon, MD, Kyu Bo Sung, MD and Ho-Young Song, MD

1 From the Department of Diagnostic Radiology Chosun University College of Medicine, Kwangju, Korea (S.G.K.); Department of Diagnostic Radiology (D.Y.L.), Cardiology Division (D.C.), Yonsei University College of Medicine, 134 Shinchon-dong, Seodaemun-ku, Seoul 120-752, Korea; Department of Diagnostic Radiology, Asan Medical Center, Ulsan University College of Medicine, Seoul, Korea (E.S.K., H.K.Y., K.B.S., H.Y.S.); Department of Radiology, Osaka University Graduate School of Medicine, Japan (M.M.); and Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea (B.O.K.). Received September 11, 2000; revision requested November 1; revision received February 2, 2001; accepted February 26. Address correspondence to D.Y.L. (e-mail: dyl@yumc.yonsei.ac.kr).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 Materials and Methods
Results
Discussion
 REFERENCES
 
The authors used a separating stent-graft to treat Stanford type B aortic dissection. The separating stent-graft consists of two stents: a stent-graft and an inner bare stent. The separating stent-graft has three parts: a proximal stent, a graft made of synthetic polyester textile fiber, and a distal stent. A 12-F introducing sheath was used. After the separating stent-graft was placed, false-lumen thrombosis was evident in all six patients during a follow-up period of 206 days. The major advantages of this technique are that a cutdown and blood pressure control are not required.

Index terms: Aorta, dissection, 94.743, 981.743 • Aorta, grafts and prostheses, 94.1286, 981.1286 • Aorta, interventional procedure, 94.1286, 981.1286


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
Materials and Methods
Results
Discussion
 REFERENCES
 
Aortic dissection is the most common nontraumatic aortic pathologic condition. The annual incidence exceeds that of spontaneous rupture of aortic aneurysms (1), with 10–20 cases per million people per year. If the condition is left untreated (2,3), 36%–72% of patients die within 48 hours of diagnosis, and 62%–91% die within 1 week (4). The number of deaths due to aortic dissection exceeds the number of deaths due to rupture of an abdominal aortic aneurysm (5). Several endovascular techniques are available for diagnosis and treatment of aortic dissection or its complications (6–10). Endovascular stent-graft placement is one of the options for treatment of aortic dissection. Since Parodi (11) reported his first clinical experience in 1991 with an endovascular graft consisting of balloon-expandable Palmaz stents covered with synthetic polyester for treatment of abdominal aortic aneurysms, various types of endovascular grafts have been used. Most of the endovascular grafts developed for treatment of abdominal and thoracic aneurysms need to be placed with a large guidance delivery sheath that necessitates surgical cutdown in the femoral artery (9–12).

Stent-graft placement is a promising nonsurgical treatment of type B dissection. Initiation of the natural healing process (false-lumen thrombosis) of sealing the proximal entry induces both consolidation of the false lumen and remodeling of the aortic wall (13). The custom design of each separating stent-graft currently limits its placement to patients undergoing elective procedures; more versatile stent-grafts are necessary to treat acutely ill patients (13). The need for surgical cutdown and blood pressure control during stent-graft deployment in the thoracic aorta is a drawback of stent-graft placement. We devised a separating stent-graft system for a less invasive and more versatile technique for treatment of aortic dissection. The purpose of the present study was to determine the feasibility and effectiveness of implantation of a separating stent-graft with percutaneous technique to treat Stanford type B aortic dissection.


   Materials and Methods
TOP
 ABSTRACT
 INTRODUCTION
 Materials and Methods
Results
Discussion
 REFERENCES
 
Selection of Patients
This study was conducted with the approval of the institutional review boards, and written informed consent was obtained from all patients. Between December 5, 1999, and July 31, 2000, six consecutive patients (Table 1) underwent endovascular repair of aortic dissection with a separating stent-graft. These patients were referred for repair on the basis of medically intractable symptoms, such as chest pain.


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  		TABLE 1. Summary of Patient Data

 
Contrast material–enhanced spiral computed tomography (CT) and digital subtraction angiography (DSA) were performed with use of a calibrated marker catheter (Cook, Bloomington, Ind) to measure the diameter and length of the aorta (D.Y.L., S.G.K.). The relationship of the aortic lesion to branch vessels, the relative degree of aortic curvature, and the exact location and size of the entry or reentry tears were also evaluated. Spiral CT was performed with a whole-body scanner (Somatom Plus-S, Siemens Medical Systems, Erlangen, Germany; HiSpeed CT/i, GE Medical Systems, Milwaukee, Wis). Scanning was performed during breath holds. Transverse contrast-enhanced CT was performed from the thoracic inlet to the iliac arteries (section thickness of 8 mm, table feed of 15 mm, reconstruction interval of 4 mm, intravenous administration of 150 mL of nonionic contrast medium [Ultravist; Schering, Berlin, Germany], flow of 3 mL/sec, scanning delay of 30 seconds). Contrast-enhanced CT revealed a Stanford type B aortic dissection in each patient: from the proximal descending thoracic aorta through the abdominal aorta to the level of the iliac artery in patients 3–6 and to the level of the renal artery in patients 1 and 2. DSA showed an entry tear in the proximal descending thoracic aorta more than 2 cm distal to the origin of the left subclavian artery in all patients.

Construction of the Separating Stent-Graft
The separating stent-grafts were handmade in our research laboratory (E.S.K.) and consisted of two parts: a stent-graft and an inner bare stent (Fig 1). The stent-graft consisted of three parts: a proximal stent, a graft made of synthetic polyester textile fabric (Dacron; Ube, Tokyo, Japan), and a distal stent. The synthetic polyester graft was attached to two different types of stents. The proximal stent was knitted from a single thread of 0.3-mm nitinol wire in a tubular configuration in an interlocking diamond-shaped pattern. The distal stent was woven from a single thread of 0.25-mm nitinol wire in a tubular configuration for preloading into a smaller tube. The proximal and distal stents were 34 mm in diameter and 3 cm long. The three parts of the stent-grafts were tied with blue monofilament (4-0 Prolene; Ailee, Pusan, Korea) by using a tapered needle. The two stents were each separated by 0.5 cm from a segment covered by the synthetic polyester. The synthetic polyester was 6–10 cm long and 30–34 mm in diameter.



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  		Figure 1. Components of a 34-mm x 12-cm separating stent-graft. Top: Proximal stent, with a synthetic polyester graft (arrowheads), and distal stent (large arrow). Bottom: Inner bare stent (small arrow).

 
The inner bare stent was knitted from a single thread of 0.3-mm nitinol wire in a tubular configuration without the interlocking pattern. The diamond-shaped pattern of the inner bare stent was longer than the proximal stent to minimize stent shortening. Gold radiopaque markers were attached to the proximal and distal parts of each of the stents.

The separating stent-grafts were introduced through a 12-F sheath (Cook). The introducing system consisted of four parts: a 12-F outer sheath made of synthetic fluorine-containing resin (Teflon; Medikit, Tokyo, Japan), a synthetic resin tube pusher (outer diameter of 3.85 mm, inner diameter of 3 mm), a coil pusher (outer diameter of 2.75 mm, inner diameter of 1.5 mm), and a 4-F catheter (Fig 2). The separating stent-grafts were preloaded into the introducing system. Proximal stents and synthetic polyester grafts were loaded into a 12-F outer synthetic resin sheath. Distal stents were loaded into the synthetic resin tube pusher. Inner bare stents were loaded into in a 10-F synthetic resin loader. After deployment, the separating stent-graft was centrally supported by a coaxial inner bare stent.



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  		Figure 2. Diagram of the components of the introducing system for the separating stent-graft: A, 12-F synthetic resin sheath; B, synthetic resin pusher; C, coil pusher; D, guide wire passes the tube; E, olive tip; F, loader for inner bare stent; G, loader pusher; and H, pusher for inner bare stent.

 
Experiment with in Vitro Aortic Model
Experiments were performed in a pulsed-flow aortic phantom (S&G Biotech, Seoul, Korea) that simulated physiologic pulsatile flow conditions. The phantom consisted of a pump, tubing, solenoid valve, and reservoir. The pump was connected to a circular polyethylene tubing system equipped with a pressure transducer. The technical feasibility of delivering the separating stent-graft was evaluated by performing 50 deployments in the flow phantom. During deployment, graft deformity or migration was observed. The water pump and solenoid valve generated a pulsed flow. The flow volume of the aortic phantom was 200 mL/min, and the pulse rate was 65 beats per minute.

Determination of Aortic Diameter prior to Stent Placement
The diameters of the true lumen and aorta were measured at two predetermined levels on each contrast-enhanced CT study, including preoperative studies. The first level was at the maximal diameter of the descending thoracic aorta, and the second was at the level of the celiac axis. The diameter of the overall aorta and its true lumen along the line perpendicular to the intimal flap were measured at the level of maximal dilatation of the descending thoracic aorta. Serial diameter changes in the abdominal aorta and its true lumen at the level of the celiac artery and false-lumen thrombosis were also evaluated.

Insertion Technique for the Separating Stent-Graft
Placement of the separating stent-grafts was performed in an angiography suite after administration of local anesthesia. A 5-F, 23-cm-long sheath was introduced via both the common femoral arteries with use of the Seldinger technique. Thoracic DSA was performed with use of a 5-F pigtail catheter (Cook), which was located in the true lumen, to evaluate the precise location and size of the entry tear. Contrast material (Visipaque 320; Nycomed, Cork, Ireland) was injected separately into the true and false lumina to evaluate branch-vessel obstruction and to find the reentry tear. The preloaded stent-graft set was advanced into the thoracic aorta over a 260-cm-long, 0.035-inch stiff guide wire (Lunderquist; Cook).

An oblique DSA image was then obtained after injection of 30 mL of contrast material with a power injector to allow precise localization of the entry tear and left subclavian artery. The separating stent-graft set was advanced until the caudal radiopaque marker of the proximal stent was located more than 2 cm above the entry tear. At this time, all patients received an intravenous bolus of 5,000 U of heparin. The proximal stent and synthetic polyester graft were deployed by fixing the synthetic resin pusher and retracting the 12-F synthetic resin sheath. The distal stent was deployed by fixing the coil pusher and retracting the synthetic resin pusher immediately after the proximal stent and synthetic polyester graft were deployed (Fig 3).



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  		Figure 3. Step-by-step diagram of the technique for deploying a separating stent-graft. a, Stent-graft (arrow) is advanced to the aortic arch over the guide wire. b, Proximal stent (arrow) and synthetic polyester graft (arrowhead) come out. c, During deployment, synthetic polyester graft (arrowhead) shows incomplete expansion. d, Distal stent (arrowhead) comes out. e, Separating stent-graft (arrowhead) is reassembled and advanced to the aortic arch. f, Inner bare stent is deployed inside the separating stent-graft (arrowhead). g, Finally, the graft (arrowhead) is fully expanded by the inner bare stent, and the entry tear is completely occluded.

 
DSA was performed during and after deployment of the separating stent-graft through the 5-F catheter (MPA; Cook), which was located between the separating stent-graft and the thoracic aortic wall (Fig 4). After the separating stent-graft, pushers, and guide wire were deployed, the passing tube was retracted until the radiopaque marker in the olive tip was located in the end of the 12-F synthetic resin sheath. At placement of the inner bare stent, the pushers and guide wire passing tube were removed after the outer sheath was repositioned in the separating stent-graft. The cartridge containing the inner bare stent was then loaded onto the guide wire by passing the end of the guide wire through the 4-F guide wire passing tube. The tube was removed once the cartridge was loaded on the guide wire. The cartridge was advanced into the adapter until the tip was securely seated in the fluted proximal end of the 12-F synthetic resin sheath. The pusher was then used to advance the inner bare stent over the guide wire into the 12-F delivery sheath.



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  		Figure 4. Patient 1. (a) Left anterior oblique DSA image obtained at 45° shows the intimal tear (arrow) located in the proximal descending thoracic aorta 10 cm distal to the origin of the left subclavian artery. (b) Left anterior oblique DSA image was obtained at 20° immediately after the separating stent-graft (arrowheads) was placed. The image shows compete occlusion of the entry tear.

 


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  		Figure 4. Patient 1. (a) Left anterior oblique DSA image obtained at 45° shows the intimal tear (arrow) located in the proximal descending thoracic aorta 10 cm distal to the origin of the left subclavian artery. (b) Left anterior oblique DSA image was obtained at 20° immediately after the separating stent-graft (arrowheads) was placed. The image shows compete occlusion of the entry tear.

 
With continuous fluoroscopic guidance, the inner bare stent was pushed through the sheath until the cephalic radiopaque gold marker of the inner bare stent was located 1 cm below the upper margin of the separating stent-graft. The inner bare stent was then deployed by fixing the pusher and retracting the 12-F synthetic resin sheath. Blood pressure was not manipulated during deployment of the separating stent-graft, but arterial pressure was monitored at the aortic arch and left common femoral artery. After the inner bare stent was deployed, the 5-F multipurpose catheter was positioned in the proximal separating stent-graft, and a left anterior oblique DSA image was obtained. A 12-F synthetic resin sheath was exchanged with a 12-F short vascular sheath (Daig, Minnetonka, Minn), which was removed when the patient’s coagulation profile was normalized.

On the first or second postprocedural day, conventional radiographs of the chest were obtained in anteroposterior, lateral, and bilateral oblique projections to evaluate the position of the separating stent-graft. Contrast-enhanced CT scans were also obtained at 1 week after stent placement to evaluate changes in the true or false lumina, entry or reentry tear, aortic size, or patency of the separating stent-graft. After the separating stent-graft was placed, the patients were monitored daily until their discharge for complete blood cell count, body temperature, and development of complications, such as distal thrombosis, when the bare stent covered the origin of the left subclavian artery.


   Results
TOP
 ABSTRACT
 INTRODUCTION
 Materials and Methods
Results
Discussion
 REFERENCES
 
Experiment with in Vitro Aortic Model
In the aortic flow phantom, the mean pressure was 236 mm Hg, systolic pressure was 246 mm Hg, and diastolic pressure was 225 mm Hg. Fifty separating stent-grafts were deployed in the phantom. No graft deformity or stent migration was noted during deployment of the separating stent-graft.

Insertion of the Separating Stent-Graft
Percutaneous transfemoral deployment of a separating stent-graft was successful and free of complications in all six patients. In patients 3 and 4, the proximal bare stent covered the origin of the left subclavian artery because the intimal tears were located in the descending thoracic aorta less than 3 cm distal to the origin of the left subclavian artery. Visibility of the separating stent-graft was excellent owing to the gold markers that were attached at both ends of the stents. The 12-F sheath was advanced easily to the thoracic aorta. Measurements of the separating stent-graft and true lumen or aorta are summarized in Table 2. The mean time required to place the separating stent-graft (defined as the time from preplacement aortography to the time of immediate postplacement aortography) was 26.3 minutes. Contrast-enhanced thoracic CT performed 1 week after the procedure demonstrated exclusion of the entry tear and a smaller false lumen (Fig 5). Complete sealing of the entry to the false lumen was documented at aortography and CT. There was no difficulty in deploying the preloaded separating stent-graft and advancing the inner bare stent through the 12-F synthetic resin sheath. The diameters of the aorta and true lumen measured at three levels before and 1 week after placement are shown in Table 2.


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  		TABLE 2. Results of Treatment of Type B Aortic Dissection with a Separating Stent-Graft

 


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  		Figure 5. Patient 1. A, Transverse contrast-enhanced CT scans depict an aortic dissection (arrow) from the proximal descending aorta through the abdominal aorta. B, Transverse contrast-enhanced CT scans obtained 1 week after placement of the separating stent-graft (arrowhead) show elimination of the entry tear and thrombosis in the false lumen. False lumen (arrow) is still noted around the reentry tear. C, Transverse contrast-enhanced CT scans obtained 7 months after placement of the separating stent-graft show complete resolution of the false lumen around the reentry tear.

 
In patient 2, sluggish perigraft leak to the false lumen was identified just after the separating stent-graft was placed. This leak was closed at follow-up CT performed 1 week after placement of the separating stent-graft. Transient postimplantation syndrome with mild leukocytosis, thrombocytopenia, and moderately elevated body temperature occurred in all patients (Table 1). Elevated body temperature was normalized at a mean of 2 days (range, 1–5 days) after the procedure, and leukocytosis and thrombocytopenia were normalized at a mean of 4 days (range, 2–7 days) after the procedure.

After the separating stent-graft was placed, false-lumen thrombosis was evident in all six patients during follow-up of a mean of 206 days (range, 70–316 days). At 1 week after stent placement, contrast-enhanced CT documented widely patent separating stent-grafts and thrombosis of the false lumen in all six patients, but a short segment of false lumen without thrombosis was noted around the reentry tear in all patients. This patent distal false lumen was not present at 7-month follow-up in patient 1. No aortic side-branch occlusion and no evidence of migration or twisting of the separating stent-grafts were noted during the follow-up period.

No transfusion or admission to the intensive care unit was required. All patients were ambulatory 1 day after placement of the separating stent-graft. There were no reports of chest pain or abdominal pain after placement. All puncture sites were well healed by using a compression system (Compressar; Instromedix, Hillsboro, Ore) for 30 minutes, and all femoral pulses were normal. The mean time of hospitalization was 10.3 days (range, 2–23 days).


   Discussion
TOP
 ABSTRACT
 INTRODUCTION
 Materials and Methods
Results
Discussion
REFERENCES
 
The best timing of surgical intervention for dissection of the descending thoracic aorta is controversial. In some series, patients with Stanford type B aortic dissection treated medically do better than patients treated surgically because of coexisting morbidities (1). Repair of the descending aortic dissection in most clinics is reserved for patients who have experienced (a) distal dissection with leakage of blood from the aorta, (b) compromised arterial supply to a specific organ or limb, (c) continued thoracic pain, or (d) extension of the dissection during satisfactory medical treatment. The inability to treat hypertension with maximal medical therapy is also an indication for repair (14).

For descending thoracic aortic dissections, the primary treatment is usually medical therapy consisting of ß blockade, antihypertensive therapy, and general supportive measures. Such treatment involves less chance of catastrophic compromise of an artery to the vital organs. Further, the average patient is considerably older and has other cardiovascular disease, factors that may compromise surgical results. But medical or surgical management is usually the treatment chosen for dissection, and both have disappointing results (13–19).

Most patients at some time during the 1st year after the acute event require surgery for acute dissection of the thoracic descending aorta (15–17). Acute dissection of the descending thoracic aorta should be aggressively treated medically if no complications exist. The patient is stabilized for approximately 4–6 weeks after treatment of the acute event in preparation for definitive resection. At this time, edema of the aortic wall has resolved, and the technical repair is easier and more secure (14). Whereas emergency surgical repair is lifesaving in ascending (type A) aortic dissection, both emergency surgery and deferred surgery for descending (type B) dissection are associated with a 6%–67% mortality rate, depending on the patient group assessed, and neither offers a substantial advantage over medical therapy (18–21). Also, paraplegia (or paresis) occurs in 7%–36% of patients who undergo surgery, depending on the extent of aortic resection and the duration of cross clamping (22–24).

Placement of a stent-graft across the primary entry tear is an effective single-step treatment that may be more efficient than endovascular techniques for the relief of ischemic complications and less invasive than aortic graft replacement at thoracotomy (13,25,26). Complete thrombosis of the false lumen was consistently achieved by Kato and colleagues (25) after closure of the initial intimal tear by means of endovascular placement of polyester-covered Z stents made in their laboratory.

Nienaber et al (13) reported stent-graft placement might be a promising nonsurgical strategy for the treatment of type B dissection. Initiation of the natural healing process (false-lumen thrombosis) by sealing the proximal entry induces both consolidation of the false lumen and remodeling of the aortic wall. Nonsurgical stent-graft placement was recommended for the treatment of type B dissection only in patients with an indication for surgical repair and with suitable anatomic characteristics (an accessible proximal entry, at least one femoral artery without dissection, and no substantial tortuosity). Moreover, the custom design of each separating stent-graft currently limits their placement to patients undergoing an elective procedure; more versatile separating stent-grafts will be necessary to treat acutely ill patients (13).

The separating stent-graft has several advantages: (a) Surgical arteriotomy is not needed, (b) blood pressure control is not required during deployment, (c) the stent-graft does not migrate during deployment, (d) the procedure time is relatively short, and (e) patients can be ambulatory 1 day after stent-graft placement. The 12-F introducer sheath is more flexible than is a larger introducer sheath; therefore; the separating stent-graft could be more easily used in patients who have tortuous or narrow iliac vessels. The mean time for placement of the separating stent-graft was 26.3 minutes ± 7.5 (SD), compared with a mean of 1.6 hours ± 0.4 for conventional stent-graft placement and 8.0 hours ± 2.0 for surgical placement (13).

Limitations of our study included no long-term results and placement of separating stent-grafts in only six patients. There have been several animal studies in which a separating stent-graft was inserted as an endoluminal patch to cover the entry site of a type B aortic dissection (27,28).

In conclusion, although further clinical trials, investigations of technical feasibility, and studies with extended follow-up are needed, these preliminary results indicate that separating stent-grafts are a feasible, safe tool for closing entry sites in the short term that warrant further study.


   FOOTNOTES
 
Abbreviation: DSA = digital subtraction angiography

Author contributions: Guarantor of integrity of entire study, S.G.K.; study concepts and design, S.G.K., D.Y.L.; definition of intellectual content, S.G.K., D.Y.L.; literature research, S.G.K., D.Y.L.; clinical studies, S.G.K., D.Y.L., D.C., B.O.K.; experimental studies, E.S.K., M.M.; data acquisition and analysis, S.G.K., D.Y.L.; , S.G.K.; manuscript editing, S.G.K., H.Y.S., D.Y.L.; manuscript review, K.B.S., D.C., B.O.K., H.K.Y.; manuscript preparation and final version approval, S.G.K.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 Materials and Methods
Results
Discussion
 REFERENCES
 

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G. Garzon, M. Fernandez-Velilla, M. Marti, I. Acitores, F. Ybanez, and L. Riera
Endovascular Stent-Graft Treatment of Thoracic Aortic Disease
RadioGraphics, October 1, 2005; 25(suppl_1): S229 - S244.
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N. Switzer
The Floating Viscera Sign
Radiology, July 1, 2004; 232(1): 244 - 245.
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S. Rudin, Z. Wang, I. Kyprianou, K. R. Hoffmann, Y. Wu, H. Meng, L. R. Guterman, B. Nemes, D. R. Bednarek, J. Dmochowski, et al.
Measurement of Flow Modification in Phantom Aneurysm Model: Comparison of Coils and a Longitudinally and Axially Asymmetric Stent--Initial Findings
Radiology, April 1, 2004; 231(1): 272 - 276.
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