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Ann Thorac Surg 2008;86:780-786. doi:10.1016/j.athoracsur.2008.05.040
© 2008 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Curved Nitinol Stent-Graft Placement for Treating Blunt Thoracic Aortic Injury: An Early Experience

Masato Yamaguchi, MDa,*, Koji Sugimoto, MDa, Takuro Tsukube, MDb, Takeki Mori, MDa, Toshihiro Kawahira, MDb, Taro Hayashi, MDb, Masahiko Nakamura, MDc, Ryota Kawasaki, MDd, Rajdeep S. Sandhu, MDe, Kazuro Sugimura, MDd, Syuichi Kozawa, MDc, Yutaka Okita, MDf

a Department of Radiology, Kobe Red Cross Hospital/Hyogo Emergency Medical Center, Kobe, Japan
b Department of Cardiovascular Surgery, Kobe Red Cross Hospital/Hyogo Emergency Medical Center, Kobe, Japan
c Department of Emergency, Kobe Red Cross Hospital/Hyogo Emergency Medical Center, Kobe, Japan
d Department of Radiology, Kobe University Hospital, Kobe, Japan
f Department of Cardiovascular Surgery, Kobe University Hospital, Kobe, Japan
e Division of Vascular and Endovascular Surgery, University Hospitals Case Medical Center, Cleveland, Ohio

Accepted for publication May 15, 2008.

* Address correspondence to Dr Yamaguchi, Department of Radiology, Kobe University Hospital, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan (Email: masato03310402{at}yahoo.co.jp).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background: Blunt trauma-induced aortic injury traditionally has been treated with early open surgical repair. However, recently endovascular stent-graft technology is considered a less-invasive therapeutic alternative, and flexible stent-grafts, such as the Matsui-Kitamura stent-graft (MKSG), are being used widely. We report our experience with the curved MKSG in treating thoracic aortic injuries.

Methods: Nine patients with traumatic thoracic aortic injury underwent endovascular surgery (8, emergency; 1, elective) with curved MKSG. The study variables were Injury Severity Score, endovascular surgery duration, aortic and stent-graft diameter, stay in the intensive care unit, follow-up period, and mortality. An MKSG was constructed using the Matsui-Kitamura stent and a polyester fabric graft. The stent-graft was placed using the transfemoral approach and the wire-tug technique.

Results: The mean Injury Severity Score was 42.3; 5 patients required 6 emergency procedures before the endovascular procedure (pneumothorax or hemothorax drainage, 5; transarterial embolization, 1). In 8 patients (88.9%), we achieved complete pseudoaneurysm exclusion or hemostasis in the injured portion. There were no postoperative complications; blood loss was minimal, and the intensive care unit stay was 13.4 days. The overall hospital mortality was 22.2% (n = 2; causes of death were unrelated to MKSG placement). Neither intervention-related mortality during follow-up (mean, 237.7 days) nor late endovascular graft-related complications (endoleak or graft migration) were noted.

Conclusions: Although this study is limited by a small sample size and short follow-up period, no collapse or stent-graft fractures were noted. Thus, MKSG placement for traumatic thoracic aortic injury appears a safe and effective therapy.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Blunt trauma, particularly high-speed motor vehicle accidents and falls from great heights, is a well-known cause of traumatic aortic injury. Because of the nature of the shearing forces and anatomic location of the aorta, blunt thoracic aortic injury is primarily located in the aortic isthmus, followed by the ascending and the distal aorta [1]. Blunt thoracic aortic injury has traditionally been treated with early open surgical repair [2], which may be limited by the large number of patients presenting with multiple comorbid conditions. Open surgery also requires heparinization, which is hazardous for patients with a bleeding disorder.

Recently, the advent of endovascular stent-graft technology has provided an attractive and less-invasive therapeutic alternative to open replacement for thoracic aortic injury. Surgical morbidity is reduced by avoiding thoracotomy, aortic cross-clamping, and cardiopulmonary bypass. With this background, minimally invasive endovascular treatment of blunt injury to the thoracic aorta is remarkably promising, considering the associated serious comorbidities that accompany such polytrauma patients [3].

Endovascular thoracic aortic repair has demonstrated excellent short-term and medium-term results in cases of degenerative aneurysms, traumatic aneurysms, and contained traumatic aortic ruptures [4, 5]. Recently, flexible stent-grafts have been widely used for treating thoracic aortic aneurysms [6, 7]. The Matsui-Kitamura stent-graft (MKSG), provided by Kanazawa University, is one such device used for aortic arch repair in several institutions in Japan. Its use in thoracic aortic aneurysm repair was first reported by a group of researchers from Kanazawa University [8]. In this paper, we have reported our early experience with curved MKSGs used for repairing blunt injury to the thoracic aorta in 9 patients, and have evaluated the technical feasibility and early clinical efficacy of this device.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Acknowledgments
 References
 
Patient Population and Evaluation
Between August 2005 and December 2007, we treated 9 patients (age, 45.8 ± 17.4 years (mean ± standard deviation; range, 19 to 70 years) with traumatic thoracic aortic injury by using a curved MKSG in 8 emergency and 1 elective procedures at two institutions experienced in endovascular procedures, Kobe Red Cross Hospital/Hyogo Emergency Medical Center (8 patients), and Kobe University Hospital (1 patient). Eight of the patients had sustained a motor vehicle accident and 1 patient fell from a significant height. No patients had previously undergone chest surgery. The injured portion included the isolated isthmus in 7 patients (78%) and the segment between the isthmus and descending aorta in 2 patients (22%). All concomitant injuries and additional procedure are listed in Table 1.


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  		Table 1 Concomitant Injuries
 
The use of curved MKSG for this particular surgical condition was approved by our ethics committee. Informed consent was obtained either from the patients themselves or from their relatives. The following variables were investigated: Injury Severity Score, duration of endovascular surgery, aortic diameter (between the origin of the left subclavian and carotid artery, and descending aorta), stent-graft properties (diameter, length, radius of curvature), duration of stay in the intensive care unit, follow-up duration, and mortality. Duration of endovascular surgery was defined from the beginning of sheath insertion to the end of stent-graft deployment. All patients were provided initial trauma care according to the Advanced Trauma Life Support guidelines [9]. Traumatic aortic injury was diagnosed based on the initial computed tomography angiogram (CTA) and plain chest radiographs of the patients. At our institutions, we use multislice computed tomography, a Somatom Plus 4 Volume Zoom (Siemens, Erlangen, Germany) or a LightSpeed Ultra 16 (GE Medical Systems, Milwaukee, WI). For intravenous contrast enhancement, we administered a bolus injection of 100 mL iohexol (Omnipaque300; Daiichi Sankyo Co, Tokyo, Japan) at a rate of 3 mL/s. Scanning was initiated 30 s after commencing the contrast injection; a 5-mm slice thickness or a 6.875-mm/s table increment (pitch, 1.375) was used for scanning. If a patient was transferred from another hospital and had a CTA, we performed the procedure based on the findings of this CTA. After the initial assessment and stabilization, patients were transferred to an angiography suite. Acute life-threatening injuries such as tension pneumothorax and hemorrhage at other sites were treated first, followed immediately by the endovascular procedure. After stent-graft placement, a CTA was obtained on the first postoperative day and at regular intervals, if possible.

Matsui-Kitamura Stent-Graft Construction and Implantation
An MKSG is constructed from a self-expanding stent, compoed of a braided single nitinol wire of 0.35 or 0.4 mm diameter and a seamless, cylindrical woven graft composed of 0.1-mm-thick polyester fabric. Nitinol alloy comprising 51% by weight of nickel and 49% by weight of titanium (Memoalloy; Tokin Inc, Tokyo, Japan) is used to shape a metallic stent. The wire was wound in a spiral fashion, and both ends of the wire were connected to a compressed, small platinum cylinder. As covering the stent completely might prevent its full expansion, the graft was attached to the stent framework only at the ends with a 5-0 monofilament suture (Fig 1).


Figure 1
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  		Fig 1. The curved Matsui-Kitamura stent-graft was constructed using the Matsui-Kitamura stent and polyester fabric. The curved Matsui-Kitamura stent-graft is a 90-degree angle. R means radius of curvature. Refer to the text for construction details.

 
The MKSG was placed in the patient in the angiographic suite under local or general anesthesia. To perform aortography, 4F sheaths (Terumo Co, Tokyo, Japan) were inserted percutaneously into the brachial artery bilaterally, and a 4F pigtail catheter was placed in the ascending aorta through the left brachial artery. We determined the access route with multiplanar reconstruction images of CTA in the pelvis or digital subtraction angiography in the pelvis. Vascular access was obtained through a surgically exposed femoral artery. In the wire-tug technique, a 0.035-inch, 300-cm-long hydrophilic guidewire (Terumo Co) was introduced through the sheath inserted in the right brachial artery, advanced with the 4F catheter, and drawn out of the exposed femoral artery. For determining the size of the endovascular graft, we measured the aortic diameter between the origin of the left subclavian and carotid artery and oversized the graft by 10% to 20%, when possible. The MKSG was deployed through the 18F, 20F, or 22F J-shaped sheath system (Cook Ind, Bloomington, IN) combined with a preloader-type introducer, designed particularly for this procedure (Fig 2). After the transverse arteriotomy of the common femoral artery was performed, and the long guidewire was taken out, the delivery system was advanced into the target segment of the aorta using the wire-tug method. On confirming the anatomic relationships between the injured aortic portion and the major branches of the aorta, we determined the best working projection and deployed the MKSG under fluoroscopic guidance. Right after deployment, postdilatation was achieved with a TMP lock balloon catheter (Tokai Medical Products Co, Aichi, Japan). At the end of the procedure, a final aortography was performed to ensure there was no endoleak, stent-graft migration, or access route injuries.


Figure 2
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  		Fig 2. The Matsui-Kitamura stent-graft was deployed through 18F, 20F, or 22F J-shaped sheath system combined with a preloader-type introducer, designed particularly for this procedure.

 

   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Acknowledgments
 References
 
The mean Injury Severity Score of the treated patients was 42.3 ±16.1. In 5 patients, six emergency procedures were performed before the endovascular procedure: five for the drainage of traumatic pneumothorax or hemothorax and one transarterial embolization for a pelvic fracture. Of 9 patients, 4 (40%) were admitted for primary trauma, and the remaining 5 patients were transferred from other hospitals owing to severe injuries or suspected traumatic aortic rupture. In 8 patients, thoracic aortic repair was performed right after the primary trauma, on emergency basis. In one of the patients, the grafts had to be procured within 1 h, whereas the other 7 patients were treated using grafts that were readily available in our hospitals. The remaining 1 patient underwent an elective procedure because the patient was diagnosed with aortic injury along with retroperitoneal hematoma at another hospital where she was kept under observation for 28 days. Subsequently, the patient was transferred to our hospital, on her demand, for endovascular treatment.

The initial endovascular placement of the curved MKSG was successful in all patients. All the MKSGs were deployed in the correct position and fitted to the aortic arch. In 8 patients (88.9%), we achieved complete pseudoaneurysm exclusion or hemostasis in the injured portion (Figs 3 and 4). Go Two patients were converted to open surgery. In 1 patient, a residual proximal type I endoleak was treated surgically after 4 days. In another patient, an open surgery was conducted on a young patient, in accordance with the surgeon's advice and the patient's wish (endovascular procedure was successful, without type I endoleak; however, open surgery was recommended to maintain successful results for a long time).


Figure 3
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  		Fig 3. Angiogram of a 59-year-old woman with severe aortic injury caused by a motor vehicle accident and complicated by severe abdominal injury (Injury Severity Score = 75). Digital subtraction angiographic image shows the aortic injury in the isthmus with extravasation to the left thoracic cavity (35° left anterior oblique projection).

 

Figure 4
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  		Fig 4. The curved Matsui-Kitamura stent-graft was deployed in the target position with close apposition to the curvature of the distal aortic arch. Digital subtraction angiographic image shows complete pseudoaneurysm exclusion and hemostasis in the injured portion.

 
The aortic diameter between the origin of the left subclavian and carotid artery is 24.7 ± 2.96 mm. The descending aortic diameter is 20.1 ± 2.79 mm. The stent properties are as follows: diameter, 32.4 ± 1.94 mm; range, 28 to 34 mm; length, 135.1 ± 11.8 mm; radius of curvature, 36.0 ± 4.19 mm. The size of the delivery system was 18F in 1 patient, 20F in 5 patients, and 22F in 3 patients. The mean duration of endovascular surgery was 66.0 ± 16.6 minutes.

In 3 patients, the rupture was located near the origin of the left subclavian artery. To achieve an adequate proximal seal, intentional covering of the left subclavian artery was essential. At follow-up, no patients presented with upper extremity ischemia or neurologic complications.

In each patient, the transfemoral approach was successful, and there were no related postoperative complications. Blood loss during the procedure was minimal and mainly caused by leakage through the valves of large sheaths used during graft insertion. The mean duration of intensive care unit stay was 13.4 days (range, 1 to 58 days). The overall hospital mortality was 22.2% (n = 2). One patient died perioperatively as a result of severe multiorgan injuries. Another patient who had multiorgan failure owing to complications from severe abdominal injury died 65 days after the procedure (Fig 5). In the case of patients who had undergone permanent MKSG placement, no intervention-related mortality was observed during the mean follow-up period of 237.7 days. Furthermore, no other late endovascular graft-related complications such as endoleaks or graft migration occurred according to the CTA at regular interval (n = 6). The studied variables are listed in Table 2.


Figure 5
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  		Fig 5. An enhanced computed tomographic scan obtained 25 days after the procedure demonstrates complete hemostasis in the injured portion without any endoleak. However, the patient experienced multiorgan failure and died 65 days after surgery as a result of severe abdominal injury and other complications. The cause of death was thus unrelated to Matsui-Kitamura stent-graft placement.

 

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  		Table 2 Patient Characteristics (n = 9)
 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Acknowledgments
 References
 
Blunt thoracic aortic injury is a life-threatening condition [10]. Acute deceleration induces shear forces that tear off the relatively mobile aortic arch from the more fixed descending aorta [11, 12]. Consequently, most (90%) blunt traumatic aortic injuries are located at the isthmus [13]. In general, blunt thoracic aortic injury progresses to free rupture of the aorta, leading to immediate death in 75% to 80% of patients failing to even receive a treatment, with only 10% to 15% of injured people reaching a hospital alive [14]. Immediate diagnosis and emergent treatment are essential, particularly in cases of active bleeding, obstruction of the aortic lumen, increasing mediastinal hematoma, pleural effusion, or compression of the respiratory system's organs [15]. However, patients requiring surgical repair of this injury have, at best, a cautious prognosis, with a significant risk of morbidity inasmuch as most patients often have multiple concomitant injuries. Recently, several series have demonstrated endovascular repair to be the new effective treatment strategy with promising results [3, 16–21]. The primary advantage of stent-graft placement for thoracic aortic injury is that it does not require cross-clamping of the aorta, initiation of extracorporeal circulation, or single-lung ventilation for lateral thoracotomy. Concomitant injuries pose no obstacle to endovascular grafting because systematic heparinization is not required and the blood loss is minor. Thus, when open surgery is contraindicated, thoracic stent grafting may be used as a viable alternative treatment.

The use of high-quality flexible stent-grafts for the treatment of thoracic aortic aneurysms has been documented in the literature [22, 23]. However, its application in Japan has been limited because commercial devices for thoracic aortic repair are not easily accessible. Under these circumstances, endografts have to be custom-built by individual physicians [24, 25]. One of these devices, the MKSG is occasionally used as a flexible stent-graft in aortic arch repair by several institutions in Japan [8, 26]. The MKSG is advantageous mainly because of its flexibility, suitability for tortuous aortic segments, and shape memory. The braided structure of the MKSG also has the advantage of minimizing the risk of aortic wall damage because it has a wider surface area that comes in contact with the aortic inner wall. Its distinctive curved configuration permits a tight fit with good apposition and no kinks within the three-dimensional curvature of the aortic arch, which effectively repairs an aortic injury.

In our series, 1 patient had type I endoleak 4 days after placement and required open surgery. We noticed the endoleak on postplacement angiography, and despite multiple attempts at fixation by balloon dilatation, the endoleak persisted. We believe that the proximal landing zone, which is commonly observed in traumatic ruptures involving the isthmus, was extremely short for appropriate fixation. The proximal landing zone is believed to stem from a short landing zone, which may be tortuous, kinked, and lined with thrombi. A steeply angulated aortic arch, which is common in young patients, affects residual type I endoleak. Additionally, characteristics of the stent-graft, including diameter, shape, radial force, porosity, and flexibility of the assembly, may influence appropriate placement. The endoleaks can usually be repaired either by balloon dilation or additional placement of a second graft [15, 19, 21]. To prevent these endoleaks, it is important to select an optimal landing zone and use a flexible, curved, and low-porosity stent-graft.

We used a 20F or 22F sheath introducer to deploy the MKSG in most of our patients. Sanada and colleagues [8] have reported the use of an 18F sheath introducer for stent-grafts up to 36 mm in diameter and a 20F sheath introducer for larger devices (up to 42 mm). Because most of our patients were emergent, we did not select low-profile introducers and reduced the time required for adequate preprocedural preparations for small sheaths. However, with adequate experience, a smaller introducer system may be used, thereby decreasing the risk of access injury and expanding the indications of this endovascular procedure.

Although the MKSG is a custom-built device, we did not always use the optimal-sized stent-graft because of the emergency nature of the cases. The selection of stent-graft size was limited; therefore, we usually selected those available with 32- or 34-mm diameter. Moreover, the descending aortic diameter tended to be smaller than the proximal portion, which was measured to determine size. Stent-graft diameter tended to be oversized in some patients. In this regard, as the innate characteristics of the MKSG accentuate its flexibility rather than radial strength, it can be manipulated with respect to its diameter by extending it along its long axis. This allows custom oversizing, permitting good apposition between the stent-graft and the aortic wall. In our series, we occasionally noted a slight extension in the covered portion of the descending aorta. Despite this, there were no complications such as spinal cord ischemia or paraplegia.

To achieve an adequate seal and an appropriate proximal landing zone, we covered the left subclavian artery in 3 patients. No neurologic or upper extremity complications were noted; this result corresponds to the findings described in other reports [18, 20, 27]. Although the intentional overstenting of the left subclavian artery without previous revascularization is generally well-tolerated and does not cause complications, cerebral problems and arm claudication have been reported [21]. Both the carotid and vertebral arteries should be evaluated thoroughly before intentional coverage. Obviously, the presence of a left-sided mammary artery to coronary arterial bypass and a dominant left vertebral artery are contraindications to covering the left subclavian artery; however, the artery should certainly be covered in the case of aortic injury when warranted. In the future, branched or fenestrated stent-grafts, currently available in selected institutions, will address the issue of preserving left subclavian flow [28, 29].

We achieved technical success in 8 of 9 (88.9%) patients with the curved MKSG. Two patients died during the study period; however, the causes of death were unrelated to the aortic rupture or stent-graft placement. In light of the life-threatening aortic injuries, particularly in polytrauma patients, stent-graft treatment may be the only alternative available. However, technical success in these patients does not necessarily result in patient survival and should be considered unrelated to patient outcomes.

Another issue is extended follow-up. Regarding long-term results, true effectiveness of this procedure is doubtful. One of the concerns is younger patients affected by acute traumatic rupture compared with elderly patients affected by other thoracic aortic diseases. Therefore, materials used for endografting must be durable. Recently, some reports have described total or near-total acute endoprosthesis collapse or infolding. Most collapses have occurred in patients treated for traumatic aortic injury and dissections rather than in those with atherosclerotic aneurysms [30, 31]. Although this study is limited by the comparatively small number of patients and short follow-up period, no collapse or stent-graft fractures were noticed in our patients. Furthermore, at follow-up, no major device complications, including perigraft leak or graft migration, were encountered, confirming the anatomic suitability of the MKSG for repairing aortic injury. Thus, MKSG placement for traumatic thoracic aortic injury appears to be a safe and effective therapy. In the future, we hope to report our mid-term and long-term results and evaluate the possibility of permanent stent-graft placement.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
References
 
The authors gratefully acknowledge Junichiro Sanada, MD, and Osamu Mastui, MD, from the Department of Radiology, Kanazawa University School of Medicine, for providing the MKSGs used in this study.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

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