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Ann Thorac Surg 1998;66:19-24
© 1998 The Society of Thoracic Surgeons


Original articles: cardiovascular

Endovascular stent graft repair for aneurysms on the descending thoracic aorta

Marek Ehrlich, MDa, Martin Grabenwoeger, MDa, Fabiola Cartes-Zumelzu, MDa, Michael Grimm, MDa, Dietmar Petzl, MDb, Johannes Lammer, MDc, Siegfried Thurnherc, Ernst Wolner, MDa, Michael Havel, MDa

a Department of Cardio-Thoracic Surgery, University of Vienna, Vienna, Austria
b Department of Medicine, University of Vienna, Vienna, Austria
c Department of Interventional Radiology, University of Vienna, Vienna, Austria

Address reprint requests to Dr Ehrlich, Department of Cardio-Thoracic Surgery, Mount Sinai Medical Center, One Gustave Levy Place, Box 1028, New York, NY 10029
e-mail: (mehrl98000{at}aol.com)

Presented at the Thirty-fourth Annual Meeting of The Society of Thoracic Surgeons, New Orleans, LA, Jan 26–28, 1998.


    Abstract
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Background. The traditional treatment of aneurysms of the descending thoracic aorta includes posterolateral thoracotomy and aortic replacement with a prosthetic graft. In this study, we report our experiences and results in endovascular stent graft placement as an alternative to surgical repair.

Methods. Between January 1989 and July 1997, a total of 68 patients (24 women) underwent replacement of the thoracic aorta. Mean age at operation was 51 years. Fifty-eight patients underwent conventional surgical treatment. All of these patients were suitable candidates for endovascular stenting; however, no stent graft material was available at the time of operation. Ten patients (1 chronic dissection, 9 atherosclerotic aneurysm) received in the past 8 months the first commercially manufactured endovascular stent graft. The mean diameter of the aneurysms in this group was 7 cm (range, 6 to 8 cm). Two stent patients were operated on using only spinal cord analgesia. All stent grafts were custom designed for each of the 10 patients.

Results. The 30-day mortality in the conventional group was 31% versus 10% in the stent group. Mean length of intervention was 320 minutes in the conventional group versus 150 minutes in the endovascular group. Spinal cord injury occurred in 5 patients (12%) in the surgical group, whereas none of the stented patients developed any neurologic sequelae. Mean intensive care unit stay was 13 days, followed by a mean of 10 days on a ward in the first group compared to 4 days in the intensive care unit and 6 days on the ward in the stent group. One stent was required in 2 patients, two stents were required in 3 patients, and four stents were deployed in 5 patients of our series. Five patients required transposition of the left subclavian artery to achieve a sufficient neck for the proximal placement of the stent. There was complete thrombosis of the thoracic aortic aneurysm surrounding the stent graft in 8 patients (80%). Two patients required restenting as a result of leakage (20%). Stent graft placing was performed through the femoral artery in 8 patients, whereas access was only achieved through the abdominal aorta in 2 patients.

Conclusions. These preliminary results demonstrate that endovascular stent graft replacement might be a promising, cheaper, and safe alternative method in selected patients with descending thoracic aneurysms.


    Introduction
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Descending thoracic aortic aneurysms still represent a potentially life-threatening situation. Resection and graft replacement of the pathologically altered aorta is the preferred method of treatment [16]. Although great strides have been achieved during the past decades in the management of patients with thoracic aortic aneurysms by new surgical techniques, intraoperative monitoring of somatosensory-evoked potentials, and spinal cord fluid drainage, postoperative morbidity and mortality rates still remain high [710]. The afflicted population is usually of older age and present at time of operation with various comorbidities such as hypertension, obstructive pulmonary disease, coronary heart disease, all of which have significant impact on the surgical outcome. Postoperative complications, such as paraplegia, renal and pulmonary insufficiency, contribute to prolonged hospital stays and higher medical cost.

Since the first successful endovascular stent graft placement in an abdominal aortic aneurysm [11], various groups have started to investigate the feasibility of thoracic aortic aneurysmal repair with transluminally placed stent grafts [12, 13]. This study was undertaken to report our initial clinical experience with the repair of descending thoracic aortic aneurysms with a commercially available endovascular stent graft and compare these results with a conventionally treated group.


    Material and methods
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Patients
Between January 1989 and July 1997, a total of 68 patients underwent replacement of the descending thoracic aorta at the University of Vienna Medical Center. Patients were grouped into two categories based on perioperative management. Group 1 consisted of all patients operated on by conventional surgical treatment. All of the 58 patients in this group were suitable candidates for endovascular stenting; however, no stent graft material was available at the time of operation. Group 2 comprised 10 patients who received in the past 8 months a commercially manufactured endovascular stent-graft. Table 1 summarizes important preoperative characteristics of both groups. Hypertension was the most common preoperative medical disorder with an incidence of 73% in all patients, followed by a history of smoking (66%) and coronary heart disease (33%).


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Table 1. Selected Preoperative Clinical Characteristics and Complications

 
The conventional technique used in the first group included profound hypothermic circulatory arrest in 42 patients, left heart bypass in 5 patients, and femoral/femoral nonheparinized roller pump in 11 patients, respectively.

All stent graft patients gave their informed consent in conformance with the protocols approved by the institutional review board of Vienna Hospital. They underwent chest radiography, spiral computed tomographic scanning, and arteriography before the procedure and at intervals after the procedure. Patients eligible for receiving a stent graft had to have at least a 1- to 2-cm long proximal and distal neck. Chronic aortic dissection was not an exclusion criteria in our stent series; however, this procedure was only performed when the false lumen was already completely thrombosed. Acute aortic dissection was a contraindication for stent graft deployment.

The mean stent graft diameter was 36 mm (range, 32 to 40 mm), and the mean length of the device was 104 mm (range, 100 to 120 mm). The preoperative characteristics of the 10 stented patients are shown in Table 2.


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Table 2. Characteristics of all 10 Patients Who Received Endovascular Stent Graft Placement

 
Endovascular grafting system
The endovascular stent graft (Talent Endoluminal Spring Graft System, World Medical Corporation, Sunrise, FL) was custom designed for each patient (Fig 1). It is a self-expanding spring-stent graft that is compressed over a multiple-lumen polyurethane placement catheter. The stent graft and catheter are loaded into a hollow sheath. The entire system is introduced into the vasculature and advanced to the aneurysmic site. The system consists of a placement catheter that has one through lumen used to carry a guidewire. The catheter also contains a polyurethane tip and central balloons. The central balloon is used to model the spring stent graft to the vessel wall after deployment. The graft by itself is made of polyester (Dacron) vascular graft and a nitinol wire stent, with spring shaped in a zig-zag serpentine formation and placed approximately 5 to 15 mm apart. A straight nitinol connecting wire extends from the proximal-most spring to the distal-most spring and serves to fix the length of the device and avoid twisting and kinking. Furthermore, the system consists of a hollow introducer sheath. The sheath includes a hemostasis valve and a side port with stopcock. The sheath’s stiffness can be controlled by injecting/withdrawing a solution into/from the side port. Finally, the system contains a push rod with plunger that includes a Touhy-Borst valve and a plunger. The valve holds the plunger in place and prevents excess blood leakage.



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Fig 1. Stent graft material used in our series.

 
Endovascular procedure
All but 2 patients were under general anesthesia, and cardiopulmonary bypass standby was available in every case. The largest femoral artery is exposed and controlled proximally and distally. If the femoral artery is considered too small in diameter, the iliac artery or abdominal aorta is used for vascular access. Five thousand units of heparin is injected intravenously. Using a percutaneous left brachial artery approach, a catheter is inserted over a guidewire localizing the subclavian artery and celiac axis and is used for aortogram. Through a transverse femoral arteriotomy, a guidewire is inserted and passed above the aneurysmal site. With use of image amplification, the endovascular stent system is passed over the guidewire and positioned at the desired location. The guidewire is removed. An arteriography is performed to verify the exact location of the proximal stent. By holding the push rod and placement catheter stationary and inflating the tip balloon, the sheath is moved downward to deploy the proximal spring. The nitinol spring expands and conforms to the shape and size of the proximal neck of the aortic aneurysm and will maintain sufficient pressure against the aorta to create and sustain a blood-tight seal. The balloon tip is slowly deflated (Fig 2). With gentle downward movement of the placement catheter, the graft is opened. The integrated balloons are used to occlude blood flow to the deployment site, fix the position of the proximal stent during deployment, model the spring stent to the vessel wall neck, and smooth wrinkles in the graft material. The push rod and placement catheter are held stationary and the sheath is moved downward. The distal nitinol spring is deployed and ballooned to seal against the distal aortic aneurysm neck. A second arteriography is performed to verify sealing of the graft. The placement system is removed, the arteriotomy is closed in the usual manner. Figure 3 shows graphically a typical stent graft at the end of the procedure. Before discharge, aortogram and spiral computer tomography is performed to document aneurysmal exclusion.



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Fig 2. Proximal stent graft deployment at the proximal descending aorta.

 


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Fig 3. Typical stent graft after final accomplishment of the procedure.

 
Statistics
Data are presented as percentage or means ± standard deviation. The data from the two groups were compared with unpaired Student’s t test. All differences were regarded as statistically significant if p was less than 0.05.


    Results
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
The 30-day mortality in the conventional group was 31% versus 10% in the stent group. Table 3 summarizes important postoperative parameters between both groups. Patients treated conventionally by left thoracotomy had longer intensive care unit as well as hospital stays. The duration of the procedure was much shorter in the stented group and there were no neurologic complications associated with endovascular stent graft placement. However, all of our 10 patients in the stent group had proximal descending aneurysms where covering of and as a consequence sacrifice of intercostal arteries with the stent graft is not of so much importance as in distal descending thoracic aortic repair. Three of the 5 patients with spinal complications in the conventional group had extension of the aneurysm into the distal descending aorta with reattachment of intercostal arteries at a level of T-11 and T-12. Four of these 5 patients have been operated with the use of profound hypothermic circulatory arrest and 1 patient had been operated with left heart bypass.


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Table 3. Intraoperative and Postoperative Parameters Between Both Groupsa

 
The deployment of the stent graft at the intended position was successfully performed in all 10 patients. Typical aortograms obtained before and after the procedure are shown in Figures 4 and 5. Stent graft placing was carried out through the femoral artery in 4 patients, iliac artery in 4 patients, whereas access was only achieved through the abdominal aorta in 2 patients (Table 4). Introduction of the sheath caused dissection of the iliac artery in 1 patient (patient 9). The sheath was removed immediately and a iliac–femoral bypass was performed. Access to the descending aorta was accomplished in the same patient from a retroperitoneal approach with introduction of the sheath directly into the abdominal aorta. Complete aneurysmal thrombosis was accomplished immediately in 8 patients (80%). Two patients had leakage into the aneurysmal sac. Patient 5 had a small proximal tract communicating with the aneurysm at the distal aortic arch. Patient 8 had leakage into the aneurysmal sac between two stents. Both patients required a second procedure and a separate stent graft prosthesis was needed to cover the residual filling site.



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Fig 4. Preoperative aortogram from a patient with a descending thoracic and left subclavian aneurysm.

 


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Fig 5. Postoperative aortogram from the same patient after transposition of the left subclavian artery and stent graft placement.

 

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Table 4. Characteristics of all 10 Patients Who Received Endovascular Stent Graft Placement

 
There was one postoperative death in the stented group. This was in a 76-year-old man with an atherosclerotic aneurysm 60 mm in diameter (patient 2). No transposition of the subclavian artery had to be carried out and the patient received two stent grafts introduced through the femoral artery. He had an uneventful postoperative recovery in the intensive care unit and was transferred to the ward on the second day after the procedure. The same patient had rupture of the descending thoracic aorta on postoperative day 7 as a result of stent penetration through the aneurysmatic aortic wall and died immediately after the event. As of this writing, none of the 9 surviving stent patients have shown a serious complication such as graft migration, aneurysm rupture, aneurysms enlargement, or a change in the position and configuration of the graft.


    Comment
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Since 1969, when Dotter [14] inserted stainless steel coils as a vascular stent in canine popliteal arteries, transluminal placement of endovascular stent grafts has been used as a treatment of abdominal aortic aneurysms as well as recently for descending thoracic aneurysms or dissections [12, 15]. Although long-term follow-up is limited at present, early experimental as well as clinical results have been promising [16, 17]. The aim of this minimally invasive technique is to achieve aneurysmal exclusion, to suppress the pressure stress on the aneurysmal sac, and to reduce mortality and morbidity rates compared with those associated with standard surgical treatment. Stent graft placement might be of particular benefit, especially in high-risk patients with descending thoracic aneurysms, because this procedure is easier and less invasive than the conventional surgical approach. It enables avoidance of left thoracotomy with the consequences of lung manipulation and compression as well as phrenic and recurrent nerve injury resulting in prolonged postoperative respiratory support. Coagulopathies associated with deep hypothermia and circulatory arrest can also be avoided by this technique.

If a patient is considered to be a candidate for endovascular stent graft placement, a number of anatomic as well as technical matters have to be taken into account. It is imperative to perform preoperative imaging studies to gain information about the precise vascular access and aneurysmal size. Longitudinal and transverse diameter of the aneurysm provide information that are needed to design a precise stent prosthesis for each individual patient. Furthermore, an aortogram should be performed before the procedure to determine the anatomic relationship to major aortic branches, such as the left subclavian artery or the celiac axis.

The perioperative mortality rate could be decreased in this series from 31% in the conventional-treated group to 10% in the endovascular stent graft group, but did not reach statistical significance owing to the small number of patients in the latter group. These results are similar to a recent stent study carried out by Mitchell and colleagues [12] from Stanford where the mortality rate in 44 patients was 7%. Furthermore, the majority of our patients who received an endovascular stent graft were considered poor candidates for conventional open repair because of various comorbidities such as previous myocardial infarction, hypertension, and coronary heart disease.

The incidence of paraplegia in descending thoracic aneurysms is reported from 0 to 18% [10, 18, 19]. There was no instance of paraplegia in our stent-treated patients. Although there is no opportunity to reimplant intercostal arteries with this new technique, most of these intercostal branches are usually thrombosed in atherosclerotic aneurysms at the time of intervention. It is unknown at this point which effect endoluminal grafting will have on spinal cord injury. However, aortic cross-clamping for a longer period with the consequences of spinal cord hypoperfusion can be avoided by this new procedure.

At this time, there are still pitfalls that have to be addressed with this surgical approach. The first concerns the device itself. In its present state, graft deployment is still relatively inexact and precise stent placement is sometimes hard to achieve. Miniaturization of the stent device has to be developed to prevent complications such as vascular trauma during introduction.

Another problem concerns perigraft leakage. This complication occurred in our study in 2 patients. The main cause of this problem was the limited anatomic suitability in 1 patient, which made it difficult to achieve a precise placement of the stent graft as well as distal migration of one stent after deployment in the second patient. Although it remains uncertain at this stage of knowledge whether leakage into the aneurysmal sack may lead to late aortic rupture, both patients with stent graft leakage had a second procedure right after the first intervention to obliterate the leakage spot.

It is our belief that an absolute contraindication for endovascular stent graft placement is a severe tortuosity of the descending thoracic aorta or iliac arteries where introduction of the stent device to the desired location might be associated with a risk of aortic or arterial rupture. Furthermore, patients with acute aortic dissections were excluded for stent graft placement in our study. Although 1 patient with a chronic dissection, where the false lumen was already thrombosed, received a stent graft, it remains uncertain whether this technique is suitable for this specific patient cohort. Furthermore, should this procedure be limited to patients with a sufficient distal and proximal neck and the absence of nearby important side branches. Therefore, transposition of the left subclavian artery was performed in 5 patients.

Two patients, where stent graft insertion was performed through the femoral artery, were operated on by the use of spinal cord analgesia. It is our belief, however, that this anesthetic technique should be limited to those patients, where access into the vascular system is planned from the groin. Manipulation of the iliac artery or abdominal aorta for graft insertion from a retroperitoneal approach might be associated with severe pain and should be performed only by general anesthesia.

Although our results with stent graft placement on the descending thoracic aorta demonstrated that this method is feasible, there remain questions and long-term considerations. Short- and long-term biologic interactions between prosthesis and aortic wall need further investigation.

In summary, our results demonstrate that insertion of an endovascular stent graft into the descending aorta is feasible, and that intraluminal aneurysm exclusion can be achieved acutely. Further studies need to be performed to determine the long-term effectiveness. This technique may become applicable for treating descending aortic aneurysm, especially in high-risk patients, as this approach is less invasive than the current conventional surgical methods.


    References
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 

  1. Cooley D.A., DeBakey M.E. Surgical considerations of intrathoracic aneurysms of the aorta and great vessels. Ann Surg 1952;135:660-680.
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  3. Cooley D.A., DeBakey M.E. Surgical consideration of excisional therapy for aortic aneurysms. Surgery 1953;34:1005-1020.[Medline]
  4. Livesay J.J., Cooley D.A., Ventemiglia R., et al. Surgical experience in descending thoracic aneurysmectomy with and without adjuncts to avoid ischemia. Ann Thorac Surg 1985;39:37-46.[Abstract]
  5. Crawford E.S., Walker H.S.J., Saleh S.A., Normann N.A. Graft replacement of aneurysm in descending thoracic aorta: results without bypass or shunting. Surgery 1981;89:73-85.[Medline]
  6. Najafi H., Javid H., Hunter J., Serry C., Monson D. Descending aortic aneurysmectomy without adjuncts to avoid ischemia. Ann Thorac Surg 1980;30:326-335.[Abstract]
  7. Hollier L.H., Money S.R., Naslund T.C., et al. Risk of spinal cord dysfunction in patients undergoing thoracoabdominal aortic replacement. Am J Surg 1992;164:210-214.[Medline]
  8. Crawford E.S., Mizrahi E.M., Hess K.R., Coselli J.S., Safi H.J., Patel V.M. The impact of distal aortic perfusion and somatosensory evoked potential monitoring on prevention of paraplegia after aortic aneurysm operation. J Thorac Cardiovasc Surg 1988;95:357-367.[Abstract]
  9. Kouchoukos N.T., Wareing T.H., Izumoto H., Klausing W., Abboud N. Elective hypothermic cardiopulmonary bypass and circulatory arrest for spinal cord protection during operations on the thoracoabdominal aorta. J Thorac Cardiovasc Surg 1990;99:659-664.[Abstract]
  10. Borst H.G., Jurmann M., Buhner B., Laas J. Risk of replacement of descending aorta with a standardized left heart bypass technique. J Thorac Cardiovasc Surg 1994;107:126-133.[Abstract/Free Full Text]
  11. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg 191;5:491–9.
  12. Mitchell R.S., Dake M.D., Semba C.P., et al. Endovascular stent-graft repair of thoracic aortic aneurysms. J Thorac Cardiovasc Surg 1996;111:1054-1062.[Abstract/Free Full Text]
  13. Inoue K.I., Iwase T., Sato M., et al. Clinical application of transluminal endovascular graft placement for aortic aneurysms. Ann Thorac Surg 1997;63:522-528.[Abstract/Free Full Text]
  14. Dotter C.T. Transluminally-placed coilspring endoarterial tube grafts: long-term patency in canine popliteal artery. Invest Radiol 1969;4:329-332.[Medline]
  15. Dake M.D., Miller D.C., Semba C.P., Mitchell R.S., Walker P.J., Liddell R.P. Transluminal placement of endovascular stent-grafts for the treatment of descending thoracic aortic aneurysms. N Engl J Med 1994;331:1729-1734.[Abstract/Free Full Text]
  16. Moon M.R., Dake M.D., Pelc L.R., et al. Intravascular stenting of acute experimental type B dissections. J Surg Res 1993;54:381-388.[Medline]
  17. Fann J.I., Dake M.D., Semba C.P., Liddell R.P., Pfeffer T.A., Miller D.C. Endovascular stent-grafting after arch aneurysm repair using the "elephant trunk". Ann Thorac Surg 1995;60:1102-1105.[Abstract/Free Full Text]
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Immediate Versus Delayed Endovascular Treatment of Post-Traumatic Aortic Pseudoaneurysms and Type B Dissections: Retrospective Analysis and Premises to the Upcoming European Trial
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E. S. Rachel, T. M. Bergamini, E. V. Kinney, M. T. Jung, H. W. Kaebnick, and R. A. Mitchell
Endovascular Repair of Thoracic Aortic Aneurysms: A Paradigm Shift in Standard of Care
Vascular and Endovascular Surgery, March 1, 2002; 36(2): 105 - 113.
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N. Uchida, H. Ishihara, M. Sakashita, M. Kanou, and T. Sumiyoshi
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Eur. J. Cardiothorac. Surg.Home page
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Eur. J. Cardiothorac. Surg.Home page
A.S. Bortone, S. Schena, G. Mannatrizio, V. Paradiso, G. Ferlan, G. Dialetto, M. Cotrufo, and L. de Luca Tupputi Schinosa
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Aortic stent-graft for patent ductus arteriosus in adults: the aortic exclusion technique
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J. M. Caiati, M. L. Marin, R. M. Flores, C. R. Smith, E. C. Martin, and G. J. Todd
Endovascular Management of an Aortobronchial Fistula Arising After Resection of a Primary Aortic Sarcoma: A Case Report
Vascular and Endovascular Surgery, January 1, 2001; 35(1): 73 - 79.
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J. Thorac. Cardiovasc. Surg.Home page
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Ann. Thorac. Surg.Home page
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PERSPECT VASC SURG ENDOVASC THERHome page
R. P. Cambria
Stent Graft Repair of Thoracic Aortic Pathology
Perspectives in Vascular Surgery and Endovascular Therapy, January 1, 2000; 13(2): 1 - 13.
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