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Eur J Cardiothorac Surg 2004;26:608-613
© 2004 Elsevier Science NL


Secondary surgical interventions after endovascular stent-grafting of the thoracic aorta

Martin Grabenwogera*, Tatjana Flecka, Marek Ehrlicha, Martin Czernya, Doris Hutschalaa, Maria Schoderb, Johannes Lammerb, Ernst Wolnera

a Department of Cardio-Thoracic Surgery, University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria
b Department of Interventional Radiology and Angiography, University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria

Received 3 December 2003; received in revised form 29 April 2004; accepted 4 May 2004.

* Corresponding author. Tel.: +43-1-40400-5620; fax: +43-1-40400-5640
e-mail: martin.grabenwoeger{at}univie.ac.at


    Abstract
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 Appendix A. Conference...
 References
 
Objective: The objective of the study was to evaluate mid-term durability and need for reinterventions after endovascular stent-grafting (ESG) in descending aortic aneurysms and dissections. Patients and Methods: Between November 1996 and February 2003 a total of 80 patients underwent ESG for the following indications: atherosclerotic aneurysms (50/80; 63%), type B dissections (20/80; 25%), penetrating ulcers (6/80; 8%), traumatic aneurysms (4/80; 5%). Two types of commercially available ESG (Talent, Medtronic, Santa Rosa, CA and Excluder, WL GORE, Flagstaff, AZ) were inserted via the femoral artery in 53 patients, via the iliac artery in 21 patients and via the abdominal aorta in 6 patients. Results: In-hospital mortality was 3.8% (n=3). Type I endoleak formation requiring endovascular reintervention was observed in 3.8% (n=3). Surgical reintervention became necessary in 4 patients (4/80; 5%). One patient experienced a retrograde type A dissection, detected in the 3 month control after ESG of an acute type B dissection, consecutively undergoing frozen elephant trunc repair. Three patients with late type I endoleak formation (mean interval: 62 months) after ESG (two atherosclerotic aneurysms, one penetrating ulcer) underwent open thoraco-abdominal repair in deep hypothermia or left heart bypass technique. All patients had an uneventful postoperative course. Conclusions: Occurrence of late endoleak formation requiring surgical reintervention after ESG is acceptably low. In atherosclerotic aneurysms the development of endoleaks is assumed to be causative related to progression of the underlying aortic disease. A close follow-up of patients after ESG is crucial.

Key Words: Endovascular stent-graft • Endoleak • Surgical repair


    1. Introduction
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 Appendix A. Conference...
 References
 
The patient population which is affected by diseases of the thoracic aorta is often debilitated with multiple co-existing illnesses, which precludes open surgical repair due to the associated significant increased risk of mortality and long term impairment [1].

Endovascular stent-graft implantation was introduced in an effort to reduce these risks and to offer a therapy option in high-risk patients [2,3].

Although, this technique was initially reserved for patients not amenable to open surgical repair, clinical success led to a rapid expansion of indications [46]. However, long-term outcome as well as limitations of this technique still remain to be elucidated [7].

Herein we want to report our experience with secondary surgical interventions after failed endovascular repair.


    2. Patients and methods
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 Appendix A. Conference...
 References
 
2.1. Patients
Between November 1996 and February 2003 a total of 80 patients underwent ESG for different indications. 50 patients (63%) were treated with stent-grafts due to atherosclerotic aneurysms, in 20 patients (25%) with type B dissection the entry tear was covered by a stent-graft, 6 patients (8%) exhibited a penetrating ulcer and 4 patients (5%) were stented after traumatic aortic lesions. Patients were subjected to a strict follow-up protocol that requires a contrast spiral computed tomography (CT) scan and clinical evaluation at 3, 6 and 12 months after stent-grafting and then annually thereafter.

Out of this cohort 4 patients (5%) had to be treated by surgical repair due to failed endovascular therapy. This subgroup of patients was aged between 57 and 78 years (mean 65 years). An atherosclerotic aneurysm was present in two patients, a penetrating ulcer in a heavily calcified aorta was the indication in another patient and one patient was treated after complicated type B dissection with ESG. All patients were treated with Talent stent-grafts (Medtronic, Santa Rosa, CA), which were placed successfully without endoleak formation. A retrograde type A dissection was observed in the follow-up after ESG placement due to type B aortic dissection (Fig. 1A–C) . This patient underwent frozen elephant trunc repair 6 months after the initial therapy [8]. Three patients with late type I endoleak formation after ESG (two atherosclerotic aneurysms, one penetrating ulcer) underwent open thoraco-abdominal repair in deep hypothermia or left heart bypass technique. Time interval between ESG and open repair in atherosclerotic patients varied between 56 and 68 months (mean 62 months).



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Fig. 1. (A) Aortic dissection type B; (B) CT-scan after ESG at discharge; (C) CT-scan 3 month after ESG showing retrograde type A aortic dissection.

 
2.2. Endovascular stent-grafts
Two different stent-graft systems are available at our department. The GORE Thoracic Excluder Endoprosthesis (W.L. Gore and Associates, Sunnyvale, CA) was used in 48 patients (60%). Exclusion of thoracic aortic aneurysms with the TALENT endoluminal stent-graft system (Medtronic, Santa Rosa, CA) was performed in 32 patients (40%).

The TALENT stent-graft consists of a nitinol wire stent shaped in a zigzag formation, which is covered with extra-thin polyester (Dacron). A straight nitinol wire severs the length of the device and avoids twisting or kinking. This self-expandable stent-graft is compressed over a placement catheter. Both the stent-graft and the catheter are loaded into a polyurethane sheath for insertion. The endoluminal stent-graft system is passed over the guidewire and positioned at the desired location as determined by intraoperative angiography. After exact positioning, the stent-graft was released by removing the sheath.

The GORE Thoracic Excluder stents are constructed differently. The system is placed into the vasculature through an introduction sheath. The stent-graft itself is mounted on a placement catheter. Development of the stent-graft is achieved by pulling on a string at the end of the placement catheter. GORE stent-grafts are available in standard sizes.

2.3. Operative procedures
The operative technique used was dependent on the localization of the secondary pathology caused by the endoleak in the distal arch or descending aorta. Patients were operated either by arch replacement via median-sternotomy using the frozen elephant-trunk technique, or distal arch and descending thoracic aorta replacement in deep hypothermic circulatory arrest or thoraco-abdominal aortic replacement using left heart bypass technique [9].

The patient with retrograde type A dissection after ESG-placement for acute type B dissection underwent ascending aorta and arch replacement by a combined approach [8]. Via mid-sternotomy and axillary artery cannulation a custom made device consisting of a proximal Dacron tube and a distal stent-graft was placed into the already stented descending aorta in an antegrade fashion through the opened aortic arch. This procedure was performed in moderate hypothermia (25 °C) and antegrade cerebral perfusion. After having accomplished the distal stent—in—stent connection, the redundant proximal portion of the device was trimmed to an appropriate length and the supraaortic branches were reinserted as a unit into the prosthesis. The anastomosis was reinforced with Teflon felts. The prosthesis was clamped prior to the aortic arch and perfusion begun via the axillary cannula. During rewarming the final proximal anastomosis was accomplished.

Late type Ia endoleak after distal arch and prox. descending aorta ESG required prosthetic repair in DHCA. The patient was placed in an oblique lateral decubitus position with the pelvis rotated to the left to allow access to the femoral arteries. Exposure of the aorta was achieved with a left thoracotomy through the fifth intercostal space and the cardiopulmonary bypass was established by cannulation of the groin vessels. The patient was cooled to 18 °C and circulatory arrest was initiated. The aneurysm sac was longitudinally opened (Fig. 2A) and the stent-grafts were harvested. Thereafter, the proximal anastomosis to the distal arch was performed and the prosthesis was clamped distal to a 8 mm side-graft. Perfusion of the supraaortic branches was reinstalled via the side-graft of the prosthesis with 1.5 l/min. The prosthesis was tailored and the distal anastomosis was done with a 3-0 prolene running suture reinforced by a teflon felt strip (Fig. 2B).



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Fig. 2. (A) After longitudinal incision of the aneurysm, the stent-graft can be easily removed. No ingrowth of host tissue can be detected. (B) The aneurysm is replaced by a 30 mm Dacron prosthesis.

 
Late type Ib endoleak located at the thoracoabdominal junction required thoraco-abdominal repair using the left-heart bypass technique. Exposure of the aorta was achieved with a left thoracoabdominal incision through the sixth intercostal space and retroperitoneal approach with ventral visceral rotation to gain access to the abdominal aorta. In preparation for LHB, all patients were moderately heparinised (100 IU/kg).

The inflow cannula was inserted into the superior pulmonary vein and the outflow cannula was inserted into the left femoral artery. LHB was initiated and the proximal descending aorta was clamped just distal the origin of the left subclavian artery and another clamp was placed in the middle of the descending thoracic aorta. Thereafter, the clamped part of the aorta was opened, stent-grafts were removed and intercostal arteries were oversewn. Gelatine impregnated woven (Sulzer Vascutek vascular prosthesis, Sulzer Medica Ltd, Renfrewshire, Scotland, Europe,) vascular prosthesis were used for replacement of the thoracoabdominal aorta.

After completion of the proximal anastomosis the aortic clamp was released and placed onto the graft. The LHB was stopped, the remainder of the aneurysm was opened and the remaining stent-grafts were removed. Nine French Pruitt balloon catheters were placed into the origins of the celiac axis, and the superior mesenteric artery. At the same time, both renal arteries were cannulated with 9 French Pruitt catheters and perfused with cold crystalloid solution. Critical intercostal arteries were attached as an unit to the graft and the aortic clamp was moved downwards to enable perfusion of the intercostal arteries. The visceral and renal arteries were reattached. After completion of reattachment, the balloon catheters were removed, the graft was flushed and the distal clamp was removed in a stepwise manner, thus resuming antegrade perfusion during completion of the distal anastomosis.


    3. Results
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 Appendix A. Conference...
 References
 
In-hospital mortality of all patients having undergone stent-grafting was 3.8% (3/80). One patient died due to migration of the stent-graft into the aneurysm sac causing rupture of the aortic wall, a second patient died due to impaired perfusion of the celiac axis with consequent multiorgan failure. The third in-hospital death occurred in a patient after ESG for complicated type B dissection developing type-A aortic dissection with pericardial tamponade 4 days after intervention. Autopsy of this patient revealed no correlation between the bare springs of the ESG and the entry-site of the dissection.

Type I endoleak formation requiring endovascular reintervention was observed in 3.8% (3/80), which is depicted in Fig. 3A and B .



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Fig. 3. (A) CT-scan shows no endoleak in the distal descending aorta 3 years after implantation. (B) 12 months thereafter, an endoleak formation followed by a significant increase in aortic diameter could be observed.

 
Surgical reintervention became necessary in 4 patients (4/80; 5%). In patients with atherosclerotic disease of the aorta time interval between primary ESG and secondary surgical intervention was 60 months (56–68 months). In the particular patient developing retrograde type A dissection after ESG for acute type B dissection, time interval was 6 months. In-hospital mortality of this subgroup was 0%. All patients survived the complex surgical repair without major complications. Intensive care unit stay varied between 3 and 10 days (mean 5.75 days). In one patient, with end-stage renal insufficiency requiring hemodialysis, prolonged weaning from ventilation was observed. Two out of the 4 patients were operated in DHCA. Circulatory arrest times were 29 and 76 min, respectively. No neurological complication was encountered. Mean hospital stay was 17 days.


    4. Discussion
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 Appendix A. Conference...
 References
 
Occurrence of late endoleak formation requiring surgical reintervention after ESG is acceptably low. Open surgical repair was necessary in 4 out of 80 patients after ESG placement (5%). All patients survived the procedure and had an uneventful postoperative course.

Following closely on the heels of early clinical experience with endografts for the treatment of patients with abdominal aortic aneurysms, endovascular stent-graft placement has developed as a safe and effective treatment modality in various diseases of the descending aorta [17]. The particular benefit of this less invasive method has been established especially in patients with a variety of co-morbidities indicating them as high-risk patients for open repair. As initial results have been encouraging, this new treatment modality has been used more liberally and short-term results are well-documented. However, long-term effectiveness of this technique still has to be evaluated [7,10,11].

In our series late endoleak formation requiring secondary surgical intervention was primarily observed after ESG for atherosclerotic aneurysms. Three patients developed type I endoleaks due to chronic enlargement of the proximal or distal landing zone. Beside the progression of the underlying atherosclerotic disease, short proximal or distal landing zones were causative for treatment failure. One of our patients with a type Ia endoleak exhibited a proximal landing zone of less than 20 mm, although a subclavian to carotid artery transposition was performed prior the ESG. The remainder with type Ib endoleaks showed a critical distal landing zone at the time of implantation, which was characterised by partial thrombus formation at the aortic wall and a critical diameter of 38 mm.

The risk of retrograde aortic dissection after ESG has been already reported [12]. We experienced this fatal complication in 1 patient. Injury of the intima by the bare springs of the Talent stent-graft device is suspected to be the cause for this complication. Based on this negative experience, the development of special designed stent-grafts for aortic dissection is warranted. Expanding stent-grafts in the friable tissue of an acute dissected aorta is different to the deployment of ESG in chronic atherosclerotic aneurysms. In atherosclerotic aneurysms the anchorage of the ESG is dependent on a relatively short proximal and distal landing zone, which necessitates high radial forces generated by the stent. In contrast, ESG for the treatment of acute dissections have to be designed differently in respect to radial force and flexibility. As the entire length of the ESG is in contact to the aortic wall, less radial force is sufficient to ensure proper fixation of the ESG. Moreover, increased flexibility of the device will reduce the risk for subsequent injury of adjacent aortic tissue.

The complexity of surgical repair is not increased by the presence of stent-grafts within the aneurysm. Considering the fact, that only the bare-springs of the stent-graft were covered by neointima at the proximal and distal landing zone, removal of the stent-grafts could be easily accomplished even after 5 years of implantation. All intercostals arteries, which had been covered by ESG were obliterated. Therefore, previous implantation of ESG does not increase the risk of subsequent surgical procedures.

Although impressive results and amazing developments have been achieved since the first introduction of ESG in 1991, this technology is still in its infancy. Especially the potential risk of device failure and the concern about long-term durability constitutes the major unresolved issue in this emerging treatment modality. Emphasis should be placed upon appropriate case selection and the stringency of life long surveillance after endovascular therapy, which will further elucidate the indications as well as the limitations of this innovative therapy.


    Footnotes
 
Presented at the joint 17th Annual Meeting of the European Association for Cardio-thoracic Surgery and the 11th Annual Meeting of the European Society of Thoracic Surgeons, Vienna, Austria, October 12–15, 2003.


    Appendix A. Conference discussion
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 Appendix A. Conference...
 References
 
Dr M. Krason (Zabrze, Poland): The first picture you have shown us, there was quite a strong angulation, about 90°, in the descending thoracic aorta when the stent-graft was placed. Don't you think that this is a contraindication and some risk factor for stent-grafting?

Dr Grabenwoger: Well, you are absolutely right. This case I showed you is certainly not an ideal case for stent-grafting. But on the other side, this was an old patient and he has a cardiomyopathy and everybody said it's not possible to replace the descending aorta. And so we decided to insert a stent-graft, although there is a kinking, although there is a relatively large distal neck.

Five years later, we had to operate on him and he's also alive now. So you can argue why not five years before, you're right. But this is always a problem in advance, you're not really sure if you're able to make a thoracoabdominal operation with a good result.

Dr Krason: I have another question regarding endoleaks. Some endoleaks, even type I, can seal spontaneously. The question is, what percentage did you leave for self-sealing and what's your idea for operation of proximal endoleak?

Dr Grabenwoger: What I have seen in the past, even if a type I endoleak, after the intervention, and then you can wait for 2 weeks, maybe you have a spontaneous closure. But it's a new development of an endoleak after some time.

And the second thing is we also measured in these patients an increase in aortic diameter. Because we were not very happy to go on surgery. But then we make a control 3 months and then the next control the next 3 months, and there was a significant expansion of the aneurysmal sac. So if there is an expansion of the aneurysmal sac and you see for 3 months there is no occlusion of the endoleak, then we go in for surgery.

And I have never seen in the past a new developed endoleak which closes afterwards. Maybe in the beginning there is an endoleak and after 1 week it's gone.

Dr Krason: Did you have a case in the large series, 80 cases, in which there were no endoleaks shown on the CT scan, angio CT, and there was aneurysm enlargement during this follow-up period? Because this is an issue, if there is an endoleak visible and when we are forced to do reoperation.

Dr Grabenwoger: Me, personally, I'm sure if you have an expansion of the aneurysmal sac, there has to be an endoleak. And sometimes there are these type II endoleaks from peripheral arteries or lumbar arteries or intercostal arteries, which are sometimes very hard to detect. Or if you overstent, for example, the left subclavian artery, and before you made only a bypass to the carotid artery, so there is a pressure of the stump of the left subclavian artery to the aneurysmal sac, so then you have an enlargement. I think enlargement of the aneurysmal sac without endoleak, it's not really possible. So there's some endoleak type II intercostal artery, peripheral artery, which is sometimes very hard to see and to observe and also then to treat.

Dr S. Takamoto (Tokyo, Japan): I'd like to ask about the indication of a stent-graft for a retrograde type A dissection. Sometimes it's good for a type B dissection. And if I see the slide, the dissecting lumen and ascending aorta is so dilated. In such a case, do you do the stent-graft as a first indication?

Dr Grabenwoger: In this case, what I showed to you here, this was a complication of the sten-graft. This was primarily a simple type B dissection. And due to the bare springs of the stent-graft, we started the operation; the bare spring was within the wall of the aortic arch. And this was certainly the induction for a retrograde type A dissection. So this is a complication of our stent-grafting of the type B dissection.

But if I have a retrograde type A dissection, I would go also for an open stenting of the entry tear and attempt to replace the ascending aorta and the arch.

Dr Takamoto: Also, what is the cause of the reopening in the false lumen after 3 months insertion of the stent-graft?

Dr Grabenwoger: No, this was no problem to operate. After 3 months, it's everything, it's like in the acute phase, there is no big difference.

Dr Takamoto: I thought that the stent-graft itself causes a perforation of intimal because they are in acute phase.

Dr Grabenwoger: Yes.

Dr J. Bachet (Paris, France): I know that you're very fond of stent-grafting in aortic disease. What is your policy, in general, towards these kinds of lesions?

My question, more specifically, is: if those 4 patients could have surgery in a second row, why didn't they get surgery the first time?

Dr Grabenwoger: I posed this question also to me, but then we have to ask every cardiologist who is inserting a stent-graft into the LAD, because it's also no problem for the surgeon to make a single bypass to the LAD. And maybe we have to do it after 3 stent-grafts in the LAD afterwards and it also goes fine.

I think most of the patients, the first row, they want less invasive approach, even maybe if it's necessary do a second intervention after some years.

And also, for me, as a surgeon, your judgments are not always okay. You see an old man and he has some co-morbidities. And the risk for a thoracoabdominal repair is high for us in Vienna here. And so I say if it's possible to insert a stent-graft, I would go for a stent-graft. Of course, in this case I presented here, in the future I think I would say in the first row operation, because it's better a planned operation than a risk of stent-grafting.


    References
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 Appendix A. Conference...
 References
 

  1. Hagan P.G., Nienhaber C.A., Isselbacher E.M., Bruckmann D., Karavite D.J., Russman P.L., Evangelista A., Fattori R., Suzuki T., Oh J.K., Moore A.G., Malouf J.F., Pape L.A., Gaca C., Sechtem U., Lenferink S., Deutsch H.J., Diedrichs H., Robles J.M., Llovet A., Gilon D., Das S.K., Armstrong W.F., Deeb G.M., Eagle K.A. The International registry of acute aortic dissection: new insights into an old disease. J Am Med Assoc 2000;283:897-903.[Abstract/Free Full Text]
  2. Parodi J.C., Palmaz J.C., Barone H.D. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg 1991;5:49-59.
  3. Dake M.D., Miller D.C., Semba C.P., Razavi M.K., Shimono T., Hirano T., Takeda K., Yada I., Miller D.C. 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]
  4. Mitchell R.S., Miller C.D., Dake M.D., Semba C.P., Moore K.A., Sakai T. Thoracic aortic aneurysm repair with an endovascular stent graft: the first generation. Ann Thorac Surg 1999;67:1971-1974.[Abstract/Free Full Text]
  5. Mitchell R.S., Dake M.D., Semba C.P., Fogarty T.J., Zarins C.K., Liddle R.P., Miller D.C. Endovascular stent graft repair of thoracic aortic aneurysms. J Thorac Cardiovasc Surg 1996;111:1054-1059.[Abstract/Free Full Text]
  6. Grabenwoger M., Fleck T., Czerny M., Hutschala D., Ehrlich M., Schoder M., Lammer J., Wolner E. Endovascular stent graft placement in the treatment of acute aortic complications. Eur J Cardiothorac Surg 2003;23(3):788-793.[Abstract/Free Full Text]
  7. Jacobowitz G.R., Lee A.M., Riles T.S. Immediate and late explantation of endovascular aortic grafts: the endovascular technologies experience. J Vasc Surg 1999;29:309-316.[CrossRef][Medline]
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  9. Fleck T., Hamilton C., Koinig M., Rajek A., Wolner E., Grabenwoger M. Thoracoabdominal aortic aneurysm repair: reducing adverse outcome with left heart bypass, selective visceral perfusion and renal protection. J Cardiothorac Vasc Anesth 2002;6:287-291.[CrossRef]
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