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Ann Thorac Surg 2007;83:450-455
© 2007 The Society of Thoracic Surgeons

Original Articles: Cardiovascular

Results After Endovascular Stent Graft Placement in Atherosclerotic Aneurysms Involving the Descending Aorta

Martin Czerny, MDa,*, Michael Grimm, MDa, Daniel Zimpfer, MDa, Suzanne Rodler, MDa, Roman Gottardi, MDa, Doris Hutschala, MDa, Johannes Lammer, MDb, Ernst Wolner, MDa, Maria Schoder, MDb

a Department of Cardiothoracic Surgery, University of Vienna Medical School, Vienna, Austria
b Department of Interventional Radiology, University of Vienna Medical School, Vienna, Austria

Accepted for publication August 15, 2006.

* Address correspondence to Dr Czerny, Waehringer Guertel 18-20, A-1090 Vienna, Austria (Email: bypass{at}eunet.at).

Presented at the Poster Session of the Forty-second Annual Meeting of The Society of Thoracic Surgeons, Chicago, IL, Jan 30–Feb 1, 2006.


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 References
 
BACKGROUND: The purpose of this study was to determine durability and need for reinterventions after endovascular stent graft placement in atherosclerotic aneurysms involving the descending aorta.

METHODS: We performed a prospective follow-up analysis of a consecutive series of 79 patients undergoing endovascular stent graft placement due to atherosclerotic aneurysms involving the descending aorta between 1996 and 2006. Acute aortic syndromes were excluded from this analysis. Mean follow-up was 42 months (range, 1 to 108 months). Data were collected for in-hospital mortality, occurrence of early and late endoleaks, reintervention due to early and late endoleaks, and survival.

RESULTS: In-hospital mortality was 6.3% (n = 5). Two of these patients underwent emergent treatment. Early type I and III endoleaks were observed in 29% of patients (n = 23). The assisted primary endoleak rate was 11%. Late type I or III endoleaks occurred in 21% (n = 17). At 1, 3, and 5 years, overall actuarial survival was 96%, 86%, and 69%, and event-free survival was 90%, 82%, and 65%, respectively. Cox proportional hazard analysis revealed that a short proximal landing zone and a high number of stent grafts used were independent risk factors for early and late endoleak formation. Late endoleak formation was an independent predictor of survival.

CONCLUSIONS: Endovascular stent graft placement in atherosclerotic aneurysms involving the descending aorta has satisfactory durability. An extensive landing zone is a prerequisite of early and late success. Further clinical investigations are warranted to evaluate long-term durability of this attractive treatment modality.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 References
 
Following closely on the heels of early clinical experience with endovascular stent grafts for the treatment of patients with abdominal aortic aneurysms [1–3], endovascular stent graft placement has developed as a safe and effective treatment modality in various diseases of the thoracic aorta [4–9]. Because initial results have been encouraging, this new treatment modality has been used more liberally, and short-term results are well documented [9, 10].

Little is known, however, about the mid-term and long-term behavior of stent grafts that are continuously exposed to the pulsatile flow conditions within the thoracic aorta [11–14]. The formation of endoleaks in areas of high exposure to shear stress has become an important issue. In addition, the stent graft itself has to comply with a variety of morphologic alterations, such as shrinkage or dilatation of the aneurysmal sac in the transverse axis and elongation or constriction in the longitudinal axis [15–17]. Material fatigue may also cause late adverse events. Finally, endotension may account for secondary interventions after stent graft placement in the descending aorta [18].

The aim of this study was to determine durability and need for reinterventions of endovascular stent graft placement in atherosclerotic aneurysms involving the descending aorta in a consecutive series of patients.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 References
 
Between 1996 and 2006, 172 patients underwent endovascular stent graft placement due to thoracic aortic diseases at our department. Acute aortic syndromes (type B aortic dissections, perforating ulcers and traumatic dissections) were excluded from this analysis. Endovascular stent grafts were placed in 79 patients because of atherosclerotic aneurysms involving the descending aorta. Demographic and clinical risk factors are summarized in Table 1. The Ethics Committee approved the study and waived the need for patient consent.


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  		Table 1. Demographic and Clinical Risk Factors
 
Data Collection and Follow-Up Protocol
Data were prospectively collected. Patients were under a strict follow-up protocol that required a contrast spiral computed tomography (CT) scan and a clinical and laboratory evaluation at 3, 6, and 12 months after surgery, and then annually thereafter. Magnetic resonance angiography was used alternatively when chronic renal insufficiency or allergy to iodinated contrast were detected. Additional investigations were obtained whenever indicated. Transesophageal echocardiography was not used to check for Doppler flow and pressures in this series.

Stent Graft Systems Used
Seven different commercially available stent graft systems were used. The types of stent grafts and the frequency of their use are summarized in Table 2. For all systems, the diameter of the stent graft was calculated from the largest diameter of the proximal or distal neck and an oversizing factor of 10% to 20% was added.


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  		Table 2. Types of Stent Grafts Used
 
Operative Procedure
All procedures were performed by a single team of surgeons and interventional radiologists. Transposition of the subclavian to the carotid artery was routinely performed before stent graft placement if the proximal neck of the aneurysm was less than 1.5 cm in the elective setting. Double transposition or total arch rerouting was performed, depending on the extent of the aneurysm. The implantation procedure was performed under general anesthesia in a special operating room facility equipped with a ceiling-mounted image intensifier with digital substraction angiography and overlay capacities (Siemens Multistar, Erlangen, Germany) and a radiolucent operating room table. Cerebrospinal fluid drainage was used selectively according to the morphology and extent of the aneurysm.

Definition of Endoleaks
Endoleaks were defined according to reporting standards [19]. Type I endoleaks were defined as attachment site leaks, with type Ia at the proximal attachment site and type Ib at the distal attachment site. Type II endoleaks were defined as branch leaks without an attachment site connection. Type III endoleaks were defined as junctional leaks between stent grafts if more than one graft was used. Type IV endoleaks were defined as graft wall porosities. Endotension was defined as an increase in maximum aneurysm diameter without detectable endoleaks.

Imaging Studies Evaluation
For the purpose of this study, postoperative imaging studies (spiral contrast CT, intravenous angiography, conventional and magnetic resonance angiography, and color duplex studies), outpatient charts, and re-admission charts within the follow-up period were evaluated.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 References
 
In-Hospital Mortality
Overall in-hospital mortality was 6.3% (n = 5). Elective stent graft placement took place in 70 patients (89%), and 3 (3.8%) died. One patient died of aneurysmal rupture caused by dislocation of the stent graft into the aneurysmal sac. Another patient died because of narrowing of the coeliac axis, with consecutive multiorgan failure, and the third patient died from myocardial infarction the day before discharge.

Nine patients (11%) underwent emergent stent graft placement. Two of these patients died, for an in-hospital mortality of 22%. One patient died from multiorgan failure resulting from hemodynamic compromise, and the second patient died owing to septicemia resulting from an aortoesophageal fistula, with development of mediastinitis.

Adverse Neurologic Events
In 4 patients (5%), temporary adverse neurologic events were observed that completely resolved at the time of discharge. All deficits where located in the left hemisphere. Two of these patients underwent emergent endovascular stent graft placement requiring overstenting of the left subclavian artery. Another patient who underwent carotid–subclavian artery bypass grafting before stent graft placement sustained a cerebellar infarction; however, the diameter of the graft to the autologous saphenous vein was critically small. In the remaining patient, manipulation within a heavily diseased aorta was regarded as the leading mechanism.

Surgical Details
Surgical access was gained transfemorally in 65%. In the remaining patients, alternative access sites were chosen. Stent graft deployment within the aortic arch was performed in 47%. Table 3 summarizes the types and numbers of rerouting procedures performed. Tables 4 and 5 Go summarize beginning and extent of aneurysms according to their frequency.


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  		Table 3. Types of Rerouting Procedures Performed
 

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  		Table 4. Beginning of Aneurysms (According to Frequency)
 

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  		Table 5. Extent of Aneurysms According to Frequency
 
Early Endoleaks and Reinterventions
Early type I and III endoleaks were observed in 29% of patients. The assisted primary endoleak rate was 11%. The remaining patients were monitored because of the inability to perform further endovascular repair. Two of these patients underwent late surgical conversion because of increasing diameter of the aneurysmal sac. No differences have been observed with regard to the type of prosthesis.

Early type II endoleaks were observed in 5 patients (6%). In 3 of these patients, an increase of maximum aneurysm diameter was observed. One patient underwent subclavian–carotid artery transposition owing to a type II endoleak originating from retrograde perfusion of the overstented left subclavian artery, one patient underwent embolization of supplying intercostal arteries, and the third patient, who showed reperfusion of the aneurysmal sac through the supreme intercostal artery, finally underwent late surgical conversion.

Long-Term and Event-Free Survival
The mean follow-up period was 42 months (range, 1 to 108 months). At 1, 3, and 5 years, overall actuarial survival was 96%, 86%, and 69% (Fig 1), and event-free survival was 90%, 82%, and 65%. No difference in survival with regard to suitability for conventional surgery could be observed (log-rank p = 0.532; Fig 2).


Figure 1
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  		Fig 1. Survival. (FUP = follow-up.)

 

Figure 2
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  		Fig 2. Survival–suitable for conventional surgery yes/no. Solid line: suitable for conventional surgery; dotted line: not suitable for conventional surgery. (FUP = follow-up.)

 
Late Endoleaks, Endotension, and Reinterventions
Late type I or III endoleaks occurred in 17 patients (21%). Of these, 10 endoleaks were treated successfully. We did not observe the formation of any type IV endoleaks in this series of patients. Endotension was observed in 2 patients, and both underwent successful redo stent graft placement and thereafter showed recurring shrinkage of the aneurysmal sac.

Cox Proportional Hazard Model: Endoleak Formation, Survival
Early endoleak formation
A short proximal landing zone (hazard ratio [HR], 6.5; p = 0.011) and a higher number of prostheses used (HR, 11.2; p = 0.001) were the only independent risk factors of early endoleak formation. Arch involvement (HR, 3.5; p = 0.063) and rerouting procedures (HR, 3.6, p = 0.059) showed a trend, but did not reach statistical significance. An early operative year did not independently predict early endoleak formation (HR, 0.6; p = 0.452; Table 6).


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  		Table 6. Cox Proportional Hazards Model—Early Endoleak Formation
 
Late endoleak formation
A short proximal landing zone (HR, 4.4; p = 0.014) and a higher number of prostheses used (HR, 6.7; p = 0.010) were also independent risk factors of late endoleak formation. Arch involvement (HR, 4.1; p = 0.042) was also an independent predictor of late endoleak formation. Interestingly, early endoleak formation was not predictive for late endoleak formation (HR, 1.2; p = 0.513; Table 7).


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  		Table 7. Cox Proportional Hazards Model—Late Endoleak Formation
 
Survival
Late endoleak formation (HR, 4.8; p = 0.029) was the only independent predictor of survival. Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (HR, 0.3; p = 0.087) and female gender (HR, 3.0; p = 0.087) showed a trend, but did not reach statistical significance. Interestingly, suitability for conventional surgery (HR, 0.9; p = 0.345) had no influence on survival (Table 8).


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  		Table 8. Cox Proportional Hazards Model—Survival
 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
References
 
Overall in-hospital mortality was 6.3%. In elective patients, in-hospital mortality was 3.8%, thereby being well in line with other recently published series [11–14, 20, 21]. In emergent patients, in-hospital mortality in this series still remained high at 22%. Causes are multifactorial. Two substantially contributing factors are hemodynamic compromise as a consequence of the initial event with consecutive systemic hypoperfusion, and an already sustained injury to adjacent structures, such as to the esophagus, which was observed in one patient in this series. Endovascular treatment in the emergent setting should therefore be regarded with caution because results may remain dismal. In case of fistulation, curative treatment probably should include both the esophagus and the descending aorta, if adequate.

Transient adverse neurologic events were observed in 5%, which completely resolved at the time of discharge. All deficits were located in the left hemisphere. Two of these patients underwent intentional overstenting of the left subclavian artery during an emergent procedure; in the remaining patients, other causes were regarded as the leading mechanism. Intentional overstenting of the left subclavian artery is being widely proposed in the literature, even in the routine setting [21]. As our own results demonstrate, however, this concept needs to be regarded with caution.

The primary intention of revascularization of the subclavian artery should not solely pertain to perfusion of the left upper extremity, because it is well known that the collateral blood supply usually is sufficient. Preserving posterior cerebral circulation has to be seen as the main objective [22]. In addition, retrograde perfusion of the aneurysmal sac through the left subclavian artery may result in type II endoleak formation [23].

Endovascular stent graft placement in atherosclerotic descending aortic aneurysms involving the aortic arch may require innovative vascular surgical approaches so that cerebral perfusion is maintained [24–27]. Depending on the extent, autologous approaches or approaches using alloplastic graft material may be used [22, 28–30]. These concepts have substantially enlarged indications in this distinct anatomic region and have enabled treatment being offered to patients not amendable for any kind of conventional procedures.

Despite the technical feasibility of inserting a stent graft into the aortic arch, sufficient sealing is not always achieved. A leading mechanism is most likely that radial forces and severely curved pathways of vessels, combined with constant friction between the stent skeleton and the graft, are more pronounced within the arch than within the descending aorta. Elongation and constriction in the longitudinal axis due to functional alterations during daily life may also contribute to this process [15, 16]. It remains to be seen if new generations of stent grafts will perform better with regard to graft-associated endoleaks and adaption to morphologic changes of the aneurysmal sac.

Early type I or III endoleaks were observed in 29% of patients, which seems surprisingly high compared with other series [11, 14]. However, most of these endoleaks sealed spontaneously because of the self-expanding capability of the device itself or else they were successfully treated by overstenting of the attachment site or by reballooning, thereby reaching an assisted primary endoleak rate of 11%. The remaining patients were observed because of the anatomy or functional inability of further vascular or endovascular repair.

We observed 5 patients (7.4%) with early type II endoleaks. In 3, a constant increase of maximum diameter of the aneurysmal sac could be observed. As a consequence, 1 patient underwent subclavian–carotid artery transposition due to a type II endoleak resulting from retrograde perfusion of the aneurysmal sac through an overstented left subclavian artery, another patient underwent embolization of the feeding intercostal vessels, and the third patient showed reperfusion of the aneurysmal sac via the supreme intercostal artery and finally underwent late surgical conversion. This was an interesting finding, because the natural history of type II endoleaks is generally believed to be less serious than the natural history of type I endoleaks. However, most of our patients with type II endoleaks required reinterventions during follow-up.

Late type I and III endoleak formation was observed in 21% of patients, all of whom had a borderline anatomy with regard to proximal or distal landing zones. This finding underlines the necessity for creating sufficient proximal and distal landing zones without any trade-off, because even if not in the initial phase, mid-term and long-term problems will arise from the initial condition. In contrast with supraaortic rerouting, few reports of visceral rerouting are available to gain sufficient distal length to safely deploy the stent graft in patients with distal aneurysm extension [31–33]. However, subsequent refinements will likely contribute to better treatment modalities in this subset of patients. Finally, branched stent grafts may add in crossing limitations of endovascular thoracoabdominal repair [34].

We did not observe type IV endoleaks in this series. Endotension occurred in 2.5%. These patients initially had first-generation Gore prostheses (W. L. Gore & Associates, Flagstaff, Ariz). Treatment was by successful redo endovascular placement of second-generation devices, resulting in recurring shrinkage of the aneurysmal sac.

Survival and event-free survival at 5 years were 69% and 65%, respectively, and well in line with other recently published series [11, 13, 14]. Without doubt, overall mortality was higher than in other cardiovascular patient subsets, but as reflected by numeric and logistic EuroSCORE levels, the comorbidities and risk factors present in this particular subset of patients were impressively high. Interestingly, in contrast to others, we did not observe any survival difference with regard to eligibility for conventional surgery [13].

The Cox proportional hazards model revealed a short proximal landing zone and a higher number of prostheses used as independent risk factors of early endoleak formation. This was an interesting finding, as the trend—in the abdominal as well as in the thoracic position—is to rather apply improved devices than to extend the length of the landing zone. Our findings thereby underline the importance of rerouting procedures, especially in the proximal aorta, to create sufficient proximal neck length. With increased device length having become available in the meantime, the number of prostheses used can be substantially reduced, thereby improving lateral stability and augmenting overlapping zones.

A short proximal landing zone and a higher number of prostheses used together with arch involvement were independent predictors of late endoleak formation. This becomes clear when additionally reflecting on the anatomy of the arch and tortuosities observed in this delicate anatomic region. Interestingly, an earlier year of implantation did not predict early or late endoleak formation. Furthermore, early endoleak formation did not predict late endoleak formation in this series.

Finally, late endoleak formation was the only predictor of survival. This becomes comprehensible when reflecting on the initial morphology and extent of these aneurysms. Because further vascular or endovascular repair is not feasible in most of these patients who have late endoleaks, it seems most likely that they die due to late rupture.

The main limitation in the study is the lack of a conventionally treated control group. The study also lacks information of causes of death in most of the patients; therefore, it remains speculative how many late deaths were related to the underlying disease.

Summarizing, durability of endovascular stent graft placement in atherosclerotic aneurysms involving the descending aorta is satisfying. Extensive gaining of landing zones is a prerequisite of early and late success. Further clinical investigations are warranted to evaluate long-term durability of this attractive treatment modality.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 

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ANN THORAC SURG ASIAN CARDIOVASC THORAC ANN EUR J CARDIOTHORAC SURG
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