Eur J Cardiothorac Surg 2004;25:394-400
© 2004 Elsevier Science NL
Chronic traumatic aneurysms of the descending thoracic aorta: mid-term results of endovascular repair using first and second-generation stent-grafts
Philippe Demersa,b,
Craig Millera,b*,
R. Scott Mitchella,b,
Stephen T. Keea,b,
R.N. Lynn Chagonjiana,b,
Michael D. Dakea,b
a Department of Cardiovascular and Thoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA
b Division of Cardiovascular and Interventional Radiology, Stanford University School of Medicine, Stanford, CA, USA
Received 22 June 2003;
received in revised form 13 November 2003;
accepted 16 November 2003.
* Corresponding author. Address: Department of Thoracic and Cardiovascular Surgery, Falk Cardiovascular Research Center, Stanford University School of Medicine, 300 Pasteur Drive, Stanford, CA 94305-5247, USA. Tel.: +1-650-725-3826; fax: +1-650-725-3846
e-mail: dcm{at}stanford.edu
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Abstract
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Objective: Endovascular stent-graft repair holds promise for treating traumatic injuries of the descending thoracic aorta. The durability of this approach, however, remains unknown. The objective is to evaluate the mid-term results of stent-graft repair of chronic traumatic aneurysms of the descending thoracic aorta. Methods: Between 1993 and 2000, endovascular repair of the descending thoracic aorta with first (custom-fabricated) and second-generation (commercial) stent-grafts was performed in 15 patients (mean age 54±13 years) at an average of 18±14 years after the injury. Because of comorbidities, 4 patients (27%) were judged not to be reasonable surgical candidates for conventional open surgical approach. Follow-up was 100% complete and averaged 55±29 months. Results: Stent-graft deployment was successful in all without need for surgical conversion. One patient died early postoperatively. No neurologic complications occurred. Two patients had a primary endoleak, one of them was successfully treated before discharge. Actuarial survival estimates at 1 and 6 years were 93±6% and 85±10%. Actuarial freedom from reintervention on the descending thoracic aorta was 93±6% and 70±15% at 1 and 6 years, respectively. Actuarial freedom from treatment failure (a conservative, all-encompassing performance indicator including endoleak, device mechanical fault, reintervention, late aortic-related death, or sudden, unexplained late death) at 1 and 6 years was 87±8% and 51±15%. Conclusions: Stent-grafting is safe in selected patients with chronic traumatic aneurysms and associated with satisfactory—but not optimal—mid-term durability. Serial follow-up surveillance imaging is mandatory to detect late stent-graft complications. Younger, good risk patients should be offered conventional open operation, reserving stent-grafting for those who are at prohibitive operative risk or who have limited life expectancy.
Key Words: Aorta • Aneurysm • Trauma • Stent-graft
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1. Introduction
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Aortic injuries secondary to non-penetrating trauma are lethal lesions, with 80–90% dying in the hour following the accident [1,2]. Without appropriate treatment, up to 50% of the initial survivors will die within the first 72 h [1]. Urgent surgical graft replacement of the aorta is the standard treatment in the acute setting, but these patients frequently have other associated major injuries. In 1–2% of the patients with traumatic aortic rupture [1], the injury is not diagnosed initially; these patients survive long enough to develop a chronic traumatic false aneurysm which portends rupture [3]. Few guidelines exist concerning management of chronic traumatic aneurysms; open operation is generally indicated for symptomatic patients and those with documented aneurysm growth [4–6]. Conventional surgical intervention for chronic traumatic aneurysms involving the distal arch and descending thoracic aorta, however, can be technically challenging and carries the potential for substantial morbidity, including stroke and paraplegia [3–6]. Endovascular stent-graft repair of thoracic aortic aneurysms was initiated at Stanford University in 1992 [7,8]. After the feasibility of stent-graft repair of thoracic aneurysms was documented, application of this less invasive technology was expanded to other thoracic aortic problems [8–11]. Recently, several authors reported the practicability of endovascular stent-graft repair for patients with acute and chronic traumatic aortic injuries [12–15]; however, the long-term results remain unknown. The objective of this study was to assess the mid-term results of endovascular stent-graft repair of chronic traumatic aneurysms of the descending thoracic aorta.
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2. Patients and methods
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2.1. Patients
From May 1993 to October 2000, 15 consecutive patients treated by the Department of Cardiothoracic Surgery underwent endovascular treatment of chronic traumatic aneurysms of the descending thoracic aorta with first- (custom-fabricated) and second-generation (Excluder®, W.L. Gore, Flagstaff, AZ) stent-grafts under an investigational protocol approved by the Stanford University School of Medicine Institutional Review Board.
The study population consisted of 13 men and two women, with a mean age of 54±13 years (median 54 years; range 30–72). Table 1 lists the baseline clinical characteristics of the patients. Because of concomitant cardiac or pulmonary comorbidities, 4 patients (27%) were judged by a surgeon not to be reasonable operative candidates for conventional ‘open’ surgical graft replacement. The mean interval between the injury and the procedure was 18±14 years (median 16 years; range 14 days–42 years). Nine patients had a history of high-speed automobile deceleration accident, five patients a motorcycle accident, and one patient had a history of gunshot wound to the left chest. Three patients had undergone a previous operation on the thoracic aorta in other institutions (patch repair in one, aortic wrapping in one, and exploratory left thoracotomy without any aortic repair in one). In three patients referred soon after the accident, delayed treatment (range 2–12 weeks) was elected due to the severity of associated multiple injuries in one patient and a delay in diagnosis in two. In the other 12 patients, increase in the size of the aneurysm (
10 mm over 12 months) was the indication for intervention.
2.2. Pre-procedural imaging
All patients underwent spiral computed tomographic angiography (CTA) scanning with 3D reconstructions to determine the exact location, distance from the left subclavian artery (LSCA), length and diameters of the diseased aortic segment, morphology of the proximal and distal landing zones, and suitability of peripheral arterial access (Fig. 1)
. The dimensions of the stent-graft were calculated from the CTA images, being oversized by 10–15% compared to the landing zone diameters and at least 30–40 mm longer than the target lesions to ensure adequate wall contact and a tight circumferential seal.
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Fig. 1. Fifty-four year old male (patient #8) with a chronic traumatic aneurysm, 7 years after a high-speed motor vehicle accident. Aortography done before and after stent-graft placement showing (A) the chronic traumatic aneurysm in the proximal descending aorta; and (B) complete exclusion of the aneurysm after stent-graft deployment. Antegrade flow in left subclavian artery remains intact.
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2.3. Device details
First-generation stent-grafts (n=7) were custom-fabricated from modified Gianturco self-expandable Z stents (Cook, Bloomington, IN) covered with a woven polyester graft (Boston Scientific Corporation, Natick, MA). A 20–24F pusher rod-sheath delivery system (Cook) was used for deployment of the device.
The second-generation commercially manufactured Gore Excluder® stent-graft (‘TAG’, W.L. Gore) was used in eight patients. This device is composed of a self-expanding nitinol stent lined with ultra-thin expanded polytetrafluoroethylene graft material and is deployed over a wire (does not require the sheath/dilator system) to be advanced above the diaphragm and avoids any sheath withdrawal maneuver. The size of the delivery system varied between 20 and 24F depending on the diameter of the device used.
2.4. Stent-graft placement
The deployment techniques have been described in detail in previous publications [7–9]. General anesthesia was used in all patients. Under fluoroscopic and transesophageal echocardiographic guidance, the chosen access artery was exposed surgically and the delivery system was advanced over a guidewire and positioned across the target lesion so as to cover the full extent of the false aneurysm. The stent-graft was then deployed after optimal positioning of the device. Whenever an endoleak was identified using transesophageal echocardiography (TEE) or angiography, ancillary procedures, such as additional stent-graft placement or coil embolization, were performed after the first few patients.
Preoperative anatomic characteristics as well as procedural data are detailed in Table 2. The femoral artery was the most common site for insertion (14 patients, 93%). No surgical conversion was necessary. In two patients, the proximal landing zone was judged to be too close to the LSCA, and these patients underwent a left common carotid-LSCA bypass graft and proximal subclavian ligation before stent-graft deployment which covered the LSCA origin.
2.5. Follow-up and definitions
The follow-up protocol included CTA imaging before hospital discharge, 6 months after stent-graft placement, and yearly thereafter (Fig. 2)
. Follow-up status was obtained by contacting all surviving patients and their primary care physicians between June and August 2002 and was 100% complete. Causes of death were determined by reviewing death certificates and, when available, autopsy reports. Follow-up time averaged 55±29 months (maximal follow-up 8.6 years; five patients remaining alive and at risk at 5 years). Primary technical success was defined as complete exclusion of the aneurysm without additional intervention. Secondary technical success was defined as complete exclusion of the diseased aortic segment after secondary intervention. Endoleak was defined as radiological or TEE evidence of blood flow outside the stent-graft, and was classified according to the published guidelines [16]. Treatment failure (Fig. 3)
was defined as a composite, all-encompassing conservative end-point, including (1) perioperative death, (2) primary or secondary endoleak, (3) late device failure, (4) reintervention, (5) late aortic-related death, and (5) all sudden, unexplained late deaths.
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Fig. 2. CT angiograms from the same patient as in Fig. 1, done (A) before the procedure, showing the chronic traumatic aneurysm; (B) 24 h after the procedure showing complete exclusion of the aneurysmal sac; (C and D) 13 and 28 months after the procedure showing absence of endoleak and progressive reduction in size of the excluded aneurysmal sac.
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Fig. 3. CT angiograms from a 69 year old (patient #11) with a chronic traumatic aneurysm treated successfully with a second-generation commercial stent-graft, who developed aneurysmal sac expansion (arrow) without any evidence of endoleak between the third (A) and fifth year (B) after initial intervention.
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2.6. Statistical analysis
Continuous variables are expressed as mean±SD and median. Continuous data were compared using Students t-test. The Kaplan–Meier method generated actuarial survival estimates, which are reported ±1 SE (SE, approximately 70% confidence limits [CL]). Actual estimates of freedom from non-fatal events were also computed, since actuarial estimates over-estimate the probability of non-fatal complications if a strong competing hazard of death is present [17]. Discrete variables or rates are expressed as proportions ±70% CL. All statistical analyses were performed with the SPSS program (version 10.0, SPSS Inc., Chicago, IL).
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3. Results
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3.1. Early outcomes
3.1.1. Procedural success
All devices were deployed successfully. A primary endoleak was detected in two patients, yielding a primary technical success rate of 87% (Table 3). One of these two patients underwent successful secondary intervention (coil embolization of a type II endoleak) 5 days after the initial procedure, for a secondary technical success rate of 93%. The other type I endoleak early in the series was not treated.
3.1.2. Early mortality
One early death occurred (7±6% mortality rate). This patient was a 47 year old man who presented 15 years after a motorcycle accident with respiratory distress; he had severe chronic obstructive pulmonary disease and a 9 cm aneurysm located 2 cm distal to the LSCA takeoff which was compressing the left mainstem bronchus. Because of his advanced lung disease, he was a poor operative candidate and underwent successful stent-graft treatment; this was complicated by respiratory failure requiring a tracheostomy and Staphylococcus aureus septicemia, and he subsequently developed a mycotic aneurysm of the stent-graft which precipitated a fatal aorto-esophageal fistula.
3.1.3. Early morbidity
No cerebrovascular accident or paraplegia occurred. One patient developed symptomatic LSCA thrombosis 12 h after stent-graft placement, which was initially treated unsuccessfully with intra-arterial thrombolysis. She then underwent a left carotid-LSCA bypass graft. Three patients had fever and leukocytosis early postoperatively without any infectious etiology identified, consistent with the so-called ‘post-implantation syndrome’; this resolved spontaneously. Excluding the patient who died during hospitalization (hospital stay 190 days), average intensive care unit stay was 1±0.3 days (median 1 day), and post-operative hospital stay was 4±2 days (median 4 days).
3.2. Late outcomes
3.2.1. Survival
The actuarial survival estimates 1 and 6 years after the procedure were 93±6% and 85±10%, respectively (Fig. 4A)
. Causes of late death were congestive heart failure in one patient and sudden, unexplained death in another.
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Fig. 4. (A) Kaplan–Meier actuarial survival estimates in all patients; (B) Actuarial freedom estimates from aortic reintervention (see text for definition) in all patients (±1 SE).
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3.2.2. Reintervention
The actuarial estimates of freedom from reintervention at 1 and 6 years were 93±6% and 93±6% (Fig. 4B). The actual freedom from reintervention rates were identical.
3.2.3. Treatment failure
The actuarial estimates of freedom from the composite end-point treatment failure were 87±8% and 51±15% at 1 and 6 years, respectively (Fig. 5A)
, while actual freedom from treatment failure was 87±8% and 67±12% (Fig. 5B). Treatment failure included early death in one patient, primary endoleak in two, secondary type I endoleak in one, late device failure (stabilization wire fracture in a second-generation stent-graft) in two, aneurysmal sac expansion in one, and late sudden, unexplained death in one.
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Fig. 5. (A) Actuarial freedom estimates from treatment failure (see text for definition) in all patients (±1 SE); (B) Actual estimates of freedom from treatment failure (±1 SE).
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3.2.4. Fate of the excluded false aneurysm
After a mean interval of 40±27 months between the procedure and based on the latest available CT scan, the maximal diameter of the excluded aneurysmal sac decreased from 64±17 to 52±22 mm (P=0.02).
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4. Comment
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Traumatic thoracic aortic injuries are uncommon—but highly lethal—injuries. Regardless of whether the injury is caused by blunt or penetrating trauma, the majority of the patients die immediately [1]. Urgent surgical graft replacement of the aorta is the standard emergency treatment in order to prevent aortic rupture and death, but the surgical risk is high because these patients frequently have multiple other-associated major traumatic injuries. In such patients, the use of systemic heparin for left heart bypass or cardiopulmonary bypass may aggravate associated neurologic, visceral, and/or orthopedic injuries; furthermore, single-lung ventilation may be impossible because of associated pulmonary injury. In contemporary series, the operative mortality rate following emergency open operation for acute blunt aortic injury ranges from 15 to 30%, and the risk of paraplegia is between 2 and 20% [18–19]. Recently, several authors have proposed initial hypotensive and negative inotropic therapy with delayed surgical treatment for hemodynamically stable patients with multiple serious injuries in an effort to reduce surgical morbidity and mortality [20,21].
In 1–2% of patients with traumatic aortic injury, the problem is not identified initially and they survive long enough to develop a chronic traumatic false aneurysm [1]. The interval between the trauma and diagnosis used to distinguish between acute and chronic traumatic aortic injuries in the literature is not uniform, varying between 36 h and 3 months [3–6,11–12]. Chronic traumatic aneurysms have different anatomic characteristics than do degenerative aneurysms; they are typically localized, calcified saccular lesions located just distal to the LSCA, making them attractive targets for endovascular stent-graft repair. In a literature review by Bennett and Cherry, 104 chronic traumatic aortic aneurysms were identified [22]; 50% of patients eventually developed symptoms, and 21% manifested radiological evidence of expansion. Moreover, late rupture occurred in nine patients. In a similar study, Finkelmeier et al. analyzed all the reported cases of chronic traumatic aneurysms between 1950 and 1980 [3]. Among 413 patients, 60 were followed without surgical intervention. The survival rates at 5 and 10 years in the unoperated patients were 70 and 65%. Of these, 20 (33%) died of aortic rupture or complications related to the chronic traumatic aneurysm.
To prevent late rupture and aortic-related death, surgical intervention for chronic traumatic aneurysms is generally recommended for all symptomatic patients and also for patients with documented radiological enlargement [3–6]. Historically, descending thoracic aortic graft replacement for chronic traumatic aortic aneurysm is associated with a mortality rate of 4–17%, and a risk of paraplegia between 1 and 4% [3]. Conventional open surgical intervention for chronic traumatic calcified aneurysm involving the distal arch and descending thoracic aorta can be technically challenging, and currently in our institution is treated using hypothermic circulatory arrest frequently to achieve a sound and safe proximal anastomosis [6].
In this series of 15 patients with chronic traumatic aneurysms, endovascular stent-graft repair was technically possible in all patients, with a secondary success rate of 93%. The majority of the patients were men, and femoral access was possible in all patients but one, despite the very large size of the primitive first-generation stent-graft delivery system. Major complications were encountered in only two patients, including symptomatic LSCA thrombosis in one and respiratory failure, sepsis, and aorto-esophageal fistula leading to early death in another patient. Proximity of the LSCA origin is a technical challenge for safe stent-graft deployment in the setting of acute and chronic traumatic injuries, and the incidence of symptomatic subclavian artery thrombosis after intentional stent-graft coverage is lower than previously thought [11–15]. In this report, prophylactic left carotid to left subclavian bypass was performed in two patients; this practice has given way to covering the LSCA whenever necessary followed by expectant management and surgical revascularization only in the cases of symptomatic arm ischemia [10], unless the patient has a patent left internal mammary artery coronary bypass (when carotid-LSCA bypass grafting and proximal LSCA ligation are mandatory before stent-grafting). The actuarial survival estimate was 85% at 6 years, which is similar to the results after conventional open surgical graft replacement [3–6]. Furthermore, the size of the aneurysm sac was significantly smaller late after stent-grafting. On the other hand, freedom from the composite end-point treatment failure was only 51% at 6 years since we observed several late complications specific to stent-graft repair: secondary type 1 endoleak (n=1), late device failure (n=2) and aneurysmal sac expansion without any evidence of endoleak (n=1)—a situation consistent with what is called endotension, which can lead to fatal aneurysmal rupture [16,24]. This underscores the importance of close surveillance imaging follow-up of all patients treated with stent-grafts to detect such late problems unique to this new endovascular approach [10]. Future results should be better due to more refined patient selection, enhanced clinical experience, and new technological advances in the design of stent-graft devices.
After the clinical use of endovascular stent-grafts to repair descending thoracic aortic aneurysms was initiated at Stanford University in 1992 [7,8], application of stent-grafting was expanded to other types of thoracic aortic problems [9–11]. Early results of endovascular repair of acute and chronic traumatic aortic injuries with a first-generation stent-graft device were first reported by our group in 1997 [11]. Stent-graft placement was possible in all 10 patients, and complications were encountered in only three. All patients were alive and well after an average of one year of follow-up. More recently, immediate endovascular treatment of patients with acute traumatic tears has been reported in several small clinical series [13,14,23], with procedural success in 100% and early mortality rates between 0 and 16%. Interestingly, no paraplegia has yet been reported, and only one early death was attributed to a procedure-related complication. Early results of stent-graft repair of chronic traumatic aneurysms have also been published by Rousseau and colleagues [12] and by Fattori et al. [15]. Rousseau reported successful stent-graft repair of chronic traumatic aortic rupture in nine patients treated between 1 month and 25 years after the accident. Two complications occurred, including one early LSCA occlusion. After an average follow-up of 11 months, all patients were alive without complications. Fattori and coworkers [15] reported eight successfully treated cases using commercial devices with no early deaths and no major complications. All patients were alive after an average follow-up of 20 months. Thus, follow-up is still short-term at best.
Two factors limit the inferences that can be drawn from our observations. First, the lack of a randomized control group precluded direct comparison with results achieved using conventional open surgical graft replacement. Second, because of the limited number of patients and the small number of adverse outcomes in this study, analysis of the results between the two generations of stent-grafts did not reveal any significant differences.
In summary, endovascular stent-graft repair of chronic traumatic descending thoracic aortic aneurysms is feasible, successful in most patients, and is associated with low perioperative mortality and morbidity rates. We now report adequate mid-term results of this less invasive approach, but room for improvement clearly exists. Since surgical graft replacement is almost always a definitive long-term solution, younger, good risk patients should be offered conventional open operation, reserving stent-grafting for those who are at prohibitive operative risk or who have limited life expectancy. Better patient selection and new, more refined stent-graft devices in the future should provide better clinical results. Since problems unique to stent-graft repair may develop late after the initial procedure, very close clinical follow-up is essential along with mandatory serial (annual) CT or MR imaging surveillance.
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Acknowledgments
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Dr Demers is supported by a Research Fellowship Award of the Heart and Stroke Foundation of Canada and is a Thelma and Henry Doelger Cardiovascular Surgical Research Scholar at Stanford University School of Medicine.
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Top
Abstract
1. Introduction
