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J Thorac Cardiovasc Surg 2006;132:332-339
© 2006 The American Association for Thoracic Surgery
Evolving Technology |
a Cardiovascular Radiology, University Hospital S. Orsola, Bologna, Italy
b Division of Cardiology, University Hospital Rostock, Rostock, Germany
c Department of Radiology, Centre Hospitalier Universitaire, Hôpital de Rangueil, Toulouse, France
d Radiologie Vasculaire, Hôpital Cariologique CHRU de Lille, Lille, France
e Department of Cardiothoracic Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands
f Department of Cardio-Thoracic Surgery, University of Vienna, Vienna, Austria
g Department of Vascular Surgery, Centre Hospitalier Universitaire, Hôpital Sainte Marguerite, Marseille, France
h Department of Interventional Radiology, Centre Hospitalier Universitaire, Hôpital de la Timone, Marseille, France
Received for publication December 26, 2005; revisions received February 21, 2006; accepted for publication March 15, 2006. * Address for reprints: Rossella Fattori, Department of Radiology–Cardiovascular Unit (pad 21), University Hospital S. Orsola, Via Massarenti 9, 40128 Bologna, Italy (Email: rossella.fattori{at}unibo.it).
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Abstract |
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METHODS: Data from 457 consecutive patients (113 emergency and 344 elective cases) who underwent endovascular thoracic aortic repair with the Medtronic Talent Thoracic stent graft (Medtronic/AVE, Santa Rosa, Calif) were collected. Follow-up analysis (24 ± 19.4 months, range 1-85.1 months) was based on clinical and imaging findings, including all adverse events. To ensure consistency of data interpretation and event reporting, one physician reviewed all adverse events and deaths for the whole cohort of patients. In the case of discrepancies, the treating physicians were queried.
FINDINGS: Among 422 patients who survived the interventional procedure (in-hospital mortality 5%, 23 patients), mortality during follow-up was 8.5% (36 patients), and in 11 of them the death was related to the aortic disease. Persistent endoleak was reported at imaging follow-up in 64 cases: 44 were primary (9.6%) and 21 occurred during follow-up (4.9%). Seven patients with persistent endoleak had aortic rupture during follow-up, at a variable time from 40 days to 35 months, and all subsequently died. A minor incidence of migration of the stent graft (7 cases), graft fabric alteration (2 cases), and modular disconnection (3 cases) was observed at imaging. Kaplan-Meier overall survival estimate at 1 year was 90.97%, at 3 years was 85.36%, and at 5 years was 77.49%. At the same intervals, freedom from a second procedure (either open conversion or endovascular) was 92.45%, 81.3%, and 70.0%, respectively.
CONCLUSION: Endovascular treatment for thoracic aortic disease with the Talent stent graft is associated with low early morbidity and mortality rates also for patients who are at high risk and treated on an emergency basis. Follow-up data indicate a substantial durability of the procedure with a high freedom from related death and secondary interventions.
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Introduction |
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Therefore, preventive surgical resection has long been considered the only treatment strategy, although associated with significant mortality and morbidity.
4-9
The advent of endovascular techniques revolutionized the management of thoracic aortic disease, enabling low-invasive repair even in high-risk patients unfit for open surgery. Compared with open surgery, stent-graft treatment is associated with decreased perioperative mortality rates and fewer complications, even in older patients with significant comorbidities.
10-23
However, data on midterm and long-term follow-up are limited. The Talent Thoracic Retrospective Registry (TTR) was designed to collect outcome data from patients who underwent endoluminal treatment with the Medtronic Talent thoracic stent graft (Medtronic/AVE, Santa Rosa, Calif) in 7 European referral centers. Data collection was focused on clinical and imaging follow-up with particular reference to mortality and long-term complications.
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Methods |
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Device Description
The Talent Thoracic stent graft is composed of a Dacron graft material supported by self-expanding nitinol springs. The springs are sewn to the graft material with polyester sutures. The graft material is a sheet of monofilament polyester with a seam joining the edges to create a cylindrical tube. Opposite the seam is the connecting bar, which attaches the most proximal and distal springs. The connecting bar provides columnar strength to the device and facilitates deployment. During implantation, the connecting bar should be oriented to the outer radius for stent-graft conformability and kink resistance. All nitinol components are surface treated to enhance long-term fatigue performance. The Talent stent graft system has many modular sections that can be used to treat a wide variety of thoracic lesions. The stent graft has three proximal and distal configurations. The proximal configurations are FreeFlo, Bare Spring (22 mm only), and Open Web, which all have a flared geometry. The FreeFlo design (different from the Bare Spring configuration) has a bare spring and a mini-support spring, which improves sealing for sizes 24 to 46 mm. The distal configurations are Bare Spring, Closed Web, and Open Web. The Open Web configuration was designed for use as distal extensions for the Talent stent-graft system.
Interventional Endovascular Procedure
General anesthesia was used for the endovascular aortic procedure in 453 of 457 patients. One hundred thirteen (27.4%) patients were treated under emergency conditions and 344 (75.3%) patients were treated electively. The mean length of covered aorta was 131.5 mm, ranging from 28 to 380 mm with one stent used in 70% of cases. The stent graft was positioned in the proximal descending aortic segment in 124 patients (neck length > 1 cm). In 54 patients the stent graft was positioned in the distal aortic arch with coverage of the left subclavian artery to extend the proximal landing zone. In 40.7% of them (22 patients) revascularization of the left subclavian artery was performed before stent-graft treatment.
Statistical Analysis
Incidence rates of events are reported by giving the number of patients experiencing the event followed by the corresponding percentage. Continuous data are reported by giving the mean ± standard deviation and/or median and the range of values observed. Where incidence rates (or proportions) were statistically compared between groups, the 
2 test or Fisher exact test was used. Stepwise logistic regression analysis was performed to determine predictors of in-hospital death and in-hospital complications (stroke, paraplegia, extension of dissection, vascular local, renal, cardiac, pulmonary). Noncorrelated variables with P < .05 at univariate analyses were included in the multivariate models; model precision was evaluated by the Hosmer-Lemeshow goodness-of-fit statistic. Estimates of times to events and the accompanying curves were generated by the method of Kaplan and Meier. Statistical analyses were carried out with SPSS software package version 13.0 (SPSS, Inc, Chicago, Ill).
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Results |
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In-hospital Complications
Major adverse events are listed in Table 2. The most common were cerebral vascular accidents and vascular trauma during the procedure. Multivariate logistic regression analysis showed that acute status (OR 2.8; 95% CI 1.5-5.2; P = .001) and ASA class IV or V (OR 2.3; 95% CI 1.2-4.4; P = .016) were independent predictors of in-hospital complications, whereas traumatic aortic injury was significantly associated to lower rate of complications (OR 0.3; 95% CI 0.1-0.8; P =.016) (86.3% of correct classification, Hosmer-Lemeshow goodness-of-fit P = .711) (Table 3). Stroke occurred in 17 patients and was significantly associated to occlusion of the left subclavian artery without previous revascularization (P = .004, Fisher exact test). Paraplegia (3 patients) and paraparesis (5 patients) occurred in 8 cases (4 degenerative aneurysm and 4 type B dissection) and was significantly associated to length of covered aorta greater than 20 cm (P = .001, Fisher exact text). At follow-up, the spinal ischemic damage was persistent in the 3 cases of paraplegia, whereas paraparesis resolved completely in 4 of 5 patients.
Mortality and Aortic Rupture at Follow-up
Clinical and imaging mean follow-up was 24 ± 19.4 months (Table 4). Ninety-five of 422 patients had more than 3 years of clinical and imaging follow-up available, including 23 with over 5 years of follow-up. Late mortality was 8.5% (36 patients), and in 11 of them death was related to the aorta: 7 cases of aortic rupture at a variable time from 40 days to 35 months, 2 extentions of dissection, and 2 aortoesophageal fistulas (Figure 1). Other cause of death included myocardial infarction, respiratory insufficiency, cerebrovascular accident, and neoplasm. In 5 patients the cause of death was not specified in the case report form. All 7 patients who had an aortic rupture during follow-up subsequently died. Among them, 6 had aortic dissection as primary disease and all 7 patients had type I persistent primary or secondary endoleak, with aneurysm expansion at imaging follow-up (Figure 2).
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Alteration of the graft material was identified in 2 patients. One patient had an aortoesophageal fistula 2 years after successful endovascular treatment of an atherosclerotic aneurysm. On CT scan, a detachment of the distal nitinol frame was noted, facing the esophageal erosion. Another case of proximal detachment of one nitinol frame had no clinical consequences.
Change in Aneurysm Dimension
The dynamics of aneurysm dimension are summarized in Table 4. Thirteen of 22 patients with endoleak type I (among patients in which this information was reported), either primary or secondary, showed an increase of the aneurysm sac (medium 9 mm, ranging from 5 to 80 mm).
Long-term Survival
Kaplan-Meier overall survival estimate at 1 year was 90.1%, at 3 years was 84.6%, and at 5 years was 74.1%. Kaplan-Meier estimate for freedom from related death was 96.0% at 1 year, 93.9% at 3 years, and 90.2% at 5 years. At the same interval, freedom from a second procedure (either open conversion or endovascular) was 92.4%, 81.3%, and 70.0%, respectively (Figure 3).
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Discussion |
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in 1994, using a homemade nitinol-Dacron stent graft in 103 patients. In 1997, commercially manufactured stent grafts enabled increasing use and growth of technical skill and knowledge in many centers.
11-20
Experience with endovascular treatment in a wide spectrum of aortic diseases demonstrates the feasibility of this approach even in unstable patients with encouraging early and midterm results.
21-23
However, long-term follow-up of the first thoracic homemade device is discouraging
24
and associated with low survival. Accordingly, experience with endovascular treatment of abdominal aortic diseases
25,26
stimulated the need for long-term outcome data and efficacy of the stent graft in aortic diseases. The present experience has some limitations: Data were retrospectively collected, with no control over the inclusion criteria for the endovascular procedure. The lack of a randomized or concurrent control patient group precluded direct comparison with conventional open surgical repair. In addition, the absence of autopsy confirmation in deceased patients does not allow in all cases exclusion of aortic rupture as a possible cause of death.
Yet, this is the first study on long-term results in a wide cohort of patients (457) over an 8-year period, with more than 3 years of clinical and imaging follow-up available in 95 patients. Early results are comparable with other reported case series: in-hospital mortality was 5%, comprising 113 patients treated under emergency condition. An advantage of endovascular repair in acute aortic syndrome is its potential to reduce blood loss
27,28
with respect to open surgery, in which back-bleeding from branch arteries and anastomotic sites or from iatrogenic venous injuries could precipitate shock and neurologic consequences. Most perioperative complications in emergency endovascular cases of this study arose from preexisting medical conditions and were not procedure related. This study showed that in patients with traumatic aortic rupture (85 patients with no mortality), endovascular stent-graft treatment strongly abated the high mortality of conventional open surgical repair.
29
In patients with complex multiple trauma, the possibility of low-invasive treatment of the aortic lesion may allow a prompt management of the other associated lesions, with limited impact on trauma destabilization and improved overall survival. The feasibility of endovascular treatment in patients with Marfan syndrome is controversial, because of the particular fragility of the aortic wall. No significant differences in results and outcome emerged from data analysis of the 15 Marfan patients with type B dissection included in this registry. However, no definite results could be drawn from such a limited number of cases.
The present study showed that the most frequent complications in endovascular procedure are stroke (3.7%) and vascular lesions at the access site (3.2%), both probably related to the difficult advancement and manipulation of the sheath, which still has a large outer diameter (22F-27F) and relative inflexibility. New developments of stent-graft material and design might reduce these problems. Among several variables examined, the only significant predictor of stroke was the occlusion of the left subclavian artery without previous revascularization. With regard to intentional left subclavian artery occlusion the available data are conflicting; although recent endovascular reports
30
suggest a relative safety if some precautions are met, surgical experience with deliberate ligation of the vertebral artery
31
leads to a 5.4% rate of ischemic complications.
Spinal cord ischemia with resultant paraplegia is of significant concern with open surgery of descending thoracic aortic aneurysms,
32
while the endovascular stent graft holds the potential for reducing the risk, avoiding crossclamping, significant blood loss, and severe hypotension. However, experience with endovascular treatment does not allow us to identify the anatomic and clinical characteristics for spinal cord ischemia. Concomitant or previous abdominal aneurysm repair has been reported as a risk factor.
26,33
In our registry, paraplegia occurred in only 3 patients and it occurred in patients without previous abdominal aortic surgery. Long-segment thoracic aortic exclusion was the most important predictor of spinal ischemia, both for patients with dissection and for those with aneurysm.
Long-term survival is one of the major concerns in patients with severe comorbidities: 56% of this population had an ASA class of III or more. In this cohort of high-risk patients, Kaplan-Meier curves at 36 months indicate a survival of 84.6% (Figure 1), with a low incidence of aorta-related deaths (9%) and secondary procedures, both surgical and interventional (11%). Long-term results confirm that endoleak is the most important risk for aortic rupture. All patients with aortic rupture during the follow-up had type I persistent endoleak. According to the literature,
34-37
type II endoleak, due to reperfusion of the aneurysm sac by intercostal arteries, is relatively uncommon (0.5% primary and 0.8% secondary endoleak) and does not seem to constitute a risk factor for aortic rupture. Migration has not been investigated previously in thoracic endografting.
38,39
Indeed, all previous case series and registries have a maximum of 1-year follow-up or a limited number of patients for longer periods. However, migration seems uncommon in this setting, even several years after implant. In the present series, migration was assessed by reporting differences in the distance of the proximal covered part of the stent graft from the left subclavian artery between the postoperative and subsequent imaging; it occurred in only 7 patients. Although the cases are few, migration was potentially caused by inadequate oversizing or disease progression proximally or distally, resulting in slow enlargement of the landing zones and subsequent loss of fixation. A major concern in endovascular treatment is the durability of the graft material, especially in the case of young patients. Fabric deterioration has been reported with almost all devices in abdominal series and also with thoracic stent grafts. With first-generation endovascular grafts using wire-formed nitinol, electrochemical corrosion leading to stent fracture has been reported, even after a short period of implantation.
24
Nitinol possesses a high elasticity and very good biocompatibility, and it is known to have good resistance to corrosion, depending on the processing techniques and the quality of the protective titanium oxide surface layer. Improvements in the manufacturing process have led to better quality material and improved the surface finish. Laser cutting, polishing, and heat treatment procedures have enhanced nitinol's corrosion resistance. Our data seem to confirm the durability of the material, with 2 cases in a cohort of 422 patients, some of whom have the stent graft in situ for more than 8 years.
In conclusion, endovascular treatment for thoracic aortic disease with the Talent stent graft carried out at high-volume referral centers is associated with low early morbidity and mortality rates also for patients at high risk and treated on an emergency basis. Follow-up data indicate a substantial durability of the procedure with a high freedom from related death and secondary interventions. Long-term surveillance will be crucial to discover complications unique to thoracic endovascular interventions and to determine which patients are appropriate candidates for stent-graft therapy.
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Footnotes |
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