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Ann Thorac Surg 2004;77:81-86
© 2004 The Society of Thoracic Surgeons
a Department of Thoracic and Cardiovascular Surgery and Division of Cardiovascular and Interventional Radiology, Stanford University School of Medicine, Stanford, California, USA
Accepted for publication April 1, 2003.
* Address reprint requests to Dr Miller, Department of Cardiothoracic Surgery, Falk Cardiovascular Research Center, Stanford University School of Medicine, Stanford, CA 94305-5247, USA
e-mail: dcm{at}stanford.edu
| Abstract |
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METHODS: Between 1993 and 2000 endovascular repair of PAU with first-generation (custom-fabricated) and second-generation (commercial) stent-grafts was performed in 26 patients (mean age, 70 years), 6 (23%) of whom had rupture. Fourteen patients (54%) were not candidates for open surgical repair. Follow-up was 100% complete (average, 51 months; maximum, 114 months). Outcome variables considered in the multivariable analysis included death and treatment failure (composite end-point comprising early death, endoleak, stent-graft mechanical fault, late aortic event, reintervention, and aortic-related or sudden death).
RESULTS: Three patients (12% ± 7% [±70% confidence limits]) died within 30 days and 2 had an early type I endoleak. Primary success rate was 92%. Actuarial survival estimates at 1, 3, and 5 years were 85% ± 8%, 76% ± 8% and 70% ± 10% respectively and actuarial freedom from treatment failure was 81% ± 8%, 71% ± 9% and 65% ± 10%. Multivariable analyses identified previous cerebrovascular accident (hazard ratio [HR] 17.1, p = 0.02) and female sex (HR 7.4, p = 0.08) as independent risk factors for death. For treatment failure the predictors were increasing aortic diameter (HR 1.1 [per mm above the mean value], p = 0.01) and female sex (HR 5.5, p = 0.09).
CONCLUSIONS: Endovascular stent-graft repair is effective but not curative treatment for selected, high surgical risk, elderly patients with a descending aortic PAU over the medium term. Assiduous serial follow-up imaging after stent-grafting is mandatory to detect late complications especially in those with a large aorta.
| Introduction |
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| Doctors Mitchell and Dake disclose that they have a financial relationship with W. L. Gore.
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Originally described by Shennan in 1934 [1] the natural history of atherosclerotic penetrating atherosclerotic ulcers (PAU) in the descending thoracic aorta was appreciated only in the 1980s, coinciding with advances in vascular imaging techniques [2]. Penetrating ulcers of the aortic wall are caused by rupture of an atherosclerotic plaque through the internal elastic lamina with subsequent hematoma formation between the media and the adventitia [3]. Unlike classic aortic dissection these localized lesions are usually located in the descending thoracic aorta, or type B according to the Stanford classification [4, 5], and can occasionally be associated with intramural hematoma (IMH). Reports discussing prognosis and treatment however did not distinguish between the two types of IMH, namely IMH caused by PAU and IMH without intimal disruption [6]. Recently Ganaha and associates [5] and Coady and coworkers [7] recognized the more serious nature of PAU, with 40% to 50% of acutely symptomatic patients progressing to acute classic dissection or aortic rupture during initial hospital admission. The Yale group also documented late rupture as well as progressive aortic dilatation in patients with PAU treated medically [8]. Therefore early surgical graft replacement of the aorta is now advocated in symptomatic patients especially those with persistent pain, increasing pleural effusion, or with a large or expanding PAU [5, 7]. Endovascular stent-graft treatment of thoracic aortic diseases is a less invasive alternative to open surgical repair for selected, high surgical risk patients [911] and three reports have described the short-term results of endovascular treatment of PAU with stent-grafts [1214]. Because such descending thoracic aortic focal lesions should be good anatomic targets for endovascular stent-grafts this approach is attractive, especially as many of these patients are quite elderly and have many comorbidities that make them poor surgical candidates. We reviewed 26 patients with symptomatic descending thoracic aortic PAU treated with endovascular stent-grafts over 8 years to determine the mid-term results of this approach and to identify risk factors for treatment failure.
| Patients and methods |
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The study population consisted of 18 men and 8 women with an average age of 70 ± 8 years (range, 55 to 85). As shown in Table 1 most patients had several risk factors; in fact 14 patients (54%) were judged by a surgeon not to be reasonable operative candidates for conventional "open" surgical repair owing to a variety of cardiac, pulmonary, neurologic, or renal comorbidities. The interval between the onset of symptoms and the endovascular procedure was 17 ± 17 days (range, 6 hours to 60 days). Indications for treatment were aortic rupture in 6 patients (23%), persistent or recurrent pain despite maximal medical therapy in 14 patients (54%), and progression of PAU or IMH size in 6 patients (23%).
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Preoperative anatomic characteristics of the diseased aortic segment as well as procedural data are listed in Table 2. The femoral artery was the most common site for insertion (14 patients, 54%). Four patients required deployment of more than one stent-graft. Simultaneous repair of an infrarenal aortic aneurysm using a retroperitoneal approach was performed in 6 patients (23%), where the new aortic graft was used as the access site for stent-graft insertion. One patient with unstable angina underwent simultaneous coronary artery bypass grafting on cardiopulmonary bypass with the stent-graft inserted through the aortic arch in an antegrade manner during hypothermic circulatory arrest. In another patient the proximal landing zone was judged too close to the left subclavian artery; a left common carotidleft subclavian bypass graft was performed before stent-graft deployment purposefully covering the left subclavian artery origin.
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| Results |
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Five patients (19% ± 8%) had postoperative complications (Table 3) including stroke with partial recovery in 1 patient, wound infection in 1, pulmonary embolism in 1, and abdominal complications in 2. No patient suffered paraplegia or paraparesis. Average intensive care unit stay was 3 ± 3 days and total postoperative hospital stay was 7 ± 5 days.
Late outcomes
The actuarial survival estimates at 1, 3, and 5 years were 85% ± 8%, 76% ± 8% and 70% ± 10% respectively (Fig 3).
Causes of late death were aortic rupture secondary to a late (untreated) type I endoleak in 1 patient, sudden, unexplained death in 1, lung carcinoma in 1, and pneumonia in 2 patients.
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| Comment |
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PAU location, epidemiology, and natural history
Penetrating ulcers are found almost exclusively in the descending thoracic aorta. Previous reports indicate that PAUs affect older patients more commonly than does classical aortic dissection [4]. The incidence of concomitant thoracic and abdominal aortic aneurysms is also higher, ranging between 38% and 42%. Accompanying medical problems including hypertension, chronic obstructive pulmonary disease, and coronary artery disease are also found in the majority of patients with PAU [4, 5] so that many are unattractive candidates for conventional open surgical procedures. In this series the mean age was 70 years and the prevalence of serious comorbidities was high.
Quint and associates [17] reported a low incidence of life-threatening complications in patients with a PAU in an imaging registry series but many asymptomatic patients were included. More recently Coady and associates [7] and Genaha and coworkers [5] described the more malignant nature of acutely symptomatic patients with a PAU, with progression to aortic rupture or classical "double-barreled" dissection occurring in 40% to 50% of patients. Even after initial stabilization with medical therapy the Yale group observed progressive aortic enlargement and evolution to late dissection or rupture in some patients [8]. Because of these findings early surgical graft replacement of the descending thoracic aorta should be considered especially in patients with uncontrollable pain, increasing pleural effusion, or with a large or deep PAU [4, 5, 7, 18].
Results of conventional surgery and endovascular stent-graft repair
The mortality rate associated with open conventional surgical graft replacement of the diseased aorta varies between 0% and 18% in patients with PAUs located in the descending thoracic aorta [5, 8, 19]. Morbidity can also be substantial after thoracotomy, especially in elderly patients with severe atherosclerosis and other major comorbidities.
Endovascular stent-graft treatment of patients with thoracic aortic diseases was initiated in 1992 at Stanford University [9]. The application of this new technology was initially focused on the treatment of descending thoracic aneurysms with custom-made devices for high-risk surgical candidates. Initial results suggested that stent-graft treatment was an reasonable alternative to open surgical repair in patients who otherwise were inoperable. Subsequently endovascular stent-graft treatment of acute aortic dissection, traumatic aortic injuries, and PAU was reported [914]. Recently Kos and coworkers [14] reported short-term results in patients with a PAU treated with second generation stent-grafts. In their series of 10 elderly patients (mean age, 74 years) including 7 acutely symptomatic and 3 with aortic rupture, the perioperative mortality was 10% ± 10%. Early minor endoleak was observed in 4 of the surviving 9 patients (type I in 3) but the leak spontaneously thrombosed in 3 patients during the initial hospitalization, yielding a procedural success rate of 90%. During short-term follow-up (3 to 15 months, mean, 9) one additional late type II endoleak was observed.
In this current series of 26 patients including 14 patients (54%) judged to be unacceptable candidates for conventional thoracotomy the procedural primary success rate was 92% and perioperative mortality was 12% ± 7%. No case of paraplegia or paraparesis was observed after endovascular treatment of these localized lesions. Survival estimates at 1 and 5 years were 85% and 70%, which is similar to that reported after conventional surgical repair [8]. The only independent determinants of death were previous cerebrovascular accident and female sex. Freedom from the composite end-point treatment failure at 1 and 5 years was 81% and 65% respectively, which compares favorably with the overall Stanford series [9]. Both larger maximal aortic diameter and female sex were identified as significant independent predictors of treatment failure. These risk factors reflect the importance of careful patient selection based on anatomic criteria and clinical factors. The six late treatment failures underscore the well-known importance of strict, serial clinical and radiologic imaging follow-up of these patients to detect late problems after endovascular stent-graft repair.
Limitations
One weakness of this study is its retrospective, observational nature, which included an 8-year interval characterized by major changes in imaging and stent-graft technologies. Also owing to our evolving experience with this new technology, patient selection criteria, and techniques changed over time. We now believe that endovascular stent-graft treatment should be offered to elderly patients at high surgical risk for conventional surgical repair. Ideal anatomic targets are localized lesions with normal-sized, minimally angulated, cylindrical proximal and distal landing zones of adequate length. Adequate vascular access in terms of arterial size and lack of excessive tortuosity and occlusive disease is also critical for a safe and successful stent-graft deployment. Another weakness of this study is related to the absence of systematic, serial imaging follow-up in all patients. At least one late imaging study was performed in only 85% of the survivors, reflecting the fact that many of these patients were referred from long geographic distances and could not return to Stanford for more assiduous imaging follow-up.
Conclusions
These mid-term results suggest that endovascular stent-graft repair is effective and is associated with low perioperative morbidity and mortality rates in selected high surgical risk, elderly patients with a PAU located in the descending thoracic aorta. Such localized pathology is an ideal anatomic target for a stent-graft. Because the use of stent-grafts is associated with endoleaks and other unique problems, it cannot be considered "curative" as in the sense of open surgical graft replacement of the aorta. Thus strict, serial radiologic imaging follow-up is mandatory to detect late complications.
| Acknowledgments |
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| Appendix. Preoperative, anatomic, and operative variables examined as potential independent risk factors in the multivariable analyses |
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Comorbidity
Preoperative status
Anatomic characteristics
Operative variables
Experience
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