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Ann Thorac Surg 2006;82:1688-1691
© 2006 The Society of Thoracic Surgeons
a Division of Cardiothoracic Surgery, Virginia Commonwealth University Medical Center/Medical College of Virginia, Richmond, Virginia
b Department of Cardiovascular and Endovascular Surgery, Arizona Heart Institute, Phoenix, Arizona
Accepted for publication May 15, 2006.
* Address correspondence to Dr Diethrich, Arizona Heart Institute, 2632 N 20th St, Phoenix, AZ 85006 (Email: ediethrich{at}azheart.com).
| Abstract |
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METHODS: Between March 2003 and September 2005, 21 patients with penetrating aortic ulcers of the descending thoracic aorta were treated with Gore TAG thoracic endoluminal stent-grafts as part of a single-center investigational device exemption protocol.
RESULTS: Mean patient age was 73 ± 12 years, and 7 (33%) of 21 were men and 14 (67%) were women. Patients presented with both acute (<14 days; 16/21, 76.2%) and chronic symptoms (5/21, 23.8%). The endoluminal stent-graft was successfully delivered in all 21 patients. No endoleaks were detected at 30-days postprocedurally or in follow-up (mean follow-up, 14 ± 18 months). The 30-day mortality was 0%, and overall mortality was 4.8% (1/21), which was unrelated to the endovascular intervention.
CONCLUSIONS: Endovascular therapy for penetrating aortic ulcers of the descending thoracic aorta is safe and feasible. The number of patients diagnosed with penetrating aortic ulcers is expected to increase as improved imaging systems are becoming more commonplace. As a result, new and safer treatment paradigms will become even more important in the treatment of aortic diseases. Compared with historical surgical results, endovascular therapy for penetrating aortic ulcers of the descending thoracic aorta appears to have less operative mortality and is as equally effective as open surgical repair. Long-term surveillance and continued investigation are warranted.
| Introduction |
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Recent studies suggest that acutely symptomatic hospitalized patients with penetrating aortic ulcers have a worse prognosis than standard patients with acute type B dissection because of a higher progression rate to aortic rupture [2]. In 1959, Shumacker and King [3] described the first successful operative repair of a ruptured descending aorta caused by a penetrating aortic ulcers. The traditional repair method for penetrating aortic ulcers, open surgical replacement of the descending thoracic aorta, is associated with a mortality of 5% to 20% [4]. More recent studies at specialized aortic surgery centers have demonstrated 30-day mortality as low as 6% [5]
Endovascular repair of the descending thoracic aorta has been described for a number of aortic pathologies, including penetrating aortic ulcers. Endoluminal grafts provide a method to treat aortic pathologies with potentially less morbidity by using the minimally invasive techniques of endovascular surgery. Although previous studies have indicated the successful repair of this pathology with endoluminal grafts [6, 7], this study reviews a single-institution experience in the treatment of penetrating aortic ulcers in 21 patients.
| Patients and Methods |
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The study population had an average age of 73 ± 12 years (range, 39 to 86 years) and consisted of 7 men (33%) and 14 women (67%). The study population had a high incidence of associated comorbidities, which are summarized in Table 1. Specifically, the American Society of Anesthesiologists physical status classification for the study group was a mean score of 4, which is defined as a patient with severe systemic disease that is a constant threat to life.
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In addition, the associated disorders of the study population varied. Two patients (9%) presented with contained ruptures of the descending aorta limited to the periadventitial space, and 2 (9%) had a free rupture with moderate bloody pleural effusions on the left side. No patient presented in hemodynamic distress. One patient had a tracheostomy that was placed previously for severe chronic obstructive pulmonary disease (COPD).
The diagnosis of penetrating aortic ulcers was determined by anatomic criteria from preoperative computed tomography (CT) examination. The diagnosis of a penetrating aortic ulcer was made when CT scanning revealed a localized area of significant atheroma with focal ulceration of the intima and media with aortic wall thickening. Patients with lesions associated with intramural hematoma, contained rupture, or pleural effusion with Hounsfield units consistent with bloody effusion were included in the study, whereas those with evidence of a large intimal dissection or predominantly aneurysmal dilation were excluded. Other exclusion criteria included myocardial infarction within 6 weeks, degenerative connective tissue disease (eg, Marfan disease or Ehler Danlos syndrome), and significant thrombus at the proximal or distal implantation sites. No patient had a penetrating atherosclerotic ulcer that required aortic arch stenting or preoperative transfer of the left subclavian artery to allow a proximal landing zone.
Thoracic aortic stent-grafting was performed under standard operating room procedures. Patients in the supine position were prepared with their left arm extended to allow access to the brachial artery in the event retrograde subclavian arterial access was required. General anesthesia was used in all patients. Stent-graft measurements were calculated from preoperative CT scan measurements and intravascular ultrasound examination during the operative procedure.
The TAG device is a self-expanding nitinol stent lined with expanded polytetrafluoroethylene graft material delivered using a coaxial over-the-wire technique. The TAG device is delivered through a sheath introduced into the common femoral artery or common iliac artery into the abdominal aorta. After access into the abdominal aorta is gained, the TAG can be advanced to the level of the thoracic aorta for deployment.
The method of surgical access for deployment was based on review of preoperative CT scans and intraoperative intravascular ultrasound. Common femoral arterial access was successfully used in 19 patients (90%). Of those 19 patients, one patient required aretroperitoneal dissection to manually straighten the external iliac to allow for sheath advancement and deployment of the TAG device, one patient had the graft advanced through the common femoral artery in a "bareback" fashion without the use of a sheath, and one patient had the sheath advanced into the external iliac artery and then the device was advanced "bareback" through the common iliac artery and up to the thoracic aorta.
Two patients (10%) required retroperitoneal approaches to allow for attachment of a 10-mm Hemashield graft (Boston Scientific, Natick, MA) anastomosed to the common iliac artery in the first patient and the distal abdominal aorta in the second patient. The first of these patients had the 10-mm Hemashield used as a conduit from the iliac artery to the common femoral artery to bypass severely diseased iliac arteries. One patient (5%) required retroperitoneal exposure to control and repair an external iliac rupture after sheath insertion into the common femoral artery failed.
The sheath sizes used for access and device diameters are listed in the operative details in Table 2. Of note, only 1 patient required more than one TAG graft to be placed. Intraoperative device migration during balloon angioplasty necessitated placement of an additional proximal device to completely cover the penetrating ulcer. Median operative time was 83 ± 39 minutes (range, 44 to 215 minutes), and median blood loss was 200 ± 139 mL (range, 50 to 550 mL).
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| Results |
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There were no operative mortalities. One postoperative complication required return to the operating room. This complication was a lower extremity malperfusion due to occlusion of the iliacfemoral Hemashield graft secondary to retroperitoneal exposure for device placement. The patient required thrombectomy of the iliofemoral graft, superficial femoral artery thrombectomy, and revision of the iliofemoral graft. There were no perioperative strokes, paraplegias, or myocardial infarctions. The average length of hospitalization was 5 days (range, 2 to 10 days).
The mean follow-up period was 14 ± 18 months for this study. Follow-up helical CT scans to evaluate for endoleaks or associated aortic pathologies were performed at 1 month, 6 months, 1 year, and then annually thereafter. All patients had adequate treatment of their penetrating ulcers with the stent-grafts. No endoleaks or graft migrations were detected at 30-days postprocedurally or in follow-up in the 21 study patients, and no adverse neurologic events occurred within the study period. There were no treatment failures, and no additional interventions were required. Postoperative results are summarized in Table 3.
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| Comment |
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In 1986, Stanson and associates [1] suggested that this entity may behave in a particularly malignant manner and warranted urgent surgical intervention to prevent transmural perforation and exsanguination. Although some studies have suggested that penetrating aortic ulcers may be observed [12], medical management generally results in one third of patients requiring early or late operation for progression of penetrating aortic ulcers to aneurysms, dissections, or perforation [13]. Ganaha and colleagues [14] found that uncontrolled pain, presence of a pleural effusion, and acute onset of symptoms are indicators of a more malignant form of penetrating aortic ulcers that have a higher risk of progression to aortic rupture and require urgent surgery.
Patients with penetrating aortic ulcers tend to be older and have extensive comorbidities that commonly include hypertension, COPD, and coronary artery disease. Open operative repair on the descending thoracic aorta has an associated operative risk of 0% to 20%, but averages about 15% in most studies [1418].
Endovascular graft placement provides an alternative strategy to treating acute aortic pathologies such as penetrating aortic ulcers. Endovascular stent-graft treatment of patients with thoracic aortic disease began at Stanford University in 1992 with the treatment of thoracic aortic aneurysm disease [19]. After this initial success, various institutions have reported endovascular treatment of thoracic aortic dissections, traumatic aortic injuries, and penetrating aortic ulcers [2024].
Open surgical repair of the descending aorta requires clamping of the aorta, a large thoracotomy incision, possible cardiopulmonary bypass, and prolonged mechanical ventilation. Because endovascular surgery generally requires only a femoral or iliac cut down for exposure, short operative times, and no clamping of the aorta, this less invasive procedure has the potential to significantly reduce the morbidity and mortality of definitive surgical correction of penetrating aortic ulcers.
This review of 21 patients presenting with penetrating aortic ulcers examines the use of the TAG thoracic stent-graft as part of a single institutional IDE trial. There were several noteworthy findings in this study. Despite the high number of comorbidities and advanced age in this patient population, there was zero operative mortality. Postoperative morbidities included one reoperation for an occluded limb of an iliacfemoral bypass graft but no perioperative myocardial infarctions, strokes, or paraplegias. The use of just one device in 20(95%) of 21 patients indicates that the focal area of pathology in penetrating aortic ulcers is optimal for treatment by endoluminal grafts. In addition, because there has been a correlation between the length of the descending thoracic aorta covered by stent-grafts and paraplegia rate, the single application of one graft may have reduced the risk of postoperative neurologic dysfunction. Freedom from end-point treatment failure was 100%, and the only death occurred at 459 days after the procedure when the patient was placed in hospice care.
These mid-term results of low morbidity and mortality compare favorably with previously published studies that have examined the use of stent-grafts in the treatment of penetrating ulcers [6, 24]. Penetrating atherosclerotic ulcers may be uniquely suited for treatment with endovascular grafts in this unhealthy population by allowing a minimally invasive means to treat a focal anatomic pathology.
The study has several limitations. It was a retrospective review of a group of patients referred to an experienced endovascular and surgical center for consultation for penetrating aortic ulcers. A prospective, randomized trial would better illustrate the safety and efficacy of open surgical repair versus endovascular treatment. In addition, the study included a limited number of patients with mid-term follow-up. Longer follow-up with this cohort of patients will determine the durability of the repair and better define the natural history of the non-stented aorta in this pathology.
Despite these limitations, the endovascular therapy of penetrating aortic ulcers in the descending aorta appear to be at least as effective with a lower morbidity and mortality when compared to historical open surgical results. Further clinical investigation in the use of endovascular stent-grafting for all aortic pathologies is required.
| References |
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P. F. Ford and M. A. Farber Role of Endovascular Therapies in the Management of Diverse Thoracic Aortic Pathology Perspectives in Vascular Surgery and Endovascular Therapy, June 1, 2007; 19(2): 134 - 143. [Abstract] [PDF] |
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