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Vascular and Interventional Radiology |
1 From the Departments of Radiology (R.F., G.N., L.L., C.G., T.P., G.G.), Cardiology (G.R.), and Cardiovascular Surgery (E.A., R.D.B.), University Hospital S. Orsola, Via Massarenti 9, 40138 Bologna, Italy. Received July 19, 2002; revision requested August 27; final revision received February 15, 2003; accepted April 1. Address correspondence to R.F. (e-mail: ross@med.unibo.it).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMATERIALS AND METHODS RESULTS DISCUSSIONREFERENCES |
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MATERIALS AND METHODS: Seventy patients with aortic dissection, intramural hemorrhage, degenerative and posttraumatic aneurysm, penetrating atherosclerotic ulcer, and pseudoaneurysm underwent endovascular treatment. Eleven patients had impending rupture and were treated on an emergency basis. Stent-grafts were customized or selected on the basis of spiral computed tomographic (CT) or magnetic resonance (MR) imaging measurements. Preprocedure diagnostic angiography was performed in patients with aortic dissection and in other selected patients. All procedures were performed in an operating room and monitored with digital subtraction angiography (DSA) and transesophageal echocardiography (TEE). Follow-up was at 1, 3, 6, and 12 months after treatment and yearly thereafter.
RESULTS: Stent positioning was technically successful in 68 cases. At DSA and TEE, complete aneurysm or false-lumen exclusion was achieved in 66 (97%) cases. No intraoperative mortality or complications occurred. In-hospital complications included transient monoparesis (one patient) and extension of dissection into ascending aorta (one patient) that was repaired surgically. Early endoleak was observed in five (7%) patients: In three (type 2), endoleak resolved spontaneously; in one (type 1), it was persistent; and in one (type 1), treatment was converted to surgery. At long term, one (1%) patient died of aortic rupture; another, of respiratory insufficiency. Five (7%) late endoleak (type 1, one caused by migration of the stent) cases were observed. In three (4%), endovascular treatment was successful; in two (3%), surgery was performed. In one patient with persistent postimplantation syndrome, treatment was converted to surgery after successful aneurysm sealing. Procedure failure (ie, aortic disease–related mortality or conversion to surgery) occurred in six (9%) patients.
CONCLUSION: Endovascular stent-graft repair is less invasive in patients with chronic and acute descending thoracic aortic aneurysm and dissection.
© RSNA, 2003
Index terms: Aneurysm, aortic, 563.73 • Aorta, diseases, 563.70 • Aorta, dissection, 563.74 • Aorta, grafts and prostheses, 563.1267 • Aorta, rupture
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTS DISCUSSIONREFERENCES |
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Endovascular techniques are emerging as an alternative approach in the treatment of aortic disease, and this approach offers a less invasive therapeutic option, even to patients who have associated diseases that contribute to their being classified in a high-risk surgical category and who would not otherwise be considered surgical candidates (10–23). The purpose of our study was to evaluate our experience with endovascular treatment of the descending thoracic aorta with commercially available self-expanding stent-grafts.
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MATERIALS AND METHODS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTS DISCUSSIONREFERENCES |
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However, 11 patients (five with aortic dissection, two with penetrating ulcers, two with posttraumatic aneurysms, and two with hemothorax caused by suture dehiscence of prosthetic grafts) were treated in the acute phase because of clinical signs or imaging features that suggested impending rupture. These signs or features included persistent thoracic pain, untreatable hypertension, periaortic hematoma, and hemothorax. Finally, three patients with aortic dissection were treated on an emergency basis within a few hours of admission to the emergency room because of active bleeding into the pleural space. In 70 patients, comorbid conditions that increased the risk of conventional surgical repair included pulmonary dysfunction (51% [36]), coronary disease (13% [nine]), renal insufficiency (15% [10]), carotid arterial occlusive disease (12% [eight]), and previous aortic or cardiac surgery (27% [19]). Twenty-six patients had only one comorbid condition, eight patients had two, five patients had three, and one patient had four, whereas the remaining 30 had none.
Preoperative Evaluation
Patients were selected for endovascular treatment on the basis of suitable anatomy for stent-graft placement. The criteria included the following: 1 cm or more of normal aortic wall at the aneurysm neck that did not involve the left subclavian artery or the celiac axis or a 1 cm or more distance of the entry site from the left subclavian artery in the aortic dissection; 42 mm or smaller diameter of the proximal and distal neck; 9 mm or larger diameter of the femoral or the iliac arteries; and no severe aortoiliac tortuosity. All the parameters were evaluated by two of the authors (R.F., G.N.) with consensus. During the same time, 94 patients admitted to our Cardiovascular Surgery Department for thoracic aortic diseases underwent conventional open surgical repair. Only 42.6% (70 of 164) of patients referred to our hospital for descending thoracic aortic repair had suitable anatomy for the endovascular stent-graft procedure.
Anatomic conditions that allowed endovascular stent placement were assessed in each patient at contrast material–enhanced spiral computed tomography (CT) (Mx Twin; Picker International, Cleveland, Ohio) or at 1.5-T magnetic resonance (MR) imaging (Signa; GE Medical Systems, Milwaukee, Wis). Before and after an injection of 80–140 mL of iopamide (Iomeron 200; Bracco, Milan, Italy), helical CT was performed in 5-mm sections, with a pitch of 1.5 and a reconstruction interval of 2.5 mm from the supraaortic vessels to the iliac and femoral arteries. The MR imaging protocol included an electrocardiogram-gated fast spin-echo double inversion-recovery sequence (repetition time of twice the R-R interval with an echo time of 40 msec [repetition time varied depending on the heart rate]; field of view, 40 cm; section thickness, 7 mm; spacing, 0 mm; matrix, 256 x 224) that was performed in the transverse and sagittal oblique planes. Contrast-enhanced MR angiography was performed with a three-dimensional dynamic fast spoiled gradient-echo sequence (repetition time msec/echo time msec, 4.4–5.4/1.4; section thickness, 3.4 mm; overlap, 1.7 mm; matrix, 320 x 192) after an intravenous bolus injection of 0.2 mmol per kilogram of body weight of gadopentetate dimeglumine (Magnevist; Schering, Berlin, Germany). A phased-array coil (Torsopa; GE Medical Systems) was used. For both MR imaging and CT, the postprocessing consisted of multiplanar reconstructions, maximum intensity projections, shaded-surface display, and volume-rendering reconstructions.
Because of its superior capability in depiction of functional information regarding flow patterns and luminal communications, MR imaging was usually performed in all patients with aortic dissection, whereas spiral CT was used in the remaining cases. Particular attention was devoted to aortic wall status at the proximal and distal neck of the aneurysm to identify mural thrombus or calcifications that could interfere with sealing of the aneurysm. Specific information was necessary in aortic dissection, and this information included identification of entry and reentry sites, relationships among true and false lumina with visceral and femoral vessels, true- and false-lumen dimension, and diameter of distal aortic arch, as well as diameter and extension of the dissection to the femoral and iliac arteries. Angiography was performed in the 22 patients with aortic dissection to confirm position and flow of entry and reentry sites and in 15 of the 48 remaining patients in whom spiral CT was not considered sufficiently reliable to visualize vascular access or aortic morphology. In patients with type B dissection, exclusion criteria from endovascular treatment were considered to be a distance of shorter than 1 cm of the entry site from the left subclavian artery and the absence of a reentry site in the abdominal aorta if the origin of one or more visceral vessels was from the false lumen. In only one patient with an entry site at 4 mm from the left subclavian artery, subclavian-to-carotid artery transposition was performed before the stent placement to create a longer proximal neck. One patient with thoracic and abdominal aneurysms underwent combined surgical resection of the abdominal aneurysm and endovascular treatment of the thoracic aorta.
Stent-Graft Systems
Two different endoluminal stent-graft systems were implanted. One stent-graft system (Talent; Medtronic, Sunrise, Fla) was used in 67 patients. In 56 cases, the stent was individually custom-made on the basis of previous CT and MR imaging measurements and was oversized more than 2–4 mm, whereas in the 11 patients with acute cases, promptly available grafts of standard measurements were used. The other stent-graft system (Thoracic Excluder; Gore & Associates, Flagstaff, Ariz) was used in cases of major proximal aortic tortuosity (ie, one posttraumatic aneurysm, one atherosclerotic aneurysm, and one case of dissection) because of its greater flexibility with respect to the Talent graft.
The Talent prosthesis consisted of a circumferential nitinol stent covered with low-profile polyester (Dacron; Medtronic). The nitinol rings at each extremity may or may not be covered with polyester. The graft was mounted over a polyurethane placement catheter (Medtronic) and was compressed into a sheath made of synthetic resin (Teflon; Medtronic). A coaxial balloon or adjunctive balloon catheter (Medtronic) was also provided to mold the stent components after deployment. The endoluminal system was passed over a guide wire (Back-Up Meier; Boston Scientific, Oakland, NJ) and positioned at the selected location. The deployment was accomplished by moving the covering sheath downward.
The Thoracic Excluder grafts were also made of a nitinol stent that was lined with polytetrafluoroethylene and was compressed and mounted on a placement catheter (Cook, Byaverskov, Denmark) that required an introducer for its advancement in the vascular system. Deployment of the stent-graft was achieved with the pulling of a string at the end of the placement catheter that was connected with a polytetrafluoroethylene covering sleeve (Gore). Adjunctive three-foil balloon catheters (Gore) were available for molding the graft after deployment.
Interventional Aortic Procedure
Endovascular stent placement procedures were performed in the operating room with patients receiving general anesthesia.
Cardiopulmonary bypass was available on a standby basis during every stent placement procedure. A team of two cardiovascular surgeons (R.D.B., E.A.) and two interventional radiologists (R.F. and T.P., G.N., or L.L.) worked together; the surgeons exposed the femoral or iliac artery to insert a 22–27-F delivery system, and the radiologists performed the stent positioning and deployment. All procedures were monitored with a portable radiographic C-arm system (series 9800; OEC Medical System, Salt Lake City, Utah) with digital subtraction angiography (DSA) and with transesophageal echocardiography (TEE) (Sonos 2000; Hewlett-Packard, Palo Alto, Calif) by using a multiplanar probe. Through a percutaneous left brachial artery approach, a 5-F pigtail catheter (Cordis; Johnson & Johnson, Warren, NJ) was placed in the aortic arch to permit aortography before stent positioning. After administration of a bolus of 5,000 IU of heparin, the endovascular stent system was inserted over the guide wire through a transverse arteriotomy and advanced with fluoroscopic and TEE guidance. The exact placement site was selected on the basis of TEE and angiographic information after careful control of aortic wall status and diameter at the neck sites. Just before the device was released, vasodilators (sodium nitroprusside, Nipride; Malesci, Florence, Italy) at a dose of 0.2–5.0 µg/kg/min and calcium blockers (diltiazem hydrochloride, Tildiem; Sanofi-Synthelabo, Milan, Italy) at a dose of 0.2–0.5 µg/kg/min were intravenously administered to decrease the systolic pressure to 50–70 mm Hg. After correct positioning of the device, the outer sheath was withdrawn slowly to deploy the stent-graft. A latex balloon was then inflated to mold the nitinol stent and to obtain a complete expansion with color Doppler TEE and fluoroscopic guidance. Subsequent balloon inflations were performed at the proximal and distal necks until the absence of flow in the perigraft zone was established with color Doppler TEE (23). Finally, an aortogram was obtained to verify proper stent-graft positioning and complete aneurysm exclusion. The sheath was then removed, and the arteriotomy was sutured. All the procedures in which it was possible to advance the delivery system into the vascular bed and to deploy the stent-graft in the selected position were considered technically successful.
During the intensive care unit and hospital stay, symptoms, in-hospital adverse events, body temperature (ie, readings obtained at least twice a day), and daily hemochrome and serum parameters were considered in each patient to the time of discharge.
Clinical and Imaging Follow-up
All patients underwent helical CT or MR imaging, depending on availability, at intervals of 1, 3, 6, and 12 months after the procedure and yearly thereafter. Helical CT was usually performed in patients with thoracic aneurysms, whereas MR imaging was more often used in patients with aortic dissection. However, in patients with renal insufficiency, MR imaging was more frequently used for both dissection and aneurysms.
CT and MR imaging protocols were the same as those used for the preoperative evaluation. The parameters evaluated by two of the authors (L.L., T.P.) in consensus were as follows: absence of flow within the aneurysmal sac, aneurysm dimension, morphology of the stent-graft (ie, position and configuration of the metallic frames, eventual kinking or rotations, irregularity of the aortic profile), and diameter and wall morphology of the proximal and distal neck. In patients treated for aortic dissection, the perfusion of abdominal vessels, especially those arising from the false lumen, was also evaluated.
According to accepted nomenclature (24–27), we classified endoleaks as follows: type 1 proximal or distal, in cases of involvement of the proximal or the distal attachment site of the endovascular graft to the vascular wall; type 2, in cases of the presence of liquid blood originating from a tributary to the aortic lumen excluded by the graft with or without outflow to a second tributary; type 3, in cases of an endoleak that arose from a defect of the graft itself as a laceration, a hole, or a component separation of modular grafts; and type 4, in cases of an endoleak caused by stent macroporosity. Further distinction was made between early endoleaks, which were detected from the time of the procedure through 6 months, and late endoleaks, which were first identified at the 12-month follow-up or later.
Statistical Analysis
The rates of mortality and leakage were estimated with the Kaplan-Meier method.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTS DISCUSSIONREFERENCES |
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No paraplegia was observed, despite the covering of the entire descending thoracic aorta in 21 cases. Transient left monoparesis was observed in the patient treated with simultaneous open abdominal aortic aneurysm repair and stent grafting of the descending thoracic aorta. Another complication occurred at the 8th posttreatment day in the patient treated for type B dissection after subclavian-to-carotid artery transposition: extension of dissection into the ascending aorta, which originated from the proximal uncovered part of the stent-graft. The patient successfully underwent surgery, with replacement of the ascending aorta and the arch, and the stent-graft was left in situ.
Neither cerebrovascular accidents and distal arterial thromboembolism nor other clinical problems (ie, myocardial, pulmonary, renal) were observed in the remaining patients.
Transient postimplantation syndrome with mild leukocytosis, elevated levels of C-reactive protein, and moderately elevated body temperature occurred in 55 (81%) of 68 patients; the maximal C-reactive protein level was 135 mg/L (normal value, <0.5 mg/L), and the leukocyte count was 10 ± 8 x 109/L (normal range, 4.80–8.50 x 109/L) on mean day 3 ± 1. Nonspecific slight-to-moderate back pain was the only symptom experienced by 30 (44%) patients, and it resolved within a mean of 3 days ± 2.
Long-term or 1–60-month Follow-up
Clinical and imaging follow-up was available in all patients at a mean time of 25 months ± 15 after treatment, and the range was 1–60 months (Table 2). One patient died of respiratory insufficiency 18 months after the procedure. Mortality caused by aortic rupture occurred in two (3%) patients. A patient with a very large (12 cm) atherosclerotic aneurysm that was completely thrombosed at 1-month CT died suddenly at 40 days after treatment. At autopsy, an erosion of the proximal stent through the superior aortic wall that caused detachment of the stent-graft and aneurysm rupture was documented. The second death was related to extension of the dissection into the ascending aorta 20 days after successful treatment of type B dissection.
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Early and Late Endoleaks
Two (3%) proximal (type 1) endoleaks were observed in the group of patients with aortic dissection at postoperative angiography and TEE (Fig 5). In one patient, two new small entry sites in the aortic arch were detected by using TEE and angiography after the sealing of a large entry site, and these entry sites were not visible before the covering of the larger entry site. Treatment of this patient was converted to surgery 1 month later. The second case of endoleak was observed, despite correct positioning of the stent-graft across the entry site and an adjunctive graft extension of 3 cm. However, a substantial reduction in blood flow was achieved in the false lumen. The patient refused surgery and was stable during the follow-up of 24 months. Three (4%) small mid-aortic (type 2) endoleaks were detected at 1 month follow-up, and they were probably an expression of incomplete thrombosis of the aneurysm sac or retrograde refurnishment from the intercostal arteries. These endoleaks sealed spontaneously, as documented at 3-month CT.
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The fifth case of late endoleak, in which the treatment was converted to surgery, was related to migration of the stent-graft from the proximal neck 1 year after aneurysm exclusion. In this case, the proximal neck consisted of a polyester graft tube (ie, placed at previous surgery performed with the elephant trunk technique). The patient underwent successful surgery. Therefore, procedure failure as an aortic rupture or a conversion of treatment to surgery occurred in six (9%) of 68 cases (Fig 6).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTS DISCUSSIONREFERENCES |
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The use of endovascular stent-grafts in the treatment of diseases of the thoracic aorta represents a promising alternative to open transthoracic surgical repair. Endovascular techniques were initially applied in the treatment of abdominal aortic aneurysms (10), and this application stimulated investigation into the feasibility of endovascular repair of the thoracic aorta. Initial clinical reports and the results of the prospective trial of the Stanford group indicated lower morbidity and mortality of endovascular treatment in comparison with findings at conventional surgery (11–22,29). Findings in our experience with two different second-generation devices confirm the low procedural risk of the endovascular technique. There were no in-hospital deaths, cerebrovascular accidents, or myocardial infarction in a cohort of 70 patients, who mostly had associated comorbidities at presentation. We did not observe any case of paraplegia, despite the covering of the entire descending thoracic aorta in 21 cases.
At present, it is not known which effect of the endovascular repair results in the development of paraplegia. However, it does not seem to be related to coverage of the intercostal arteries, whereas embolic causes, blood loss, or insufficient collateral circulation appear to expose the patient to a major risk of spinal damage. Findings from the Stanford experience and some initial reports in the literature suggest that a 1%–3% incidence of paraplegia in cases should be expected. In particular, if simultaneous open abdominal and endovascular thoracic repair is performed (19), the loss of lumbar and thoracic intercostal arteries increases the risk of paraplegia caused by insufficient collateral circulation (30). Accordingly, the case of monoparesis observed in our series occurred in a patient in whom the endovascular thoracic repair was associated with a concurrent open surgical repair of an abdominal aneurysm. Unsuccessful technical positioning or deployment occurred in two (3%) cases.
The recognition of unsuitable anatomy, such as excessive tortuosity of the aortic arch or inadequate vascular access, is the first point of the learning curve for endovascular aortic treatment. Choosing patients with unsuitable anatomy may be prevented with appropriate selection of cases. A major in-hospital complication, extension of dissection, occurred in the only case in which an artificial neck was created by subclavian-to-carotid artery transposition. In other series, findings were reported about the coverage of the left subclavian artery with or without previous use of subclavian-to-carotid artery transposition to extend the proximal landing zone for endovascular treatment (19,22). The proximal uncovered part of the stent-graft crosses the aortic arch up to the innominate artery, and this positioning constitutes potential damage to the ascending aorta or an adjunctive problem if conversion of treatment to surgery becomes necessary. The radial forces of self-expanding stent-grafts seem to act better in straight rather than in curved segments, as reported by Mitchell et al (19). The second case of extension of dissection observed in our series, an event that led to the patient’s death, occurred with a stent-graft positioned adjacent to the left subclavian orifice. For these reasons, we believe that a suitable proximal neck for stent-graft placement should be a distance of 1 cm or more from the left subclavian artery.
In the long term, changes of aneurysm morphology and dilatation of the aortic wall at the neck sites seem to constitute the major cause of treatment failure. Four late endoleaks and one case of aortic rupture occurred in five of 18 atherosclerotic aneurysms. The combination of atherosclerotic wall changes and tortuosity of the thoracic aorta observed in atherosclerotic aneurysms might induce a modification in stent-graft fixation with time because of the relative rigidity of the stent-graft system with respect to the aortic configuration. Conversely, endovascular treatment of posttraumatic aneurysms shows excellent long-term results. No cases of late treatment failure occurred. The traumatic aortic injury involves a limited portion of aortic circumference, and the stent-graft usually is fixed to normal aortic walls. Migration of the stent-graft also has been described in other series (21). The case that we observed was not related to aortic wall dilatation because the proximal stent fixation was a polyester tube (ie, elephant trunk technique). Finally, no cases of alteration of graft material were observed during the follow-up.
In conclusion, the optimal treatment of thoracic aortic aneurysm and dissection constitutes an unsolved problem. The evolution of endovascular techniques offers a potential opportunity for treatment even in high-risk patients. Because of considerable morbidity and mortality of conventional open surgical repair of the descending aorta, patients with thoracic aortic diseases might benefit even more from an endovascular alternative than would patients with an abdominal aortic aneurysm. In selected cases, the second-generation stent-graft devices seem to improve the safety and reliability of treatment with an endovascular stent. However, long-term follow-up is necessary to assess the durability and effectiveness of this less invasive therapy.
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FOOTNOTES |
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Author contributions: Guarantor of integrity of entire study, R.F.; study concepts, R.F., G.N.; study design, R.F.; literature research, L.L., C.G., E.A.; clinical studies, R.F., G.N., T.P.; data acquisition, T.P., G.R., L.L.; data analysis/interpretation, R.F., G.N., G.R.; manuscript preparation and definition of intellectual content, R.F.; manuscript editing, R.D.B., G.N., E.A.; manuscript revision/review, R.F., G.N.; manuscript final version approval, R.F., G.G.
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTS DISCUSSIONREFERENCES |
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