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CLINICAL STUDIES |
From the Departments of Diagnostic Radiology (J.Y.W, D.Y.L, S.I.P), Cardiovascular Surgery (B.C.C.), and Cardiology (W.H S, H.M.K), Yonsei University College of Medicine, Seoul; Department of Cardiovascular Surgery (C.S.Y), Konyang University, Daejeon; Department of Diagnostic Radiology (B.H.P), College of Medicine, Dong-a University; and Department of Radiology (G.S.J), Kosin Medical College, Pusan, Korea.
Received August 28, 2000; revision requested October 25; revision received December 28; accepted January 2, 2001. Address correspondence to D.Y.L., Department of Diagnostic Radiology, Yonsei University College of Medicine, 134 Shinchon-dong, Seodaemun-gu, Seoul 120-752, Korea; E-mail: dyl{at}yumc.yonsei.ac.kr
Index terms: Aorta, aneurysm Aorta, dissection Aorta, grafts and prostheses
| ABSTRACT |
|---|
MATERIALS AND METHODS: Stent-grafts were placed in the descending thoracic aortas of 23 patients with saccular aneurysms (n = 11) and Stanford type B chronic aortic dissections of the descending thoracic and abdominal aorta (n = 12). All stent-grafts were individually constructed of self-expandable stainless steel stents covered with polytetrafluoroethylene. Vascular access was achieved through the femoral artery in all patients. Clinical status of each patient was monitored and postoperative CT was performed within 1 month of the procedure and at 312-month intervals after the procedures.
RESULTS: Successful exclusion of the primary entry tears of dissections and the inlets of saccular aneurysms was achieved in all but two patients with aortic dissection. The overall technical success rate was 91.3% (dissection: 10 of 12 = 83%; aneurysm: 11 of 11 = 100%). All patients in whom technical success was achieved showed complete thrombosis and significant decrease in diameter of the thoracic false lumen (preoperative: 5.3 cm ± 0.9; postoperative: 4.3 cm ± 0.9; P = .004) or aneurysm sac (preoperative: 5.3 cm ± 1.7; postoperative: 2.8 cm ± 2.5; P = .001). In addition, five patients demonstrated complete resolution of the dissected thoracic false lumen (n = 2) and aneurysm sac (n = 3). However, in all patients with aortic dissection, the abdominal aorta was not significantly changed in size (P = .302) and shape and their false lumen flows remained persistent. Immediate postoperative complications were detected in 12 patients (52%); 10 had fever, leukocytosis, and elevation of C-reactive protein, another had wound infection, and another had transient abdominal pain. Three patients died 2, 3, and 12 months after the procedure: one from septic shock, another from underlying mediastinitis, and the other from an unexplained cause. The remaining 20 patients were well after the procedure (19 days; mean, 3 days), without any stent-graftrelated complications or discomfort (follow up period: 1065 mo; mean: 25.1 mo ± 15.6). The cumulative survival rate after the stent graft was 100% at 30 days and 91% at 12 months.
CONCLUSIONS: For treatment of aortic dissection and saccular aneurysm of the descending thoracic aorta, endovascular stent-graft repair may be a technically feasible and effective treatment modality.
| INTRODUCTION |
|---|
Many groups have investigated the feasibility of the endovascular stent-graft upon the descending thoracic aorta. Among them, Dake, Mitchell, and colleagues (811) reported a large series of clinical trials concerning the stent-graft of descending thoracic aorta and their results were very encouraging; however, to verify stent-graft implantation as a favorable alternative to surgical reconstruction in aneurysmal disease of the descending thoracic aorta, further investigations and long-term follow-up of the results in many institutions are mandatory. This study was undertaken to report our experience with transcatheter endovascular stent-graft placement and to evaluate the feasibility, safety, and clinical outcomes in the aneurysmal disease of descending thoracic aorta.
| MATERIALS AND METHODS |
|---|
Twelve patients had Stanford type B aortic dissections. All were chronic and the interval between the initial diagnosis of aortic dissection and stent-graft treatment ranged from 15 days to 69 months (mean: 13.8 mo ± 18.9). All aortic dissections simultaneously involved the abdominal aorta below the level of the renal arteries, with contiguous extension. The distal extent of dissections varied from the infrarenal aorta to both iliac arteries. All 12 patients with aortic dissection showed patent false lumen flows from the proximal primary entry tear to the distal re-entry sites in the abdominal aorta or iliac artery.
All 11 aneurysms in this study were saccular and their etiologies were degenerative (n = 9), infectious (n = 1), or related to Behcet disease (n = 1). One case with an infectious origin was a result of contiguous mediastinitis caused by esophageal abscess and perforation.
Preoperative Imaging
Before the procedures, all patients
underwent contrast-enhanced spiral CT and digital subtraction
aortography to measure the dimension of the aorta and the false lumen
or aneurysm. Spiral CT scans of the aorta were evaluated with
collimation of 7 mm with a table feed of 7 mm/sec, 120 kV, and 220
mA. Patients underwent injection of 120150 mL of contrast medium
at a rate of 3.0 mL/sec. Ten to fifteen seconds after the end of
the arterial phase acquisition, a second acquisition was performed.
All images were reconstructed with a 4-mm increment. Aortography
was performed with the use of a calibrated marker catheter (Cook,
Bloomington, IN). We injected 2530 mL of contrast medium at a
rate of 15 mL/sec and obtained 46 images per second.
Aortic dissections.
The maximum
diameters of dissected descending thoracic aortas were 4.07.3 cm
(mean: 5.1 cm ± 1.0). The distances between the left subclavian
artery and the entry tear of the dissection were 3.512 cm (mean: 8.4
cm ± 4.2). Entry tears were 1.72.8 cm in length (mean: 2.0 cm ±
0.6).
Saccular aneurysms.
The maximum
diameters of aneurysm sacs were 2.38.0 cm (mean: 5.4 cm ± 1.9). The
distances between the left subclavian artery and aneurysm inlet were
217 cm (mean: 12.3 cm ± 5.9). The longitudinal lengths of
aneurysm inlets were 0.65.1 cm (mean: 1.5 cm ± 1.1). The
diameters of proximal necks were 1.72.8 cm (mean: 2.1 cm ±
0.4) and those of distal necks were 0.72.5 cm (mean: 1.8 cm ±
0.6).
Angiographies of the femoral, external iliac, and common iliac arteries allowed accurate sizing of these arteries, which had to measure 7 mm or greater in diameter to provide adequate vascular access.
Stent-Grafts
Stent-grafts were individually constructed
and gas-sterilized before use. Each custom-fabricated stent-graft was
constructed of a stainless-steel endoskeleton, composed of
self-expanding Gianturco-type stents (Taewoong Medical, Seoul, Korea)
interconnected with 5.0 polypropylene sutures (Ethicon/Johnson &
Johnson, Edinburgh, UK) and covered with balloon-dilated
polytetrafluoroethylene (Impra, Tempe, AZ) material. We used
thin-walled graft materials with 6- and 10-mm diameters and each was
dilated to a maximum of 18 mm and 35 mm, respectively.
All stent-grafts were manufactured to be 10%15% larger than the diameter of the nonaffected aorta proximal to the entry tear or aneurysm inlet. The stent-grafts were determined to be approximately 56 cm longer than the longitudinal length of the inlet in saccular aneurysms. For the aortic dissection, stent-graft length was determined to cover not only the entry tear but also the four or five nearby intercostal arteries, so as to block the backflow through the re-entries located in the exit sites of adjacent intercostal arteries. The stent-grafts had mean diameters of 2.8 cm ± 0.4 (range: 2.23.5 cm) and 8.4 cm ± 2.4 (range: 5.511.0 cm) in saccular aneurysms and mean lengths of 3.5 cm ± 0.4 (range: 3.04.0 cm) and 9.8 cm ± 1.8 (range: 8.012.0 cm) in aortic dissections.
Procedures
All procedures were performed in angiography
units under local (n = 13) or epidural (n = 10)
anesthesia and full hemodynamic monitoring with patients in the
supine position. Vascular access was obtained through the femoral
artery after surgical cutdown and a 5-F catheter was advanced to the
proximal ascending aorta over a 0.035-inch-diameter hydrophilic guide
wire (Terumo, Tokyo, Japan). After removal of the hydrophilic guide
wire, an exchangeable (260 cm) 0.035-inch-diameter Amplatz
super-stiff guide wire (Boston Scientific/Medi-tech, Watertown, MA)
was inserted. Then, we advanced the 20- or 22-F stent-graft delivery
sheath (Keller-Timmerman Sheath; Cook) over the guide wire until the
tip of the delivery sheath was proximal to the aortic lesion.
Patients underwent anticoagulation with intravenous heparin (5,000
IU) before insertion of the stent-graft delivery sheath. Aortography
via contralateral percutaneous femoral artery approach with use of a
5-F multipurpose catheter with multiple side holes (Cook) was
performed before and after stent-graft deployment.
Before deployment of the stent-graft device, mean aortic pressure was decreased to the range of 5060 mm Hg with use of intravenous nitroprusside infusion to prevent the downstream migration of the partially deployed stent-graft caused by rapidly flowing blood and decreased after-load of the left ventricle. After lowering blood pressure, we deployed the stent-graft by rapidly withdrawing the introducer sheath. After deployment, intravenous nitroprusside infusion was stopped.
A postdeployment aortogram was obtained to confirm the exact location of the stent-graft, the absence of perigraft leakage, and the patency of adjacent branch vessels. Subsequently, the delivery sheath was removed and the arteriotomy site was repaired. After completion of all procedures, patients were sent to the intensive care unit and stayed there for 12 days.
Follow-up
Follow-up spiral CT was performed within 1
month of the procedures, at 36-month intervals for 2 years, and
annually thereafter. Each patient was followed for 265 months and
the mean follow-up was 22.5 months ± 16.0. We defined the result
of the procedure as technical success when the primary entry
tear of aortic dissection or the inlet of saccular aneurysm was
completely excluded from the circulation and perigraft leakage was
not detected on either completion aortography or serial follow-up
CT.
In patients with aortic dissection, we retrospectively assessed the extent of thrombosis in the thoracic and abdominal false lumen. We also measured the diameter of the aorta and its true lumen along the line perpendicular to the intimal flap at the level of maximum dilation in the descending thoracic aorta and the level of renal artery in the abdominal aorta. In patients with saccular aneurysm, we confirmed complete obliteration and thrombosis of aneurysm sac and evaluated the serial changes of the maximal diameter of aneurysm sac.
Statistical Analysis
All data are presented as means ±
SD. The data concerning aortic measurements before and after the
stent-graft procedure were compared with use of the paired Student
t-test. All differences were regarded as statistically
significant if the P value was less than 0.05. Through a
retrospective review of medical records, we calculated cumulative
survival rates of the patients with use of the Kaplan-Meier method
with 95% CIs.
| RESULTS |
|---|
Aside from these two technical failures, one patient underwent consecutive stent-graft placement because residual flow was detected in thoracic false lumen even after successful occlusion of the primary entry tear by the first stent-graft procedure. Immediate aortography depicted abundant backflow through the large re-entry tear just distal to the first stent-graft and we deployed another stent-graft to cover the re-entry site. However, this second stent-graft migrated to the abdominal aorta just above the celiac artery and the large re-entry remained patent. Nevertheless, the thoracic false lumen of the patient has been gradually thrombosed for 30 months.
Of 12 patients with aortic dissection, 10 with successful occlusion of primary entry showed complete thrombosis of the thoracic false lumen (Fig 1). Among these 10, the maximum diameter of the descending thoracic aorta decreased in eight; their mean values were 5.6 cm ± 0.9 and 4.3 cm ± 1.0, respectively, before and after the procedure. The remaining two patients showed no remarkable changes in size of their thoracic aorta. Overall, the mean values of the maximum diameter of the descending thoracic aorta was significantly decreased from 5.3 cm ± 0.9 to 4.3 cm ± 0.9 (P = .004) and the diameter of the true lumen was significantly increased from 1.2 cm ± 0.5 to 2.6 cm ± 0.9 (P = .001) in 10 patients in whom technical success was achieved. Two patients in whom technical success was achieved had complete disappearance of thoracic false lumen at 15 and 36 months.
|
Saccular Aneurysm
The inlets of saccular aneurysms were
successfully occluded in all 11 patients, for a technical success
rate of 100%. Complete thrombosis and decreased size aneurysm sac
size were seen on follow-up CT (Fig 2). The mean
diameter of the saccular aneurysms decreased significantly, from 5.3
cm ± 1.7 to 2.8 cm ± 2.5 (P = .001, mean follow-up duration:
22.1 mo ± 17.0). In addition, complete resolution (disappearance)
was achieved in three patients 1, 6, and 12 months after the
procedure (Fig 3).
|
|
In 23 patients who underwent stent-graft placement, three died 2, 3, and 12 months after the procedures. The first patient who died had end-stage renal disease and died of septic shock, of which the origin was unclear. The second death occurred as a result of massive hemoptysis. Because autopsy was not performed in this patient, we presumed that the aggravation of preexisting mediastinitis was the cause of hemoptysis. The third patient, who had shown complete thrombosis of the aneurysm sac on 1-month follow-up CT, died at home from an unexplained cause. The remaining 20 patients who survived were well 19 days (mean = 3) after the procedure, reporting no complication or discomfort related to stent-graft placement (follow-up range: 1065 mo; mean: 25.1 mo ± 15.6). The cumulative survival rate was 100% at 30 days and 91% at 12 months.
| DISCUSSION |
|---|
In the technical aspect of stent-graft deployment, we experienced two cases of occlusion failure, both of which were in patients with aortic dissection. One was caused by perigraft leakage. It is known that the incidence of perigraft leakage in stent-grafts is approximately 7%52%; 40%88% of cases of perigraft leakage resolve spontaneously, but perigraft leakage can increase the size of aneurysm to the point of rupture (4,6,22,23). Kato et al (24) successfully managed 10 cases of perigraft leakage with coil embolization in 140 patients with aortic aneurysms who were treated with stent-grafts implantation (24). We also attempted coil embolization in one patient, but only partially disturbed blood flow through the entry tear, which turned out to be insufficient to induce thrombosis of the thoracic false lumen on follow-up CT. Fortunately, the patient has not shown further enlargement of the false lumen and her primary symptom of abdominal pain has been relieved for more than 2 years after the stent-graft procedure and coil embolization. The other occlusion failure was caused by stent-graft migration just distal to the entry tear, the false lumen of which could not be excluded from the circulation. Because each stent-graft was custom-made according to the dimension of each aorta, a second stent-graft that could fit this patient was not readily available in that instance. Later, the patient refused further procedures despite persistent chest pain.
Aside from the one case of stent-graft migration that resulted in a technical failure, we experienced another case of stent-graft migration. In that patient, despite the successful occlusion of the primary entry tear by the first stent-graft, the completion aortogram showed residual thoracic false lumen flow by the backflow through the large reentry tear just distal to the stent-graft. We deployed the second stent-graft immediately after the first one that had not been properly expanded as a result of the compression by high false lumen pressure. The distal portion of the first stent-graft was taking on a reversed funnel shape because the thoracic true lumen was most severely collapsed near the entry site, which we think allowed the distally overlapped second stent-graft to migrate downward.
Ten patients (43%) had transient postimplantation syndrome with fever, leukocytosis, and elevation of C-reactive protein, of which the etiology was not clearly documented. Velazquez et al (12) reported no definitive infectious etiology accounting for these findings and others suggested that a nonspecific systemic inflammatory reaction might result in this syndrome. Although no serious morbidity or mortality was associated with postimplantation syndrome, we discovered an incidence of postimplantation syndrome of 42%, which was similar the 58%75% rates in other reports of aortic stent-grafts (12,18). We believe efforts should be made to overcome this unfavorable and potentially harmful phenomenon and we are planning to perform clinical trials involving prophylactic use of antibiotics and a modification of the graft material.
We did not experience any neurologic complications associated with spinal ischemia. It is known that blockage of the intercostal artery by a stent-graft may cause paraplegia. Although no patient was excluded because of the anatomy of the intercostal artery, we did not have a case with such complications. In our study, the lengths of stent-grafts were relatively shorter than those used in other studies (11), ranging from 5.5 cm to 12.0 cm and covering only 37 segments of thoracic vertebrae. There may have been a lot of room to develop collateral flows from the adjacent intercostal arteries. In addition, total procedure time from surgical cutdown of the femoral artery to deployment of the stent-graft was no more than 30 minutes in all cases. We could also complete the procedure with a small amount of blood loss, which took place only at surgical cutdown of the femoral artery. All these circumstances were helpful in preventing the neurologic complication. More discussion and verification of the causes of stent-graftinduced paraplegia are necessary.
In thoracic aortic aneurysms, 1- and 5-year survival rates for patients without operation have been estimated to be 60% and 20%, respectively (13,25) and postsurgical mortality ranges have been estimated at 5%20% (2628). In contrast, no immediate postoperative mortality occurred in our patients with aneurysms. Every aneurysm sac was effectively excluded from the circulation and showed complete thrombosis and decreased size. In addition, complete resolution and disappearance of aneurysm sac was achieved in 27% of our cases, even in the patient with Behcet disease, which is known to be difficult to improve with surgical or medical management (29).
In 12 patients with aortic dissection, 10 with successful occlusion of the entry site displayed complete thrombosis and eight of those 10 showed decreased diameter of the thoracic false lumen. Moreover, two had only minimal aortic wall thickening on follow-up CT performed 15 and 36 months after the procedure. Thrombosed false lumen is known to be associated with a lower risk of future adverse events and a better survival rate than patent false lumen (30). Our treatment strategy for aortic dissection was exclusion of the primary entry tear from the systemic circulation, which proved to be enough to induce thrombosis and regression of the thoracic false lumen, even with the residual flow across the large reentry at the distal thoracic aorta. The stent-graft was a relatively safe and successful modality to meet the primary purpose of the treatment. This procedure was indicated for most of our patients with aortic dissection by intractable chest or abdominal pain, which were relieved after exclusion of the entry sites.
After deployment in the descending thoracic aorta affected with the chronic aortic dissection, the configuration of the implanted stent-graft was gradually changed from an oval shape to a round shape by expanding the diameter of the true lumen, even after the complete thrombosis of the false lumen had been made (Fig 1). These findings may imply continuous radial force on the aortic wall, which enables the implanted stent-graft to completely interrupt the blood flow and its pressure into the dissected false lumen until complete thrombosis or complete resolution can be made.
All aortic dissections included in this study involved the descending thoracic and abdominal aorta. When the stent-graft had occluded the primary entry tear in the descending thoracic aorta, the thoracic false lumen became obliterated with thrombosis; however, all abdominal false lumens remained patent. These findings resulted from persistent blood flow across the multiple re-entry sites located in the abdominal aorta or iliac arteries, but the blood flow in the abdominal aorta could not disturb the thrombus formation in the thoracic segment of the aortic false lumen. In this process, the entry site in the descending thoracic aorta, which had been occluded by the stent-graft, was shifted to the abdominal aorta, usually near the exit site of the major branch vessels. Although this "entry shift" took place, it did not cause any changes in the size and shape of the abdominal aorta and its false lumen on serial follow-up CT. We think further follow-up is needed to reveal the fate of the abdominal false lumen and whether it is actually stabilized.
In conclusion, endovascular stent-graft placement for chronic dissection and aneurysm of the descending thoracic aorta is a reasonable alternative to surgical repair. Complete exclusion of the dissected false lumen and the aneurysm sac were achieved with a remarkable technical success rate. Further studies need to be performed to determine the many requisites such as fixed methodology for the procedure itself and other supportive care to reduce the postoperative morbidity and mortality rates. Long-term follow-up is also mandatory to clarify the progress of the thrombosed false lumen and aneurysm sac and the long-term efficacy of this procedure.
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