Background The treatment of aortic aneurysms with endovascularstents or stentgraft prostheses is receiving increasingattention as an alternative to major abdominal surgery. To definethe clinical value of this technique, we prospectively studiedthe use of stentgraft endoprostheses made of nitinoland covered with polyester fabric for the treatment of infrarenalabdominal aortic aneurysms.
Methods We treated a total of 154 patients at three academichospitals. Twenty-one patients with aortic aneurysms not involvingthe aortic bifurcation received straight stentgrafts,and 133 patients with aortic aneurysms involving the bifurcationand the common iliac arteries received bifurcated stentgrafts.After a unilateral surgical arteriotomy, the endoprostheseswere advanced through the femoral arteries and placed underfluoroscopic guidance. Computed tomography and intraarterialangiography were performed during an average follow-up of 12.5months.
Results The primary success rate, defined as complete exclusionof the abdominal aortic aneurysm from the circulation, was 86percent in the group receiving straight grafts and 87 percentin the group receiving bifurcated grafts. In three patientsthe procedure had to be converted to an open surgical operation.Minor (n = 13) or major (n = 3) complications associated withthe procedure (including 1 death) occurred in 10 percent ofthe patients. All patients had a postimplantation syndrome,with leukocytosis and elevated C-reactive protein levels.
Conclusions Our results suggest that endovascular treatmentof infrarenal abdominal aortic aneurysms is technically feasibleand can effectively exclude abdominal aortic aneurysms fromthe circulation. With further refinement, endoluminal repairmay emerge as an interventional strategy to treat infrarenalaortic aneurysms, especially in patients at high surgical risk.
The routine management of aortic aneurysms is surgical, withplacement of a graft in the involved segment.1,2 Surgical treatmentof nonruptured abdominal aortic aneurysms is associated withan overall mortality rate of 1.4 to 7.6 percent,3,4,5 and therate is as high as 10 percent in patients with symptomatic aneurysms.6With the percutaneous placement of endoluminal stentgrafts,major abdominal surgery and the related morbidity and mortalitycan be avoided. This is particularly important because of thehigh incidence of coexisting morbid conditions7,8 in unselectedpatients between 65 and 80 years of age, in whom the prevalenceof abdominal aortic aneurysm is rather high (3 percent).9,10
The use of endoprostheses was first proposed by Dotter in 1969.11In 1986 Balko et al. reported the repair of artificially inducedaneurysms with polyurethane prostheses in animals.12 This wasfollowed by several reports of experimental endoluminal graftingin animal models.13,14,15,16,17,18,19,20,21,22 The use of straightgrafts in patients with aortic dissection or abdominal aorticaneurysms was first described in 1991 by Parodi et al.23 Sincethen, endoluminal treatment of aneurysms of the thoracic andinfrarenal abdominal aorta with different types of endoprostheseshas been used in a number of centers.24,25,26,27,28,29,30,31,32,33,34,35,36
We report the short-term and midterm results of stentgraftingfor infrarenal abdominal aortic aneurysms with polyester-coverednitinol endoprostheses in 154 patients who would have otherwiserequired surgical repair. The aim of this study was to assessthe feasibility, rate of complications, and clinical effectivenessof endoluminal treatment of infrarenal abdominal aortic aneurysms.
Methods
Selection of Patients
Among 331 patients with infrarenal abdominal aortic aneurysmswho were referred to the three study hospitals between August1994 and April 1996 for evaluation, a total of 154 patients(47 percent) were treated by transfemoral placement of straightor bifurcated stentgrafts for aneurysms with maximaldiameters of 3.7 to 9.7 cm (mean, 5.4). Seventy-four patientswere treated at University Hospital, Freiburg, Germany; 47 atHenriettenstiftung, Hannover, Germany; and 33 at UniversityHospital, Vienna, Austria. The base-line clinical characteristicsof the patients and the types of abdominal aneurysms presentare listed in Table 1.
Table 1. Clinical Characteristics of 154 Patients with Abdominal Aortic Aneurysms Who Were Treated with Endoluminal StentGrafts.
The patients were selected on the basis of the anatomy of theaneurysm and the classification of the infrarenal abdominalaortic aneurysm. Patients selected for endoluminal therapy wereeligible for the study irrespective of their eligibility forsurgery.
To be included in the study the patients had to have an aneurysmclassified as type A, B, or C. A type A aneurysm had proximaland distal aortic necks that were more than 10 mm in lengthand less than 25 mm in diameter without involvement of the iliacarteries. A type B aneurysm involved the aortic bifurcationand had a proximal aortic neck that was more than 10 mm in lengthand less than 25 mm in diameter, with a common iliac arterythat was less than 12 mm in diameter. A type C aneurysm hada proximal aortic neck that was more than 10 mm in length andless than 25 mm in diameter and involved the common iliac arteriesand the iliac bifurcation (diameter, <12 mm).
Patients were excluded from the study if they had type D aneurysms(involvement of both internal iliac arteries), type E aneurysms(proximal aortic neck of <10 mm in length or >25 mm indiameter), or stenosis or occlusion of the superior mesentericartery, or if they were not available for follow-up.
The patients were divided into two groups according to the typeof the abdominal aortic aneurysm. In one group, only the abdominalaorta was involved (type A aneurysm), requiring the implantationof a straight stentgraft. In the second group, the aorticbifurcation or the bifurcation and the common iliac arterieswere involved (type B or C aneurysm), requiring the implantationof a bifurcated stentgraft.
All patients were informed about the procedure in detail andgave their written consent. The study protocol was approvedby the ethics committees of the three centers.
Endoprostheses
The stentgraft (Mialhe Stentor, MinTec, Freeport, Bahamas,and Vanguard, Boston Scientific, Oakland, N.J.) is a self-expandingendoprosthesis composed of a nitinol frame annealed into a tubularzigzag configuration by a 7-0 polypropylene thread37 and coveredwith a 0.1-mm woven-polyester fabric. The stentgraftsare straight (Figure 1A) or bifurcated (Figure 1B), dependingon the anatomy of the aneurysm.34 The bifurcated device hastwo components that are introduced separately and then joinedintraluminally: the larger component consists of an aortic andiliac graft with a short branch 10 mm in diameter into whichthe smaller component, which is placed in the contralateraliliac artery, is inserted. The devices are commercially availablein standard sizes (total length, 153 or 165 mm; diameter ofthe aortic section, 22, 24, or 26 mm; diameter of the iliacsection, 10 or 12 mm), or they can be custom-made.
Figure 1. StentGrafts Used for the Endoluminal Treatment of Infrarenal Abdominal Aortic Aneurysms.
The grafts are composed of a nitinol frame covered with a thin woven-polyester fabric. Panel A shows the straight stentgraft in which the top of the graft is not covered by fabric and has a row of barbs for anchoring into the proximal neck of the aneurysm. Panel B shows the bifurcated graft. The graft has two components that are inserted separately and then joined: the primary component consists of an aortic and iliac stentgraft with an attachment site for the secondary component, which is placed in the contralateral iliac artery.
Preprocedural Evaluation and Implantation Technique
To determine the length and diameter of the aneurysms, we performedmultiplane angiography using a graduated catheter and spiralcomputed tomography with three-dimensional vascular reconstructionsat least one week before the procedure in all patients consideredfor stentgraft implantation.34
The implantations were performed with the patients under generalanesthesia (n = 151) or local anesthesia (n = 3) in the angiographysuite (in the German hospitals) or in the operating room (inthe Austrian hospital) by teams of interventional radiologistsand vascular surgeons. The vascular surgeon performed the arteriotomy,and the radiologist placed the stentgraft. The patientswere prepared for surgery in case serious complications occurredor the endoluminal technique failed. The technique of placingthe stentgraft illustrated in Figure 2 and the peri-interventional and postinterventional managementhave been described previously.34
Figure 2. Placement of the Bifurcated StentGraft.
In Panel A, the aortic section with the attached iliac limb is implanted with use of a delivery system inserted through a surgical cutdown below the renal arteries. In Panel B, the contralateral iliac limb is inserted percutaneously.
Follow-Up Protocol
The follow-up protocol included intraarterial angiography andspiral computed tomography. The first follow-up study was performedin all patients before discharge, within seven days after theinitial procedure. Thereafter, all follow-up examinations wereperformed on an outpatient basis: the second examination wasconducted 3 months after the procedure (computed tomography),the third examination 6 months later (intraarterial angiographyand computed tomography), and the fourth and fifth examinationsafter 12 and 24 months, respectively (computed tomography).
Statistical Analysis
Continuous variables are expressed as means ±SD. Thelaboratory measurements made before and after stentgraftimplantation were compared by Student's t-test. A P value below0.05 was considered to indicate statistical significance.
Results
Primary Technical Results
Primary technical success, defined as the complete exclusionof the abdominal aortic aneurysm from the circulation, withrestoration of normal blood flow, was achieved in 134 of the154 patients (87 percent).
Type A Aneurysms
Transfemoral treatment with straight grafts was technicallysuccessful in 18 of 21 patients with type A abdominal aorticaneurysms (86 percent). Immediately after the procedure, angiographyrevealed proximal leaks in two patients due to short proximalnecks, which led to dislodgment of the stents, and a distalleak in one patient due to a short distal neck (<10 mm) (Table 2).
Table 2. Causes of Primary or Secondary Failure of Endoluminal Treatment of Abdominal Aortic Aneurysm.
The average length of time needed to implant the stentgraftwas 43±21 minutes in the first 6 patients and 30±5minutes in the last 15 patients. The total length of the procedure(including arteriotomy and closure) was 88±24 minutes(range, 50 to 220). The average hospital stay was 6.75±2.5days.
Type B and C Aneurysms
Endovascular repair with a bifurcated stentgraft wastechnically successful in 116 of 133 patients with type B orC aneurysms (87 percent) (Figure 3A and Figure 3B). In threepatients the procedure had to be converted to surgical repair.In one patient a coiled external iliac artery ruptured duringthe insertion of the delivery system, requiring emergency surgery.In the two other patients the 18-French introducer system couldnot be advanced to the abdominal aorta because of marked tortuosityof the iliac arteries and inadequate diameter of the externaliliac artery (<7 mm), requiring elective open surgical repair.
Figure 3. Implantation of a Bifurcated Graft in a 73-Year-Old Patient with an Infrarenal Abdominal Aortic Aneurysm.
In Panel A, an arteriogram with a calibrated catheter obtained before the procedure shows an infrarenal abdominal aortic aneurysm with involvement of the aortic bifurcation (type B aneurysm). In Panel B, an angiogram taken after the procedure shows the restored aortic lumen with complete exclusion of the aneurysmal sac. There is no leak at either end of the bifurcated endoprosthesis (arrows). In Panel C, follow-up computed tomography 12 months later confirms the exclusion of the aortic aneurysm by the absence of contrast enhancement within the aneurysmal sac. The diameter of the aneurysmal sac is virtually the same as it was before treatment. In Panel D, computed tomography at 24 months demonstrates that blood flow into the endoprosthesis remains good, with no evidence of a leak. The maximal diameter of the aneurysmal sac is now 5 mm smaller than it was at 12 months. In addition, the iliac limbs of the graft have shifted after thrombosis of the aneurysm.
Technical failure due to marked angulation of the proximal aneurysmalneck (>80 degrees) followed by dislodgment of the stentgraftand a proximal leak occurred in three patients. Because of thelarge diameter of the common iliac artery, three patients haddistal leaks from the lower end of the iliac limbs. Minor ormajor leaks related to tears in the polyester fabric occurredin the right or left iliac limb in eight patients immediatelyafter the procedure (Table 2).
In 17 patients, the iliac bifurcation had to be covered unilaterallywith an additional stentgraft to seal a distal leak.In one other patient we had to extend both iliac limbs withcovered nitinol stents. This resulted in obstruction of bothinternal iliac arteries without clinically affecting the pelvicor intestinal blood supply, and the aortic aneurysm thrombosedcompletely with no evidence of retrograde flow to the aneurysmthrough the internal iliac arteries.
The average length of time needed to implant the stentgraftwas 67±26 minutes in this group, with the entire proceduretaking an average of 105±31 minutes (range, 45 to 270).The average hospital stay was 11.5±13.1 days (range,4 to 83). As we gained more experience with the technique, theaverage hospital stay decreased to six days for the last 45patients.
Complications and Management
There were 13 minor and 3 major complications, including 1 perioperativedeath related to the intervention, in 16 patients (10 percent)(Table 3).
Table 3. Complications of Endoluminal Repair of Infrarenal Abdominal Aortic Aneurysms in 154 Patients.
Minor Complications
Clinically and angiographically evident macroembolization intoperipheral vessels was detected in three patients and successfullymanaged by local thrombolysis in one, aspiration thrombectomyin one, and Fogarty catheterization in one. Peripheral microembolizationof cholesterol to a toe was observed in one patient and treatedby intraarterial infusion of prostaglandin.
In two patients serum creatinine concentrations rose from 1.8and 2.1 mg per deciliter (160 and 185 µmol per liter)to 4.0 and 3.8 mg per deciliter (355 and 336 µmol perliter), respectively, requiring temporary hemodialysis.
Femoral-artery damage at the access site occurred in two patients.In both, the common femoral artery was heavily calcified andwas injured during advancement of the delivery system. Surgicalpatching of the artery was needed in both. Arteriovenous fistuladeveloped in one patient at the site of the percutaneous punctureand was surgically repaired. In one other patient who was receivinganticoagulation therapy a local hematoma developed at the puncturesite, requiring surgical intervention. Lymph fistulas were observedin two obese patients after surgical arteriotomy.
In one patient with occlusion of the left iliac limb within24 hours after the stentgraft procedure, local thrombolysiswith a total dose of 15 mg of recombinant tissue plasminogenactivator was successful.
Major Complications
In addition to the patient with rupture of the coiled externaliliac artery during the introduction of the delivery system,a patient with atrial fibrillation had embolic occlusion ofthe left limb of the graft four days after the procedure andcomplete occlusion of the aortic section two days later. Localthrombolysis resulted in complete resolution of the thrombus.This process was complicated, however, by microembolizationto the left foot, which ultimately required amputation.
One patient with cirrhosis of the liver (ChildPugh classC) and a transjugular intrahepatic portosystemic stentshuntplaced two years previously died of acute hepatic failure eightdays after the intervention because of massive bleeding froma gastric ulcer and hepatorenal syndrome.
Postimplantation Syndrome
Fever (temperature, 38.0 to 39.7°C) developed in 87 of the154 patients (56 percent) after treatment and lasted for 4 to10 days, without evidence of bacteremia or graft infection.In all patients, laboratory tests showed leukocytosis (range,9800 to 29,500 cells per cubic millimeter) and a mild or markedelevation of C-reactive protein concentrations (range, 4 to34.1 mg per deciliter).
Follow-Up
As of this writing, the average length of follow-up is 13 months(range, 8 days to 26 months). Five of 154 patients were followedfor 24 months, 66 for 12 months, 89 for 6 months, and 123 for3 months. There was only one death during the entire study period.
Patients with Straight Grafts
Two patients with minor persistent proximal leaks after dislodgmentof the stent and one patient with a major distal leak were successfullytreated 4 and 12 months, respectively, after the initial procedureby the placement of an additional straight graft (for the proximalleaks) or an overlapping bifurcated graft (for the distal leak).
Patients with Bifurcated Grafts
Follow-up studies in patients with bifurcated grafts revealedno migration of stentgrafts but a total of 11 persistentleaks. Three patients had a leak at the upper end of the graft;the leak thrombosed spontaneously in one patient and was correctedby the implantation of an additional short straight stentgraftin the other two patients. The three persistent leaks at thelower end of the stentgraft were successfully sealedby the implantation of an additional covered nitinol stent.Leaks related to tears in the polyester fabric thrombosed spontaneouslyin two of eight patients within seven days after the intervention.In four patients the tear was treated by placing a second coveredstent, resulting in complete thrombosis. The remaining two patientsdeclined further intervention.
Angiography at six months did not demonstrate any long-termocclusive disease of the external iliac arteries attributableto the placement of the delivery system.
Once the abdominal aortic aneurysm was excluded from the circulation,no further expansion of the aneurysmal sac was observed. Computedtomography of the infrarenal aorta demonstrated a reductionof 2 to 4 mm in the diameter of the aneurysmal sac at 12 months(Figure 3C), and a substantial shrinkage of 5 to 15 mm at 24months (Figure 3D). Circumscribed spontaneous reperfusion ofthe aneurysm from the right or left iliac limb was detectedin four patients at three and six months of follow-up. In addition,follow-up studies demonstrated minor late reperfusion of theaortic aneurysm with evidence of retrograde blood flow throughthe hypogastric and lumbar arteries in three patients. Theseleaks were successfully embolized with platinum coils.
Discussion
Elective surgical repair with synthetic grafts is the standardapproach to the treatment of abdominal aortic aneurysms andis associated with a perioperative mortality rate of 4 percent.4We evaluated stentgrafts placed percutaneously for thetreatment of abdominal aortic aneurysms as an alternative tomajor abdominal surgery. Becker et al. were the first to implanta covered stent into a subclavian aneurysm in humans.38 Theuse of a nonbifurcated stentgraft in patients with infrarenalaortic aneurysm was first reported by Parodi et al. in 1991.23The use of various stented or nonstented grafts for the endoluminalrepair of abdominal aortic aneurysm has been reported subsequently.24,25,26,27,29,31,32,33,34,35,36
Currently, there are five types of stentgrafts underclinical investigation. Parodi31 treated 50 patients with abdominalaortic aneurysms with nonbifurcated Dacron grafts sutured tostents with an expandable balloon, with a primary success rateof 80 percent and a 30-day mortality rate of 8 percent. Whiteet al.27 and May et al.28,32 used a nonstented balloon-expandablegraft consisting of a conventional Dacron graft with metallicimplants (Sydney endograft). They treated 53 patients with aorticaneurysms with straight grafts and a limited number of patientswith bifurcated grafts, with an initial success rate of 81 percent.The intervention was associated, however, with frequent local(32 percent) or systemic (17 percent) complications and a perioperativemortality rate of 3.7 percent.
The third type of stentgraft, designed by Chuter et al.,18consists of a Dacron sleeve anchored by stents at each end.It was implanted in 22 patients, with an initial success rateof 55 percent and a complication rate of 45 percent, includingone perioperative death.33
The only type of stentgraft approved by the Food andDrug Administration is the EVT device (Endovascular Technologies,Menlo Park, Calif.), composed of a Dacron tube with self-expandingcrowns at both ends for anchoring. Moore and Vescera29 and Balmet al.35 respectively treated 10 and 31 patients with infrarenalabdominal aortic aneurysms using straight grafts, with primarysuccess rates of 80 percent and 77 percent. The rate of localand systemic adverse effects was considerable, with one perioperativedeath and a total morbidity rate of 74 percent.35
In our study we implanted a fifth type of nonbifurcated or bifurcatedstentgraft based on a self-expandable nitinol frameworkcovered with a thin polyester fabric for the endovascular repairof abdominal aortic aneurysms. Our initial technical successrate in patients with type A, B, or C aneurysms was 87 percent.The rate of minor complications was 8 percent, the rate of majorcomplications was 2 percent, and the perioperative mortalityrate was 0.6 percent.
Incomplete sealing between the stentgraft and the aorta,defined as technical failure, was a major problem in our studygroup. Primary failure, which occurred in 13 percent of thepatients, was due to problems with access, to dislodgment ofthe stentgraft resulting in proximal leaks, to distalleaks from the lower end of the iliac limbs because the diameterof the common iliac artery was too large, or to leaks from theright or left iliac limb related to tears in the polyester fabric.Secondary failure with minor spontaneous reperfusion was observedin seven patients at three and six months and was due eitherto a tear in the polyester along the iliac limb or to reperfusionthrough the lumbar arteries. Technical failure was successfullytreated in all patients who agreed to the intervention, resultingin complete exclusion of the aortic aneurysm and restorationof normal blood flow and a secondary success rate of 97 percent.
In the series studied by Parodi,31 aneurysms generally decreasedin size by 10 to 20 percent during a mean follow-up of 17 monthsafter stentgraft implantation. In our study detailedcomputed tomographic measurements of the infrarenal aorta after6 and 12 months showed only slight reductions in the diameterof the aneurysmal sac, whereas in patients followed for 24 months,successful endoluminal treatment resulted in a substantial shrinkageof the aneurysm. In no case was an increase in the diameterof the aneurysmal sac observed during follow-up in patientswith initially successful exclusion of the abdominal aorticaneurysm.
At present, our main concern is the durability of stentgraftmaterial and the fixation system, which is crucial to the successof this endoluminal technique. Refinements of the stent frameworkand, particularly, its polyester fabric are now in progress.The enlargement of the diameter of the aortic section and theiliac limbs will potentially increase the number of patientsin whom this technique is appropriate.
In conclusion, on the basis of our initial results and a limitedfollow-up of an average of 13 months, endoluminal repair ofinfrarenal abdominal aortic aneurysms with the use of straightor bifurcated grafts is a feasible, safe, and effective alternativeto conventional surgery. Although we do not yet have extendedfollow-up data on the durability, safety, efficacy, and costsof stentgrafts, the approach may be a viable therapeuticoption, especially in patients at high surgical risk, and shouldbe evaluated in a prospective, randomized study comparing endoluminaland surgical repair to determine the clinical benefits of thisnew technique.39,40
We are indebted to Christian Schlensack, M.D., for providingthe laboratory data after stentgraft implantation, toUte Rogalski for her help in the preparation of the photographicreproductions, and to Helmut Müller for artwork.
Source Information
From the Departments of Diagnostic Radiology (U.B., M.L.) and Cardiovascular Surgery (F.B., G.S.), University Hospital, Freiburg, Germany; the Departments of Radiology (G.V., D.T.) and Surgery (G.N.), Henriettenstiftung, Hannover, Germany; and the Departments of Angiography and Interventional Radiology (J.L., S.T.) and Vascular Surgery (G.K., P.P., T.H.), University Hospital, Vienna, Austria.
Address reprint requests to Dr. Blum at the Department of Diagnostic Radiology, University Hospital Freiburg, Hugstetter Str. 55, D-79106 Freiburg, Germany.
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Infrarenal Aortic Aneurysms
Matsumura J. S., Pearce W. H., Yusuf S. W., Wenham P., Hopkinson B. R., Hoch R. C., Blum U., Beyersdorf F., Ernst C. B.
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336:1756-1758, Jun 12, 1997.
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