The Perth endoluminal bifurcated graft system - development and early experience

The study aim was to develop a reliable endoluminal graft system that would enable the deployment of a bifurcated graft for infrarenal abdominal aortic aneurysms. A life-size plastic model was made of an abdominal aorta and iliac arteries, with a 50-mm infrarenal abdominal aortic aneurysm. This model was used to develop and test self-expanding graft systems, based on a barbed Gianturco stent and series of stainless-steel ‘Z’ stents within a woven Dacron graft. The bifurcated system developed involves a trouser graft with one long leg and one short. This graft system is delivered through one femoral artery with deployment of the proximal aortic end infrarenally and the longer trouser leg within the ipsilateral common iliac artery. The short trouser leg is left hanging free within the distal end of the aneurysm cavity, just above the bifurcation. It is held open by a self-expanding stent and is cannulated from the contralateral femoral artery with a guide wire. A simple straight self-expanding stented graft is then deployed to extend this short trouser leg down into the common iliac artery, effectively creating an extension to the short leg. The graft system has been deployed in 21 patients with satisfactory exclusion of the aneurysm in 17 (81%). There has been one mortality and no conversion to open repair. All 17 aneurysms remain excluded at median follow-up of 30 (range 4–60) weeks. None of the four graft stents that leaked (two proximal and two distal) sealed spontaneously. Deployment of the uncovered Gianturco stent across the renal artery origins in 18 cases (85%) has not been associated with renal artery occlusion or deterioration in renal function at a median follow-up of 30 (range 4–60) weeks. The ability to deploy a bifurcated system increases the potential for endoluminal treatment of abdominal aortic aneurysm. Copyright © 1996 The International Society for Cardiovascular Surgery.     

Migration of a bifurcated endovascular graft into an iliac aneurysm: endovascular salvage and future prevention--a case report

The FDA approval of endovascular grafts for the treatment of abdominal aortic aneurysms has been associated with a dramatic increase in the use of these devices. Major referral centers are reporting the treatment of 75% to 80% of their patients with infrarenal abdominal aortic aneurysms with endovascular devices. The large quantity of endovascular devices being used has produced a growing number of management issues that are often not predictable during the preoperative assessment. These issues require complex intraoperative decision making and innovative techniques for their management as reflected by the subsequent case report. An 82-year-old patient presented with a 7.8-cm abdominal aortic aneurysm. The aneurysm extended into the common iliac arteries bilaterally. The right common iliac artery was 6.5 cm and the left common iliac artery was 2.0 cm in maximal diameter. The preoperative work-up, including a computed tomography scan and arteriogram, suggested that he would be a potential candidate for endovascular repair. The plan was to extend the graft into the right external iliac artery after embolization of the right hypogastric artery and to seal the left limb in the ectatic left common iliac artery using an aortic extender cuff. During the endovascular repair of the aortoiliac aneurysms using the AneuRx bifurcated graft, the main device became dislodged from its infrarenal attachment site and migrated into the large right common iliac artery aneurysm with the iliac limb ending in the distal external iliac artery. A new bifurcated device was deployed from the left side to attempt an endovascular salvage of the difficult situation. The new graft was partially deployed down to the iliac limb. This allowed cannulation of the contralateral stump through the original endovascular graft that had migrated distally. The two grafts were connected with a long iliac limb. This allowed stabilization of the endovascular reconstruction by increasing its columnar strength. The deployment of the second bifurcated graft was completed and the central core with the runners removed safely without migration of the second bifurcated component. The reconstruction was completed with an aortic cuff in the left common iliac artery. The use of the aortic cuff was useful to preserve the left hypogastric artery. No intraoperative endoleak was noted. The patient did well and was discharged the day following the procedure. The follow-up computed tomography scan shows the abdominal aortic aneurysm excluded by the endovascular graft with a defunctionalized portion of one bifurcated graft within the right common iliac aneurysm. There is no evidence of endoleak and the abdominal aortic aneurysm had decreased in size at 6 months. This case demonstrates one of the unique management problems that may arise during endovascular graft placement. Events that initially would suggest failure of the endoluminal treatment may be corrected using advanced endovascular techniques by an experienced surgeon. However, there will be times that the prudent decision will be conversion to open repair. Only good clinical judgement and adequate training will prevent catastrophic outcomes.     

Balloon-expandable common iliac artery occluder device for endovascular aneurysm repair

This study was performed to evaluate the efficacy of a balloon-expandable Palmaz stent common iliac artery occluder device for endovascular stent-graft repair of aortoiliac aneurysms. Eighty-four patients (79 men, 5 women; age range 60-95 yr; mean age, 76 yr) with aortoiliac aneurysms underwent endovascular stent-graft repair. The repair consisted of a stent-graft extending from the abdominal aorta to the iliac or common femoral artery, a cross-femoral bypass graft, and an endovascular arterial occluder device within the contralateral common iliac artery. The occluder device consisted of a 5-cm segment of 6-mm diameter polytetrafluoroethylene (PTFE) graft with a purse-string suture occluding the leading end and a Palmaz stent sutured to the trailing end. The occluder device was delivered through a 17F catheter via an arteriotomy. Eighty-three of the 84 patients received aortic endografts. In one case, infrarenal aortic rupture occurred during deployment of the aortic stent requiring conversion to an open surgical repair. Initial technical success for occluder device insertion was achieved in 78 of the remaining 83 patients. Failure to advance the occluder device delivery sheath through a diseased iliac artery occurred in one patient. Common iliac artery rupture occurred during balloon expansion and occluder device deployment in two patients. Two patients required additional coil embolization of the common iliac artery adjacent to the occluder device at the time of stent-graft insertion to correct incomplete iliac occlusion. Delayed occluder device-related complications included one patient with a postoperative iliac endoleak who required percutaneous coil embolization and one patient with a postoperative iliac endoleak in whom a contained aortic aneurysm rupture developed that was treated by surgical ligation of the common iliac artery. Use of the Palmaz stent-based iliac artery occluder device is an effective technique to induce common iliac artery thrombosis to facilitate endoluminal stent-graft aneurysm repair.     

Aorto uni-iliac modification of a bifurcated stent graft for endovascular aneurysm repair: Expanding the versatility of a modular device

As endografting technology advances, anatomical constraints limiting access and deployment have become less of a burden. While unsuitable candidates for endografting exist, these patients are becoming less frequent. To broaden the applicability of endovascular abdominal aortic aneurysm repair (EVAR), we have modified the bifurcated AneuRx device into a unilimb modular prosthesis, by placing an aortic extender cuff across the flow divider, thus excluding its contralateral limb. This technique was used with success in 3 groups of patients: with occlusion of 1 iliac artery, with a nontraversable iliac stenosis, or with a small calcific aortic bifurcation. In these patients, anatomy can make it difficult, if not impossible, to place a bifurcated stent graft. Whether as a planned preoperative procedure or as a ;;bail-out' maneuver, this procedure has been successful in avoiding open surgical conversion.     

Periprosthetic leak and rupture after endovascular repair of abdominal aortic aneurysm: The significance of device design for long-term results

We present a case of abdominal aortic aneurysm treated with an endovascular bifurcated aortic graft in which a periprosthetic leak caused by a tear in the polyester prosthesis appeared between 9 and 12 months after surgery. The tear appeared adjacent to a suture breakage that caused separation of two struts of the nitinol wire framework in the body of the stent graft. The leak was sealed with insertion of a new endovascular tube graft into the body of the bifurcation. Eight months later, the patient had a nonfatal rupture of the abdominal aortic aneurysm because detachment of the second limb from the bifurcation caused a new major periprosthetic leak. According to the manufacturer of this device, suture breakage with separation of metal components is commonly seen, but perforation of the polyester prosthesis caused by movement of the metal stent against the fabric has not been reported. It is likely that this occurred in our patient. Detachment of the second limb from the bifurcated stent, causing a rupture, has been described before. Increasing angulation and tortuosity of the stent graft, as a result of either remodeling of the sac or elongation of the stent, and reduced compliance to angulation after the stent-in-stent procedure might have contributed to the detachment in this case.     

Deployment and Healing of an ePTFE Encapsulated Stent Endograft in the Canine Aorta

n = 3), 1 month (n= 3), 3 months (n= 3), 6 months (n= 9), and 1 year (n= 3). Dimensions of the infrarenal aorta were determined with intravascular ultrasound (IVUS) and angiography prior to deployment of devices. Real-time fluoroscopy and IVUS were used to monitor device deployment with both imaging modalities repeated following implantation. Gross inspection and microscopic evaluation was performed on the explanted specimens following in vivo evaluation by CT scan, IVUS, and angiography prior to retrieval of the specimens. The prostheses were easily deployed from the femoral access site. Oversizing of the deployment balloon compared to the aortic diameter was necessary to accommodate the 10% device recoil observed following balloon deflation, however, all devices were seated against the aortic wall as evidenced by IVUS. At explant, all devices ware widely patent with limited luminal thrombosis observed in four specimens (19%). Devices were well-incorporated by cellular ingrowth into the ePTFE with the formation of neointima. No device migration or postdeployment recoil was observed. ePTFE graft material between stents protruded slightly into the vessel lumen accounting for a 10% luminal reduction. Fully supported ELG's consisting of balloon expandable stents encapsulated in ePTFE are easily deployed using a low-profile delivery system. Specimens demonstrated uniform long-term patency and healing up to 1 year in a canine aortic model. Those preliminary findings support further study of this fully supported prosthesis in the treatment of arterial disease.     

Geometric comparison of aortic bifurcation prostheses to the normal and atherosclerotic human aorta, and clinical trial of a vertical seamed bifurcation prosthesis

The 12 bifurcation prostheses generally available in the United States were compared. One was woven Teflon, two woven Dacron, and nine knitted Dacron. Ten were "seamless" in construction, and two were "seamed," but close examination revealed that all prostheses actually were seamed at the bifurication point. The grafts varied considerably in construction, porosity, and geometry. To compare the geometries, each prosthesis was preclotted in plasma, inflated to 120 mm. Hg, and quick frozen in alcohol and dry ice. Transverse and frontal bisections of the frozen specimens were photographed with a millimeter scale for sizing. For comparison, eight human aortofemoral bifurcations were distended and frozen similarly. The prostheses had far wider bifurcation shelves than did the normal aortas. The five normal human aortofemoral bifurcations had an average ratio of limb: body diameter of 0.61; the three atherosclerotic specimens averaged 0.49. The prostheses had an average limb:body diameter ratio of 0.48. or the "seamless" grafts, 0.48 for the circular transverse limb-seamed grafts, and 0.58 for the vertical-seamed grafts. Vertical-seamed aortic bifurcation grafts implanted in 102 patients between 1970 and 1976 (average follow-up, 29.5 months) have developed only a single limb closure, at 53 months.     

Results of endoluminal grafting of abdominal aortic aneurysms are dependent on aneurysm morphology

The aim of this prospective study was to analyze the outcome of elective endoluminal grafting in patients with various morphologies of abdominal aortic aneurysms (AAA). Between May 1992 and May 1994, endoluminal repair of AAA was undertaken in 40 patients. After detailed imaging by means of CT scanning and arteriography, aneurysms were classified into one of two types according to the following criteria: type I (suitable for transfemoral implantation of a straight tube graft), AAA with a proximal neck (2 cm or longer), a distal neck (1.5 cm or longer), and an iliac artery diameter of 8 mm or greater (N=19); or type II (requiring tapered aortoiliac or bifurcated grafts or access through an iliac approach), AAA that did not fit the type I criteria (N=21). Radiographic guidance was used to pass the aortic endografts (38 Dacron and 2 PTFE) via a delivery sheath introduced through the femoral or iliac arteries into the aorta. The configuration of the aortic endografts was tubular in 26 patients, tapered aortoiliac in 11, and bifurcated in three. Successful endoluminal repair was achieved in 17 (89%) of 19 patients with type I AAA and in 15 (71%) of 21 patients with type II AAA. All failed endoluminal repairs proceeded to successful open repair, and there were no deaths during the period of hospitalization for the operation. The mean operative time and mean hospital stay were shorter in patients with type I AAA compared to patients with type II AAA. The incidence of postoperative complications was 37% in type I endoluminal repairs compared to 71% in type II endoluminal repairs. There was one cardiac death (procedure related) within 30 days, and there were three late deaths (one cardiac, one from liver failure in a type II AAA repair, and one from a ruptured esophagus in a type I repair). These preliminary results suggest that there is a better outcome in transfemoral endoluminal tube graft repair of aneurysms conforming to type I criteria compared to endoluminal repair of the more complex type II AAA.Presented at the Society for Vascular Surgery/International Society for Cardiovascular Surgery North American Chapter Meeting, Seattle, Wash., June 6–8, 1994.     

Endoluminal aortic aneurysm repair using a balloon-expandable stent-graft device: A progress report

We describe our experience with endoluminal repair of abdominal aortic aneurysms using the stent-graft device. Twenty-four patients underwent 25 procedures in the 27-month period ending December 31, 1992. Twenty-one of the patients were considered high-risk candidates for conventional surgical repair. The endoluminal stented grafts were aortoaortic in 16 procedures and unilateral aortoiliac in eight. One patient underwent a second procedure consisting of an ilioiliac graft to repair a separate common iliac artery aneurysm. Technical problems were primarily related to retrograde transluminal access across the iliac arteries, tortuous aneurysms, and misjudgments as to measurement of length. One patient died and another required secondary deployment of a distal stent at 4 months; subsequent aneurysm expansion mandated surgical replacement at 18 months. It is clear that this device and methodology will have to undergo further refinement before the technique is acceptable for wider clinical application. Current experience, however, is encouraging. Aneurysm exclusion with an endoluminal prosthesis is likely to become an important therapeutic alternative over the next several years.Presented at the Eighteenth Annual Meeting of The Peripheral Vascular Surgery Society, Washington, D.C., June 6, 1993.     

Predicting iliac limb occlusions after bifurcated aortic stent grafting: anatomic and device-related causes

OBJECTIVE: Graft limb occlusion may complicate endovascular abdominal aortic aneurysm repair. The precise etiologic factors that contribute to the development of these graft limb thromboses have not been defined. We evaluated our experience with bifurcated aortic endografts to determine factors that may predict subsequent limb thrombosis. The management of the thrombosed limbs and the results after treatment were also investigated. METHODS: During a 4-year period, 351 patients with aortic aneurysms underwent treatment with bifurcated endografts (702 graft limbs at risk). These 351 bifurcated devices included AneuRx (Medtronic, Minneapolis, Minn; n = 35), Ancure (Guidant, Menlo Park, Calif; n = 8), Gore (W.L. Gore & Associates, Sunnyvale, Calif; n = 25), Talent (World Medical, Sunrise, Fla; n = 255), Teramed (Teramed, Minneapolis, Minn; n = 10), and Vanguard (Boston Scientific Vascular, Natick, Mass; n = 18). Details regarding the type of device, mechanism of deployment, and aortoiliac artery anatomy were collected prospectively and analyzed. Graft limbs were analyzed for diameter, use of additional endograft iliac extensions, deployment in the external iliac artery, and endograft to vessel oversizing. Follow-up included physical examination, duplex ultrasonography, and spiral computed tomographic scans at 1 month, 6 months, and 12 months and annually thereafter. The follow-up period ranged from 2 to 54 months, with a mean follow-up period of 20 months. RESULTS: Twenty-six of 702 limbs (3.7%) had an occlusion develop. The risk of limb thrombosis was associated with a smaller limb diameter. Mean graft limb diameter was 14 mm in the occluded population, and patent limbs had a mean diameter of 16 mm. Thrombosis occurred in 16 of 291 limbs (5.5%) that were 14 mm or less and in 10 of 411 limbs (2.4%) that were greater than 14 mm (P =.03). Extension of a graft to the external iliac artery was performed in 96 of the 702 limbs. Eight of these 96 limbs (8.3%) had thrombosis develop as compared with 18 of 606 (3.0%) that extended to the common iliac artery (P =.01). No significant association was present between limb thrombosis and the contralateral or ipsilateral side of a device, the configuration of the iliac graft limb end (closed web, open web, or bare spring), or the degree of iliac graft limb oversizing. AneuRx, Ancure, Vanguard, and Talent grafts each sustained limb occlusions, with no occlusions seen among the Gore and Teramed devices. No significant increased risk of graft limb thrombosis was observed in unsupported grafts (1/16; 6.3%) versus supported grafts (25/686; 3.6%; P = not significant). Thromboses occurred between 1 day and 23 months after surgery. Thirteen of the 26 thromboses (50%) occurred within 30 days of surgery. Presenting symptoms were mild to moderate claudication in eight patients (30.8%), severe claudication in 16 patient (61.5%), and paresthesia and rest pain in two patients (7.7%). Eighteen of 26 patients (69.2%) eventually needed intervention to reestablish flow to the occluded limb, including thrombolysis and stenting in two patients (7.7%), axillary femoral bypass in one patient (3.8%), femoral-femoral bypass in 13 patients (50.0%), and axillary-bifemoral bypass in two patients (7.7%). All patients with mild to moderate symptoms under observation had improvement in symptoms with no further interventions necessary. All revascularizations were successful in relieving symptoms. CONCLUSION: Graft limb occlusion is a recognized complication of endovascular treatment of abdominal aortic aneurysms that may be associated with smaller graft limb diameter and extension to the external iliac artery. Occlusions usually necessitate additional intervention for resolution of ischemic symptoms. The use of small diameter grafts should be avoided when possible to reduce the risk of graft limb occlusions.     

Regression of an abdominal aortic aneurysm after endograft exclusion

We describe the regression of a 6.5 cm diameter abdominal aortic aneurysm in a 71-year-old patient within 1 year of aortic endograft placement. The aneurysm decreased in size to 4 cm at 3 months and was 3.3 cm at 8 months on duplex examination. By 1 year a spiral computed tomographic study confirmed complete regression of the aneurysm, with mild shortening and angulation of the unsupported body of the aortoiliac endoluminal prosthesis. The case demonstrates a potential of endograft treatment of aortic aneurysms and describes the changes in prosthesis configuration and position that occurred after implantation. (J Vasc Surg 1997;26:133-7.)     

Preliminary clinical outcome and imaging criterion for endovascular prosthesis development in high-risk patients who have aortoiliac and traumatic arterial lesions

Purpose: This report reviews our preliminary experience of prospective treatment of arterial lesions with endoluminal grafts in a Food and Drug Administration (FDA) approved, investigator-sponsored Investigation Device Exemptions study. The utility and accuracy of various imaging methods, including angiography, cinefluoroscopy, computed tomography (CT), intravascular ultrasonography (IVUS), and duplex scanning, in performing the procedures was also assessed.Methods: Thirty-one patients were evaluated; 17 patients were treated, including 11 with abdominal aortic aneurysms, one with an aortic occlusive lesion, two with iliac artery aneurysms, and three with traumatic arteriovenous fistulas. Twelve of the 14 patients who had aorta and iliac artery lesions were high-risk. The mean follow-up of patients treated was 9 months (range, 6 to 15 months).Results: Aortoaortic endoluminal interposition procedures were not successful for treating abdominal aortic aneurysms early in the study (n = 3). Aortoiliac endoluminal bypass, contralateral iliac artery occlusion, and femorofemoral bypass procedures were successful in seven of eight subsequent cases (88%), with no incidence of endoleaks at either the proximal or distal fixation sites using the deployment methods described in this report. The 30-day operative mortality rate on follow-up evaluations for patients who underwent aortoiliac procedures was 14% (two of 14). Other major complications included transient renal failure in three patients that required short-term (two to eight times) dialysis, one arterial perforation and one dissection, and one prolonged intubation. No myocardial infarctions or strokes occurred. After major complications or identification of limitations in the study, the protocol was modified with the approval of the FDA to help avoid the recurrence of the same problems. There were no deaths or complications in the trauma cases.Conclusions: Contrast-enhanced CT (axial images and spiral reconstructions) was the most accurate method to determine candidacy for aortoiliac procedures and to choose the site for deployment of the devices. Angiographic scans were misleading in several patients regarding the critical determinants of patient candidacy and device deployment, particularly regarding the presence of a distal aortic neck. Cinefluoroscopy was used in all patients and was particularly useful for determining the continuity of vascular structures and the anatomy of branch arteries and for enabling precise positioning of stent devices. Determination of fixation sites and assessing dimensional information by cinefluoroscopy and angiography were limited by inaccuracies produced by image magnification, parallax, and uniplanar views. IVUS was used to determine the morphologic features of vascular structures (i.e., calcium, thrombus), to perform real-time observation of the expansion of devices, and to assure firm fixation of balloon-expanded stents before the procedures were completed. Duplex scanning was very helpful in assessing and identifying precisely the location of arteriovenous fistulas before intervention and provided assessment at follow-up intervals. Three-dimensional reconstruction imaging technologies such as spiral CT were particularly helpful for assessing the morphologic features of vascular anatomy before the intervention and at follow-up intervals, whereas 3-D IVUS provided a similar real-time perspective during the procedure. (J Vasc Surg 1996;24:556-71.)     

Endovascular management of iliac limb occlusion of bifurcated aortic endografts

Although aortic endograft iliac limb occlusion is an uncommon event, its treatment is problematic because standard surgical thrombectomy risks graft dislodgment or component separation. Although femorofemoral bypass grafting can restore perfusion to the affected limb, its longevity may be inferior to reestablishing patency of the endograft itself and represents a failure of the endograft procedure. With aortic endografts now commercially available, implanting surgeons must be aware of this important complication and well versed in all of the endovascular treatment options. We report three cases of endoluminal management of unilateral iliac limb occlusion of bifurcated aortic endografts.     

Open stent grafting for abdominal aortic aneurysm in a patient with a severely calcified abdominal aorta

We describe a 74-year-old male who underwent open stent repair for an infrarenal abdominal aortic aneurysm with a severely calcified aortic neck. The stent graft was constructed by covering a 50-mm long Gianturco Z stent (diameter: 20 mm) with a Dacron prosthesis (diameter: 20 mm). The stented Dacron graft was inserted into the calcified aortic neck, was then sutured to the trimmed aneurysmal wall, and was anastomosed to a bifurcated prosthesis. The distal ends of the bifurcated prosthesis were anastomosed to both common femoral arteries, and the terminal aorta was closed. The patient had an uneventful postoperative course. This procedure may be a feasible and safe way to repair infrarenal abdominal aortic aneurysm with a severely calcified aortic neck.     

Modular bifurcation endoprosthesis for treatment of abdominal aortic aneurysms.

OBJECTIVE: The authors analyzed a single group's experience treating abdominal aortic aneurysms (AAAs) with a new self-expanding, modular, bifurcated device. SUMMARY BACKGROUND DATA: Successful exclusion of AAAs by prototype devices has led to several controlled clinical trials evaluating prostheses designed and manufactured specifically for this application. METHODS: Sixteen patients (15 males, 1 female) of American Society of Anesthesiologists grade 2 through 4 and average age of 72 years had AAAs (average 57-mm diameter) treated as part of a phase I Food and Drug Administration-approved trial. RESULTS: All patients were treated successfully with no surgical conversions. No endoleaks or aneurysm enlargement was noted either predischarge by contrast computed tomography or on follow-up at 1 month by duplex ultrasound examination. At 6 months, 12 of 13 patients who were observed for this interval had no endoleaks, whereas one patient (patient 3) showed a small area of extravasation that appeared to arise from the device in an area that was traumatized at the time of deployment. One procedure-related mortality (6%) occurred in a patient who died of septic complications secondary to a gangrenous gallbladder diagnosed 1 day after the procedure. There were no device-related mortalities. Complications included two iliac artery dissections, two groin wound infections, and two transient elevations of serum creatinine. Other significant variables including median procedure length (5 hours), intensive care unit stay (1 day), hospitalization postprocedure (4.5 days), and blood loss (1100 mL) all decreased as the study progressed. Blood replacement in all but three patients was accomplished by autotransfusion or banked-autologous blood replacement. At 6-month follow-up in 13 patients, the maximum diameter of the aneurysm decreased by an average of 5.6 mm (range, 0-15 mm), and the maximal cross-sectional area decreased an average of 20.3% (range, 0-72%). CONCLUSIONS: This study suggests that endovascular prosthesis exclusion of AAAs using a self-expanding modular device may be effective in many patients who are otherwise surgical candidates for repair if further clinical studies confirm these observations.     

Five-year outcomes from a prospective,multicenter study of endovascular repair of iliac artery aneurysms using an iliac branch device

ObjectiveWe have reported the 5-year results of a pivotal prospective, multicenter study conducted in the United States of a specifically designed iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, AZ) for endovascular repair of aortoiliac aneurysms and common iliac artery aneurysms.MethodsA total of 63 patients (98.4% male; mean age, 70 years) with aortoiliac or common iliac artery aneurysms had undergone implantation of a single IBE device and a bifurcated aortoiliac stent graft. Patients with bilateral common iliac artery aneurysms (n = 22; 34.9%) had undergone either staged occlusion or surgical revascularization of the contralateral internal iliac artery before study enrollment. At 5 years, 36 of the 63 patients had completed the final study follow-up examinations, including clinical examinations (n = 35) and computed tomography (n = 32), with the results evaluated by an independent core laboratory and adverse events adjudicated by a clinical events committee.ResultsAt 5 years, freedom from all-cause mortality was 85.7% and freedom from aneurysm-related mortality was 100%. The nine deaths that had occurred (range, 132-1898 days) were adjudicated as unrelated to the aneurysm or procedure. Primary patency of the internal and external iliac artery IBE limbs was 95.1% and 100%, respectively. No patients had experienced new-onset buttock claudication on the IBE side or self-reported new-onset erectile dysfunction. The common iliac artery diameter on the IBE side was either unchanged or had decreased by ≥5 mm in 30 of the 31 patients (96.8%) with a baseline (1 month) and 5-year (range, 1641-2006 days) computed tomography scan available. Of the 31 evaluable patients, 9 (29.0%) had had an increase of ≥5 mm in the aortic diameter, 5 of whom had had a concurrent type II endoleak. No type I or type III endoleaks or device migration were identified by the core laboratory. Six patients had undergone eight secondary interventions, including five interventions for a type II endoleak. The freedom from secondary intervention was 90.5%.ConclusionsThe 5-year results of our prospective, multicenter study have confirmed the safety, efficacy, and durability of the IBE device for the treatment of aortoiliac and iliac artery aneurysms. The device effectively prevented common iliac artery aneurysm rupture, maintained the patency of the internal iliac artery, and avoided the complications associated with internal iliac artery sacrifice. Although common iliac artery aneurysm enlargement was rare, abdominal aortic enlargement was more common, suggesting that the outcomes of endovascular aneurysm repair might be different for patients with or without associated common iliac artery aneurysms.     

Serial Doppler echocardiographic evaluation of small-sized sorin bicarbon prostheses

OBJECTIVE: The Sorin Bicarbon prosthesis (Sorin Biomedica, Saluggia, Italy) is a bileaflet valve with curved-profile leaflets, a rolling hinge mechanism, and a pyrolytic carbon-coated titanium alloy housing and sewing ring. Although the Sorin Bicarbon prosthesis has been implanted in greater than 80,000 patients, and reference values on the hemodynamic performance of valve prostheses are needed to avoid patient-prosthesis mismatch, few Doppler echocardiographic data are available on the prosthesis in the aortic position. The aim of this study is to provide a detailed echocardiographic evaluation of the hemodynamic performance and regression of left ventricular hypertrophy after aortic valve replacement with the Sorin Bicarbon prosthesis. METHODS: The study included 182 patients who received a 21-mm (n = 61) or 23-mm (n = 121) Sorin Bicarbon prosthesis for pure or prevalent aortic stenosis who underwent serial echocardiograms at 3, 6, and 12 months after aortic valve replacement. RESULTS: Mean and peak gradients significantly decreased (P <.001) during follow-up to values of 12 +/- 3 and 22 +/- 6 mm Hg for the 21-mm prosthesis and values of 11 +/- 4 and 19 +/- 6 mm Hg for the 23-mm prosthesis at 1 year. Left ventricular mass index showed a 17% decrease to 120 +/- 27 g/m(2) in recipients of the 21-mm prosthesis (P <.001) and a 21% decrease to 123 +/- 29 g/m(2) in recipients of the 23-mm prosthesis (P <.001). A larger prosthesis size was the only predictor of a higher left ventricular mass index regression. Among recipients of the 21-mm prosthesis, body surface area of greater than 1.85 m(2) was associated with a lower regression of left ventricular mass index. The effective orifice area index was 1.00 +/- 0.11 and 1.08 +/- 0.14 cm(2)/m(2) in recipients of the 21-mm and 23-mm prostheses, respectively. CONCLUSIONS: Size 21 mm and 23 mm Sorin Bicarbon prostheses show low transprosthetic gradients, with significant reduction of left ventricular mass index during the first postoperative year. The reported effective orifice areas might be useful for aortic valve replacement in patients with a small aortic annulus to avoid patient-prosthesis mismatch.     

Experiences and results with the Endologix-bifurcated endovascular graft

Since the first endograft implantation for treatment of abdominal aneurysms the development of modern stentgrafts has progressed in many ways. In 1999 we started implantations using the PowerLink aortic stent graft by Endologix-company. The PowerLink aortic stent graft is a bifurcated, self-expanding, sutureless endovascular graft, covered with PTFE. This aortic stent graft facilitates the complete covering of the infrarenal aorta and the iliac arteries. The anatomical localization at the natural aortic bifurcation provides anti-gravitational supporting force, preventing distal migration of the device. From 1999 to 2005 we implanted 297 PowerLink aortic stent grafts. Our follow-up examinations showed a low rate of renal infarctions (3.0 %), a limb occlusion rate of 2.7 % and a total endoleakage rate of 16.8 %. Our conclusion is, that this is a very safe device for repair of abdominal aneurysms, associated with a low-risk of complications.     

The epidemiology of abdominal aortic diameter

BACKGROUND: The diameter of the abdominal aorta is central to the diagnosis of abdominal aortic aneurysm. This study aimed to determine the associations between the diameter of the abdominal aorta at three distinct locations and the traditional cardiovascular disease risk factors as well as calcified atherosclerosis. METHODS: A total of 504 patients (41% women) underwent whole body scanning by electron beam computed tomography (EBCT) and a standardized assessment for cardiovascular disease risk factors. The resulting EBCT images were retrospectively interrogated for the diameter of the abdominal aorta just inferior to the superior mesenteric artery (SMA), just superior to the aortic bifurcation, and at the midpoint between the SMA and bifurcation. RESULTS: Mean patient age was 57.8 years. The mean (SD) diameter was 21.3 (2.9) mm at the SMA, 19.3 (2.5) mm at the midpoint, and 18.6 (2.2) mm at the bifurcation. In a model containing the traditional cardiovascular disease risk factors, age (standardized beta = 0.96), male sex (beta = 3.06), and body mass index (standardized beta = 0.68) were significantly associated with increasing aortic diameter at the SMA (P < .01 for all). The significance of the associations for these variables was the same for aortic diameter at the midpoint and bifurcation. Furthermore, a 1-unit increment in the calcium score in the abdominal aorta and iliac arteries was associated with 0.13-mm (P < .01) and 0.09-mm (P = .02) increases, respectively, in aortic diameter at the SMA. The results were similar for the midpoint (beta = 0.19, P < .01; beta = 0.12, P = .01, respectively) and bifurcation (beta = 0.09, P < .04; beta = 0.09, P = .03, respectively). CONCLUSIONS: Age, sex, body mass index, and the presence and extent of calcified atherosclerosis in both the abdominal aorta and iliac arteries are significantly associated with increasing aortic diameter independent of the other cardiovascular disease risk factors.     

Preservation of hypogastric artery blood flow during endovascular aneurysm repair of an abdominal aortic aneurysm with bilateral common and internal iliac artery involvement: utilization of off-the-shelf stent-graft components

A 72-year-old male presented with a 7.4-cm abdominal aortic aneurysm with bilateral common and internal iliac involvement. To maintain pelvic perfusion, preservation of the patient's left hypogastric artery (HA) was pursued. Two weeks after right HA embolization, endovascular repair of the patient's aneurysms was performed using a branched endograft approach. A 22-mm main body bifurcated endograft was unsheathed and the proximal covered stent was removed. The contralateral gate was preloaded with a wire and catheter. The device was resheathed and placed in the left common iliac artery. The preloaded wire in the contralateral gate was snared from the right side, establishing through-and-through femoral access. A contralateral femoral sheath was advanced up and over the aortic bifurcation from the right side into the contralateral gate of the bifurcated endograft. The repair was bridged to the left HA using a balloon-expandable stent-graft, followed by standard endovascular abdominal aortic aneurysm repair. Completion angiography demonstrated exclusion of patient's aneurysms, without evidence of endoleak, and maintenance of pelvic blood flow through the left HA. The patient recovered without complication and was discharged home on postoperative day 4. This technique illustrates the technical feasibility of using a preloaded commercially available endograft to preserve HA blood flow and maintain pelvic perfusion during endovascular aortic aneurysm repair.