EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy.

OBJECTIVE: The study aimed to review the results of endovascular aneurysm repair (EVAR) using a novel sac-anchoring endoprosthesis in patients with favourable and adverse anatomy. DESIGN: This is a prospective, multicentre, clinical trial. MATERIALS: The Nellix endoprosthesis consists of dual, balloon-expandable endoframes, surrounded by polymer-filled endobags, which obliterate the aneurysm sac and maintain endograft position. METHODS: The study reviewed worldwide clinical experience and Core Lab evaluation of computed tomography (CT) scans. RESULTS: From 2008 to 2010, 34 patients (age 71 ± 8 years, abdominal aortic aneurysm (AAA) diameter 5.8 ± 0.8 cm) were treated at four clinical sites. Seventeen patients (50%) met the inclusion criteria for Food and Drug Administration (FDA)-approved endografts (favourable anatomy); 17 (50%) had one or more adverse anatomic feature: neck length <10 mm (24%), neck angle >60° (9%) and iliac diameter >23 mm (38%). Device deployment was successful in all patients; iliac aneurysm treatment preserved hypogastric patency. Perioperative mortality was 1/34 (2.9%); one patient died at 10 months of congestive heart failure (CHF); one patient had a secondary procedure at 15 months. During 15 ± 6 months follow-up, there were no differences in outcome between favourable and adverse anatomy patients. Follow-up CT extending up to 2 years revealed no change in aneurysm size or endograft position and no new endoleaks. CONCLUSIONS: Favourable and adverse anatomy patients can be successfully treated using the Nellix sac-anchoring endoprosthesis. Early results are promising but longer-term studies are needed.

Exertional disruption of axillofemoral graft anastomosis. 'The axillary pullout syndrome'.

Five cases of exertional disruption of the axillary anastomosis occurred at intervals of 13 to 30 days after axillofemoral polytef (polytetrafluoroethylene [PTFE]) graft insertion. Graft evulsion was preceded by effort and heralded by axillary pain, an expanding hematoma, and a pseudoaneurysm formation. Proximal control of the subclavian artery by a supraclavicular approach or balloon allowed safe wound exploration. Successful reconstruction required lengthening of the graft or replacement. Secondary disruption occurred with simple repair. Although temporary postoperative brachial plexus neuropathy was common, no significant hand ischemia was noted. Twenty-two reports of axillary anastomotic disruption were made to the Food and Drug Administration, Washington, DC, during a 2-year period, and one manufacturer of polytef grafts provided data on 10 reports received throughout 7 years. Surface anatomy measurements in 20 control patients demonstrated that arm abduction and lateral flexion of the body increased the distance between the axillary and femoral arteries by a mean of 15.5%. Similar measurements taken from the proximal axillary artery showed a mean length increase of less than 10%. This complication may be avoided by inserting the polytef graft with several centimeters of excess length and positioning the axillary anastomosis medial to the pectoralis minor muscle.

Pathogenesis determines late morbidity of axillosubclavian vein thrombosis.

The late consequences of axillosubclavian vein thrombosis were evaluated through a clinical follow-up of 41 patients (45 limbs) treated from July 1975 to December 1985. The causes of the obstruction were classified into two main groups: Intrinsic damage, consisting of thrombophlebitis due to intravenous drug abuse (11 patients), central venous catheterization (10 patients), and hypercoagulability state (2 patients); and extrinsic obstruction, involving effort-induced or thoracic outlet obstruction (9 patients), underlying neoplastic disease (5 patients), trauma (3 patients), and congenital venous malformation (1 patient). Clinical diagnosis was confirmed by upper arm venography in all 41 patients, and all were initially treated by anticoagulation with heparin for 1 to 2 weeks, usually followed by oral warfarin for a variable period of 1 week to 5 years. Only three patients had an operation (rib resection for thoracic outlet obstruction, thrombectomy and clavicle fixation, and repair of a congenital venous malformation). Major early morbidity consisted of a documented pulmonary embolus in five patients, two in Group I and three in Group II, for an overall incidence of 12 percent. Clinical follow-up of up to 5 years revealed that chronic morbidity was related to our classification. Thrombosis secondary to intrinsic damage rarely caused persistent symptoms and responded well to anticoagulation alone. Conversely, when extrinsic obstruction was the cause, only 50 percent of patients were symptom-free, whereas many had disabling intermittent arm swelling and pain. Repeat venography in severely symptomatic patients revealed persistent obstruction with no recanalization. We conclude that patients with axillosubclavian venous thrombosis due to intrinsic damage do not require treatment other than anticoagulants, whereas patients with extrinsic obstruction often have poor long-term results from conventional therapy and therefore should be considered for adjunctive treatment with thrombolysins or operative intervention.

The impact of intravascular ultrasound (IVUS) on endovascular interventions.

Intravascular ultrasound (IVUS) has undergone rapid evolution with the recent expansion of endovascular techniques and devices. This device can aid the surgeon, cardiologist, and interventional radiologist by increasing the accuracy of imaging and by adding important information to peripheral vascular and coronary interventions. Modern intravascular ultrasound provides a detailed view of the lumen, wall, and surrounding structures of blood vessels. Compared with other modalities, the diagnostic advantages of IVUS for examining arterial wall architecture and lesion morphology are evident. IVUS can determine lesion shape, length, and configuration, as well as identifying and examining the origins of branches and tributaries. Using this information, IVUS can guide the choice of appropriate angioplasty techniques, aid in the placement of endovascular devices, and assess and follow the efficacy of such interventions. IVUS helps reduce the use of radiation and contrast agents. Even though intravascular ultrasound requires additional equipment, personnel, and interpretative skills, it can be invaluable as a sensitive real-time imaging tool for complex endovascular interventions, therapeutic challenges, and diagnostic dilemmas.

Forward-looking intravascular ultrasonography: in vitro imaging of normal and atherosclerotic human arteries.

Inadequate guidance of angioplasty devices limits the endoluminal treatment of high grade atherosclerotic stenoses and total occlusions. Conventional intraluminal ultrasound systems (IVUS) enable lateral cross-sectional imaging of tomographic sections of the vessel wall, but do not offer imaging in front of the catheter. This study describes our initial experience with a forward-looking intravascular ultrasound (FL-IVUS) system (Echoeye, EchoCath, Inc., Princeton, NJ). The acoustic beam from a 25.5 MHz piezoelectric transducer on a 7.5 Fr catheter is mechanically rotated in a forward-looking spiral fashion at 300 cycles/second. Sixty-four axially aligned, cross-sectional, real time images are obtained from a truncated, 60 degree conical volume located 5 to 10 mm from the catheter tip. Luminal dimensions (n = 51) of human cadaveric femoral arteries (cast in agar and submerged in saline) measured by the FL-IVUS were compared to histologic cross-sections of the vessel with a correlation of r = 0.92. FL-IVUS accurately imaged the narrowing lumen in front of total occlusions and the geometry at vessel branches, and identified the location of lesions and the shape and morphology of vessel wall thickness. The 7.5 Fr FL-IVUS over-estimated luminal dimensions in vessels larger than 5 mm. We conclude that FL-IVUS imaging shows promise as a new, accurate method for identifying and characterizing high grade atherosclerotic stenoses and total occlusions, and expands the current capabilities of conventional IVUS systems.

The ideal guidance imaging system for endovascular interventions.

Endovascular interventions enable a minimally invasive approach to a variety of cardiovascular lesions. Small catheter-based delivery systems have rapidly evolved, diversifying endovascular therapeutic options. Coronary and peripheral vascular occlusive lesions may be amenable to angioplasty dilatation, intravascular stenting and ablation with mechanical atherectomy devices or lasers. New experimental transluminally placed endovascular stented grafts (TPEGs) have demonstrated feasibility for treating aneurysmal arteries, arteriovenous fistulas, and atherosclerotic occlusions. Improvements in imaging systems have provided better resolution of lesions, have improved patient selection and interventional strategy, and are invaluable for precise performance of procedures. The ideal guidance system should provide realtime imaging by a combination of complimentary modalities. These include cinefluoroscopy and contrast angiography, catheter-based intravascular ultrasound and angioscopy.

Aortic aneurysm morphology for planning endovascular procedures.

Endovascular prosthesis repair of abdominal aortic aneurysms is based upon the development of low-profile devices that can be expediently deployed within the aneurysm, excluding it from intraluminal pressure. Many factors affect the treatment of patients in this manner, including the morphology of the proximal and distal fixation sites, the diameter and disease state of the access vessels, and the ability of the device to conform to the many anatomic variations of aneurysms. In addition, preliminary data suggest there is progressive shrinkage and morphologic change in the configuration of an aneurysm following exclusion, which not only affects the alignment of the device but may also influence its healing and stability. This paper reviews the morphologic parameters of aneurysms relevant to endovascular repair and describes the imaging technologies used to assess these parameters before, during, and after intervention.

Utility of intravascular ultrasound in peripheral interventions.

Endovascular imaging techniques encompass a variety of methods, including angiography, computed tomography, magnetic resonance imaging, angioscopy, and intravascular ultrasound. Each method provides unique information regarding the continuity of vascular structures and the morphology and distribution of lesions. Although arteriography has been the "gold standard" for imaging arterial anatomy, recent data have confirmed that even sophisticated arteriographic imaging substantially underestimates the degree of residual lesions, and that future observations and end-points for treatment will most likely be determined by data accumulated by computed tomography, magnetic resonance imaging, angioscopy, and intravascular ultrasound. Successful therapeutic applications of endovascular devices have developed because of improved patient selection using computed tomography, spiral computed tomography, magnetic resonance imaging, and computerized high-resolution angiography. Procedural success has been enhanced by improved mobile cinefluoroscopy, angioscopy, intraluminal ultrasound monitoring of angioplasty procedures, and the use of intravascular ultrasound for stent and stent-graft sizing and deployment. Newly developed methods and low-profile delivery systems enabling deployment and fixation of vascular prostheses by an endoluminal approach have heightened the interest of many interventionalists, particularly surgeons, in the use of endovascular surgical techniques. The evolution of this method promises to add a new dimension to the treatment of vascular lesions and relies heavily on the incorporation of miniaturized imaging systems, such as intravascular ultrasound, as a means to provide precise placement of devices.

Low dose heparin therapy: in vitro verification of antithrombotic effect.

Low dose heparin therapy has been used routinely for prophylaxis of deep venous thrombosis, yet in vitro data regarding its antithrombotic effects are sparse. The effects of heparin on venous thrombus formation were studied in an in vitro perfusion system. Fresh blood collected from human volunteers was treated with varying heparin doses and perfused at a shear rate of 100 sec-1 over everted, injured porcine vein segments, simulating conditions in the venous circulation. Platelet and fibrin deposition were measured by use of indium 111 and iodine 125 radiolabels, respectively. The effects of heparin on the intrinsic coagulation cascade were monitored by the activated clotting time. Increasing doses of heparin resulted in significant reductions in fibrin and platelet deposition (ANOVA F = 2.67 and 3.17, respectively, p less than 0.05). At a dose of only 0.19 USP units/ml blood, equivalent to a 1000 unit bolus of heparin in a 70 kg man, a noticeable reduction in both fibrin and platelet deposition was observed without an increase in the activated clotting time. These data confirm the antithrombotic effects of heparin at low dose ranges and may explain the clinically observed phenomenon of deep venous prophylaxis without an appreciable alteration in the conventional coagulation assays.

Future alternatives to heparin: low-molecular-weight heparin and hirudin.

The antithrombotic effects of standard heparin were compared with those of low-molecular-weight heparin (LMWH) and hirudin by use of an in vitro perfusion system. Fresh blood collected from human volunteers was treated with varying doses of these three agents and perfused in a recirculating system over everted porcine vein segments. A low shear rate (100/sec) was selected to simulate conditions in large arteries and veins. Platelet and fibrinogen deposition were evaluated with indium 111 and iodine 125 radiolabels, respectively. Anticoagulant activity was assessed by measuring the activated clotting time (ACT). Anti-Xa activity was assayed to determine the degree to which these agents used antithrombin III pathways. Low-molecular-weight heparin was the weakest anticoagulant, requiring 32 micrograms/ml blood to double the ACT. By contrast, the ACT doubled with only 0.75 and 1.10 micrograms/ml blood of heparin and hirudin, respectively. Heparin and hirudin inhibited platelet and fibrin deposition at equivalent doses. Low-molecular-weight heparin was a less potent inhibitor of fibrin than heparin or hirudin. Hirudin, a direct thrombin inhibitor, exhibited minimal anti-Xa activity, contrasted with 0.14 anti-Xa units/micrograms for LMWH and 0.13 anti-Xa units/mg for heparin. These data suggest that heparin and hirudin are more potent anticoagulants and antiplatelet agents than LMWH.

Endoluminal graft exclusion of a proximal para-anastomotic pseudoaneurysm following aortobifemoral bypass.

PURPOSE: To describe a case of endoluminal graft exclusion of a proximal para-anastomotic pseudoaneurysm that occurred 17 years following aortobifemoral bypass for occlusive disease. METHODS AND RESULTS: The lesion was found on abdominal ultrasound examination as part of a work-up for acute abdominal pain and upper gastrointestinal bleeding in a 67-year-old male. A 5-cm saccular pseudoaneurysm was confirmed by preintervention aortography and spiral computed tomography (CT) scanning. Because of the patient's acute symptoms and high-risk medical condition (cardiomyopathy), he was deemed a candidate for endoluminal bypass. At the time of intervention, intravascular ultrasound (IVUS) interrogation identified a 3.5-cm-long separation of the existing aortic graft from the proximal aortic stump with a large pseudoaneurysm. The lesion was isolated and repaired by placement of an aortic-to-right iliac endoluminal bypass, ligation of the left limb of the aortofemoral graft, and femorofemoral bypass to restore blood flow to the lower extremities. Spiral CT scans at 48 hours and 3 months following the procedure confirmed complete isolation of the lesion. CONCLUSIONS: This case illustrates the feasibility of endografting for repair of aortic para-anastomotic pseudoaneurysms, and it also highlights the potential role of IVUS imaging in endoluminal graft deployment.

Deployment technique and histopathological evaluation of an endoluminal vascular prosthesis used to repair an iliac artery aneurysm.

PURPOSE: To describe the deployment technique, function, and gross healing of an endoluminal vascular prosthesis deployed in a high-risk patient for treatment of a common iliac artery (CIA) aneurysm. METHODS: An 82-year-old, high-risk male with a 4-cm-diameter CIA aneurysm approximately 4.5 to 5 cm long was treated with endoluminal exclusion of the lesion using a 6-cm-long, 14-mm-internal diameter Dacron vascular prosthesis with Palmaz 308 stents sutured to either end of the graft. Intravascular ultrasound (IVUS) imaging facilitated sizing of the endograft and its accurate positioning so as to occlude both the aneurysm and the hypogastric artery, which was a potential source of retrograde flow to the aneurysm. Exclusion of the lesion and occlusion of the hypogastric artery were demonstrated on delayed angiographic images and contrast computed tomography scans obtained at 16 days postprocedure. Unfortunately, the patient died 67 days following implantation from a nonprocedure-related gastrointestinal complication. RESULTS: At autopsy, the aortoiliac segment was excised and examined grossly and histologically; the evaluation confirmed complete isolation of the aneurysm by the fully expanded endoluminal prosthesis. The surface of the vascular graft was covered by a glistening, thin, fibrinous membrane. The graft material was filled with hypocellular compact fibrinous material with no evidence of endothelialization. These observations confirm preliminary sealing and isolation of the iliac artery aneurysm as healing of the endograft progressed. CONCLUSIONS: The data acquired from the analysis of this specimen provide information regarding the utility and early healing of an endograft used for iliac artery aneurysm exclusion. This case also exemplifies the utility of IVUS in endograft deployment.

Iliac to popliteal artery bypass through the iliac wing: An alternative extracavitary route for management of complex groin injuries.

Extracavitary bypass through the iliac wing allows placement of the grafts into the posterior thigh and is another alternative route when an obturator bypass is not possible, or an axillary-popliteal bypass is to be avoided. The transiliac wing bypass is relatively simple and easy to perform. The bypass route is short and direct, has excellent inflow, and is accompanied by minimal neurological or bleeding risks. An illustrative case is presented with a complete description of the operative technique. Review of the literature is also included.

Abdominal pain and hemoperitoneum: sole presenting symptoms for "leaking AAA" after endovascular repair.

PURPOSE: To describe an unusual presentation of impending aortic endograft rupture and successful endovascular rescue. CASE REPORT: A 77-year-old man with an enlarging aortic aneurysm was treated with a Talent bifurcated endoprosthesis; a moderate endoleak that appeared to be related to either proximal or distal fixation sites was noted in the body of the aneurysm. The patient was observed for 1 month, and repeat imaging demonstrated persistent endoleak without major increase in the aneurysm diameter. Another examination was scheduled for 3 months hence, but, 2 months later, the patient presented with abdominal pain and a hemoperitoneum. A proximal extension cuff resolved the leak and led to resolution of the hemoperitoneum. CONCLUSIONS: A leaking aneurysm can be repaired using endovascular techniques in patients with an existing endograft. The need for frequent imaging surveillance of patients with endoleak is underscored.

Failed AAA endograft exclusion due to type II endoleak: explant analysis.

PURPOSE: To report the patient history and analysis of an explanted modular bifurcated endograft that was implanted to exclude an abdominal aortic aneurysm (AAA). CASE REPORT: An 80-year-old man with a 6-cm AAA underwent uneventful endovascular implantation of a bifurcated AneuRx stent-graft. His postprocedural clinical course was uneventful, although persistent contrast enhancement of the aneurysm remained via the inferior mesenteric artery (IMA). By 6 months, an endoleak connecting to the lumbar and mesenteric arteries became apparent. Over the ensuing 12 months, the endoleak and aneurysm enlarged; branch artery embolization was attempted in 4 percutaneous procedures. Despite successful IMA occlusion, the aneurysm continued to increase in diameter and volume, necessitating conversion to a conventional bypass at 20 months. Analysis of the explanted specimen revealed an intact endograft with fibrous incorporation of the stent framework at the proximal and distal fixation sites only; no incorporation of the endograft was noted within the aneurysm. The feeding channel for the endoleak was not identified. CONCLUSIONS: Serial imaging is a vital component of endograft surveillance, and persistent type II endoleaks that cannot be completely embolized endanger the longevity of the aneurysm exclusion. Explant analysis can play an important role in understanding the mechanisms of endograft failure.

Computed tomography assessment of abdominal aortic aneurysm morphology after endograft exclusion.

OBJECTIVES: Assessment of the long-term function of endografts to exclude abdominal aortic aneurysm (AAA) includes determination of aneurysm dimensions and morphologic changes that occur after implantation. This study reports the dimensional analysis of patients treated with AneuRx bifurcated endoprostheses with postintervention, 1-year (n = 51), 2-year (n = 28), and 3-year (n = 10) postimplantation contrast computed tomography data. METHODS: Maximal diameter (D) and cross-sectional area (CSA) of the AAA were measured from axial computed tomography images. Total volume, AAA thrombus volume (AAA volume minus the volume of the device and luminal blood flow), diameter of the aorta at the level of the renal arteries and within the device, distance from the renal arteries to the device, length of the device limbs, and the angle of the proximal neck were also determined at the same follow-up intervals after deployment with computed tomography angiograms reconstructed in an interactive environment. RESULTS: Fifty-one of 98 consecutively treated patients with the AneuRx bifurcated prosthesis (29 "stiff" and 22 "flexible" body devices) had complete data from the postprocedure and follow-up computed tomography studies available for analysis. Max D, CSA, total volume of the AAA, and AAA thrombus volume decreased sequentially from year to year compared with the postimplantation values. D and CSA decreased or were unchanged in all except four patients, two who had unrestricted enlargement of the aneurysm with eventual rupture and one who had surgical conversion for continued expansion despite four diagnostic angiograms and attempted embolizations. Total volume of the AAA increased in 11 of 51 patients at 1 year, eight of whom had endoleaks at some interval during the follow-up. Thrombus volume increased more than 5% in four of these patients, including the two with eventual rupture and the one conversion. Patients with endoleaks who had spontaneous thrombosis or were successfully treated either remained at the same volume or had decreased volume on subsequent examinations. D at the renal arteries increased an average of 0.9 mm during the first year, with a concomitant increase of 2.8 mm within the proximal end of the device related to the self-expanding nature of the Nitinol suprastructure. Subsequent enlargement of the proximal neck continued at a slow rate in some cases but never exceeded the diameter of the endoluminal device. The distance from the renal arteries to the device increased by an average of 3 mm over the first year, with the greatest increases occurring in patients with a "stiff" body device and those with rapid regression (>10% total volume) in 1 year. As regression of the AAA occurred, the angle of the proximal neck varied from -5 degrees to +25 degrees from the original alignment. Limb length varied from -8 mm to +10 mm, with no consistent pattern for the change, that is, ipsilateral or contralateral limb. CONCLUSION: Significant variation in the quantitation of aneurysm size occurs depending on the technique of computed tomography assessment used. In most patients diameter assessment is adequate, although volumetric analysis appears to be very helpful in certain patients who do not show aneurysm regression, or in whom the diameter increases or where endoleaks persist. Three-dimensional reconstruction and volumetric analysis are also useful to assess the mechanism by which the endovascular device accommodates to morphology changes and to determine criteria for reintervention.