Percutaneous arterial closure in peripheral vascular disease: a prospective randomized evaluation of the Perclose device.

BACKGROUND: Patients with peripheral vascular disease have been excluded from initial studies of percutaneous suture-mediated closure devices (SMCD) despite representing a significant proportion of those requiring endovascular intervention. We sought to determine whether these devices could be safely used in patients with peripheral vascular disease. METHODS: Patients were stratified into two groups and five subgroups on the basis of indication for arteriography, and they were prospectively randomized at the end of the procedure to receive either the SMCD or manual compression. Ankle-brachial index was determined and duplex ultrasound scanning of the accessed femoral artery was performed, before and after the procedure. Ultrasound data included peak systolic velocity, minimum intraluminal vessel diameter, and presence or absence of calcified plaque. Time to hemostasis, ambulation, and discharge were recorded, and major or minor complications were noted. RESULTS: Of 102 patients included in the study, 52 patients were randomized to receive the SMCD. There was no difference in ankle-brachial index, minimum intraluminal vessel diameter, or peak systolic velocity in the accessed vessel after closure with SMCD or manual compression. Time to hemostasis, ambulation, and discharge was significantly less in the SMCD group (P =.001). Presence of calcified plaque was not associated with complications (P =.146). In the SMCD group, hemostasis was achieved with 49 of 52 devices (94.2%). There were six complications (5.9%), two of which were major and required operative intervention. All complications were hemorrhagic and not occlusive. There was no difference in overall complication rate between SMCD (7.7%) and manual compression (4.0%) groups (P =.678). No infection was noted in any of the 102 patients. CONCLUSIONS: Suture-mediated percutaneous arterial closure can be safely performed in patients with peripheral vascular disease, even in the presence of calcified plaque. This closure technique enables shorter time to hemostasis, ambulation, and hospital discharge. There are observed differences in minor, but not major, complication rates for MC versus percutaneous arterial closure in patients with peripheral vascular disease, but these differences did not achieve statistical significance in this small series.

Repair of bilateral iliac artery aneurysms associated with a congenital pelvic kidney.

The association of iliac artery aneurysms with a congenital pelvic kidney is extremely rare. Although multiple techniques are well described for renal preservation with renal ectopia in the setting of aortic reconstruction, few reports exist describing techniques for renal preservation in the setting of bilateral iliac artery aneurysms. A case is presented of a middle-aged man with a 6-cm right common iliac artery aneurysm and a 3-cm left common iliac artery aneurysm and a right pelvic kidney. A double-proximal-clamp technique and temporary shunting to the pelvic kidney were used during the aneurysm repair. The technical aspects of this procedure are presented as well as a brief discussion of the various options for renal preservation with renal ectopia when repairing complex aneurysmal disease.

Chronic ergot toxicity: A rare cause of lower extremity ischemia.

Chronic ergot toxicity is a rare cause of lower extremity ischemia. The cornerstone of therapy in ergot toxicity is to discontinue the use of caffeine, cigarettes, and all ergot-containing medications. Although multiple different therapies have been recommended for acute toxicity, no specific treatment is uniformly recommended in chronic toxicity. We present a case of long-term ergot use for migraine headaches in a woman who had severe chronic lower extremity claudication. This case demonstrates the unique features associated with the diagnosis and management of chronic ergot toxicity. We recommend a conservative approach consisting of observation, antiplatelet agents, and the discontinuance of ergots. If symptoms progress to rest pain or gangrene, surgical treatment should be considered.

The fate of a patent carotid artery contralateral to an occlusion.

The finding of carotid stenosis contralateral to a carotid occlusion is becoming more frequent. While the neurologic outcomes in this patient population have been described, the rate of disease progression measured by duplex examination and the eventual need for carotid endarterectomy has not been described. In this study, a computerized database of carotid duplex examinations was reviewed and clinical data were obtained from clinic records. From 9124 studies 117 patients were identified. Thirty patients had previous carotid surgery on the patent side and were excluded. Of 87 patients 33 required carotid endarterectomy on the patent side. The rate of disease progression and/or the performance of a carotid endarterectomy by life-table analysis was 85.9% over 8 years. There were 10 neurologic events during the follow-up period. Patients with carotid stenosis and contralateral occlusion are at significant risk for disease progression. Follow-up should be more frequent and of longer duration in this patient population. A significant number of patients with carotid artery occlusion will require a carotid endarterectomy of the patent contralateral carotid.

Hemostatic efficacy of fibrin sealant (human) on expanded poly-tetrafluoroethylene carotid patch angioplasty: a randomized clinical trial.

PURPOSE: The efficacy of solvent-detergent-treated fibrin sealant (human [FSH]) for controlling anastomotic bleeding from expanded polytetrafluoroethylene (ePTFE) patch angioplasty during carotid endarterectomy was evaluated, and FSH was compared with thrombin-soaked gelatin sponge (Gelfoam; TSG). METHODS: The study was of a randomized, open-label, single-site, single-treatment, parallel design that took place in a referral center with hospitalized patients. Forty-seven adult patients (33 men, 14 women) underwent elective carotid endarterectomy. Patients were randomized to receive either FSH (N = 24) or TSG (N = 23). FSH was obtained as an investigational new drug. FSH was applied as a liquid by means of a dual-syringe technique. Heparin anticoagulation, patch thickness, and suture type were standardized. Two different needle sizes were used (CV-6, PT-13: N = 21 [FSH: N = 10, TSG: N = 11]; CV-6, PT-9: N = 26 [FSH: N = 14, TSG: N = 13]). The FSH or TSG was applied to the ePTFE patch, and then blood flow was restored through the carotid artery. Degree of anticoagulation was assessed by anti-factor Xa activity. The time from restoration of carotid blood flow until achieving hemostasis was recorded. The blood loss from patch suture hole bleeding was measured. Completion intraoperative duplex ultrasound scanning was performed in all cases. Heparin was reversed with protamine sulfate. The primary end point was successful hemostasis within 15 minutes of restoration of carotid blood flow. The secondary end points were the amount of blood loss caused by suture line bleeding and the time to achieve hemostasis. RESULTS: There was no difference in the number of patients with complete hemostasis at 15 minutes (TSG, 13 of 23; FSH, 12 of 24; P =.77). The measured blood loss was 99.0 +/- 119.9 (SD) mL for TSG, and 105.0 +/- 107.9 mL for FSH (P =.86). The time to hemostasis was the same for both groups (TSG, 16.5 +/- 16.5 minutes; FSH, 16.6 +/- 14.2 minutes; P =.97). Within both treatment groups, the use of larger needles (PT-13) was associated with greater blood loss (FSH, 169.7 +/- 124.2 mL; TSG, 172.7 +/- 151.5 mL) than was the use of smaller needles (PT-9; FSH, 58.8 +/- 66.3 mL; TSG, 34.1 +/- 25.6 mL; P =.036, P =.001, respectively). There were no postoperative strokes or bleeding complications in either group. No abnormalities were shown in either group by means of completion carotid duplex ultrasound scanning. CONCLUSION: FSH was equivalent, but not superior to, TSG in achieving hemostasis during carotid endarterectomy performed with ePTFE patch angioplasty. Adhesion properties of FSH to ePTFE are possibly different than those to native tissue and warrant additional investigation.

Determination of 60% or greater carotid stenosis: a prospective comparison of magnetic resonance angiography and duplex ultrasound with conventional angiography.

The morbidity and cost of conventional angiography (CA) have focused recent efforts in cerebrovascular imaging upon the exclusive use of noninvasive techniques. Our purpose was to prospectively evaluate carotid magnetic resonance angiography (MRA) and to compare its accuracy with color-flow duplex (CFD). Fifty patients were prospectively evaluated with CA and MRA after clinical and CFD findings indicated the need for carotid angiography. CFD measurements of peak systolic velocity (PSV) and end-diastolic velocity (EDV) were made. MRA results were categorized as 0%-39%, 40%-59%, 60%-79%, or 80%-99% stenosis or occluded. Determination of percent carotid stenosis by CA was made as in the North American Symptomatic Carotid Endarterectomy Trial (NASCET). Using receiver operating characteristic (ROC) curves, the probability of correctly predicting a > or =60% stenosis using various CFD thresholds and MRA was assessed. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in determining > or =60% stenosis were estimated. For MRA the sensitivity was 85% (95% Confidence Interval [CI] = 69%-94%), specificity 70% (CI = 56%-81 %), PPV 68% (CI = 53%-80%), and NPV 86% (CI = 72%-94%). For CFD the sensitivity was 89% (CI = 74%-96%), specificity 93% (CI = 82%-98%), PPV 89% (CI = 74%-96%), and NPV 93% (CI = 82%-98%). When MRA and CFD results were concordant (n = 64), the sensitivity was 100% (CI = 89%-100%), specificity 95% (CI = 81%-99%), PPV 94% (CI = 77%-99%), and the NPV was 100% (CI = 92%-100%). The area under the ROC curve for CFD was 95%, compared to 83% for MRA (p = 0.0005). We conclude that the low specificity of MRA precludes its use as the definitive imaging modality for carotid stenosis. The 93% specificity of CFD alone warrants its consideration as a definitive carotid imaging study. By ROC curve analysis, CFD offers superior accuracy to MRA. Our data support noninvasive preoperative carotid imaging for detecting a threshold stenosis of > or =60% whether CFD is used alone, or in combination with the selective use of MRA.

Primary stenting of atherosclerotic renal artery ostial stenosis.

Percutaneous transluminal angioplasty for atherosclerotic ostial lesions of the renal arteries has resulted in high restenosis rates. Recent reports of angioplasty with intravascular stenting show improved results over angioplasty alone. The purpose of this study is to review the results of primary stenting of ostial renal artery stenosis at our institution. Twenty one patients (11 men, 10 women, age 63 +/- 11 years), with atherosclerotic renal artery ostial stenosis in association with hypertension or renal insufficiency underwent renal angioplasty with primary stenting during a 2-year period. Medical records were reviewed for indications, technical success, complications, restenosis, response of hypertension and response of renal insufficiency. A technical success was defined as a normal postprocedure arteriogram with no residual stenosis and no residual gradient. Restenosis was defined as > or =60% diameter reduction identified by arteriography, or duplex scan demonstrating a renal artery to aortic ratio of > or =3.5. Thirty-three stents were placed in 25 arteries with four patients having bilateral procedures. All patients were hypertensive. Nine patients (43%) had chronic renal insufficiency (creatinine > or =1.5 mg/dl). One patient was on hemodialysis. The immediate technical success rate was 95%. Six complications occurred in four patients (two pseudoaneurysms, two dissections requiring additional stents, renal failure, and atheroembolization). Mean arterial blood pressure improved from 117 +/- 13.4 to 103 +/- 12.8 mmHg (p = 0.002) after stenting. Serum creatinine levels decreased from 1.48 +/- 0.57 to 1.31 +/- 0.41 (p = 0.07). Eight patients developed restenosis. The mean follow up was 13 +/- 7 months. Life table analysis showed a cumulative restenosis rate of 65 +/- 18% at 24 months. We advise caution in the application of renal stenting for the treatment of ostial lesions, particularly in patients for whom standard surgical revascularization options are available.

Presentation and management of venous aneurysms.

PURPOSE: Venous aneurysms have been reported to occur in most major veins. These aneurysms may be misdiagnosed as soft tissue masses or as inguinal or femoral hernias. Venous aneurysms of the deep system have been associated with deep venous thrombosis (DVT) and pulmonary embolism (PE). To more precisely characterize these lesions, we reviewed our experience with the disease. METHODS: A retrospective analysis of our experience over 22 years was performed. The presentation and management of these lesions were reviewed and compared with the literature. RESULTS: Thirty-nine venous aneurysms were reported in 30 patients. There were 14 men and 16 women. The patients' ages ranged from 3 to 75 years. Thirty aneurysms were located in the lower extremities, four in the upper extremity, and five in the internal jugular vein. Fifty-seven percent of lower extremity aneurysms occurred in the deep system. Patients' symptoms were a mass (75%) associated with pain (67%) and swelling (42%). Thromboembolism occurred in six patients, DVT in three, and PE in three. Eight of nine patients (89%) who had aneurysms of the superficial venous system had their condition misdiagnosed. Diagnosis was made by phlebography (60%), color flow duplex scanning (27%), continuous-wave Doppler scanning (10%), or magnetic resonance imaging (10%). The aneurysm size ranged from 1.7 to 6.0 cm. Management consisted of tangential excision in five (17%), total excision in 23 (77%), and observation in seven (6%). CONCLUSIONS: Venous aneurysms are unusual vascular malformations that occur equally between the sexes and are seen at any age. Most patients have a painful mass of the extremity, and diagnosis is achieved by radiologic examination. Superficial venous aneurysms of the inguinal region are often misdiagnosed. Thromboembolism is more common in aneurysms involving the deep venous system. Because of their potential morbidity, management should be surgical in the majority of cases.

Saphenous vein versus polytetrafluoroethylene carotid patch angioplasty.

BACKGROUND: The optimal material for carotid patch angioplasty after endarterectomy remains uncertain. This study compares the early outcome and recurrent stenosis rates between saphenous vein (SV) and expanded polytetrafluoroethylene (ePTFE) carotid patch angioplasty. METHODS: The results of 421 consecutive carotid endarterectomies performed over a 72-month period were reviewed. Postoperative complications and restenosis rates, defined as > OR = 60% narrowing measured by color flow duplex, were compared. RESULTS: Patch angioplasty was performed with SV in 287 and with ePTFE in 110 cases. Patients who had undergone primary closure (n = 20) or whose form of closure was unknown (n = 4) were excluded. The mean age of patients and length of follow-up was similar between groups. Women were more likely to be patched with ePTFE than were men (36% versus 23%, P = 0.02). One death occurred in each group (0.3% SV, 0.9% ePTFE, P = 0.47), and four strokes occurred in each group (1.4% SV, 3.6% ePTFE, P = 0.22). Cervical hematomas requiring operative evacuation occurred in five SV closures and in three ePTFE closures (1.7% versus 2.7%, P = 0.69). Vein harvest site complications occurred in 6 patients (2%) who had undergone SV patch angioplasty. Recurrent stenosis occurred in 3 patients with SV closure and in 3 patients with ePTFE closure (1.0% versus 2.7%, P = 0.35). The 60-month restenosis rates by life table analysis were 2.6% +/- 2.1% for SV and 10.7% +/- 7.9% for ePTFE (P = 0.17). CONCLUSIONS: The incidence of postoperative complications is similar with SV or ePTFE patch angioplasty; however, vein harvest site complications are avoided with the use of ePTFE. Recurrent stenosis at 5 years occurs infrequently with either SV or ePTFE.

The fate of residual defects following carotid endarterectomy detected by early postoperative duplex ultrasound.

BACKGROUND: The purpose of this study is to evaluate the results of color-flow duplex ultrasound (CFD) soon after carotid endarterectomy (CEA) to determine the incidence of residual abnormalities and their effect on subsequent outcome and management. METHODS: We reviewed 318 consecutive CEAs performed over a 48 month-period. Of these, 206 were followed up with CFD, 195 prior to discharge and 11 at first follow-up (within 9 weeks). Patients (43) followed up with only oculoplethysmography (OPG) or those with no OPG or CFD (69) were excluded from the study. All CEAs were performed under general anesthesia with routine shunting and patch angioplasty. RESULTS: Twelve of the 206 studies (5.8%) were abnormal. Two patients with an abnormal CFD sustained perioperative stroke, both of whom had distal intimal lesions of > 60% diameter stenosis by velocity criteria. Four patients had > 60% stenosis and were reoperated upon to correct technical errors. The remaining 6 patients are asymptomatic. Four had residual lesions of < 60% stenosis, three of which have returned to normal on subsequent CFD. Two residual lesions had > 60% stenosis; one returned to normal by CFD and the other remains abnormal at 10 months. In the group of 192 normal postoperative CFD studies, there were no strokes, deaths, or redo procedures (0%, 95% confidence interval 0% to 1.54%) compared with a combined 50% rate (6 of 12) of either stroke (2 of 12) or redo procedure (4 of 12) when the postoperative CFD was abnormal (95% confidence interval 22.3% to 77.7%, P < 0.0001). During the study period the CEA stroke rate was 0.9% (3 of 318), with a combined stroke-mortality rate of 1.3% (4 of 318). CONCLUSIONS: Early postoperative CFD identified residual abnormalities in 5.8% of carotid endarterectomies despite a low overall stroke mortality rate. One half of these abnormalities resulted in stroke or required operative correction. Colorflow duplex ultrasound is useful in identifying residual abnormalities following CEA and should be considered for intraoperative use.

Antithrombotic effects of hirulog in a rat carotid endarterectomy model.

Although hirulog, a specific, direct inhibitor of thrombin, can prevent thrombosis in unstable angina and angioplasty without inducing excessive bleeding, it has not been used in a surgical setting. In the present study, the antithrombotic activity of hirulog was assessed in rats undergoing carotid endarterectomy. Three groups of anesthetized male Sprague-Dawley rats received either intravenous heparin (10 U/kg bolus followed by 90 U/kg/hr, n = 4), high-dose hirulog (0.8 mg/kg bolus followed by 2.2 mg/kg/hr, n = 7), or saline (n = 6) before endarterectomy and until termination of the protocol 30 min later. Platelet deposition, as measured by scanning electron microscopy, in rats receiving this high dose of hirulog was reduced by 63% (+/- 14%, SE) compared to controls (P = 0.004) and by 36% (+/- 16%) in heparinized rats (P - 0.07). Both groups had prolonged postsurgical bleeding. Infusion of hirulog at a lower dose (0.4 mg/kg bolus followed by 1.0 mg/kg/hr, n = 8) was not associated with prolonged bleeding; however, platelet deposition was reduced by only 16% (+/- 27%, P = 0.30), although 125I-fibrin deposition was reduced by 64% (+/- 11%, P = 0.004). In the high-dose hirulog group, plasma hirulog levels, as determined with a quantitative thrombin time, were three times higher (95% CI: 1.5-4.5 times) than in the group receiving the lower hirulog dose [11.6 +/- 2.3 (SE) micrograms/ml vs 3.9 +/- 0.6 micrograms/ml; P = 0.0022]. However, the mean activated partial thromboplastin time with the higher dose was similar to that of the lower dose (110 +/- 4 vs 90 +/- 13 sec, P - 0.09). The antithrombotic activity of hirulog can be maximized by titrating the dose, monitoring plasma drug levels, and possibly administering the drug after surgery to avoid prolonged bleeding.