Endoleak as a predictor of outcome after endovascular aneurysm repair: AneuRx multicenter clinical trial.

OBJECTIVE: The purpose of this study was to determine whether evidence of blood flow in the aneurysm sac (endoleak) is a meaningful predictor of clinical outcome after successful endovascular aneurysm repair. METHODS: We reviewed all patients in Phase II of the AneuRx Multicenter Clinical Trial with successful stent graft implantation and predischarge contrast computed tomographic (CT) imaging. The clinical outcome of patients with evidence of endoleak was compared with the outcome of patients without evidence of endoleak. The CT endoleak status before hospital discharge at 6, 12, and 24 months was determined by each clinical center as well as by an independent core laboratory. Endoleak status at 1 month was assessed with duplex scanning examination or CT at each center without confirmation by the core laboratory. RESULTS: Centers reported endoleaks in 152 (38%) of 398 patients on predischarge CT, whereas the core laboratory reported endoleaks in 50% of these patients (P <.001). The center-reported endoleak rate decreased to 13% at 1 month. Follow-up extended to 2 years (mean, 10 +/- 4 months). One patient had aneurysm rupture and underwent successful open repair at 14 months. This patient had a Type I endoleak at discharge but no endoleak at 1 month or at subsequent follow-up times. There were no differences between patients with and patients without endoleak at discharge in the following outcome measures: patient survival, aneurysm rupture, surgical conversion, the need for an additional procedure for endoleak or graft patency, aneurysm enlargement more than 5 mm, the appearance of a new endoleak, or stent graft migration. Despite a higher endoleak rate identified by the core laboratory, neither the endoleak rate reported by the core laboratory nor the endoleak rate reported by the center at discharge was significantly related to subsequent outcome measures. Patients with endoleak at 1 month were more likely to undergo an additional procedure for endoleak than patients without endoleaks. Patients with Type I endoleaks at discharge and patients with endoleak at 1 month were more likely to experience aneurysm enlargement at 1 year. However, there was no difference in patient survival, aneurysm rupture rate, or primary or secondary success rate between patients with or without endoleak. Actuarial survival of all patients undergoing endovascular aneurysm repair was 96% at 1 year and was independent of endoleak status. Primary outcome success was 92% at 12 months and 88% at 18 months. Secondary outcome success was 96% at 12 months and 94% at 18 months. CONCLUSIONS: The presence or absence of endoleak on CT scan before hospital discharge does not appear to predict patient survival or aneurysm rupture rate after endovascular aneurysm repair using the AneuRx stent graft. Although the identification of blood flow in the aneurysm sac after endovascular repair is a meaningful finding and may at times indicate inadequate stent graft fixation, the usefulness of endoleak as a primary indicator of procedural success or failure is unclear. Therefore, all patients who have undergone endovascular aneurysm repair should be carefully followed up regardless of endoleak status.

Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate aNd discharge (STAND I and STAND II) trials.

Despite advances in other aspects of cardiac catheterization, manual or mechanical compression followed by 4 to 8 hours of bed rest remains the mainstay of postprocedural femoral access site management. Suture-mediated closure may prove to be an effective alternative, offering earlier sheath removal and ambulation, and potentially a reduction in hemorrhagic complications. The Suture To Ambulate aNd Discharge trial (STAND I) evaluated the 6Fr Techstar device in 200 patients undergoing diagnostic procedures, with successful hemostasis achieved in 99% of patients (94% with suture closure only) in a median of 13 minutes, and 1% major complications. STAND II randomized 515 patients undergoing diagnostic or interventional procedures to use of the 8Fr or 10Fr Prostar-Plus device versus traditional compression. Successful suture-mediated hemostasis was achieved in 97.6% of patients (91.2% by the device alone) compared with 98.9% of patients with compression (p = NS). Major complication rates were 2.4% and 1.1%, and met the Blackwelder's test for equivalency (p <0.05). Median time to hemostasis (19 vs 243 minutes, p <0.01) and time to ambulation (3.9 vs 14.8 hours, p <0.01) were significantly shorter for suture-mediated closure. Suture-mediated closure of the arterial puncture site thus affords reliable immediate hemostasis and shortens the time to ambulation without significantly increasing the risk of local complications.

AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial.

The results of a prospective, nonrandomized, multicenter clinical trial that compared endovascular stent graft exclusion of abdominal aortic aneurysms with open surgical repair are presented. During an 18-month period, 250 patients with infrarenal aneurysms underwent treatment at 12 study sites-190 patients underwent endovascular repair using the Medtronic AneuRx stent graft (Sunnyvale, Calif), and 60 underwent open surgical repair. There was no significant difference in operative mortality rates between the groups. The patients who underwent stent grafting had significant reductions in blood loss, time to extubation, and days in the intensive care unit and in the hospital, with an earlier return to function. The major morbidity rate was reduced from 23% in the surgery group to 12% (P <. 05) in the stent graft group. There was no difference in the combined morbidity/mortality rates between the two groups. Primary technical success at the time of discharge for the patients with stent grafts was 77%, largely as a result of a 21% endoleak rate. At 1 month, the endoleak rate had decreased to 9%. There was no difference in the primary or secondary procedure success rates at 30 days between the surgery and stent graft groups. The primary graft patency rate at 6 months was 98% in the surgery group and 97% in the stent graft group. The aneurysm exclusion rate at 1 month and 6 months was 100% in patients who underwent surgery and 91% in patients who underwent stent grafting. Stent graft migration occurred in three patients and resulted in late endoleaks; each endoleak was corrected by means of endovascular placement of a stent graft extender cuff. There have been no aneurysm ruptures and no surgical conversions to open repair in the stent graft group. Stent graft repair compares favorably with open surgical repair, with a reduced morbidity rate, shortened hospital stays, and satisfactory short term outcomes.

Palmaz stent in atherosclerotic stenoses involving the ostia of the renal arteries: preliminary report of a multicenter study.

Palmaz balloon-expandable stents were placed in 28 hypertensive patients with atherosclerosis involving the ostia of the renal arteries. Stents were placed to treat elastic recoil immediately after conventional angioplasty in 20 patients and restenosis after percutaneous transluminal angioplasty in eight patients. Technical success (greater than 30% residual stenosis) was achieved in 27 patients. Complications occurred in five patients. At follow-up (1-25 months), hypertension was cured in three patients and improved in 15 patients, with a cumulative cure or improvement of 64% at 6 months. Of 14 patients with a serum creatinine level of 1.5 mg/dL (132.6 mumol/L) or greater before the placement of stents, five demonstrated improved renal function, five showed stabilization of their condition, and four demonstrated deterioration. Follow-up angiography (2-18 months) was performed in 18 patients. Restenosis was present in seven patients and was accompanied by a relapse of hypertension in only three patients. Of the other four patients with restenosis, two had no initial improvement and two had an initial response without a relapse of hypertension. In this preliminary study, renal stents were beneficial in many patients with poor results from conventional angioplasty for ostial atheroma.

Clinical and anatomical considerations for nonoperative therapy in tibial disease and the results of angioplasty.

For a 6-year period, 96 patients had 146 below-knee angioplasties. There were 31 total occlusions and 95 multiple stenoses. All patients had distal ischemia, and 40% had gangrene. The primary success rate was 97%, and the 2-year limb salvage rate was 83%. The ankle/brachial index increased from a mean of 0.25 before the procedure to 0.62 afterward. At 2 years (35 patients), the mean ankle/brachial index was 0.55. For the same period, 320 femorodistal bypasses were performed. The results of angioplasty are comparable to those of surgery, but angioplasty is only suitable in about 20-30% of patients presenting with isolated tibial disease. Suitable lesions are five or fewer stenoses and occlusions 5 cm or less in length.

Angioplasty and stenting of completely occluded iliac arteries.

Percutaneous angioplasty and placement of balloon-expandable intraluminal stents were performed in 12 iliac occlusions in 12 patients. Indications were limb salvage in seven and claudication in five. After successful stenting, ankle-brachial indexes improved by 0.15 or more in 11 of 12 patients (mean increase, 0.40), transstenotic pressure gradients decreased to less than 5 mm Hg (mean, 0.58 mm Hg) in all patients, and improvement in clinical grade was seen in all patients. At follow-up at 1-14 months (median, 6 months), ankle-brachial indexes were stable (mean, 0.95), and clinical grades were unchanged in all patients. Complications occurred in two patients; both experienced distal embolization, and one, who was receiving corticosteroid therapy, also suffered stent thrombosis. Local surgical embolectomy was successful in both patients, and the thrombosed stent was recanalized with urokinase. This early experience suggests that stenting may play an important role in the management of iliac occlusions, especially in poor surgical candidates.

Peripheral laser-assisted balloon angioplasty. Initial multicenter experience in 219 peripheral arteries.

In this multicenter clinical series of peripheral laser-assisted balloon angioplasty with an argon laser-heated, metallic-capped fiberoptic, angiographic and clinical success was achieved in a total of 155 (71%) of 219 attempted lesions. When the anatomy of the lesion was subjectively categorized by the angiographer into those considered possible or impossible to treat by conventional balloon angioplasty, clinical success was achieved in 116 (78%) of 149 lesions considered possible to treat with balloon angioplasty (39 [95%] of 41 stenoses and 77 [71%] of 108 occlusions). More importantly, clinical success was achieved in 39 (56%) of 70 lesions considered impossible to treat by conventional means. The incidence of complications, including vessel perforation (4.1%), with this new technique was equal to that reported for conventional balloon angioplasty, decreased with operator experience, and was less than that reported for argon laser angioplasty with bare fiberoptics. Thus, laser thermal angioplasty with a laser-heated, metallic-capped fiberoptic is a safe procedure that is easily learned by physicians skilled in interventional techniques. It allows for nonsurgical treatment of lesions considered difficult or impossible to treat by conventional balloon angioplasty.

A double-blind comparative study of the safety, tolerability, and efficacy of ioversol and iohexol in peripheral and visceral arteriography.

A randomized, double-blind, parallel-group clinical study was conducted to compare the efficacy, tolerability, and safety of ioversol 320 mg I/mL (Optiray, 320 Mallinckrodt Medical, Inc., St. Louis, MO) and iohexol 300 mg I/mL (Omnipaque 300, Winthrop Pharmaceuticals, New York, NY). The study was conducted in 50 patients undergoing peripheral arteriography and in ten patients undergoing visceral arteriography. In the peripheral group, 92% of the radiographs acquired using Optiray were rated excellent or good. Eighty-eight percent of those acquired with Omnipaque were so rated. In the visceral study all radiographs in both groups were rated excellent or good. Patient tolerance was also impressive. We used a four-point rating scale (1 - none; 4 = severe) to score both heat and pain sensations. For peripheral patients the average heat score was 2.4 in the Optiray group versus 2.3 in the Omnipaque group. The average pain scores were 1.1 in both groups. For visceral patients, the average heat scores were 2.4 in both groups, while the pain scores were 1.7 for the Optiray group versus 1.0 for the Omnipaque group. No clinically significant changes in vital signs were observed in any of the patients. One clinically significant change in the electrocardiogram (ECG) tracing was noted after an Optiray injection, but it was not felt to be drug induced. There were five instances in which laboratory values rose from their normal baseline values, but all changes were minor. There was only one adverse reaction in the entire study. A short episode of coughing occurred in one patient who received Omnipaque for a peripheral study; the coughing resolved spontaneously. Both Optiray and Omnipaque proved to be efficacious, well tolerated, and safe for intra-arterial use in peripheral and visceral vessels.

Arterial occlusive disease below the knee: treatment with percutaneous transluminal angioplasty performed with low-profile catheters and steerable guide wires.

In 98 patients with arterial occlusive disease below the knee who were candidates for limb salvage surgery, percutaneous transluminal angioplasty (PTA) was performed with a low-profile balloon catheter and steerable guide wire system. Sixteen patients had bilateral disease; thus, there were 114 endangered limbs and 145 diseased vessels, including 19 with a single stenosis, 94 with multiple stenoses, and 32 with total occlusions. Primary anatomic success was achieved in all stenosed vessels and in 28 occluded vessels. Initial limb healing without amputation was achieved in 88% of limbs. In four patients occluded vessels could not be recanalized; thus, the four affected limbs were amputated. Two years after PTA, 32 of 37 patients available for follow-up had viable pain-free extremities. Cumulative limb salvage rate at 2 years was 86%. At this time, below-the-knee PTA is still recommended only for limb salvage candidates. However, with this new catheter and guide wire system, success rates have been increased and complication rates decreased. PTA may be useful in selected patients with severe claudication.

Percutaneous transluminal angioplasty of the iliac arteries: intravenous digital subtraction angiography for follow-up.

A group of 25 patients who had suspected aortoiliac disease was screened using digital subtraction angiography (DSA) and conventional catheter arteriography with an overall accuracy of 88% for DSA. A second group of 50 consecutive patients who had undergone iliac angioplasty at least two years previously was examined with DSA, and a satisfactory examination was obtained in 94% of the cases; 89% of the angioplasty sites remained free of significant stenotic disease without evidence of complications related to angioplasty. We compared findings of DSA of the aortoiliac segment with findings of Doppler examinations and found the procedures to be complementary. We conclude that DSA is a reliable method for follow-up of iliac angioplasty sites, and meets with considerable acceptance from patients.

Percutaneous transluminal angioplasty of the renal arteries: intravenous digital subtraction angiography for follow-up.

A group of 50 consecutive patients who had undergone successful renal angioplasty two or more years previously was studied by video digital subtraction angiography (DSA). Thirty additional patients were studied by both DSA and conventional catheter arteriography. Among the 30 patients, DSA findings agreed with the arteriographic findings in 87% of the examinations: 92% of the postangioplasty patients had satisfactory DSA examinations. Using DSA two years after angioplasty, we were able to determine a restenosis rate of 22.5% among patients with atherosclerosis and of 0% among patients who had fibromuscular disease. DSA provides a useful method to follow-up renal angioplasty, and it is well accepted by patients.

Reversal of digitalis-induced mesenteric vasospasm by sodium nitroprusside.

Digitalis constricts the peripheral vasculature. When digitalis is administered to patients whose mesenteric blood flow is reduced secondary to heart failure, the vasoconstrictor action coupled to reduced mesenteric flow may result in mesenteric ischemia or hemorrhagic bowel necrosis. The clinical syndrome of mesenteric ischemia secondary to heart failure and excess digitalis developed in a patient. Splanchnic vasoconstriction was proved angiographically. Both the vasospasm and clinical evidence of mesenteric ischemia were promptly reversed by sodium nitroprusside.

Percutaneous transluminal renal angioplasty.

One to 2 percent of the 25,000,000 hypertensive patients in the United States have renovascular hypertension. Until recently, the treatment of choice for a patient with an ischemic, renin-producing kidney that caused hypertension involved a major abdominal operation. Percutaneous catheter techniques are now available that permit correction of a renal artery stenosis under fluoroscopic guidance. This percutaneous transluminal angioplasty procedure has received much attention, but to date no long-term follow-up studies are available. Because of the limited life-expectancy of patients with a generalized arteriosclerotic process and the relatively high risk of operative procedures in this group of patients, it would seem appropriate to consider percutaneous transluminal renal angioplasty as an alternative method in the management of the patient with renovascular hypertension.

Radiologic examination of the heart.

The radiologic examination of cardiovascular disease in the elderly requires focus on an adjusted norm, cardiovascular calcifications, and atherosclerosis as presented in the plain film findings. The judicious use of noninvasive radiographic techniques in conjunction with echocardiography, electrocardiography, and clinical examination should lead to appropriate care for the elderly patient.