Chester R. Jarmolowski

Endovascular Stents for Carotid Artery Occlusive Disease

Purpose: To study the feasibility and safety of endovascular stenting of cervical carotid artery stenosis. Methods: Between April 1994 and May 1997, 108 consecutive patients (58 men; mean age 70.1 years) with ≥ 70% carotid stenosis were treated with percutaneous stent implantation under a protocol that featured independent neurological review. Forty-four percent were asymptomatic. Over half the lesions (59%) were in the internal carotid artery; the mean stenosis was 86%. Palmaz stents were implanted without cerebral protection following preliminary balloon dilation; two Wallstents were used in long lesions. Results: Carotid stents were successfully placed in 108 of 114 (95%) lesions. Of the 6 technical failures, 5 were access related and 1 was due to seizures during balloon dilation. Two major (1.8%) and 2 minor (1.8%) strokes occurred (3.7% stroke rate for 108 patients; 3.5% in 114 procedures), all in symptomatic patients, one of whom died. There were 5 (4.4%) transient ischemic attacks and 2 (1.8%) brief seizure episodes during dilation. One patient died of a cardiac event on day 20. The all stroke or death rate was 5.3% based on 114 arteries at risk (5.6% in 108 patients). In the mean 6-month follow-up (range 1 to 36) of 97 eligible patients, 3 (3.1%) died from unrelated causes. There was 1 restenosis (1.0%) from a stent compression, which was successfully redilated. There were no neurological sequelae, cranial palsies, or cases of stent or vessel thrombosis in follow-up. Conclusions: The use of stents in the treatment of cervical carotid occlusive disease appears feasible, effective in the short term, and without excessive risk of periprocedural stroke.

Comparison of thrombolytic therapy of lower-extremity acute, subacute, and chronic arterial occlusions

Our purpose was to study the effectiveness of thrombolytic therapy in treating acute, subacute, and chronic arterial occlusions in a multicenter retrospective study. Intraarterial urokinase infusion was performed in 235 patients for occluded native arteries. There were 70 (30%) with acute and 26 (5%) with subacute occlusions, and 141 (59%) with chronic symptoms for longer than 3 mo. Complete thrombolysis was achieved in 60 (86%) of the acute, 20 (77%) of the subacute, and 106 (75%) of the chronic occlusions. Adjunctive interventional procedures were performed as needed. Long-term follow-up revealed a primary patency of 87%, 85%, and 76% for the acute, subacute, and chronic occlusion groups, respectively. We conclude that the rate of complete thrombolysis of chronic occlusions proved slightly more efficient for acute and virtually the same for subacute occlusions. Long-term follow-up demonstrated a higher failure rate with chronic than with acute occlusions, probably due to worsened peripheral vascular runoff.

Management of Neurological Complications of Carotid Artery Stenting

PURPOSE To review the neurological complications associated with extracranial carotid artery stenting and to preliminarily assess techniques used to manage these complications. METHODS Between April 1994 and August 2000, 450 patients (270 men; mean age 70.2 years, range 27-89) had stents implanted to treat 472 cervical carotid artery stenoses. Over half (257, 57%) of the patients were symptomatic. A variety of stents were implanted percutaneously after predilation of the lesion; a third of the patients received glycoprotein IIb/ IIIa inhibitors intraprocedurally in addition to a standard oral antiplatelet regimen (aspirin and ticlopidine or clopidogrel). Occurrence and management of neurological complications within the 30-day periprocedural period were reviewed. RESULTS There were 14 (3.1%) transient ischemic attacks (TIAs), 10 (2.2%) minor strokes, and 3 (0.7%) major strokes. Among 6 (1.3%) procedure-related deaths, 4 had neurological causes. The total stroke and death rate was 4.2% (n = 19). All the TIAs, 4 of which occurred between 1 and 14 days poststenting, were treated medically, as were the minor strokes, 3 of which occurred >24 hours after stenting. Only 2 minor stroke patients had mild residual upper extremity motor deficits. Intra-arterial thrombolytic therapy was administered in 5 cases (2 major strokes survivors and 3 patients who suffered a neurologically-related death); occlusions were identified in the proximal middle cerebral artery (MCA) in 3 and the distal MCA in 2. Angiographic improvement was noted in 4 (80%), but only the 2 (40%) with distal MCA occlusions did well clinically. CONCLUSIONS Neurological complications following carotid artery stenting are inevitable. The occurrence of minor strokes >24 hours following stenting may indicate a possible late embolic phenomenon, which warrants investigation. Likewise, the marginal efficacy of intra-arterial thrombolytic therapy demonstrates an inability to lyse embolic plaque and underscores the need for effective distal protection.

New Reperfusion Devices: The Kensey Catheter, the Atherolytic Reperfusion Wire Device, and the Transluminal Extraction Catheter

Substantial interest exists in the development of reperfusion and recanalization devices that would aid in the management of both peripheral vascular and coronary artery occlusive disease. Several of these devices are now in multicenter investigative trials. The atherolytic reperfusion wire incorporates a 0.035-inch guide wire with a modified tip to recanalize the lumen through the totally obstructed vascular segment. Clinical experience in the initial 12 patients has been successful. The Kensey catheter, a high-speed rotational recanalization device, has been used in 110 patients in a multicenter trial. Technical success has been reported in 77% of the patients and clinical success in 55% of the patients, with follow-up periods of 3 months to 1 year. The transluminal extraction catheter (TEC) is a torque-controlled atherectomy catheter that incorporates an aspiration device into a distal rotational cutter. Consequently, distal embolization has not been a clinical problem in the 95 patients treated with the TEC catheter for peripheral vascular disease. Technical success has been accomplished in 87 (92%) patients. Three-month follow-up studies in 16 patients showed that restenosis occurred in four, two of whom had undergone combined atherectomy and angioplasty.

Evaluation of Glycoprotein IIb/IIIa Inhibitors in Carotid Angioplasty and Stenting

PURPOSE To review the immediate neurological and bleeding complications associated with the use of glycoprotein (GP) IIb/IIIa inhibitors in patients undergoing extracranial carotid artery stent placement. METHODS A retrospective review was performed of 550 patients (321 men; mean age 71.1 years, range 28-91) who underwent carotid artery angioplasty and stent placement. Glycoprotein IIb/IIIa inhibitors were given prophylactically along with heparin to 216 patients, whose outcomes were compared to a control group of 334 patients who received intravenous heparin alone. Primary endpoints were the immediate and 30-day neurological complications, including transient ischemic attacks (TIAs), minor and major strokes, and neurologically-related deaths. The secondary endpoint was any abnormal bleeding. RESULTS The all stroke/neurological death rate in 216 patients treated with heparin and GP IIb/IIIa inhibitors was 6.0% (13 events) compared 2.4% (8 events) in the 334 patients in the heparin-only control group (p=0.0430). Two of the 4 neurologically-related deaths in the GP IIb/IIIa inhibitor group resulted from intracranial hemorrhages; there were no intracranial hemorrhages in the heparin-only group. There was 1 episode of extracranial bleeding in the GP IIb/IIIa inhibitor group treated with embolization. The incidences of significant puncture-site bleeding requiring transfusion were similar in the groups. CONCLUSIONS Neurological complications following percutaneous carotid artery interventions have been relatively few. The neurological sequelae in carotid stent patients receiving glycoprotein IIb/IIIa inhibitors were more numerous and consequential, which suggests that the use of GP IIb/IIIa inhibitors in carotid stenting should be discouraged.

Carotid Artery Stent Placement—Ready for Prime Time?

FEW medical debates have been more controversial than that between carotid stent placement and carotid endarterectomy (CEA). This is understandable considering that CEA, after the published report of the North American Symptomatic Carotid Endarterectomy Trial (NASCET) trial (1), represented the gold standard for managing carotid artery occlusive disease (1,2). The NASCET trial (1) was initiated in 1988 and completed in 1991. Patients with symptomatic internal carotid artery stenosis greater than 70% were randomized to receive either CEA or medical management. The periprocedural stroke and death rate in the trial was 5.6%. A cumulative 2-year stroke rate of 9% in patients who underwent CEA, versus 26% in patients who underwent medical management, was noted. Surgeons who participated in the trial were carefully given credentials based on a perioperative stroke and death rate lower than 6% in their most recent 50 consecutive patients who had undergone CEA. What is less understood in the NASCET trial is the 7.6% incidence of cranial nerve palsy and the significant neck hematoma rate of 5.5% (1). In contrast to the high-risk carotid artery stent placement registries and the high-risk randomized clinical Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial, NASCET and the Asymptomatic Carotid Atherosclerosis Study (ACAS) trial were trials involving patients at low risk, without significant comorbidity (3,4). Patients with contralateral occlusion comprised the only high-risk subset within the NASCET trial and, in those patients, a perioperative stroke and death rate of 14% was described (1). In the European Carotid Surgical Trial, a perioperative stroke and death rate of 7.1% and a cranial nerve palsy rate of 6.4% were described (5). Chaturvedi et al (6), in a multicenter study, reported an 11% stroke and death rate after CEA, which was believed to represent an accurate account of “real world” endarterectomy results. During this same period, single institutional centers began reporting their data after carotid stent placement in patients in high-risk subsets (7–11). Most of these patients would not have been eligible for enrollment in either the NASCET or ACAS studies. In our experience, only 9% of 540 patients who underwent stent placement would have been eligible for enrollment in either of the NASCET or the ACAS studies (8). However, the Food and Drug Administration declared that carotid stent placement represented a high-risk procedure that would require institutional review board approval and a Food and Drug Administration–approved Investigational Device Exemption before proceeding. It was not until Medicare approved reimbursement for carotid stent placement performed at an approved trial site that carotid stent placement became an acceptable alternative to CEA in a selected high-risk subset of patients.

A Comparison of Balloon-Mounted and Self-Expanding Stents in the Carotid Arteries: Immediate and Long-Term Results of More Than 500 Patients

Purpose: To compare the rates of neurological complications and restenosis for balloon-mounted (BM) versus self-expanding (SE) stents deployed in the extracranial carotid arteries. Methods: Among 513 patients (312 men; mean age 71.3 years, range 27–91) who underwent carotid artery stent placement, 496 received 520 stents. The patients were followed with periodic duplex ultrasound examinations; angiography was performed whenever the duplex scan identified a >50% stenosis or symptoms warranted investigation. Periproce-dural data on complications were analyzed on an intention-to-treat basis, while intermediate-term neurological complications were compared in stented patients. Results: In the periprocedural period, there were 19 (3.7%) transient ischemic attacks, 10 (1.9%) minor strokes, 6 (1.2%) major strokes, and 8 (1.6%) deaths among the 513 patients. Five (1.0%) of the deaths were related to neurological complications (3.9% all stroke/neurological death rate). Among the 496 patients receiving 247 (48%) BM stents and 273 (52%) SE stents in 518 arteries, the all stroke/neurological death rates were 3.6% and 4.0%, respectively (p>0.05). During a mean follow-up of 20.6 months (range to 5.6 years), the 3-year freedom from all fatal and ipsilateral nonfatal strokes excluding the 30-day periprocedural period was 95.0% for BM stents and 95.2% for SE devices. Vessel patency (>50%) at 3 years was 92.0% in the population: 96.3% for BM stents and 83.7% for SE stents (p=0.0422). Conclusions: The rate of neurological complications following carotid stenting has been relatively low overall, and no differences were found relative to the type of stent deployed. Vessel patency was excellent at 3 years, with slightly better patency in BM stents, but because of their vulnerability to compression, they will not replace SE stents.

Subclavian Artery Angioplasty for Treatment of Coronary Artery Steal Syndrome

Three patients underwent percutaneous transluminal angioplasty for treatment of subclavian artery stenosis producing the coronary artery steal syndrome. Technical success and immediate relief of angina were achieved in all three patients. Clinical follow-up ranged from 4 to 16 months. One patient developed clinical evidence of restenosis. Subclavian artery angioplasty may be a safe and efficacious technique for the treatment of the coronary artery steal syndrome.

Infrainguinal directional atherectomy: long-term follow-up and comparison with percutaneous transluminal angioplasty

PurposeTo assess the long-term results of directional atherectomy (DA) for femoropopliteal artery atherosclerotic lesions and to compare the results to those previously reported for percutaneous transluminal balloon angioplasty (PTA).Materials and MethodsEighty-four percutaneous DA procedures performed on 75 patients between July 1988 and August 1992 were retrospectively reviewed and evaluated for technical and initial clinical success. Long-term patency was assessed with a combination of ankle-brachial index measurements and angiography.ResultsInitial technical success was achieved in 77 of 84 procedures (92%). Follow-up of 72 patients was obtained, including 74 of the 84 (88%) DA procedures with a mean follow-up of 17.4 months (range 1–48 months). Primary patency was 78% at 1 year and 57% at 2 years. Patients with diabetes, complete luminal occlusion, or limb salvage situations had significantly lower patency.ConclusionsFemoropopliteal artery DA can be performed safely with a high technical and initial clinical success. Long-term patency is improved when compared with published series for PTA. With this improvement in mind, DA may have a place in the treatment of focal infrainguinal stenoses.

Antegrade popliteal puncture: Technical note

Percutaneous transluminal angioplasty was performed via an antegrade popliteal puncture. This technique was utilized because the patient had a superficial femoral artery occlusion and coexistent popliteal stenoses, with the occlusion unable to be traversed in the usual common femoral artery antegrade approach. To our knowledge, this technique has not been described in the literature. The clinical utility of this approach and important anatomical considerations will be discussed.