Carotid Stenting with Cerebral Protection: First Clinical Experience Using the PercuSurge GuardWire System

Abstract

Purpose:

To study the feasibility and safety of carotid angioplasty and stenting using a new cerebral protection device that temporarily occludes the distal internal carotid artery (ICA).

Methods:

Forty-eight high-risk patients (39 men, mean age 69.1 ± 8 years, range 54 to 86) with 53 ICA stenoses underwent percutaneous angioplasty and stenting via the femoral approach under cerebral protection afforded by a 0.014-inch GuardWire balloon occlusion device. Mean stenosis was 82.1% ± 9.65% (range 70 to 96) and mean lesion length was 16.0 ± 7.5 mm (range 6 to 50). Thirty-three (62%) lesions were calcified, and 38 (72%) were ulcerated. Thirty-two (60%) of the lesions were asymptomatic. With the occlusion balloon inflated in the distal ICA, the lesion was dilated and stented. The area was cleaned by aspiration and flushed via an aspiration catheter advanced over the wire. Blood samples were collected from the external carotid artery (ECA) and analyzed to measure the size and number of particles collected. Computed tomography and neurological examinations were performed the day after the procedure.

Results:

Immediate technical success was achieved in all patients with the implantation of 38 Palmaz stents, 8 Expander stents, and 11 Wallstents. Carotid occlusion was well tolerated in all patients but 1 who had multiple, severe carotid lesions and poor collateralization. Mean cerebral flow occlusion time was 346 ± 153 seconds during predilation and 303 ± 143 seconds during stent placement. Total mean flow occlusion time was 542 ± 243 seconds. One immediate neurological complication (transient amaurosis) occurred in a patient who had an anastomosis between the external carotid (EC) and ICA territories. Debris was removed in all patients with a mean 0.8-mm diameter catheter.

Conclusion:

Cerebral protection with the GuardWire device is easy, safe, and effective in protecting the brain from cerebral embolism. Larger studies are warranted.

Keywords

carotid occlusive disease stenosis internal carotid artery embolization Palmaz stent Wallstent Expander stent

Get full access to this article

View all access options for this article.

References

Zarins

. Carotid endarterectomy: The gold standard. J Endovasc Surg 1996;3:10–15.

Henry

Amor

Masson

. Angioplasty and stenting of the extracranial carotid arteries. J Endovasc Surg 1998;6:293–304.

Henry

Amor

Masson

. Endovascular treatment of atherosclerotic stenosis of the internal carotid artery. J Cardiovasc Surg 1998;39(Suppl 1):141–150.

Yadav

Roubin

Iyer

. Elective stenting of the extracranial carotid arteries. Circulation 1997;95:376–381.

Diethrich

Ndiaye

Reid

. Stenting in the carotid artery: Initial experience in 100 patients. J Endovasc Surg 1996;3:42–62.

Bergeron

Becquemin

Jausseran

. Percutaneous stenting of the internal carotid artery: The European CAST I study. J Endovasc Surg 1999;6:155–159.

Chastain

Gomez

Iyer

. Influence of age upon complications of carotid artery stenting. J Endovasc Surg 1999;6:217–222.

Roubin

Yadav

Iyer

. Carotid stent-supported angioplasty: A neurovascular intervention to prevent stroke. Am J Cardiol 1996;78(Suppl 3A):8–12.

Wholey

Bergeron

. Current global status of carotid artery stent placement. Cathet Cardiovasc Diagn 1998;44:1–6.

10.

Wholey

Jarmolowski

. Endovascular stents for carotid artery occlusive disease. J Endovasc Surg 1997;4:326–338.

11.

Webb

Carere

. An emboli containment system for saphenous vein graft angioplasty. (Abstr.) J Am Coll Cardiol 1998;31(Suppl 2A):236A.

12.

Orgogozo

Dartigues

. Methodology of clinical trials in acute cerebral ischemia: Survival, functional, and neurological outcome measures. Cerebrovasc Dis 1991;1(Suppl 1):100–111.

13.

Martin

Gailloud

Sugiu

. In-vitro models of human carotid atheromatous disease. In: Henry

Amor

, eds. Ninth International Course Book of Peripheral Vascular Intervention. Paris, Europa Edition, 1998:541–546.

14.

Bettmann

Katzen

Whisnant

. Carotid stenting and angioplasty (AHA Science Advisory). Circulation 1998;97:121–123.

15.

Joint Officers of the Congress of Neurological Surgeons and the American Association of Neurological Surgeons. Clinical Position Statement: Carotid angioplasty and stent: An alternative to carotid endarterectomy. Neurosurgery 1997;40:344–345.

16.

Joint Council of the Society for Vascular Surgery and the International Society for Cardiovascular Surgery, North American Chapter. Statement regarding carotid angioplasty and stenting. J Vasc Surg 1996;24:900.

17.

Théron

Courtheoux

Alachkar

. New triple coaxial catheter system for carotid angioplasty with cerebral protection. AJNR Am J Neuroradiol 1990;11:869–874.

18.

Mathur

Roubin

Iyer

. Predictors of stroke complicating carotid artery stenting. Circulation 1998;97:1239–1245.

19.

Ohki

Marin

Lyon

. Ex vivo human carotid artery bifurcation stenting: Correlation of lesion characteristics with embolic potential. J Vasc Surg 1998;27:463–471.

20.

Holdsworth

McCollum

Bryce

. Symptoms, stenosis, and carotid plaque morphology: Is plaque morphology relevant? Eur J Vasc Endovasc Surg 1995;9:80–85.

21.

AbuRahma

Covelli

Robinson

. The role of carotid duplex ultrasound in evaluating plaque morphology: Potential use in selecting patients for carotid stenting. J Endovasc Surg 1999;6:59–65.

22.

Biasi

Mingazzini

Baronio

. Carotid plaque characterization using digital image processing and its potential in future studies of carotid endarterectomy and angioplasty. J Endovasc Surg 1998;5:240–246.

23.

Carr

Cheanvechai

Virmani

. Histology and clinical significance of the carotid atherosclerotic plaque: Implications for endovascular treatment. (Editorial) J Endovasc Surg 1997;4:321–325.

24.

Nicolaides

Shifrin

Bradbury

. Angiographic and duplex grading of internal carotid stenosis: Can we overcome the confusion? J Endovasc Surg 1996;3:158–165.

25.

Reid

. Commentary: Carotid plaque characterization: Helpful to endarterectomy and endovascular surgeons. J Endovasc Surg 1998;5:247–250.

26.

Reid

Diethrich

Marx

. Intravascular ultrasound assessment in carotid interventions. J Endovasc Surg 1996;3:203–210.

27.

Hayward

Davies

Lamont

. Carotid plaque morphology: A review. Eur J Vasc Endovasc Surg 1995;9:368–374.

28.

Théron

Payelle

Coskun

. Carotid artery stenosis: Treatment with protected balloon angioplasty and stent placement. Radiology 1996;201:627–636.

29.

Oesterle

Baim

Hayasse

. A coaxial catheter system for prevention of distal embolization. (Abstr.) J Am Coll Cardiol 1998;31(Suppl 2A):236A.

30.

North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med 1991;325:445–453.

31.

Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic carotid artery stenosis. JAMA 1995;273:1421–1428.

32.

Riles

Imparato

Jacobwitz

. The cause of perioperative stroke after carotid endarterectomy. J Vasc Surg 1994;19:206–216.

33.

Ackerstaff

RGA

Jansen

Moll

. The significance of microemboli detection by means of transcranial Doppler ultrasonography monitoring in carotid endarterectomy. J Vasc Surg 1995;21:963–969.

34.

Jansen

Ramos

LMP

Heesewijk

JPM

. Impact of microembolization and hemodynamic changes in the brain during carotid endarterectomy. Stroke 1994;25:992–997.

35.

Kachel

. Results of balloon angioplasty in carotid arteries. J Endovasc Surg 1996;3:22–30.

36.

Théron

. Cerebral protection during carotid angioplasty. (Letter) J Endovasc Surg 1996;3:484–485.