Procedure Complications of Carotid Angioplasty and Stent
Procedure Complications of Carotid Angioplasty and Stent
Object: The goal in this retrospective study was to examine the procedural complication rate for carotid angioplasty and stent placement performed without cerebral protection devices.
Methods: Between March 1996 and December 2003, 167 carotid angioplasty and/or stent placement procedures were performed without cerebral protection devices in 152 patients (57 women and 95 men whose mean age was 64 years, range 19–92 years). Seven of these patients underwent angioplasty alone. Eighty-nine patients presented with focal neurological symptoms. Indications for surgery included atherosclerosis, radiation-associated stenosis, dissection, pseudoaneurysm, and stretched endovascular coils from aneurysm treatment. In this study, the patients' medical records were reviewed for clinical characteristics, techniques used, and resulting intraprocedural and 30-day complication rates.
The intraprocedural stroke rate was four (2.4%) of 167; this included three hemispheric strokes and one retinal embolus. All events occurred in patients who had symptomatic stenosis. The procedural transient ischemic complication rate was six (3.6%) of 167, as was the procedural nonneurological complication rate. During the 30 days post-procedure, one patient had died and three had suffered permanent ischemic events (two cerebral and one ocular). The composite 30-day postprocedural stroke and death rate was eight (5%) of 160. The rate of asymptomatic angiographically confirmed abnormalities was 0.6% (one treated vessel that was occluded but asymptomatic). The 30-day rate of nonneurological complications was 2.5%. A strong association between intraprocedural thromboembolic events (eight cases) and prior ischemic symptoms was found (p = 0.01).
Conclusions: Carotid angioplasty and stent placement without cerebral protection devices is safe, particularly in patients without symptomatic stenosis.
Cerebrovascular disease is the third leading cause of death in the US. Carotid artery atherosclerotic disease may account for up to 30% of all strokes. Results in several clinical trials have shown a benefit for CEA over conservative medical management in preventing strokes in patients with CA stenosis. In 1991, the NASCET demonstrated a 17% absolute risk reduction for ipsilateral stroke over 2 years with endarterectomy compared with medical management in symptomatic patients with severe CA stenosis of at least 70%. More recently, CEA in patients with symptomatic but more moderate stenosis of 50 to 69% has been shown to reduce the absolute risk of ipsilateral stroke over 5 years by 6.5%. Patients included in the NASCET were younger than 80 years of age and did not have organ failure or cancer that was judged likely to cause death within 5 years, nor did they have nonatherosclerotic CA disease or cardiac disease associated with thromboembolic symptoms. Patients were also excluded if they had previously undergone an ipsilateral CEA. Carotid angioplasty and stent placement has been advocated in these high-risk surgical patients. Most recently, in the SAPPHIRE trial, researchers found that CA stent placement with a cerebral protection device was not inferior to CEA in a population of high-risk surgical patients.
The use of carotid angioplasty and stent placement in patients who are good surgical candidates is under investigation. There have been a few multicenter randomized trials designed to compare angioplasty and stent placement procedures with CEA. The CAVATAS did not show a significant difference in stroke or death rates between the two techniques. The Wallstent trial was stopped early because of safety considerations in the angioplasty and stent placement group.
Embolic stroke is the primary complication related to this procedure. In an effort to reduce the incidence of this complication, cerebral protection devices have been developed. These devices include distal filters or balloons designed to filter or divert emboli, or that use flow reversal in the CA to prevent distal embolization. Based primarily on the results of the SAPPHIRE trial, which was performed without an unprotected angioplasty control group, several physicians have recommended that carotid angioplasty and stent placement procedures only be performed with protection devices.
All of these protection devices add complexity and additional instrumentation to the angioplasty and stent placement procedure. Whether the risks inherent in the use of these devices outweigh their benefits has not been established. Our goal in this study was to report our experience with carotid angioplasty and stent placement without the use of cerebral protection devices. Because the current standard of care at our institution is endarterectomy for patients with surgically amenable CA stenosis, all the patients in this series were considered poor surgical candidates by referring surgeons. This is a retrospective study of patient characteristics, techniques used, and the resulting procedural and 30-day complication rates. Factors associated with the occurrence of intraprocedural thromboembolic events were investigated.
Object: The goal in this retrospective study was to examine the procedural complication rate for carotid angioplasty and stent placement performed without cerebral protection devices.
Methods: Between March 1996 and December 2003, 167 carotid angioplasty and/or stent placement procedures were performed without cerebral protection devices in 152 patients (57 women and 95 men whose mean age was 64 years, range 19–92 years). Seven of these patients underwent angioplasty alone. Eighty-nine patients presented with focal neurological symptoms. Indications for surgery included atherosclerosis, radiation-associated stenosis, dissection, pseudoaneurysm, and stretched endovascular coils from aneurysm treatment. In this study, the patients' medical records were reviewed for clinical characteristics, techniques used, and resulting intraprocedural and 30-day complication rates.
The intraprocedural stroke rate was four (2.4%) of 167; this included three hemispheric strokes and one retinal embolus. All events occurred in patients who had symptomatic stenosis. The procedural transient ischemic complication rate was six (3.6%) of 167, as was the procedural nonneurological complication rate. During the 30 days post-procedure, one patient had died and three had suffered permanent ischemic events (two cerebral and one ocular). The composite 30-day postprocedural stroke and death rate was eight (5%) of 160. The rate of asymptomatic angiographically confirmed abnormalities was 0.6% (one treated vessel that was occluded but asymptomatic). The 30-day rate of nonneurological complications was 2.5%. A strong association between intraprocedural thromboembolic events (eight cases) and prior ischemic symptoms was found (p = 0.01).
Conclusions: Carotid angioplasty and stent placement without cerebral protection devices is safe, particularly in patients without symptomatic stenosis.
Cerebrovascular disease is the third leading cause of death in the US. Carotid artery atherosclerotic disease may account for up to 30% of all strokes. Results in several clinical trials have shown a benefit for CEA over conservative medical management in preventing strokes in patients with CA stenosis. In 1991, the NASCET demonstrated a 17% absolute risk reduction for ipsilateral stroke over 2 years with endarterectomy compared with medical management in symptomatic patients with severe CA stenosis of at least 70%. More recently, CEA in patients with symptomatic but more moderate stenosis of 50 to 69% has been shown to reduce the absolute risk of ipsilateral stroke over 5 years by 6.5%. Patients included in the NASCET were younger than 80 years of age and did not have organ failure or cancer that was judged likely to cause death within 5 years, nor did they have nonatherosclerotic CA disease or cardiac disease associated with thromboembolic symptoms. Patients were also excluded if they had previously undergone an ipsilateral CEA. Carotid angioplasty and stent placement has been advocated in these high-risk surgical patients. Most recently, in the SAPPHIRE trial, researchers found that CA stent placement with a cerebral protection device was not inferior to CEA in a population of high-risk surgical patients.
The use of carotid angioplasty and stent placement in patients who are good surgical candidates is under investigation. There have been a few multicenter randomized trials designed to compare angioplasty and stent placement procedures with CEA. The CAVATAS did not show a significant difference in stroke or death rates between the two techniques. The Wallstent trial was stopped early because of safety considerations in the angioplasty and stent placement group.
Embolic stroke is the primary complication related to this procedure. In an effort to reduce the incidence of this complication, cerebral protection devices have been developed. These devices include distal filters or balloons designed to filter or divert emboli, or that use flow reversal in the CA to prevent distal embolization. Based primarily on the results of the SAPPHIRE trial, which was performed without an unprotected angioplasty control group, several physicians have recommended that carotid angioplasty and stent placement procedures only be performed with protection devices.
All of these protection devices add complexity and additional instrumentation to the angioplasty and stent placement procedure. Whether the risks inherent in the use of these devices outweigh their benefits has not been established. Our goal in this study was to report our experience with carotid angioplasty and stent placement without the use of cerebral protection devices. Because the current standard of care at our institution is endarterectomy for patients with surgically amenable CA stenosis, all the patients in this series were considered poor surgical candidates by referring surgeons. This is a retrospective study of patient characteristics, techniques used, and the resulting procedural and 30-day complication rates. Factors associated with the occurrence of intraprocedural thromboembolic events were investigated.