Carotid Stenting In High-risk Patients Research Articles

Simultaneous Bilateral Carotid Stenting in High-risk Patients: A Single-center Experience with Review of Literature

Background: The aim of the present study is to determine the role of simultaneous carotid artery stenting in high-risk patients with triple vessel coronary artery disease and to determine the safety and efficacy of the procedure in these cases. Materials and Methods: The present study is a retrospective analysis of 33 patients who underwent carotid artery stenting in the same setting in our institution from 2009 to 2016. There were 22 male and 11 females with a mean age of 65 years (53–76 years). Demographic factors clinical characteristics and atherosclerosis risk factors were documented. Results: Technical success was 100% in our series. Intraprocedural and postprocedural events in the form of hypotension and bradycardia due to hemodynamic depression were seen in 11 patients. We did not encounter hyperperfusion syndrome in any of our patients. Twenty-nine patients underwent cardiac bypass surgery after 3 weeks, and 4 patients were kept on medical management for coronary artery disease. No deaths or major strokes occurred in our series. Conclusion: Simultaneous bilateral carotid artery stenting is a safe treatment option even in patients with high-risk factors and can be considered as the therapeutic option in patients with significant bilateral carotid artery disease.

Carotid artery stenting with distal filter protection: single-center experience in high-surgical-risk patients

Carotid artery stenting (CAS) is an efficient alternative procedure for the treatment of high-surgical-risk patients with symptomatic and asymptomatic carotid stenosis. The use of cerebral protection systems might decrease procedural risk of stroke and death. We report our initial experience with protected carotid stenting in high-risk patients with severe carotid artery disease. From January 2006 until July 2008 we routinely performed CAS using a distal filter protection device in 65 consecutive high-surgical-risk patients with 72 high-grade carotid stenoses. Technical success rate was 97.2%. Neurologic periprocedural complications included two transient ischemic attacks and one major stroke. Three filter-related complications were managed without negative results to the patients. The overall in-hospital and 30-days MACE rate was 1.5%, 3.6% in symptomatic patients and 0% in asymptomatic patients. In our series of high-risk patients, CAS with the use of a distal filter protection system was safe and effective with a low incidence of periprocedural complications.

Outcome evaluation of carotid stenting in high-risk patients with symptomatic carotid near occlusion.

Management of symptomatic carotid near occlusion especially in high-risk patients is different from outcome analysis of NASCET. We evaluated outcome in high-risk patients with symptomatic near occlusion. For 48 patients with near occlusion out of 166 symptomatic high-risk patients who underwent carotid stenting, we assessed the procedural success defined as residual stenosis <30%, modified Rankin Scale (mRS) at one and six months following stenting, and the 13 cerebrovascular factors related to the outcome. Initial National Institutes of Health Stroke Scale (NIHSS) ≥4, 1-3 and 0 were 13, 14 and 21 patients each. We compared the outcome with patients who underwent CAS (n=118) due to symptomatic stenosis without near occlusion during the same period. Our procedural success rate was 98%. A good outcome (mRS ≤2) was achieved in 44 patients (92%) at six months. There were five events (10%) within six months, i.e. three minor strokes, one major stroke caused by hemorrhage, and one death excluding two deaths not related to stroke. Hyperperfusion (n=4) was the most common cause of events leading to two minor strokes and a major stroke. Although initial NIHSS (P = .012) was related to poor outcome (mRS >2) compared to the CAS group, there was no statistical significance between two groups in the event rate of stroke, death or restenosis. The outcome of carotid stenting in high-risk patients with symptomatic near occlusion did not reveal any difference compared with CAS. Poor outcome was related to the initial NIHSS (≥4). Hyperperfusion tended to be more commonly related to an event occurring after stenting.

Procedural Outcome and Midterm Result of Carotid Stenting in High-Risk Patients

Carotid endarterectomy is the standard treatment for carotid stenosis, but carotid artery stenting has emerged as a potential alternative. Elective carotid artery stenting was performed in 42 patients aged 42 to 79 years (mean, 67.05 +/- 8.67 years) after ultrasonography, computed tomography, magnetic resonance angiography and a neurological evaluation. There was bilateral carotid stenosis in 23 patients (55%), with > 90% stenosis in 18 vessels. All patients had significant associated coronary lesions. An emboli protection device and self-expanding stents were used. One year later, the patients were evaluated by Doppler sonography and selective angiography. Technical success was achieved in all procedures. During follow-up, 1 (2.4%) patient died from myocardial infarction, 1 underwent coronary artery bypass and 14 (40%) had minor complaints including occasional dizziness. No other neurological events were noted. Restenosis was found in one case, but selective angiography ruled out a significant lesion. One patient suffered embolization, but recovered completely within 24 hours. In 7 (17%) patients with type C arch interruption and a tortuous carotid course, stenting was successful and they had no embolization or restenosis. Carotid artery stenting is recommended in high-risk patients.

Invited commentary

The ARCHeR trial represents an important contribution that provides data regarding the safety and efficacy of the Guidant Acculink and Accunet carotid stent and filter systems and also adds to the growing data pool on the results of carotid stenting in high-risk patients. It is important, however, that the limitations of this study be fully understood. The ARCHeR trial is not a prospective, randomized, controlled trial. It is not a comparative trial at all. It is an industry-sponsored, multi-institutional case registry. This registry was developed in order to accumulate a body of data on the performance of the Guidant products with a major goal of gaining Food and Drug Administration approval. It must be noted that the majority of the coauthors of this paper are either Guidant employees or consultants or receive financial support from Guidant. In order to garner Food and Drug Administration approval, the authors needed to show that the results of treatment with their product were not inferior to the results of standard treatment (carotid endarterectomy; CEA). As a basis for comparison, they used historical controls derived from selected series in the literature. By methods that are difficult to understand, they arrived at a control group (CEA) composite adverse event rate of 14.4%, to which they compare their stenting results (composite adverse event rate of 9.6%). Bias in selection of the series used to determine their control group adverse event rate is evident. The control group even included series of patients undergoing simultaneous coronary artery bypass grafting and CEA, a group in which stroke and mortality rates are high and in which the majority of strokes and deaths are not CEA related. In their appendix, the authors cite many series to support their control group adverse event rate, but they omit several series as well. For example, in 2003, Gasparis et al1Gasparis A.P. Ricotta L. Cuadra S.A. Char D.J. Purtrill W.A. Van Bemmelen P.S. et al.High risk carotid endarterectomy fact or fiction?.J Vasc Surg. 2003; 37: 40-46Abstract Full Text Full Text PDF PubMed Scopus (113) Google Scholar reported on 228 high-risk CEA patients.1Gasparis A.P. Ricotta L. Cuadra S.A. Char D.J. Purtrill W.A. Van Bemmelen P.S. et al.High risk carotid endarterectomy fact or fiction?.J Vasc Surg. 2003; 37: 40-46Abstract Full Text Full Text PDF PubMed Scopus (113) Google Scholar Their definition of high risk was at least as stringent as that used by the ARCHeR team (age >80 years, myocardial infarction in the prior 6 months, New York Heart Association class III or IV angina, Canadian Heart Association (CHA) class III or IV congestive heart failure, steroid- or oxygen-dependent chronic obstructive pulmonary disease, creatinine of 3 mg/dl or greater, contralateral occlusion, carotid reoperation, prior neck irradiation, or high lesion). The 30-day results of CEA in these patients included mortality, myocardial infarction, and stroke rates of 0.4%, 0.9%, and 0.9%, respectively, with a combined stroke/death rate of 1.3%. There are other reports of CEA in high-risk patients that call into question the validity of the ARCHeR authors’ control group adverse event rate.2Reed A.B. Gaccione P. Belkin M. Donaldson M.C. Mannick J.A. Whittemore A.D. et al.Preoperative risk factors for carotid endarterectomy defining the patient at high risk.J Vasc Surg. 2003; 37: 1191-1199Abstract Full Text Full Text PDF PubMed Scopus (113) Google Scholar, 3Ouriel K. Hertzer N.R. Beven E.G. O’Hara P.J. Krajewski L.P. Clair D.G. et al.Preprocedural risk stratification identifying an appropriate population for carotid stenting.J Vasc Surg. 2001; 33: 728-732Abstract Full Text Full Text PDF PubMed Scopus (166) Google Scholar Even if the reader discounts the comparative data in this article, the results are interesting. In symptomatic patients, the 30-day stroke, death, and combined stroke/death rates were 10.9%, 2.2%, and 11.6%, respectively. In asymptomatic patients, the rates were 3.8%, 2.0%, and 5.4%. It should be noted that just as in the CEA trials, the results achieved in ARCHeR by experienced carotid interventionalists in large programs may not be reflective of the results likely to be achieved by less highly selected or experienced interventionalists. The data on durability are also notable. Although the target lesion revascularization rate at 1 year was only 2.2%, fully 26% of patients had 50% to 69% restenosis, and 5% had more than 70% restenosis at 1 year. In the relatively small number of patients followed up for 2 and 3 years, the incidence of 50% to 69% and greater than 70% restenosis did not increase. While the ARCHeR trial contains a wealth of data on the results of carotid stenting with the Guidant products, it does not provide a valid assessment of the relative merits of stenting and CEA in the management of high-risk patients. Definitive assessment of the relative merits of stenting and CEA awaits properly designed and conducted prospective randomized controlled trials.

Protected Carotid Stenting in High-Risk Patients With Severe Carotid Artery Stenosis

The purpose of this study was to determine the safety of carotid artery stenting with a unique distal embolic protection system in high-risk patients with severe carotid stenosis. Previous studies suggest that some patients with carotid stenosis and serious comorbid conditions are at high risk for carotid endarterectomy, and may be safely treated by carotid artery stenting. A prospective non-randomized multicenter registry of 419 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted between April 2004 and October 2004. Carotid artery stenting was performed with the Protégé Self-Expanding Nitinol Stent and the SPIDER Embolic Protection System (ev3 Inc., Plymouth, Minnesota). Aspirin and clopidogrel were prescribed at least 24 h before and three months after revascularization. The primary outcome was the combined incidence of major adverse cardiac and cerebrovascular events at 30 days after intervention, including death, stroke, and myocardial infarction. A secondary outcome was the technical success, defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%. Technical success was achieved in 408 of 419 patients (97.4%). The primary end point was observed in 26 patients (6.2%), including death in 8 (1.9%), nonfatal stroke in 14 (3.3%), and nonfatal myocardial infarction in 4 (1%). Independent predictors of death or stroke at 30 days included duration of filter deployment, symptomatic carotid stenosis, and baseline renal insufficiency. For some patients with severe carotid stenosis and high-risk features for carotid endarterectomy, carotid artery stenting with distal embolic protection is a reasonable alternative for revascularization.

Carotid stenting in high-risk patients: design and rationale of the SAPPHIRE trial.

Carotid stenting in high-risk patients: design and rationale of the SAPPHIRE trial.