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Published on: September 25, 2009
Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30-day outcomes in the EMPiRE
Daniel G Clair1, L Nelson Hopkins, Manish Mehta
1Department of Vascular Surgery, Heart and Vascular Institute, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio 44195, USA. CLAIRD@ccf.org
Insights
The GORE Flow Reversal System offers effective neuroprotection during carotid artery stenting (CAS), showing low stroke and death rates. This innovative device is safe for a wide range of patients undergoing CAS procedures.
Area of Science:
- Cardiovascular Medicine
- Interventional Neurology
- Medical Devices
Background:
- Carotid artery stenting (CAS) involves risks, with existing embolic protection devices having limitations.
- The GORE Flow Reversal System is a novel, proximally placed device designed for distal neuroprotection during CAS.
- This system reverses internal carotid artery blood flow to divert emboli away from the brain.
Purpose of the Study:
- To investigate the safety and efficacy of the GORE Flow Reversal System in a prospective, multicenter, single-arm clinical study (EMPiRE Clinical Study).
- To evaluate 30-day major adverse events (MAE) in high-surgical-risk patients undergoing CAS with the flow reversal system.
- To compare the observed MAE rate against an objective performance criterion (OPC) derived from previous CAS studies.
Main Methods:
- The study enrolled 245 high-surgical-risk patients with carotid stenosis undergoing CAS using the flow reversal system.
- Outcomes assessed included a composite of stroke, death, myocardial infarction, and transient ischemic attack within 30 days post-procedure.
- Patient demographics included a mean age of 70 years, with 32% symptomatic and 16% aged 80 years or older.
Main Results:
- The overall MAE rate was 4.5% (11 patients), significantly lower than the OPC (P=0.002).
- The combined stroke and death rate was 2.9%, with no major ischemic strokes reported.
- Subgroup analyses for symptomatic, asymptomatic, and octogenarian patients met American Heart Association guidelines, with death and stroke rates ranging from 2.6% to 3%.
Conclusions:
- The GORE Flow Reversal System demonstrated a low stroke and death rate, among the lowest reported in CAS trials.
- The system proved to be safe and effective for neuroprotection during CAS.
- The study suggests the flow reversal system benefits a broad spectrum of patients undergoing carotid artery stenting.
Background:
Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single-arm EMPiRE Clinical Study investigated a proximally placed device (GORE Flow Reversal System) that provides distal neuroprotection during CAS by reversing blood flow in the internal carotid artery, thereby directing emboli away from the brain.
Methods:
The study evaluated 30-day outcomes in 245 pivotal high-surgical-risk patients (mean age, 70 years; 32% symptomatic; 16% ≥80-years old) with carotid stenosis who underwent CAS using the flow reversal system. The primary endpoint was a major adverse event (MAE; stroke, death, myocardial infarction, or transient ischemic attack) within 30 days of CAS. The MAE rate was compared with an objective performance criterion (OPC) derived from CAS studies that included embolic protection.
Results:
The MAE rate was 4.5% (11 patients; P=0.002 compared with the OPC). The stroke and death rate was 2.9%. No patient had a major ischemic stroke. Six patients (2.4%) had intolerance to flow reversal. The death and stroke rates in the symptomatic, asymptomatic, and octogenarian subgroups were 2.6, 3, and 2.6%, respectively, meeting American Heart Association guidelines for carotid endarterectomy.
Conclusion:
The stroke and death rate in this study was among the lowest in CAS trials. The results indicate that the flow reversal system is safe and effective when used for neuroprotection during CAS and that it provides benefits in a broad patient population.