Publisher's Synopsis
Stroke is the third leading cause of death following diseases of the heart and cancer. A majority of strokes are classified as ischemic in nature (87%), with intracerebral hemorrhagic (10 percent) and subarachnoid hemorrhagic stroke (3%) accounting for the rest. Every year in the U.S., approximately 795,000 people develop a new or recurrent stroke, with 610,000 first attacks and 185,000 recurrent attacks. The annual rate of strokes is expected to increase to 1.2 million cases by the year 2025, a troubling trend that underlines the urgency of adequate ischemic stroke treatment. Stroke occurs more commonly in females than males, especially at older ages. Blacks have a two-fold higher risk of first-ever stroke than Caucasians, with age-adjusted incidences of 6.6 per 1000 in black men as compared with 3.6 per 1000 in Caucasian men. In 2006, 43.6 deaths occurred due to stroke per 100,000 people in the U.S., averaging out to one death due to stroke every 3 to 4 minutes. In 2005, the overall mortality rate from stroke was approximately 44.7 per 100,000 for Caucasian males, 70.5 per 100,000 for black males, 44.0 per 100,000 for Caucasian females, and 60.7 per 100,000 for black females. Lower mortality rates were seen in Hispanic, Asian, and American Indian populations as compared with Caucasian populations. Stroke is the leading cause of long-term disability in the U.S. Thirty percent of stroke survivors require outpatient rehabilitation services and 15 to 30% of patients remain permanently disabled. Significant decreases in health-related quality-of-life are also seen following a stroke. Studies have shown that at-risk patients view the consequences of experiencing an ischemic stroke as being worse than death. Additionally, evidence has demonstrated the significant impact of ischemic stroke on caregiver burden and quality-of-life in caregivers. The goal of this technical brief is to describe neurothrombectomy devices currently being used or actively investigated in the treatment of patients with acute ischemic stroke, and to summarize the evidence supporting their use. This technical brief is based on a systematic scan of the literature. Key questions, methods, and approaches were defined by the University of Connecticut/Hartford Hospital Evidence-based Practice Center after discussions with representatives from the Agency for Healthcare Research and Quality and clinical content and technical experts. Key Questions addressed in this review include: KQ1. What are the different types of neurothrombectomy devices in use or in development for treatment of acute ischemic stroke? 1a. What are the existing FDA indications for each device? 1b. Which devices are being used off-label for this indication? 1c. What is the status of FDA approval for each device? 1d. What are the theoretical advantages and disadvantages of these devices compared to other treatment options? 1e. What are the potential safety issues and harms associated with the use of these devices? 1f. What is the extent of utilization of the different devices? KQ2. From a systematic scan of studies of different types of neurothrombectomy devices, what are the type(s) of devices, study designs and sizes, patient characteristics, comparators used in comparative studies, lengths of follow-up, concurrent or prior therapies, outcomes measured, and adverse events, harms, and safety issues reported? 2a. Type(s) of devices 2b. Study design and size 2c. Patient characteristics 2d. Comparator used in comparative studies 2e. Length of follow-up 2f. Concurrent or prior therapy 2g. Outcomes measured 2h. Adverse events, harms and safety issues reported KQ3. What are the variables associated with use of the devices that may impact outcomes (e.g. time to deployment, training/expertise of interventionalist, location of infarct, concurrent therapies)?
