INSTOR™

INterventional Stroke Therapy Outcomes Registry™

 Overview

INSTOR™ is the first prospective interventional/endovascular stroke therapy registry in the world. Emergency treatment of acute ischemic stroke is undergoing rapid change.  Combination mechanical/pharmaceutical therapies can now result in excellent clinical outcomes for stroke victims.  Arguably, emergency treatment of acute ischemic stroke is the most complex multidisciplinary crisis operation a hospital chooses to undertake.  The complexity of acute stroke care necessitates a well-organized system involving several medical specialties, numerous hospital services, complex neuroimaging, interdepartmental collaboration, and rapid transportation to several different areas in a medical institution.  The entire multistep process mandates high levels of coordination and necessitates excellent multidisciplinary management.  Optimal system performance requires an institutional commitment to continuous process improvement.  A robust mechanism for analysis of the various steps, individual components, and actual processes is indispensable for optimizing patient outcomes.

INSTOR™ was designed to be a complete evaluation tool for improving emergency stroke therapy in your hospital.  INSTOR™ can act as the ultimate repository for all data concerning emergency stroke care (both IV and endovascular) for your hospital, either for each individual patient or in the aggregate. INSTOR™ provides a means to evaluate the safety and efficacy of the interventions used for acute stroke treatment both for IV tPA as well as endovascular therapies.

INSTOR™ is a powerful tool intended to be used for ongoing quality assessment, process analysis, and thus leading to improved clinical outcomes in both primary and/or comprehensive stroke centers.  INSTOR™ is a robust, HIPAA-compliant, self-prompting, automated-reminder computerized system for evaluation and analysis of in-hospital system processes.  INSTOR™ can track not only individual clinical outcomes but also the entire process that resulted in these outcomes.  With use of INSTOR™ it is possible to find the strengths and weaknesses in the overall process and thus implement beneficial change.  INSTOR™ also acts as a benchmarking tool to allow your hospital to compare itself with anonymous aggregate data from other institutions in a HIPAA compliant manner.

INSTOR™ fulfills the Quality Assurance and training standards requirements mandated by numerous organizations including the American Stroke Association (1), the Society of NeuroInterventional Surgery (2), The Society of Interventional Radiology (3), the Society of Vascular and Interventional Neurology (2), the American Society of Neuroradiology (3) , the American Heart Association (1), and The American Academy of Neurology (2).

1)  Leifer DL, Bravata DM, Connors JJ, et al. Metrics for Measuring Quality of Care in Comprehensive Stroke Centers: Detailed Follow-Up to Brain Attack Coalition Comprehensive Stroke Center Recommendations: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2011;42:849-877.
2) Meyers PM, Schumacher HC, Alexander MJ, et al. Performance and training standards for endovascular ischemic stroke treatment Writing Group for the American Academy of Neurology, AANS/CNS Cerebrovascular Section, Society of NeuroInterventional Surgery, and the Society of Vascular & Interventional Neurology. J NeuroInterv Surg 2009;1:10–12.
3) Connors JJ, Sacks DS, Black CM, et al. Training Guidelines for Intra-arterial Catheter-directed Treatment of Acute Ischemic Stroke: A Statement from a Special Writing Group of the Society of Interventional Radiology. J Vasc Interv Radiol 2009; 20:1507–1522

This article, by Amy Rothman Schonfeld, originally appeared
at Hospitalist News

OLYMPIC VALLEY, CALIF. — Three existing stroke registries remain underenrolled, in large part because physicians do not know about them.

Although neurointerventionists may be aware of these registries, physicians on the front lines of stroke treatment often are unaware of them or are reluctant to participate because of the time and diligence required, said Dr. John J. Connors III, medical director of the NeuroVascular Research Foundation.

The first registry, known as INSTOR (Interventional Stroke Therapy Outcomes Registry), was primarily designed to collect information on intra-arterial lysis for large-vessel occlusion. At first, 159 sites expressed interest in participating, but most have not entered any patients since INSTOR’s launch in 2002. Nevertheless, 20 active sites have contributed 278 patients, making it the largest database in the world that focuses on this type of stroke treatment.

A second registry, INTRASTOR (Intracranial Angioplasty and Stenting Outcomes Registry), was created to evaluate whether angioplasty and stenting can prevent stroke by treating atherosclerotic disease in the brain. At a poster presented at the annual meeting of the Society of Neurointerventional Surgery, data from 199 patients with 201 lesions indicated that 89% (178) of patients had greater than 70% stenosis. In all, 90 patients were treated with angioplasty alone, 72 by primary stenting, and 29 by angioplasty followed by stenting. (Data were unavailable for eight patients.) After treatment, 74% of patients had less than 33% residual stenosis, and 14% of patients had 34%–50% residual stenosis. Symptomatic complications included 10 patients with permanent neurologic deficits, 26 with minor complications that fully resolved, and 3 patients who died.

A third registry that was recently launched, known as INSTOR II, is designed to collect more complete information on the use of mechanical and combination interventions for acute ischemic stroke. These interventions include mechanical retrievers and a device that delivers intracranial ultrasound-aided lysis.

“While randomized control trial data are always preferable, any data are better than none. The INSTOR registries include [data on] patient selection, usually with [CT angiography] to choose patients with large-vessel occlusions,” Dr. Connors said.

The registries are already revealing worthwhile information, he noted. For instance, data from INSTOR I show that almost one-fifth of the 278 patients were on Coumadin, but 45 of these 53 patients had international normalized ratio levels lower than 2.0, indicating suboptimal doses that might have allowed a cardiogenic embolus in a patient who was known to be at risk. Other data suggest that many of the patients were treated with acetylsalicylic acid but had a presumed cardiogenic embolus and possibly should have been on Coumadin.

“Registries are necessary for proof that neurointerventional procedures work, are recommended by the Brain Attack Coalition in Comprehensive Stroke Centers, are mandated by certain health care agencies—including the state of Florida [and] several medical societies—and will be mandated by upcoming stroke-treatment training guidelines. Decisions by [the Centers for Medicare and Medicaid Services] have been based upon registry data,” Dr. Connors said.

The data from the registries—if adequate numbers are achieved—should help remove any concerns about the efficacy of endovascular intervention for appropriately selected patients.

“Collecting these data in the long run is beneficial for the science of endovascular stroke therapy and prevention, but requires the commitment of both individual physicians and medical leadership,” Dr. Connors said.