CASSH Registry: Rationale and Study Design
Stroke: Vascular and Interventional Neurology
Abstract
Background
Carotid artery disease, a major cause of strokes, often results from carotid atherosclerotic stenosis. Although carotid endarterectomy has long been the standard treatment, carotid artery stenting (CAS) emerged as an alternative for high‐risk surgical patients. Operator experience plays a crucial role in reducing complications, with neurointerventional specialists demonstrating proficiency in CAS. However, they are often underrepresented in CAS studies. The CASSH (Carotid Artery Stenting Outcomes in Comprehensive Stroke Hospitals) registry aims to provide comprehensive insights into CAS outcomes, particularly when performed by neurointerventionalists at comprehensive stroke centers.
Methods
The CASSH is a multicenter, prospective, observational study currently enrolling patients with carotid artery stenosis undergoing CAS performed by neurointerventional physicians. All the participating sites will screen and report cases that meet inclusion criteria, on a monthly basis. The decision of whether to use CAS is at the discretion of the interventionalist.
Results
We will collect patients’ baseline clinical, demographic, and radiographic data. In addition, we plan to collect procedure variables and postoperative clinical and imaging data. Outcomes include the rate of postoperative symptomatic stroke (hemorrhagic/ischemic), access site complications, in‐stent thrombosis, and mortality.
Conclusion
Current literature underrepresents neurointerventionalists in CAS studies, especially as it pertains to procedural expertise and outcomes. CASSH is a prospective observational study that will enhance our understanding of CAS management and outcomes, emphasizing the benefits of neurointerventional expertise within comprehensive stroke centers.
Nonstandard Abbreviations and Acronyms
- CAS
- carotid artery stenting
- CASSH
- Carotid Artery Stenting Outcomes in Comprehensive Stroke Hospitals
- CEA
- carotid endarterectomy
- CSC
- comprehensive stroke center
Clinical Perspective
•
The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) published results >2 decades ago. The reported risk of stroke in carotid artery stenting was slightly higher than in endarterectomy. Several advances have been made in the endovascular treatment of carotid artery disease since then. Some of these newer techniques include flow reversal, or transradial stenting and trans‐carotid artery stenting. Although the CREST II trial is continuing to enroll patients, the carotid artery stenting debate has moved in a different direction.
•
After the introduction of Joint Commission–certified comprehensive stroke centers (CSCs) in 2012, many regional hospitals achieved this highest level of certification. The Brain Attack Coalition and the Joint Commission ensure that CSCs must provide highly trained multidisciplinary teams and units to care for patients with stroke. A widespread network of CSCs has essentially changed the emergency medical services transfer pattern of patients with stroke. More and more patients are now being treated at CSCs. Recent studies have reported better outcomes in these advanced stroke centers. Several studies have also reported improved procedural outcomes at high‐volume centers.
•
Therefore, we believe that it is critical to systematically assess current advances in technology, variation in endovascular techniques, and other advances in carotid artery stenting performed at higher‐volume CSCs. This information will help us design more informed and up‐to‐date clinical trials in the future.
Carotid artery disease is a significant stroke cause, with carotid atherosclerotic stenosis accounting for up to 20% of ischemic stroke causes.1 There are several means of carotid artery interventions, including carotid endarterectomy (CEA), transcarotid artery revascularization, and carotid artery stenting (CAS). CEA has long been considered the gold standard of therapy and involves the surgical exposure of the carotid artery and removal of the occlusive plaque. Transcarotid artery revascularization was developed to circumvent aortic arch manipulation, using direct carotid exposure combined with cerebral blood flow reversal to reduce the inadvertent risk of embolism. CAS is an endovascular procedure designed to treat carotid artery stenosis via transfemoral or transradial endovascular access and stent placement in the internal carotid artery. Historically, patients considered to be at increased risk of open surgical complications have been offered CAS as an alternative to CEA or transcarotid artery revascularization. For years, the Centers for Medicare & Medicaid Services restricted CAS reimbursement for carotid artery stenosis at increased surgical risk. Current guidelines recommend the use of certain anatomic features, comorbidities, and age to select between modalities of treatment.2, 3, 4 Multiple studies have shown that symptomatic and asymptomatic patients have similar long‐term postoperative complication rates when undergoing CEA or CAS.5, 6, 7, 8, 9, 10, 11, 12 Given the above studies, the Centers for Medicare & Medicaid Services has recently accepted the Multispecialty Carotid Alliance appeal to remove the high surgical CEA risk requirement for CAS reimbursement.13
The role of operator experience in reducing complications of CEA has been established in the literature, with a learning curve required to decrease periprocedural complications.14, 15 Neurointerventional physicians are practitioners from 3 specialties (neurology, radiology, and neurosurgery) who have received additional neurointerventional training focused solely on intracranial and extracranial endovascular procedures. This allows the providers to be well versed in carotid anatomy, crossing high‐risk lesions, deploying embolic protection devices, and, if need be, providing emergent mechanical thrombectomy if iatrogenic complications occur.
The CASSH (Carotid Artery Stenting Outcomes in Comprehensive Stroke Hospitals) registry will significantly contribute to prior literature as it represents a novel and comprehensive exploration into the risk/benefit ratio of CAS for different patient populations. Through optimal control over study design, standardized data collection, and the reduction of recall bias, our study will provide further insight into the clinical course and functional outcomes among patients who receive CAS. Aptly, the objective of this written work is to help quantify the risk of CAS performed by neurointerventionalists for patients with carotid artery stenosis at comprehensive stroke centers (CSCs).
Methods
Data are available upon reasonable request to the corresponding author.
Study Aim
The field of neurointerventional surgery has seen remarkable growth, now featuring more formalized training through dedicated fellowship programs. This study contributes uniquely to the extensive literature on CAS by specifically examining CAS conducted by fellowship‐trained neurointerventionalists within the highest level of neurologic care provided at CSCs.
As such, the registry will be used to:
1.
Determine the rate of success for CAS, current CAS techniques, and associated postprocedural complications when performed by neurointerventionalists in CSCs.
2.
Evaluate the clinical course and functional outcomes among patients who receive CAS.
Overview of the Study Design
This proposal will prospectively review patient medical records and procedure details of patients undergoing CAS admitted to the participating CSCs starting in January 2023. Procedures and testing will follow the standard of care at the participating hospital. Types of anesthesia will also be collected (general anesthesia, monitored anesthesia care, intravenous, and local) along with periprocedural blood pressure parameters.
Patient's angiogram reports, imaging data, reports from electronic medical records, and data will be uploaded to the study database. As a standard of care and practice, and following the CREST protocol, the degree of preprocedure stenosis will be obtained through diagnostic digital subtraction angiography. In case of discordance between the preprocedure radiological report of the preprocedural noninvasive imaging and the findings on digital subtraction angiography, the gold standard will be digital subtraction angiography. We expect a sample size of 500 patients. We intend to use a waiver of consent to collect patient information.
This is a medical record review registry. We will not impact the care management of the patients included in this study.
Inclusion Criteria
1.
Age 18 to 100 years
2.
Carotid artery stenosis secondary to atherosclerotic disease, further definition as follows:
a.
Symptomatic patients were defined as individuals who were admitted to comprehensive stroke hospitals because of anterior circulation ischemic events, including retinal artery occlusion, amaurosis fugax, and transient ischemic attacks, which were confirmed by angiography and associated with carotid artery stenosis of ≥50% according to The North American Symptomatic Carotid Endarterectomy Trial criteria, within 180 days of initial evaluation.
b.
Asymptomatic patients were characterized by having stenosis of ≥70%, but no events in the 6 months leading up to their CAS.
Exclusion Criteria
1.
Pregnant patient
2.
Contraindication to antiplatelet or anticoagulation therapy
3.
Baseline modified Rankin Scale score is >3
4.
<5 years’ life expectancy
5.
Patients with tandem lesions receiving acute intracranial procedures with concomitant emergent CAS
6.
Stent requirements for other causes of carotid stenosis, such as trauma, dissection, carotid web, or otherwise unspecified
7.
Lack of embolic protection device deployment is not an exclusion criterion
8.
Intracranial hemorrhage on initial imaging
Outcomes
Primary outcomes:
1.
Thirty‐day periprocedural mortality
2.
Postoperative symptomatic ischemic stroke
3.
Postoperative symptomatic intracranial hemorrhage
4.
Myocardial infarction
5.
Thirty‐day modified Rankin Scale score
Secondary outcomes:
1.
Nonperiprocedural mortality
2.
Asymptomatic intracranial hemorrhage
3.
Transient ischemic attack, amaurosis fugax, and minor nondisabling ischemic events
4.
Distal embolization events successfully addressed with no residual neurologic deficits
5.
Access site complications
6.
Symptomatic bradycardia, including pulseless electrical activity
7.
Early in‐stent thrombosis (within 30 days)
8.
Late in‐stent thrombosis (>1 up to 12 months)
9.
Dissection secondary to CAS
10.
Other complications not specified elsewhere, including hemodynamic instability
11.
Ninety‐day modified Rankin Scale score
12.
One‐year clinical follow‐up (modified Rankin Scale score) and 1‐year radiographic follow‐up (carotid ultrasound, magnetic resonance angiography of the neck, computed tomography angiography of the neck, or digital subtraction angiography).
Variables Collected
Variables, such as age, medical comorbidities, imaging findings, and procedural technical details, will be collected. Physician background training will also be collected (ie, interventional neurologists, interventional neuroradiologists, and endovascular neurosurgeons).
Participating Centers
Data will be collected from the US CSCs certified by the Joint Commission or Det Norske Veritas. The CSC certification process was designed to ensure centers' capabilities to manage complex neurosurgical and neuroendovascular cases with neurologic and neurosurgical expertise.16 Care at a CSC has been shown to reduce stroke‐related mortality and improve stroke outcomes and quality of care.17 Up to 40 centers will participate in our study.
Statistical Analysis
Data from HCA Healthcare Houston Kingwood and other institutions will be compiled by reviewing patient medical records (in electronic medical records), radiographic imaging data (from electronic medical records and imaging databases, including Picture Archiving and Communication System), and procedure notes from the electronic medical records. Study personnel will retrospectively review the records of patients, and data will be entered into a database on a routine basis. The patients will be identified after undergoing CAS, and they already have an established physician‐patient relationship. Data use agreements will be executed as required by the participating institutions.
Participating sites will self‐report data to the primary site principal investigator (HCA Healthcare Houston Kingwood), on a monthly basis. Data will be saved in an HCA Healthcare–owned and secured computer. The primary site principal investigator and his research team will be the only individuals with access to all received data. Data received from a contributing site will not be shared with other contributing sites, and local sites will receive summary updates on the analysis progress that does not include individual patient information. Collected data will be analyzed using SPSS.
Results
The CASSH registry is currently active at 12 sites. In ≈15 months, we have received data on 297 patients from 8 centers. The Figure is a flowchart that demonstrates the patients received to date for 2023.
Discussion
In most of the previously published CAS studies, the specialty of the physicians varied considerably, with neurointerventional specialists being underrepresented. The CREST trial reported no difference among subspecialty providers in terms of outcome. However, no neurointerventionalists were part of the randomization phase, and only 21% of the operators were from a neuroradiologist or neurosurgeon background.18, 19 The carotid acculink/accunet post‐approval trial to uncover unanticipated or rare events (CAPTURE)‐II registry for CAS in high‐surgical‐risk patients reported similar outcomes among operators from different specialties. Notably, <20% of participants were neurointerventionalists.20 The asymptomatic carotid trial (ACT) I investigators showed similar outcomes between CEA and CAS in asymptomatic patients aged ≤79 years, with <10% being from a neurointerventional background.9 Carotid stenting for high surgical‐risk patients; evaluating outcomes through the collection of clinical evidence (CHOICE) was a multicenter prospective single‐arm study to examine the operator's experience measured by carotid stenting time‐related variables. Cardiologists had a reduced dwell time for embolic protection devices (time between deployment and recovery) compared with vascular surgeons and interventional neurologists/radiologists. Decreased dwell time was also associated with the operator's experience. Neurointerventional specialists comprised only 9% of the study proceduralists.21 The CASONI (Carotid Artery Stenting Outcomes by NeuroInterventional Surgeons) is a multicenter retrospective study that we conducted, demonstrating low periprocedural stroke or mortality with CAS performed by fellowship‐trained neurointerventionalists.
The stenting and angioplasty with protection in patients at high risk for endarterectomy investigators trial, performed in 2004, showed no difference in outcomes between CEA and CAS in high‐surgical‐risk patients.11 The trial investigators were mentioned in the appendix but were not separated by fellowship training. Neurointerventional specialists were identified on <10% of the investigator lists on individual online searches. Other CAS studies did not include neurointerventionalists, did not mention the practitioner's subspecialty, or had few participating fellowship‐trained neurointerventional specialists.9, 11, 18, 20, 21, 22, 23
This study will help quantify the risk of CAS performed by neurointerventionalists for patients with carotid artery stenosis at CSCs.
Neurointerventionalists undergo years of specialized fellowship training focused on intracranial and cerebrovascular pathologies, routinely accessing the carotid artery. Through this rigorous training, neurointerventionalists cultivate a wealth of knowledge and skills, honing their expertise with higher caseloads, complex cases, and the intricate navigation of varied anatomies (eg, aortic arches). Furthermore, they adeptly incorporate transfemoral or transradial approaches into their practice, enhancing their ability to deliver comprehensive care.
In addition, performing CAS at CSCs offers specialized expertise, advanced technology, and a multidisciplinary approach, ensuring optimal patient care. Staffed by highly trained neurointerventionalists and equipped with state‐of‐the‐art medical technology, CSCs provide precise interventions and minimize complications. Adherence to rigorous accreditation standards ensures high‐quality care, making CSCs the preferred choice for carotid artery stenosis procedures and leading to better outcomes for patients. Furthermore, CSCs are ideal because of their provision of 24/7 neurocritical care coverage, meticulous preoperative and postoperative monitoring, and extensive experience handling high stroke volumes, ensuring optimal patient outcomes and safety throughout the entire treatment process.
Our findings will provide key information on assessing the risk/benefit ratio of the procedure for different patient populations. When compared with prior literature, as a prospective study, our written work will account for comprehensive risk factors leading to complications, laterality with postoperative ischemic strokes, intracranial hemorrhage, and extensive primary and secondary outcomes. The results of this study may aid in future studies in evaluating the efficacy and safety of CAS compared with more invasive alternative therapies. Moreover, we contend that this written work will demonstrate a reduction in complications and risks associated with carotid artery stenosis procedures when performed by neurointerventionalists, particularly within CSCs.
Limitations
Although our study offers valuable insights, several limitations should be acknowledged, given the medical record review character of our data collection. Data quality variability, the accuracy and completeness, relied heavily on the documentation within medical records. Although typically this is a limitation, our data derive from CSCs, each of which is typically equipped with protocols allowing for standardized data collection. Furthermore, our study's data will be self‐reported by each center, and will not undergo review by independent adjudication entities. Factors, such as patient‐reported outcomes, socioeconomic status, and lifestyle factors, were not included, potentially limiting the depth of analysis and understanding of certain associations. Despite these limitations, our study provides valuable insights and lays the groundwork for future research to address these constraints and build on our findings.
Definitions
1.
Technical success: ability to access the carotid artery, deployment of the stent successfully, and with a residual stenosis of no more than 20%
2.
Amaurosis fugax: temporary loss of vision in 1 eye because of insufficient flow of blood to the retina
3.
Transient ischemic attack: temporary focal brain or retinal deficits caused by vascular disease that clear completely in <24 hours
4.
Periprocedural mortality: death within 30 days from CAS
5.
Postoperative symptomatic ischemic stroke: an acute neurologic ischemic event of at least 24 hours’ duration with focal signs and symptoms. These are considered complications of CAS if they occurred within 30 days of the procedure.
a.
One or both of the following could be used as confirmatory evidence but not necessary for the designation of stroke:
i.
A 2‐point increase in the National Institute of Health Stroke Scale
OR
ii.
An appropriate new or extended abnormality seen on computed tomography or magnetic resonance imaging. The National Institutes of Health Stroke Scale will determine stroke severity as of 3 months from the occurrence of the stroke
b.
Computed tomography scans following a suspected event will be required and should be a minimum of 6 hours after the occurrence of an event to allow adequate detection and up to 3 months after the occurrence of an event, the interval between scheduled patient contact by clinic or telephone visit
6.
Postoperative symptomatic intracranial hemorrhage will be evaluated by Second European‐Australasian Acute Stroke Study Investigators (ECASS II) classification.
7.
Minor nondisabling ischemic events: an arterial‐occlusive infarction, manifesting as an abrupt onset of neurologic impairment. Defined as National Institutes of Health Stroke Scale score of <4. This impairment must last for at least 24 hours. Furthermore, individuals must maintain nondisability, indicated by a modified Rankin Scale score of ≤2 or lower, across all cases
8.
Myocardial infarction: diagnosis will rely on several factors, including the patient's clinical history of chest pain, changes observed on the ECG, and levels of serum cardiac enzymes. When there is definitive evidence of myocardial ischemia coupled with an elevation in cardiac enzymes (creatine kinase‐MB or troponin) exceeding twice the upper limit of normal, as established by the clinical center's laboratory, this will be officially considered a myocardial infarction
a.
Definitive evidence of myocardial ischemia is as follows:
i.
Typical chest pain or equivalent symptoms consistent with myocardial ischemia
ii.
ECG evidence of ischemia: new ST‐segment depression or elevation exceeding 1 mm in ≥2 contiguous leads
b.
Further classification as follows:
i.
ECG criteria:
1.
Presence of new pathologic Q waves in ≥2 contiguous leads, evident on the discharge ECG but not the baseline ECG, or present on the 30‐day ECG but not the baseline or discharge ECG
ii.
Enzyme criteria:
1.
In the setting of coronary artery bypass surgery, creatine kinase‐MB or troponin levels surpass 5 times the upper limit of that of the individual center's normal
2.
Following coronary intervention, creatine kinase‐MB or troponin levels surpass 3 times the upper limit of that of the individual center's normal
3.
In the absence of coronary artery bypass grafting or coronary intervention, creatine kinase‐MB or troponin levels surpass 2 times the upper limit of that individual center's normal
9.
Hemodynamic instability: categorized as periprocedural hypertension, hypotension, or bradycardia
a.
Hypertension: an increase in blood pressure that requires continuous intravenous medication infusion or >1 dose for over an hour following CAS
b.
Hypotension: a decrease in blood pressure that requires continuous intravenous medication infusion or >1 dose for over an hour following CAS
c.
Bradycardia: a sustained decrease in heart rate necessitation treatment with medication or a pacemaker
10.
Access site complications
a.
Pseudoaneurysm
b.
Access site hematoma
c.
Artery occlusion
d.
Arteriovenous fistula
e.
Infection
f.
Nerve injury
g.
Regional pain syndrome
Sources of Funding
None.
Disclosures
All data and records generated during this study will be kept confidential per institutional policies and Health Insurance Portability and Accountability Act on subject privacy. The investigator and other site personnel will not use such data and records for any purpose other than conducting the study. No identifiable data will be used for future study without obtaining institutional review board approval. The study personnel will make every effort to minimize the risk of confidentiality breaches. The data will be compiled and stored electronically on secure servers at HCA Healthcare Houston Kingwood (behind the firewall) for at least 6 years after the study is terminated. No paper records will be kept or stored. A second proposal will be submitted if future analysis is to be performed beyond this period. This research was supported (in whole or in part) by HCA Healthcare and/or HCA Healthcare–affiliated entity. The views expressed in this publication represent those of the author(s) and do not necessarily represent the official views of HCA Healthcare or any of its affiliated entities.
Dr Mohamad Ezzeldin: Speaker for Viz AI. and Imperative Care. Investment in Galaxy Therapeutics.
Dr Ameer Hassan: Consultant/speaker: Medtronic, Microvention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera Therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, Rapid Medical, Imperative Care, Galaxy Therapeutics, Route 92, and Perfuze
Principal investigator: COMPLETE study, Penumbra (International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device) registry; LVO SYNCHRONISE, Viz.ai (Observational Study of Automated Detection for Identification, Triage, and Timely Intervention in Large Vessel Occlusions); Millipede Stroke Trial (Millipede AspiRation for Revascularization in Stroke) clinical study, Perfuze; RESCUE, ICAD, Medtronic
Steering committee/publication committee member: Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT), Thrombectomy 6 to 24 hours after stroke with a mismatch between deficit and infarct (DAWN), Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke 2 (SELECT 2), EXPEDITE II, Middle meningeal artery embolization for chronic subdural hematoma (EMBOLISE), The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes (CLEAR), ENVI, Complex intracranial aneurysms: a DELPHI study to define associated characteristics (DELPHI), distal ischemic stroke treatment with adjustable low‐profile stentriever (DISTALS), Data and Safety Monitoring Board (DSMB), COMAND trial
Dr Peter Kan: Stryker consultant
Dr Ali Alaraj: Consultant for Cerenovus
Dr Omar Tanweer: Consulting agreements: Viz.AI, Inc, Penumbra, Inc, Balt, Inc, Stryker Inc, Imperative Inc, Q'Apel Inc. Proctor: Microvention Inc, Medtronic Inc.
Dr Kaustubh Limaye: Consultant for Medtronic, Stryker, Scientia Vascular, and Gravity Medical Technology.
Dr Farhan Siddiq: Consultant for Microvention; grants from the National Institutes of Health, Child Neurology Society (CNS), and The Society of NeuroInterventional Surgery (SNIS), nonrelated to this project.
Osama O. Zaidat serves on the Editorial Board of S:VIN. Editorial Board Members are not involved in the handling or final disposition of submissions.
Disclosures
HCA Houston Healthcare Kingwood Institutional Review Board has determined this retrospective research activity to be exempt or excluded from Institutional Review Board (IRB) oversight in accordance with current regulations and institutional policy. Our internal reference number for this determination is 2023‐149. There was no direct patient contact in performing this study. In addition, our patients sign a data usage form at registration related to data collection and utilization of their data for research. The research was overseen in our research protocol submitted for IRB review and research committee who holds monthly ethics reviews. Osama O. Zaidat serves on the Editorial Board of S:VIN. Editorial Board Members are not involved in the handling or final disposition of submissions.
Acknowledgments
None.
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Stroke: Vascular and Interventional Neurology
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© 2024 The Author(s). Stroke: Vascular and Interventional Neurology published by Wiley Periodicals LLC on behalf of American Heart Association; The Society for Vascular and Interventional Neurology. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
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Received: 7 May 2024
Accepted: 18 June 2024
Published online: 27 August 2024
Published in print: November 2024
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