Ethical Considerations in Endovascular Thrombectomy for Stroke.

INTRODUCTION: Stroke is a leading cause of morbidity and mortality globally. Endovascular mechanical thrombectomy is considered for patients with large vessel occlusion stroke presenting up to 24 hours from onset and is being increasingly utilized across diverse clinical contexts. Proactive consideration of distinctive ethical dimensions of endovascular thrombectomy (EVT) can enable stroke care teams to deliver goal-concordant care to appropriately selected patients with stroke but have been underexplored. METHODS: A narrative review with case examples was conducted. RESULTS: We explain and critically evaluate the application of foundational bioethical principles and narrative ethics to the practice of EVT, highlight key ethical issues that may emerge in neuroendovascular practice and develop an ethical framework to aid in the responsible use of EVT for people with large-vessel occlusive ischemic stroke. CONCLUSIONS: EVT for stroke introduces important ethical considerations. Salient challenges include decision-making capacity and informed consent, the telos of EVT, uncertainty, access to care, and resource allocation. An ethical framework focusing on combining patient values and preferences with the best available evidence in the context of a multidisciplinary care team is essential to ensure that the benefits of EVT are responsibly achieved and sustained.

A randomized pragmatic care trial on endovascular acute stroke interventions (EASI): criticisms, responses, and ethics of integrating research and clinical care.

BACKGROUND: The Endovascular Acute Stroke Intervention (EASI) trial was conceived as a pragmatic care trial, designed to integrate trial methods with clinical practice. Reporting the EASI experience was met with objections and criticisms during peer review concerning both scientific and ethical issues. Our goal is to discuss these criticisms in order to promote the pragmatic approach of care trials in outcome-based medical care. METHODS: The comments and criticisms of 11 reviewers from 5 journals were collected and analyzed. The EASI protocol was also compared to the protocols of seven thrombectomy trials using the pragmatic-explanatory continuum indicator summary (PRECIS). RESULTS: Main criticisms of EASI concerned selection criteria that were judged to be too vague and too inclusive, brain and vascular imaging methods that were not sufficiently prescribed by protocol, lack of blinding of outcome assessment, and lack of power. EASI was at the pragmatic end of the spectrum of thrombectomy trials. CONCLUSION: The pragmatic care trial methodology is not currently well-established. More work needs to be done to integrate scientific methods and ethical care in the best medical interest of current patients.