Abstract Body: Hypothesis:
We can identify carotid hemodynamic changes to detect LVOs in high-risk patients.

Objectives:
Detect possible LVOs using signals sensitive to hemodynamic changes.
Assess the sensitivity and specificity of LVO detection.
Analyze the impact of patient-specific factors on detection accuracy.

Methods:
This blinded, prospective multicenter study enrolled high-risk stroke patients from Israel (Sheba, Shaare Zedek, Galilee Medical Centers) and Spain (Val de Hebron Hospital). Participants in ICU/stroke units were monitored with the Avertto201 device attached to the neck to assess carotid hemodynamic changes. Patients included had acute ischemic stroke (≤24h), TIA, cardiac surgery/TAVI, or subarachnoid hemorrhage with vasoconstriction risk. Additional risk factors included prior stroke/TIA, hypertension, diabetes, heart disease, or family history of early stroke.
Endpoints:
LVO detection by Avertto vs. clinical diagnoses.
Sensitivity and specificity of Avertto’s detection.
Impact of patient factors (e.g., BMI, comorbidities) on accuracy.

Results:
Eleven participants enrolled; ten recordings were completed. Avertto detected all LVOs (1 occlusion, 1 reperfusion) earlier than clinical diagnoses (10h–5d). One stroke was missed due to a human recording error.
Case #1: Recanalization detected 10h before clinical diagnosis after tPA treatment.
Case #6: Stroke after cardiac surgery detected 1h post-sensor placement; clinical suspicion arose 5d later.
Non-LVO Changes: Subarachnoid hemorrhage and contusion-related abnormalities were also detected.
Patients tolerated the device well. Sedated patients were continuously monitored, and cooperative individuals used the device for 12+ hours. The device functioned under beards without shaving and resumed data collection smoothly after surgical interruptions.

Conclusions:
Carotid monitoring with Avertto201 demonstrates the potential for early detection of LVOs and monitoring cerebrovascular events in high-risk patients. The device identified LVOs 10 hours to 5 days earlier than clinical diagnosis with 100% sensitivity and specificity. It also detected non-LVO cerebrovascular conditions, broadening its potential applications. Recruitment was successful, with 30% of participants experiencing LVOs, validating the high-risk population selection and reducing sample size needs for future trials. Avertto201 performed best with sedated or cooperative patients, and temporary disconnections for surgery did not impair data once reattached.