Robot-Assisted Transcranial Doppler Versus Transthoracic Echocardiography for Right to Left Shunt Detection.
Publication Title
Stroke; a journal of cerebral circulation
Document Type
Article
Publication Date
11-1-2023
Keywords
Aged; Female; Humans; Male; Middle Aged; Echocardiography; Echocardiography, Transesophageal; Foramen Ovale, Patent; Prospective Studies; Robotics; Stroke; Ultrasonography, Doppler, Transcranial; echocardiography; embolic stroke; embolism; ischemic stroke; patent foramen ovale; robotics; ultrasound.; washington; swedish; oregon; portland
Abstract
BACKGROUND: Right to left shunt (RLS), including patent foramen ovale, is a recognized risk factor for stroke. RLS/patent foramen ovale diagnosis is made by transthoracic echocardiography (TTE), which is insensitive, transesophageal echocardiography, which is invasive, and transcranial Doppler (TCD), which is noninvasive and accurate but scarce.
METHODS: We conducted a prospective, single-arm device clinical trial of robot-assisted TCD (raTCD) versus TTE for RLS diagnosis at 6 clinical sites in patients who presented with an event suspicious for embolic cerebrovascular ischemia from October 6, 2020 to October 20, 2021. raTCD was performed with standard TCD bubble study technique. TTE bubble study was performed per local standards. The primary outcome was rate of RLS detection by raTCD versus TTE.
RESULTS: A total of 154 patients were enrolled, 129 evaluable (intent to scan) and 121 subjects had complete data per protocol. In the intent to scan cohort, mean age was 60±15 years, 47% were women, and all qualifying events were diagnosed as ischemic stroke or transient ischemic attack. raTCD was positive for RLS in 82 subjects (64%) and TTE was positive in 26 (20%; absolute difference 43.4% [95% CI, 35.2%-52.0%];
CONCLUSIONS: raTCD was safe and ˜3 times more likely to diagnose RLS than TTE. TTE completely missed or underdiagnosed two thirds of large shunts diagnosed by raTCD. The raTCD device, used by health professionals with no prior TCD training, may allow providers to achieve the known sensitivity of TCD for RLS and patent foramen ovale detection without the need for an experienced operator to perform the test. Pending confirmatory studies, TCD appears to be the superior screen for RLS compared with TTE (funded by NeuraSignal).
REGISTRATION: URL: https://www.
CLINICALTRIALS: gov; Unique identifier: NCT04604015.
Clinical Institute
Cardiovascular (Heart)
Clinical Institute
Neurosciences (Brain & Spine)
Specialty/Research Institute
Cardiology
Specialty/Research Institute
Neurosciences
DOI
10.1161/STROKEAHA.123.043380 http
