Abstract Details

Title Robot-assisted transcranial Doppler versus transthoracic echocardiography for right to left shunt detection: “Real World” First-Look

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) S20 - Cerebrovascular Disease and Interventional Neurology: Clinical Trials and Outcomes Studies (3:54 PM-4:06 PM)

Poster/Presentation
Number 003

Background Right to left shunt (RLS), including patent foramen ovale (PFO), is a recognized risk factor for stroke. A multicenter, prospectively enrolled device trial of robot-assisted transcranial Doppler (raTCD) vs transthoracic echocardiography (TTE) for RLS/PFO detection was completed. This demonstrated raTCD detecting all and large RLS at approximately 3 times the rate of TTE (any RLS: raTCD 64% vs TTE 20% [absolute difference 43.4% (95% CI 34.3%-52.5%), p < 0.001]).

Objective To determine if device trial results (NCT04604015) are generalizable to routine practice.

Design/Methods We conducted a multi-site retrospective review of prospectively collected “real-world” clinical data of raTCD for RLS diagnosis. All patients referred for a clinical study at the participating sites who underwent raTCD were included. Outcomes included demographics and rate of RLS detection, all and large (Spencer Logarithmic Scale ≥3), and the results were compared to the results of BUBL.

Results 350 patients underwent raTCD across three participating sites. The mean age was 56 ± 13 years compared to 59 ± 14 years in BUBL (p = 0.03, 95% CI 0.20-5.49). Both cohorts were 46% female. The clinical population had any RLS on raTCD in 54% (189/350) compared to 64% in BUBL (p= 0.14, 95% CI -0.02-0.18). Large RLS was detected in 26% (91/350) of the clinical population as compared to 28% in BUBL (p = 0.89, 95% CI -0.08-0.11).

Conclusions The same raTCD device that was safe and 3 times more likely to diagnose RLS than TTE in a device trial detected all and large RLS in clinical practice at a rate similar to that demonstrated in the device trial, supporting the notion that raTCD may allow providers to achieve the known sensitivity of TCD for RLS and PFO detection without the need for an experienced operator to perform the examination in routine clinical practice.

Authors/Disclosures
Mark N. Rubin, MD (Edward Hines, Jr. VAMC) PRESENTER	Dr. Rubin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NovaSignal. Dr. Rubin has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for INSPE.
Ira Chang, MD (Blue Sky Neurosciences)	Dr. Chang has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novasignal . Dr. Chang has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novasignal .
Michael F. Waters, MD, PhD, FAAN (Mount Sinai Scholl of Medicine)	Dr. Waters has nothing to disclose.
Ruchir Shah, MD (CHI Memorial Hospital)	Dr. Shah has nothing to disclose.
Thomas G. Devlin, MD, PhD (Memorial Hospital)	Dr. Devlin has received personal compensation for serving as an employee of Neuroscience Innovation Foundation. Dr. Devlin has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Nova Signal. Dr. Devlin has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Viz.ai. Dr. Devlin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Devlin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Devlin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Viz,ai. Dr. Devlin has received personal compensation in the range of $5,000-$9,999 for serving as an officer or member of the Board of Directors for Neuroscience Innovation Foundation. Dr. Devlin has stock in Nova Signal. Dr. Devlin has stock in Viz.ai. The institution of Dr. Devlin has received research support from Viz.ai. Dr. Devlin has received research support from Nova Signal. Dr. Devlin has received intellectual property interests from a discovery or technology relating to health care.
Andrei V. Alexandrov, MD (Department of Neurology, UTHSC)	The institution of Dr. Alexandrov has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NovaSignal. Dr. Alexandrov has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NovoNordisc. Dr. Alexandrov has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AstraZeneca. Dr. Alexandrov has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for American Society of Neuroimaging. Dr. Alexandrov has received publishing royalties from a publication relating to health care.