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Abstract Details

Transcranial Doppler Bubble Study Technique in a Clinical Trial: Valsalva Maneuver and Body Position Matter but IV Location Does Not
Cerebrovascular Disease and Interventional Neurology
S10 - Vascular Interventions and Innovative Technologies (11:27 AM-11:39 AM)
002

A prospective, multicenter device clinical trial demonstrated robot-assisted TCD, run by health care professionals with no prior TCD training, was 3x more likely to diagnose any, including large, RLS as compared to TTE. Valsalva maneuver, body positioning and IV placement have been reported to affect results in observational studies but not in the setting of a clinical trial.

This is a secondary analysis of BUBL, a clinical trial (www.clinicaltrials.gov; NCT04604015), to ascertain the effects of transcranial Doppler (TCD) bubble study technique on results, including right to left shunt (RLS) presence and size.

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. Robot-assisted TCD was performed with standard TCD bubble study technique, including runs with and without Valsalva, supine and at 45o incline. IV location was tracked, acknowledging recommendations for right antecubital placement as technically ideal.

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. Valsalva maneuver and bed positioning increased RLS grade in 28% and 19%, respectively, including patients from RLS absence to presence and “small” to “large” grades. Antecubital IV placement had a RLS positivity rate of 63.6% and “other location” had a RLS positivity rate of 63.2%.

Technical aspects of TCD bubble study performance matter, including Valsalva maneuver and upright positioning, increasing not only sensitivity but the size grade of the RLS. IV location does not affect rate of RLS detection.

Authors/Disclosures
Mark Rubin (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.
Ruchir Shah (CHI Memorial Hospital) Dr. Shah has nothing to disclose.
Teddy Youn (Barrow Neurological Institute) Dr. Youn has nothing to disclose.
John Volpi Dr. Volpi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NovaSignal. Dr. Volpi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for W.L. Gore. Dr. Volpi has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Diamedica. Dr. Volpi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Janssen. Dr. Volpi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amgen. Dr. Volpi has received intellectual property interests from a discovery or technology relating to health care.
Aaron Stayman (Swedish) Dr. Stayman has nothing to disclose.
Theodore Lowenkopf Dr. Lowenkopf has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Hart Wagner. The institution of Dr. Lowenkopf has received research support from Boerhinger Inglheim. Dr. Lowenkopf has received personal compensation in the range of $500-$4,999 for serving as a Consultant with terumo medical.
Georgios Tsivgoulis (NEURODIAGNOSTICS AND NEUROTHERAPEUTICS PC) Dr. Tsivgoulis has nothing to disclose.
Andrei Alexandrov (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.