Objective:

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

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]).

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.