NovaSignal Corporation has announced the results of a multicentre, prospective, single-arm study indicating that the company’s autonomous NovaGuide intelligent ultrasound is three times more likely to detect right-to-left shunt (RLS)—a recognised risk factor for stroke—than standard of care transthoracic echocardiography (TTE). These results were presented in a late-breaking science session at the International Stroke Conference (ISC 2022; 9–11 February, New Orleans, USA).
“In the stroke population, RLS detection—especially due to a patent foramen ovale (PFO)—is important to reduce the risk of future stroke,” said the study’s principal investigator Mark Rubin (University of Tennessee Health Science Center, Memphis, USA). “We have known for decades that transcranial Doppler (TCD) is exquisitely sensitive for RLS detection, but expertise is scarce. NovaGuide broadens the availability of TCD, allowing any provider to help their patients benefit from the sensitivity of TCD for RLS detection. The BUBL study results underscore the potential for using this diagnostic capability to improve the management of ischaemic stroke patients.”
The BUBL clinical trial assessed use of NovaGuide compared to TTE for RLS diagnosis. The study enrolled adults (≥18 years) who presented with neurological signs and symptoms, which included embolic stroke or transient ischaemic attack, on the differential diagnosis. The primary outcome was the percent shunt detection rate of NovaGuide relative to standard of care TTE.
Among the 129 evaluable participants, RLS detection rate was 63.6% with NovaGuide (82 patients) and 20.9% by TTE (27 patients) for a difference of 42.6% (95% confidence interval [CI]=28.6%–56.7%, p<0.001). Additionally, NovaGuide accurately identified 35 patients (27%) with intervenable shunts (Spencer Logarithmic Scale ≥3), while TTE identified 13 (10%) of these cases for a difference of 17.1% (95% CI=6.9%–27.2%, p=0.002). The primary safety endpoint of adverse events with NovaGuide was 0% (95% CI=0%–2.8%).
“Stroke care has advanced significantly in recent years, but those who have suffered a stroke have a high risk of recurrence,” said Robert Hamilton, chief scientific officer and co-founder of NovaSignal. “RLS is a known risk factor for stroke and these study findings underscore the importance of utilising NovaGuide as a diagnostic technology. It substantially improves detection of RLS compared to current standard of care. The results of this study suggest there may be many undiagnosed patients with RLS who are not receiving appropriate medical management with today’s diagnostic standards.”