LAS VEGAS – A set of electrodes arrayed in a standard, vascular-access catheter sheath accurately alerted operators to access-site bleeding in a first-in-human study with 60 patients treated at any of five U.S. centers.
“The Early Bird bleed-monitoring system was safe, easily incorporated in standard flow of work, and demonstrated the capacity to detect bleeding before progression to a more severe or symptomatic phase,”, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. The study in 60 patients undergoing standard intravascular procedures via femoral-artery access – most often transcatheter aortic valve replacement – showed that an alert for access-site bleeding occurred with a of 0.84, compared with CT imaging for bleeding, a score that shows “almost perfect” concordance between the two methods, noted Dr.
The study protocol called for keeping the sheath in place for up to 12 hours post procedure, and in practice the sheath remained in place for an average of about 160 minutes post procedure; 31% of the bleeds occurred during the procedure, with the remaining 69% occurring later. Another notable finding from the CT imaging at the time of sheath removal was that only 4 of the 60 patients had absolutely no bleeding, while 34 patients (57%) had blood infiltration at the access site and 22 patients (37%) had an access-site hematoma. No patients had retroperitoneal bleeding, but the system is designed to also detect bleeding within that space.
The Early Bird system received de novo classification as a new device from the Food and Drug Administration in March 2019; based on this, Saranas – the company developing the device – will likely start U.S. marketing before the end of 2019, Dr. Généreux said during a press briefing. The company is planning a registry of cases that use the device to collect data on patient outcomes to try to eventually document the clinical impact and cost-effectiveness of the system. Until now, standard of care has been to identify vascular-access associated bleeds once they become overt or symptomatic. If bleeds are identified at an earlier stage they could potentially be resolved before symptoms develop or become severe and hence provide a potential opportunity for cost savings.
Although the current study did not target specific types of patients, it makes sense in routine practice to target the device to patients at high risk for either developing a bleed or complications secondary to a bleed, such as patients undergoing transcatheter aortic valve replacement, patients receiving a mechanical circulatory assist device, or patients scheduled for complex procedures that will use multiple sheaths, he said.
A couple of years ago, Dr.
Dr. Généreux has been a consultant to Saranas and to several other companies. He is also chief medical officer for Saranas and has an equity interest in the company.
SOURCE: P. SCAI 2019, .