An international study has found that transcatheter cerebral embolic protection (TCEP) is safe, provides effective capture of embolic debris and does not change neurocognitive function for transcatheter aortic valve replacement (TAVR) patients.
Findings from the SENTINEL Trial have been published in the Journal of the American College of Cardiology (JACC), and researchers from NewYork-Presbyterian/Columbia University Medical Center will present the findings as part of the late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics (TCT) conference this weekend in Washington, D.C.
TAVR is a minimally invasive procedure to replace or repair a damaged heart valve for patients too sick to undergo open heart surgery. In TAVR, doctors insert a replacement valve via a catheter that is threaded through a small incision. Guided by imaging technology, physicians place the new valve without having to take out the old, damaged valve. While less invasive than open heart surgery, the procedure carries a risk of neurological complications, such as stroke, due to embolization of debris during valve replacement. Roughly three to six percent of TAVR patients experience a stroke caused by embolic debris that becomes dislodged when the valve is replaced. TCEP is designed to catch this debris and prevent it from reaching the brain.
"This is currently the largest randomized trial to examine the safety and efficacy of using neuroprotection during TAVR," said Dr. Susheel Kodali, Director of the Structural Heart and Valve Center at NewYork-Presbyterian/Columbia University Medical Center and lead author of this study. "As more patients across the country are undergoing TAVR to replace or repair damaged heart valves, we need to have an understanding of how to better protect them from experiencing complications. We're encouraged by what we're seeing so far."
This multicenter trial included 363 patients at 19 hospitals—17 in the U.S. and two in Germany. Using the Sentinel® TCEP device, the patients undergoing TAVR were randomized into a safety arm (TCEP only) and two imaging cohorts, in which patients were randomly treated with TCEP (device arm) or without TCEP (control arm). The primary safety endpoint was major adverse cardiac and cerebrovascular events at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on MRI scans at 2-7 days. All patients underwent thorough neurological assessments 30 days and 90 days after the procedure.
The device and control arms were designed to analyze the following areas of neurocognitive function: bi-hemispheral and hemisphere-specific attention, executive function, processing speed, working memory, visual memory, mental status and depression.
Results showed that TCEP was safe and captured embolic debris in 99 percent of patients, however the primary endpoint - the reduction in median new lesion volume on MR scans - was not met. There were several limitations associated with the trial that likely contributed to this, including: the embolic protection afforded by the Sentinel® device excluded the territory of the left vertebral artery; different TAVR devices were included and the randomization scheme was not stratified according to valve category; and the sample size was too low to assess clinical outcomes.
"The SENTINEL Trial should impact future research on neuroprotection during TAVR," said Dr. Kodali. "While there were several limiting factors inherent within the study, our ultimate goal is to provide patients with safer TAVR outcomes, and this is an important step in achieving that."
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