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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.”

Dr. Kodali will be presenting these results at the TCT conference on Tuesday, Nov. 1 and will be available to speak about the study’s findings.

The study was funded by Claret Medical, Inc. See the paper for all additional disclosures of conflicts of interests.

NewYork-Presbyterian

NewYork-Presbyterian is one of the nation’s most comprehensive healthcare delivery networks, focused on providing innovative and compassionate care to patients in the New York metropolitan area and throughout the globe. In collaboration with two renowned medical school partners, Weill Cornell Medicine and Columbia University College of Physicians & Surgeons, NewYork-Presbyterian is consistently recognized as a leader in medical education, groundbreaking research and clinical innovation.

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Columbia University Medical Center

Columbia University Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center is home to the largest medical research enterprise in New York City and State and one of the largest faculty medical practices in the Northeast. The campus that Columbia University Medical Center shares with its hospital partner, NewYork-Presbyterian, is now called the Columbia University Irving Medical Center. For more information, visit cumc.columbia.edu or columbiadoctors.org.