Feature | September 22, 2014

TAVR Cerebral Protection Device Reduces Stroke Risk

Results of CLEAN-TAVI trial reported at TCT 2014

September 22, 2014 — A first-of-its kind study found that using a cerebral protection device during transcatheter aortic valve replacement (TAVR) can significantly reduce the number and volume of cerebral lesions in high-risk patients with severe aortic stenosis. Stroke risks are higher with TAVR than surgical valve replacement, so embolic protection of the carotid arteries would greatly help to reduce this risk and make TAVR a safer procedure. Findings were reported Sept. 13 at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.

The trial used a device made by Claret Medical, which deploys two embolic protection nets in the ostium of both carotid arteries. The system is inserted via radial access and combines a guidewire, guide sheath and the double embolic protection devices into a single device.

Stroke remains a major predictor of mortality after TAVR. Cerebral protection devices are designed to reduce the risk of stroke by capturing and removing embolic debris that can be released during the procedure. CLEAN-TAVI was a prospective, randomized, double-blind single-center study, and the first trial to examine the impact of a cerebral protection device in preventing magnetic resonance imaging (MRI) -detected brain lesions during TAVR. The primary endpoint was the number of lesions in the protected brain region as determined by diffusion-weighted MRI (DW-MRI) subtraction at two days post TAVR. Secondary endpoints included the total lesion volume at two and seven days after TAVR and lesion number at seven days.

A total of 100 patients with severe aortic stenosis who were at increased surgical risk were recruited and randomly assigned in a 1:1 ratio to TAVR with cerebral protection (device group) or TAVR alone (control group). Patients underwent MRIs of the brain before and at two and seven days after TAVR. After two days, the median number of lesions in the protected regions in the device group was significantly lower than the control group (4 versus 10, respectively, p=0.009). At seven days after TAVR, the median lesion number was also significantly lower in the device group compared to the control group (3 versus 7, p=0.0023). In addition, the median total lesion volume in the protected area was significantly smaller in the device group compared to the control group at two days (246 mm3 versus 527 mm3, respectively, p=0.0023) and at seven days (101 mm3 versus 292 mm3, p=0.002). 

“In patients with severe aortic stenosis who are at increased surgical risk, the use of a cerebral protection device during TAVR significantly reduced the number of cerebral lesions in the protected brain regions,” said lead investigator Axel Linke, M.D., a professor at the University of Leipzig Heart Center in Germany. “Device use also reduced the volume of cerebral lesions as determined by DW-MRI.”

The CLEAN-TAVI trial was funded by the University of Leipzig Heart Center, Claret Medical and Medtronic. Linke reported grant/research support from Medtronic and Claret Medical; and consulting fees/honoraria from Medtronic, St. Jude Medical, Claret Medical, Boston Scientific and Edwards Lifesciences.

For more information: www.crf.org, www.tctconference.com

Related Content

Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init