ACC and EuroPCR - Benefits of TriGuard Cerebral Protection Device during TAVR

Data Presented at ACC (March 2015) and EuroPCR (May 2015) Demonstrate Benefits of Keystone Heart’s TriGuard™ Cerebral Protection Device during TAVR. Based upon results from the DEFLECTIII trial, the CE marked TriGuard™ Cerebral Protection Device has improved in-hospital safety outcomes and cognitive scores at discharge during Transcatheter Aortic Valve Replacement (TAVR). Based on changes in NIH Stroke Scale, patients protected with TriGuard had 10% absolute reduction in stroke (4.9% vs. 14.3%). Minor strokes were under detected without detailed NIHSS assessment. 

DEFLECTIII - Study Overview
Design:
Multicenter prospective single-blind randomized controlled trial at 13 sites (EU/IL)

Objective:
To evaluate the safety, efficacy and performance of TriGuard protection compared with unprotected TAVR.

Sample Size:
Exploratory study with no formal hypothesis testing.
86 patients selected to benchmark events for the design of a pivotal RCT.

DWI-MRI Results


DW-MRI Results with TriGuard
Patients with No
Ischemic Brain Lesions

DW-MRI Results with TriGuard
Percent of Patients Based on
Total Lesion Volume (mm3) (PT)

DW-MRI Results patients with NO Ischemic Brain Lesions TriGuard Lansky DEFLECTIII LBT ACC finalAJL website DW-MRI Results Percent patients total lesion volume TriGuard Lansky DEFLECTIII LBT ACC finalAJL website

 

Conclusions

  1. Use of the TriGuard was safe and provided complete cerebral coverage in 87% of cases
  2. TriGuard protection increased the proportion of patients completely free of ischemic brain lesions by more than 50% and reduced single and maximum lesion volume by about 40%
  3. TriGuard appears to prevent cognitive decline and was associated with improved short-term and delayed memory at discharge compared to controls
  4. Stroke was under-reported based on systematic NIHSS assessment
  5. Protected patients had a 10% absolute lower stroke rate
  6. DEFLECT III provides proof of concept of the benefits of neuroprotection with the TriGuard device during TAVR and will benchmark event rates for a planned definitive randomized US approval trial

Click below to view the full presentation, by Alexandra Lansky at ACC 2015.   




Click below to view the full presentation by Andreas Baumbach at EuroPCR 2015.

DEFLECT III - Baumbach Andreas - EuroPCR 2015



*The DEFLECT III Trial: A Prospective Randomized Evaluation of the TriGuard Embolic DEFLECTion Device during Transcatheter Aortic Valve Replacement 
Alexandra Lansky, MD, Yale University School of Medicine, New Haven, CT
Joachim Schofer, Szilard Voros, Adam Brickman, Didier Tchetche, Pieter Stella, Jochen Reinöhl Thomas Cuisset, Daniel Blackman, Michael Cleman, John Forrest, Gil Bolotin, Med Spitzer, Martine Gilard, Thomas Modie, David Hildick-Smith, Kevin Abrams, Michael Haude, and Andreas Baumbach 

More detailed information can be found in the news section and also in the press release issued by the American College of Cardiology - Benefits Seen for First-in-Field Brain Shield Used with TAVR - Device designed to deflect particles dislodged during valve replacement.
The TriGuard Cerebral Protection Device is not commercially available in the USA.