Transcatheter Aortic Valve Replacement (TAVR)
Stroke continues to be a devastating complication of transcatheter aortic valve replacement (TAVR) and other endovascular and surgical procedures. Recently, new ischemic brain lesions, or “silent” infarcts, have been shown to occur in more than 90% of TAVR patients. These lesions have been associated with adverse neurologic and cognitive consequences, as well as dementia. They have also been shown to increase the risk of stroke by two to four times in future years, according to population-based studies published in the 2013 American Stroke Association/American Heart Association consensus guidelines.1
Claret Medical’s cerebral protection system has been shown to significantly reduce the volume and number of brain lesions and subsequent neurological events following TAVR, enabling a safer TAVR procedure, which is important as the procedure expands to younger and lower-risk patients.
|Study||Principal Investigator||Location||# Patients||Trial Type||Procedure||Data|
|First in Man||Prof. Christoph Naber||3 centers in Brazil & Germany||40||Registry||TAVR (CoreValve & Sapien)||EuroIntervention March 2012|
|MISTRAL-I||Dr. Nicolas van Mieghem||Rotterdam, Netherlands||40||Registry||TAVR (CoreValve & Sapien)||Circulation October 2013|
|CLEAN-TAVI||Prof. Axel Linke||Leipzig University, Germany||100||Randomized||TAVR (CoreValve)||JAMA August 2016|
|MISTRAL-C||Dr. Nicolas van Mieghem||4 centers in Netherlands||74||Randomized||TAVR (Sapien 3, Sapien XT, CoreValve)||EuroIntervention July 2016|
|SENTINEL* IDE||Drs Susheel Kodali, Samir Kapadia, & Prof. Axel Linke||17 centers in USA & 2 in Germany||363||Randomized||TAVR (Sapien XT, Sapien 3, CoreValve, EvolutR)||JACC November 2016|
|SENTINEL-H||Prof. Christoph Naber||10 centers in Europe||220||Registry||TAVR (All-comers)||Presented at EuroPCR 2016|
|TEVAR – Essen||Prof. R Alexander Jánosi||West German Heart & Vascular Center, Essen Germany||5||Pilot Study||TEVAR||Presented at LINC 2016|
|TEVAR – London||Drs Mo Hamady & Gagandeep Grover||Imperial College, London England||8||Pilot Study||TEVAR||Presented at ISET 2016|
|LAAO – Hamburg||Prof. Felix Meincke||AK St Georg, Hamburg Germany||5||Pilot Study||LAAO||Presented at TCT 2015|
|V-in-V||Dr. Tobias Schmidt and Dr. Christian Frerker||AK St Georg, Hamburg Germany||15||Registry||Aortic and Mitral
|BMJ May 2016|
*Commercially available valves in the US.
- Sacco RL, Kasner SE et al. AHA/ASA Expert Consensus Document: An Updated Definition of Stroke for the 21st Century. Stroke. 2013;44:2064-2089.
The Sentinel CPS has received the CE Mark and is commercially available in Europe. It is limited to investigational use in the United States.