About Protected TAVR™
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The Risk of Brain Injury During TAVR
Stroke can be a devastating complication of cardiovascular procedures, such as transcatheter aortic valve replacement (TAVR), thoracic endovascular aortic/aneurysm repair (TEVAR), left atrial appendage occlusion (LAAO) and transcatheter mitral valve repair and replacement.
A stroke can be obvious (“clinically-apparent”) or clinically-hidden, which is known as a “silent” stroke. A clinically-apparent stroke has the characteristics with which most people are familiar: sudden muscle weakness or numbness on one side of the body; abrupt loss of vision, speech or coordination; severe headache; and dizziness or loss of consciousness. The American Heart Association defines a “silent” stroke as a type of brain injury caused by small lesions forming in the brain that can only be seen on brain scans, but does not exhibit the characteristics of a clinically-evident stroke.1
While “silent,” this sub-class of stroke exhibits subtle symptoms that are associated with cognitive deficiencies, such as thinking, processing speed and memory impairment, and can have a negative impact on daily activities, such as managing a household, paying bills, shopping and relating to others.1, 2 It is also linked to impaired mobility, physical decline, depression, dementia, Alzheimer’s Disease and Parkinson’s Disease over time.2 “Silent” strokes can lead to a two- to four-fold increase in the risk of a clinically-apparent stroke in the future,3 as well as an increased risk of death.
During cardiovascular procedures, both types of stroke can be caused by debris generated by the procedure, which travels through the blood stream to the brain and becomes lodged there, restricting the blood and oxygen supply, and potentially causing permanent brain damage. The debris often consists of tissue and/or other organic matter that comes loose during the procedure.4, 5, 6
The 30 day clinically evident stroke rates after TAVR procedures ranges from 3-5%, while “silent” strokes have been found in the vast majority of TAVR patients.5
Despite the prevalence of brain injury resulting from these procedures, cerebral protection is not commonly used today. However, new technology is beginning to change this.
Protecting the Brain During TAVR
A new type of protection has been designed to help safeguard patients from the risk of stroke caused by debris that may travel to the brain during certain cardiovascular procedures. The Sentinel™ Cerebral Protection System (CPS), used in “protected TAVR” and other protected procedures, is the only device that filters, captures and removes this potentially damaging debris before it can reach a patient’s brain.
View a Protected TAVR Procedure
The Sentinel CPS filters blood traveling through the arteries to the brain, and is removed at the end of the procedure. In clinical studies the system has been shown to significantly reduce the size and number of brain lesions, reducing the risk of neurological damage after the procedure.7, 8
Protected TAVR Studies
Watch Dr. Linke discuss key findings from the CLEAN-TAVI trial
The landmark CLEAN-TAVI randomized clinical trial of 100 patients showed a 57% reduction in total volume of new brain lesions and a 50% reduction in the number of new brain lesions post-procedure in those patients undergoing protected TAVR with the Sentinel CPS, when compared to unprotected TAVR patients7. The randomized MISTRAL-C trial of 63 patients validated these findings, showing a 52% reduction in the total new lesion volume post-procedure after protected TAVR using the Sentinel CPS8.
In the CLEAN-TAVI trial, neurologists who examined patients’ brains after the unprotected TAVR procedure observed a neurological deficit in 28% of these patients7. The MISTRAL-C trial went one step further, proving that the Sentinel CPS offers a cognitive benefit, as well, with protected TAVR patients demonstrating better brain function after TAVR than unprotected patients8.
The SENTINEL clinical trial, the first randomized trial to have taken place in the U.S. (and Germany), confirmed the findings of both the CLEAN-TAVI and MISTRAL-C trials. SENTINEL demonstrated that Sentinel CPS adds no risk to the TAVR procedure and in fact makes it an even safer procedure.11
If you are a candidate for TAVR, ask your doctor what they can do to protect your brain while treating your heart.
The Sentinel CPS has received the CE Mark and is commercially available in Europe. It is limited to investigational use in the United States.
- 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
- Windham GB, et al. Small Brain Lesions and Incident Stroke and Mortality. Ann Intern Med. 2015;163:22-31
- Eggebrecht H, et al. Risk of Stroke After Transcatheter Aortic Valve Implantation (TAVI): A Meta-Analysis of 10,037 Published Patients. EuroIntervention. 2012;8:129-138
- Van Mieghem N et al. Incidence and Predictors of Debris Embolizing to the Brain During Transcatheter Aortic Valve Implantation. J Am Coll Intv. 2015;8:718-24
- Schäfer et al. Embolic Protection During Transcatheter Aortic Valve Implantation with the Claret Montage Filtration System, as presented at DGK 2014
- Van Mieghem N et al. Histophathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement. 2013;127-2194-2201
- Linke A. CLEAN-TAVI: A Prospective, Randomized Trial of Cerebral Embolic Protection in High Risk Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement. Transcatheter Cardiovascular Therapeutics (TCT). 2014
- Van Mieghem N, et al. MISTRAL-C: A Prospective Randomized Trial of Embolic Protection During Transcatheter Aortic Valve Replacement. Transcatheter Cardiovascular Therapeutics (TCT). 2015
- Van Mieghem N et al. Incidence and Predictors of Debris Embolizing to the Brain During Transcatheter Aortic Valve Implantation. J Am Coll Cardiol Intv. 2015;8:718-24.
- Ghanem, et al. Risk and Fate of Cerebral Embolism After Transfemoral Aortic Valve Implantation: A Prospective Pilot Study With Diffusion-Weighted Magnetic Resonance Imaging, J. Am. Coll. Cardiol. 2010;55;1427-1432
- Kodali, et al. TCT, 2016