About Protected TAVR™
WATCH A VIDEO ABOUT PROTECTED TAVR
TAVR is an effective and popular method to replace a diseased aortic heart valve in a minimally invasive way, but recent studies have found that almost one in 10 patients experience a clinically-apparent stroke due to the procedure.1 The majority of strokes occur during the procedure or within the first 72 hours,1 caused by debris – often calcium, tissue or other organic and foreign matter 2,3,4 – that breaks loose and travels through the bloodstream towards the brain. There it may become lodged, restricting the blood and oxygen supply to the brain, and potentially causing a stroke and permanent brain damage.
Cerebral debris found in Claret filters
A recent study found that the procedural stroke rate after TAVR is much higher than previously reported – 9.1%1 compared to reported stroke rates ranging from 1%-5%. The higher figure is a result of neurologists reviewing brain imaging after TAVR who are trained to identify stroke, rather than observational-only reports from physicians.
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 technology is available to help safeguard patients from the risk of stroke during TAVR and other selected cardiovascular procedures. The Sentinel, used in “protected TAVR” and other protected procedures, is the only device that filters, captures and removes potentially dangerous debris before it can reach a patient’s brain.
Leading physicians have indicated their preference for the Sentinel system if they or a loved one plan to undergo TAVR.
View a Protected TAVR Procedure
The Sentinel 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
Watch patient testimonials from the public comment session of the Feb 23, 2017 FDA Circulatory System Devices Panel advisory committee meeting which concluded with a near-unanimous endorsement of Sentinel, the first cerebral protection device for TAVR evaluated by the FDA.
Profession: Retired Urologist
Home State: Texas
Introduction: Gentleman in his 80’s with symptomatic severe aortic stenosis who was deferring his TAVR procedure until the Sentinel became available.
Click here to view testimonial video
Profession: Public service with the local Sheriff’s Department
Home State: Florida
Introduction: Gentleman in his 70’s with symptomatic severe aortic stenosis who had a TAVR procedure using the Sentinel.
Click here to view testimonial video
Protected TAVR Studies
Watch Dr. Linke discuss key findings from the CLEAN-TAVI trial
The Sentinel Cerebral Protection System has been shown to reduce strokes by 63% in the first 72 hours after TAVR – when most strokes occur.5 In clinical studies, the Sentinel removed visible debris headed towards the brain in 99 percent of TAVR cases.1 It can be used by the vast majority of patients, and is compatible with any commercially-available TAVR valve.
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, when compared to unprotected TAVR patients6. 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 Sentinel7.
In the CLEAN-TAVI trial, neurologists who examined patients’ brains after the unprotected TAVR procedure observed a neurological deficit in 28% of these patients6. The MISTRAL-C trial went one step further, proving that the Sentinel offers a cognitive benefit, as well, with protected TAVR patients demonstrating better brain function after TAVR than unprotected patients7.
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 adds no risk to the TAVR procedure and in fact makes it an even safer procedure.8
If you are a candidate for TAVR, ask your doctor about protected TAVR and if the Sentinel system will be used to protect your brain from stroke during the procedure.
U.S. Clinical Trial Centers
- Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377.
- 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
- Data from SENTINEL Trial, included in device’s Instructions for Use (IFU). To view IFU click here.
- 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.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Click here for the Indication, Contraindications, Warnings, and Precautions.