Medical Specialties > Structural Heart > SENTINEL™ Cerebral Protection System

Strokes are underdiagnosed.

Many physicians and centers report stroke rates of 1% or less, but true clinical stroke rates are often far higher than recognized and reported.

Stroke icon
Stroke definitions and classifications have changed over time with neuroimaging advances.1-3
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Most studies do not use routine imaging or proactive discharge exam by neurologists.
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Studies using routine discharge exam by neurologists show higher clinical stroke rates.4
 
1. Mokin, Expert Review Of Neurotherapeutics, 2016;  2. Leon B et al. J Am Coll Cardiol, 2011;57:259-69;  3. Kappetein A et al., European Heart J., 2012;33:2403-18;  4. Messé S, et al., Circulation.2014;129:2253-61.
 

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The reality of stroke.

Any stroke can devastate your patients and their families. Even minor cognitive events can result in significant negative consequences on their quality of life. There are many subtle, often-undetected, clinically unrecognized signs and symptoms of post-TAVR strokes that can have far-reaching effects

 
The facts of stroke

The Reality of Stroke


 
1. Manoharan G, et al., J Am Coll Cardiol Intv 2015; 8:1359-67. 2. Wendler O, et al., Circulation 2017; 135: 1123–1132. 3. Seeger J, et al., Eur Heart J. 2018 Dec 24. doi: 10.1093/eurheartj/ehy847. 4. Haussig S et al., JAMA 2016; 316:592–601. 5. Kapadia S, Kodali S, Makkar R, et al., Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017; 69(4): 367–377.
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New data shows low risk is still risk.

TAVR is expanding to increasingly broader patient populations and risk indications. However, the capture and analysis of embolic debris in low to intermediate risk patients had yet to be prospectively examined, until now.

The SENTINEL Low – Intermediate Registry:

Characterization of cerebral emboli capture using SENTINEL during TAVR1

STUDY DESIGN: N = 50 low-intermediate surgical-risk patients; Real-world, multicenter, prospective registry.

Clinical Highlights

  • Of 100 filters analyzed from 50 patients, debris was found in 100% (50/50) of patients*
  • Debris type and size from low to intermediate surgical risk TAVR patients consistent in rate, type and particle size of captured debris in high surgical risk patients in the SENTINEL IDE Trial2
 
*Participating sites: Cleveland Clinic (Cleveland, OH), UPMC Pinnacle (Harrisburg, PA), Columbia (New York, NY), Atrium Health (Charlotte, NC)

** Debris included arterial wall, acute thrombus, valve tissue, calcification and foreign material. Myocardium, organizing thrombus and necrotic core were observed less frequently. Majority (78%) of debris particles were 150-499 in maximum diameter; Larger size particles (≥1000), which can cause significant vessel obstruction, were present in 5% of patients.

1. The SENTINEL Low-Intermediate - Registry (LIR): Characterization of Cerebral Emboli Capture Using the Sentinel Device during TAVR in Low to Intermediate Risk Patients. Presented at CRT 2021 by Dr. Aloke Finn, CV Path Institute.

2. SENTINEL IDE Trial. Data presented at SENTINEL FDA Advisory Panel, February 23, 2017 .
 

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The cost of stroke is high.

Not just in terms of your patient's quality of life, but in sheer economics.

 
The cost of stroke

Patient Cost


1. SENTINEL IDE Trial. Data presented at SENTINEL Advisory Panel, February 23, 2017.   2. Huded C, presented at TCT 2018
 
The cost of stroke

Program Cost


 1. Alqahtani F, et al. Clinical and economic burden of acute ischemic stroke following transcatheter aortic valve replacement. Structural Heart. 2018;3(1):72:73.

 

 
 
Perspectives on Cerebral Embolic Protection
 

 
Stroke happens
Stroke happens
 6 SENTINEL IDE Trial. Data presented at SENTINEL Advisory Panel, February 23, 2017.

 

 

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