Medical Specialties > Structural Heart > SENTINEL™ Cerebral Protection System

SENTINEL™ Cerebral Protection System (CPS)

The SENTINEL Cerebral Protection System protects the brain from harmful debris released during the TAVR procedure.
Protected TAVR™ with SENTINEL CPS gives you the power to reduce stroke.

Instructions for Use

 

 

Stroke Risk is Unpredictable

 

Stroke and neurological impairment
can be a serious and potentially
devastating event.


The effects are often underreported and underdiagnosed.1-5
Stroke risk is unpredictable, independent of experience, operator volume or risk score.

 
1. Manoharan, 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.
 

 

In the SENTINEL IDE, prospective assessment by neurologists revealed that almost

TAVR patients showed overt signs of ischemic brain injury, post-procedure.

Most cerebrovascular events take place acutely within 24 hours of the index procedure.
 

 
 
Sentinel
 

The SENTINEL IDE showed
a high rate of debris capture.7


Clinical evidence shows that cerebral embolic debris is generated in the vast majority of patients undergoing TAVR, regardless of patient risk profile or valve type.7, 9, 10

The SENTINEL IDE showed that 1 in 4 TAVR patients had an average of 25 pieces of debris captured and removed by the SENTINEL Cerebral Protection System (CPS) that were visible to the naked eye.5

Debris captured by SENTINEL CPS

 
5. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377. | 7. SENTINEL IDE Trial. Data presented at SENTINEL Advisory Panel, February 23, 2017. | 9. Van Mieghem NM, Schipper ME, Ladich E, et al. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation 2013;127:2194–201. | 10. Schäfer U. Safety and Efficacy of Protected Cardiac Intervention: Clinical Evidence for Sentinel Cerebral Embolic Protection. Interv Cardio Review. 2017;12(2):128–32.
 
 

Debris Captured in 99% of Procedures7
SENTINEL IDE Trial

Captured Debris
 
 

 
 
Watch the video to hear physician
perspectives on embolic debris during TAVR.
 
Having that visual confirmation of captured debris, I know I've done right by the patient."
 
Debris Capture Video
 

 
 

The capture of embolic debris is universal regardless of valve types or patient risk profile, supporting the potential benefit of using cerebral embolic protection in all TAVR procedures. 5, 7, 11, 12

Debris Capture
independent of STS score 5, 11, 12


The data in the chart did not reach statistical significance, per Fisher’s Exact Test.

 
5. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377. | 7. SENTINEL IDE Trial. Data presented at SENTINEL Advisory Panel, February 23, 2017. | 11. Schmidt et al. JACC Cardiovasc Interv. 2018. 9(13):1262-1273. | 12. Jensen et al., Prevalence and etiopathology of thromboembolic debris during transcatheter interventional aortic valve replacement: results of the SENTINEL H-study, EuroPCR 2016.
 
 

 

Stroke Burden 

 

Stroke and stroke-related incidents can account for increased hospital
costs, increased length of stay, and higher readmission rates.13


 
13. Alqahtani F et al. SH Journal, 3(1):72–73.
 

 
 
Learn more about Stroke
Economics and the Use of SENTINEL
CPS to Grow your TAVR Program
 
Transitioning from mild cognitive impairment to mild dementia can add $6,000 excess cost per patient."
 
Use of Sentinel to Grow your TAVR Program

Courtesy of Dr. Hemal Gada, UPMC Pinnacle

 

 
 

Guidelines


The Centers for Medicare & Medicaid Services (CMS) has approved the SENTINEL CPS (US only website) for a new technology add-on payment (NTAP), effective October 1, 2018.

 

The physical and emotional impact
of stroke affects both patients
and their caregivers.


Cerebral protection may reduce long-term cognitive impairment.

Stroke or neurological impairment fears from patients include: losing the ability to live independently, creating a burden on their families and the need for higher levels of skilled care.
 
Hear a TAVR patient’s perspective
on cerebral protection with TAVR
 
I wanted to have my brain protected."
 
Patient testimonial
 
 

 

Clinical Data

 

A growing body of clinical evidence
provides a strong foundation for the
benefits of Cerebral Embolic
Protection and the SENTINEL Cerebral
Protection System.


 
 

 
 
Hear a Contemporary Review of the Data
Supporting the Use of SENTINEL in TAVR
 
Sentinel is Safe, Effective and we see a 60-70% reduction in All-Stroke with this device."
 
Clinical Evidence Video

Courtesy of Prof. Jochen Whorle, University of Ulm

 

 
 

SENTINEL IDE Randomized Control Trial7 is the first randomized clinical trial approved by the FDA evaluating cerebral protection in TAVR.


SENTINEL IDE Trial: All-Stroke Post-TAVR7

  • Primary Safety endpoint met with a
    30-Day MACCE rate of 7.3%
  • Statistically significant 63% peri-procedural (≤72 hours) stroke reduction with SENTINEL CPS
  • Cerebral debris captured and removed in 99% of patients protected with the SENTINEL device

95% of SENTINEL patients were evaluated by neurologists
Clinical Events Committee included stroke neurologists

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

SENTINEL CPS Achieves Favorable Safety Outcomes in IDE Trial7


 

* MACCE defined as Death (any cause), Stroke (any),
Acute Kidney Injury (Stage 3).

 

 
 

SENTINEL CPS Demonstrates Consistent Reductions in New Lesion Volumes

SENTINEL CPS Demonstrates Consistent Reductions in New Lesion Volumes
 Cerebral Emboli detected on DW-MRI increases the risk of overt Stroke by 2-4 times15
 
4. Haussig S et al., JAMA 2016;316:592–601. | 7. SENTINEL IDE Trial. Data presented at SENTINEL Advisory Panel, February 23, 2017. | 14. Van Mieghem N, et al. EuroIntervention 2016;12:499-507. | 15. Vermeer SE, et al., Lancet Neurol. 2007; 6 : 611.
 

 
 

Sentinel CPS Demonstrates Consistent Reductions in Stroke Across Multiple Randomized Control Trials and Global Real World Studies5, 16-18

 
A 60-80% peri-procedural relative reduction in neurologist-adjudicated TAVR All-Stroke
with an average absolute reduction of 3-4% at 72 hours & 7 days post TAVR
SENTINEL CPS Demonstrates Consistent Reductions in New Lesion Volumes
 
5. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377. | 16. Van Mieghem N, Snapshots from Real World High Volume Single Center Experiences with Sentinel Cerebral Embolic Protection During TAVR, Erasmus Medical Center, presented at TVT 2018. | 17. Seeger J., Snapshots from Real World High Volume Single Center Experiences with Sentinel Cerebral Embolic Protection During TAVR, University of Ulm, presented at TVT 2018. | 18. Chakravarty T, Snapshots from Real World High Volume Single Center Experiences with Sentinel Cerebral Embolic Protection During TAVR, Cedars Sinai Medical Center, presented at TVT 2018.
 

 

Largest Propensity Matched Meta-Analysis Comparison shows stroke and all cause mortality reduction with SENTINEL CPS17


 

All-procedural Stroke

All procedural stroke

All-cause Mortality or Stroke

All cause mortality or stroke

Disabling Stroke

Disabling stroke
 

SENTINEL CPS is by far the most widely studied cerebral protection device with safety demonstrated for over 3,500 patients across three randomized trials and independent real world studies.16-18

 

16. Van Mieghem N, Snapshots from Real World High Volume Single Center Experiences with Sentinel Cerebral Embolic Protection During TAVR, Erasmus Medical Center, presented at TVT 2018. | 17. Seeger J., Snapshots from Real World High Volume Single Center Experiences with Sentinel Cerebral Embolic Protection During TAVR, University of Ulm, presented at TVT 2018. | 18. Chakravarty T, Snapshots from Real World High Volume Single Center Experiences with Sentinel Cerebral Embolic Protection During TAVR, Cedars Sinai Medical Center, presented at TVT 2018.

 

 

Procedural Efficiency

 

SENTINEL CPS Does Not Impact Cath Lab Workflow or Procedural Timing7


MINIMAL INTERFERENCE with advancement of the TAVR device

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