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Medical Specialties > Structural Heart > SENTINEL™ Cerebral Protection System

SENTINEL™ Cerebral Protection System

Stroke is unpredictable. It can happen to any TAVI patient. No matter their age. No matter their background. Even minor cognitive events can represent life-changing effects for your patients and their families.

We believe it's time to look at the effects of every stroke, and reassess how we can prevent them going forward.

Instructions for Use

 

Stroke Risk is Unpredictable

 

Stroke Data & Occurence

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.

4%

Weighted-average all-stroke rates
across contemporary studies -
independent of center experience,
operator volume or patient risk score.

>9%

Stroke rate showing
in studies that include a mandated
neurological assessment.

 
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

1 in 10

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

Most cerebrovascular events take place acutely within 24 hours of the index procedure.
 
 
 
SENTINEL Cerebral Protection System (CPS)
 

Debris Matters

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 TAVI, regardless of patient risk profile or valve type.7, 9, 10

The SENTINEL IDE showed that 1 in 4 TAVI patients had an average of 25 pieces of debris larger than 0,5mm of size captured and removed by the SENTINEL Cerebral Protection System (CPS) that were visible to the naked eye.5

Debris captured by SENTINEL CPS

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 TAVI.
 
Whenever you implant a valve debris will dislodge and travel to the brain."
 
Debris Capture Video Nicolas van Mieghem
 
 
 

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 TAVI procedures. 5, 7, 11, 12

Debris Image Library

View Images

Debris Capture
independent of STS score 5, 11, 12


Debris Capture independent of STS score

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 

 

Economic Data

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

Hospitalization
costs are

33%


HIGHER


for TAVI procedures
with stroke

Hospital length
of stay is

6 DAYS


LONGER


(on average) for TAVI
procedures with stroke

30-Day
readmissions are

31%


HIGHER


for TAVI procedures
with stroke

 
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 TAVI Program
 
But it is not only mortality. It is also clearly morbidity and its costs, hospital stay and logistics of the procedure."
 
Daniel Blackman video
 
 

Patient Testimonial

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 TAVI patient’s perspective
on cerebral protection with TAVI
 
I wanted to have my brain protected."
 
Patient testimonial
 
 
 

Clinical Data

 
SENTINEL Cerebral Protection System (CPS)

Growing Clinical Evidence

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 TAVI
 
Sentinel is Safe, Effective and we see a 60-70% reduction in All-Stroke with this device."
 
Clinical Evidence Video

Courtesy of Prof. Jochen Wöhrle, University of Ulm

 
 
 

Randomized Controlled Trials

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

SENTINEL IDE Trial: All-Stroke Post-TAVI7

  • 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

Statistically significant 63% peri-procedural (≤72 hours) stroke reduction with SENTINEL CPS

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

 

SENTINEL CPS Achieves Favorable Safety Outcomes in IDE Trial7


SENTINEL CPS IDE Trial Performance

 

SENTINEL CPS IDE Trial Safety Outcomes

* 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 TAVI All-Stroke
with an average absolute reduction of 3-4% at 72 hours & 7 days post TAVI
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 TAVI, 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 TAVI, 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 TAVI, Cedars Sinai Medical Center, presented at TVT 2018.
 
 

Post Approval Studies

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 TAVI, 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 TAVI, 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 TAVI, Cedars Sinai Medical Center, presented at TVT 2018.

 
 

Procedural Efficiency

 

SENTINEL is Safe, Fast, and Effective

SENTINEL CPS Does Not Impact Cath Lab Workflow or Procedural Timing7

 

99.4%


PROCEDURAL SUCCESS with at least 1 filter deployed (94.4% with both filters)

 

4 MINS


median deployment time
to place both filters

90%


of anatomies covered
with one size



0.4%


access site-related vascular
complication rate.

MINIMAL INTERFERENCE with advancement of the TAVI device

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

 

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