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 Cerebral Protection System High Rate of Debris Capture
 

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

SENTINEL Cerebral Protection System Debris Capture During TAVR Procedure

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

99% of Debris Captured in TAVR Procedures using SENTINEL CPS, Graph
 
 

 
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."
 
Physician’s Perspective on Embolic Debris in TAVR Procedures, Video Thumbnail
 

 
 

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

TAVR Procedure Debris Image Library

Debris Capture
independent of STS score 5, 11, 12


Debris Captured Independent of STS Score, Graph

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."
 
Stroke Economics & Use of SENTINEL Cerebral Protection System, Video Thumbnail

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.

SENTINEL Cerebral Protection System Guidelines, Thumbnail

 

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."
 
TAVR Patient Perspective on SENTINEL Cerebral Protection System, Video Thumbnail
 
 

 

Clinical Data

 
 SENTINEL Cerebral Protection System 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 TAVR
 
Sentinel is Safe, Effective and we see a 60-70% reduction in All-Stroke with this device."
 
Data Review for SENTINEL Cerebral Protection System in TAVR Procedure, Video Thumbnail

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

SENTINEL

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


SENTINEL Cerebral Protection System Achieved Favorable Safety Outcomes, Graph

 

SENTINEL Cerebral Protection System IDE Trial Data, Graph

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

 

 
 

SENTINEL CPS Demonstrates Consistent Reductions in New Lesion Volumes

SENTINEL Cerebral Protection System Demonstrated Reductions in New Lesion Volumes, Graph
 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 Cerebral Protection System Demonstrated Reductions in Stroke, Graph
 
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

SENTINEL Cerebral Protection System Demonstrated Reductions in All-Procedural Stroke, Graph

All-cause Mortality or Stroke

SENTINEL Cerebral Protection System Demonstrated Reductions in All-Cause Mortality or Stroke, Graph

Disabling Stroke

SENTINEL Cerebral Protection System Demonstrated Reductions in Disabling Stroke, Graph
 

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.

 

Join Now
Top