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Reducing the risk of stroke.^1,2,3
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Stroke Happens

Preventing it depends on acknowledging it.

It only takes one piece, and 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. So it’s time to take another look at the effects of every stroke, and reassess how we can prevent them.

Any stroke can be devastating

Any stroke can devastate your patients and their families. Even minor cognitive events can result in significant negative consequences on their quality of life.

Of patients identify maintaining independence and being able to perform daily activities as their primary goals following a TAVI procedure*

The rates are underestiated. But the effects are impossible to ignore.

^{* Coylewright M, Palmer R, O’Neil E, et al., Patient-defined goals for the treatment of severe aortic stenosis: A qualitative analysis. Health Expect. Oct 2016:19(5): 1-36-1043}

The Facts of Stroke

2-4%

Weighted-average All-Stroke
rate across contemporary
studies, independent of
center experience, operator
volume, or patient risk score.^1-6

1/10

Post-procedure TAVI patients show overt signs of ischemic
brain injury⁷

6x

Increase in stroke-related
30-day mortality, post-TAVI⁸

^{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. 6. Kapadia, et al. N Engl J Med 2022. 7. SENTINEL IDE Trial. Data presented at SENTINEL Advisory Panel, February 23, 2017. 8. The CENTER Collaboration. N = 10982 Patients undergoing TF-TAVR with Edwards™ balloon-expandable valves or Medtronic™ self-expanding valves between 2007-2018 from 3 national registries and 7 local registries or prospective clinical trials.}

The Cost of TAVI related Stroke is high

In the Short Term ...

5-10

Times Higher

Risk of short-term mortality.^2,3

60%

Longer Hospital Stay

In patients with stroke following TAVI compared to patients without stroke.¹

~7%

Average Increase

In hospitalization costs for every additional day spent in hospital.⁴

1) Vlastra W, et al. Predictors, Incidence, and Outcomes of Patients Undergoing Transf emoral Transcatheter Aortic Valve Implantation Complicated by Stroke. From the CENTER-Collaboration. Circulation: Cardiovascular Interv entions. 2019;12:e007546.
2) Werner N, al. Incidence and clinical impact of stroke complicating transcatheter aortic valve implantation: results from the German TAVI Registry. Catheter Cardiovasc Interv 2016;88:644–653. 52.
3) Stortecky S, et al. Cerebrovascular accidents complicating transcatheter aortic valve implantation: frequency, timing and impact on outcomes. EuroIntervention 2012;8:62–70.
4) Epstain D, et al. THE HOSPITAL COSTS OF CARE FOR STROKE IN NINE EUROPEAN COUNTRIES. Health Econ. 17: S21–S31 (2008).

…but also, in the Long Term

3/4

Of All TAVI-Related Stroke Is Major

Those patients return home with moderate or severe disability and increased healthcare consumption.¹

15 years

After Experiencing A Stroke

Over 60% of survivors are still living with disability, ~40% have depression and 30% have cognitive impairment.²

€10-20 k

Social Costs Of Stroke

Average total cost* of patient & caregivers productivity loss, only in the first year after experiencing stroke.³

1) Vlastra W, et al. Predictors, Incidence, and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation Complicated by Stroke. From the CENTER-Collaboration. Circulation: Cardiovascular Interventions. 2019; 12:e007546.
2)Crichton SL, et al. Patient outcomes up to 15 years after stroke: survival, disability, quality of life, cognition and mental health Journal of Neurology, Neurosurgery & Psychiatry 2016; 87:1091-1098.
3) Kotseva et al. Patient and caregiver productivity loss and indirect costs associated with cardiovascular events in Europe. Eur J Prev Cardiol, 2019 Jul; 26(11).
* Country -range.

Costs can be significant for hospitals, healthcare systems & the society

Wilkins, E, et al. European Cardiov ascular Disease Statistics 2017. Brussels: European Heart Network; 2017.
The picture shows the breakdown of Healthcare and Societal costs of stroke (assessed in 2017) reported in The Burden of Stroke in Europe report conducted by King’s College London f or the Stroke Alliance f or Europe (SAFE).

Burden of TAVI-Related Stroke in 5 European markets and Economic Benefits of CEP

Number of TAVI procedures per Country perf ormed in 2020 (EMEA NC Reimbursement database & Atlas 2021).
*Assuming all anatomically eligible patients were receiv ing SENTINEL CEP dev ice.
Clinical assumptions: Seeger et al., 2019 (TAVI-related stroke rate); Durko et al., 2018 and ISTAT database (population projections).
Economic assumptions: The economic burden of TAVI-related stroke includes acute phase management, outpatient care, rehabilitation, nursing and societal costs.
Costs were weighted on the clinical course of TAVI-related stroke surv iv ors (Huded TCT 2018), estimated at 1 y ear and adjusted to 2020 values.

The cost of TAVI-related stroke is meaningful

Stroke has an impact on the quality-of-life of patients, their families and caregivers. And in addition to this, patients experiencing stroke have higher costs due to hospitalization, longer LoS, hospital re-admissions, rehabilitation and social costs.

Societal Costs of Stroke

13,773€

Increased mean cost for patient & caregivers,
just in the first year after experiencing stroke⁸

^{8. Kotseva et al. Patient and caregiver productivity loss and indirect costs associated with cardiovascular events in Europe. Eur J Prev Cardiol, 2019 Jul;26(11).}

SENTINEL Results

SENTINEL is clinically shown to be safe, able to capture and remove debris potentially reducing the risk of stroke, especially disabling stroke.*

See the Data

^{* PTAVR Trial. Kapadia, et al. N Engl J Med 2022.}

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