Transcatheter Aortic Valve Implantation (TAVI) 400 TAVI på Karolinska
Clinical needs finding presentation tavi
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Transcript of Clinical needs finding presentation tavi
TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI)
Preventing Cerebral Embolization
Schulich Innovation Research Day 2015
TeamMentor
Sam Radhakrishnan, MD
Director, Cardiac Catheterization Labs
Schulich Heart Centre
TeamYaron Arbel - MD, Clinical Fellow, Interventional Cardiology, Sunnybrook HSC
Stefano Picone - Director of Finance, Colibri Technologies
Abhi Pushparaj - PhD Candidate, Neuropharmacology, CAMH
Jill Cates - MSc, Surgical Education, University of Toronto
Mehdi Ataei - MSc, Mechanical Engineering, York University
Aortic Stenosis (AS)• Aortic Stenosis (AS): narrowing of the exit of the left
ventricle of the heart• Symptoms include shortness of breath, fainting spells,
angina, etc.• Prognosis is poor with 30-50% one year mortality rate for
those that do not undergo a valve replacement
HEALTHY STENOTICImages from Edwards Lifesciences
Transcatheter Aortic Valves
Implantation (TAVI) or Replacement (TAVR) • Relatively new minimally invasive procedure
• First performed on patient in 2002
• Three retrograde approaches:• Transfemoral• Transaortic• Transubclavian
• One anterograde approach: Transapical
TAVI Procedure
Projected Global TAVI Growth
Projected Global TAVI Market
The Problem: STROKE
60-80% 2-4%
Timing of Stroke Post-TAVI
Stortecky & Windecker Circulation. 2012;126:2921-2924 Copyright © American Heart Association, Inc. All rights reserved.
Problem & Need Statements
Problem Statement• The risk of cerebral embolization
occurring during TAVI is clinically problematic
Need Statement• A solution capable of reducing the risk of
cerebral embolization during TAVI by at least 50%
Stakeholder Analysis
Insurers- No change in
reimbursement
Hospitals- Solution cost vs cost
savings- Improved quality of
care & outcomes- Increase TAVI volume
Physicians- Ease of
use/training- No complications- Facilitate adoption
in lower risk patients
Industry- Demonstrated in trial
of reasonable size/cost
- Increase TAVR volumes
- Platform potential
Patients- Less fear of SAEs- No change in co-
pays- Minimize recovery
time
Needs Criteria● Clinically meaningful outcome
o Reduction of clinical stroke by at least 50% without other SAEs
● Affordable for providers and payorso Less than 10% increase in device cost per
procedure● Non-negative time/workflow impact on physicians
o Be trained & use with confidence, apply to lower-risk AS patients
● Industry path to profitabilityo Sales from solution + uptick in THVs
Global Market Size- Transcatheter heart valves cost $25,000 - $30,000- Estimated price of solution is 5-10% of THVs (i.e. $1,250 - $3,000)- Lifetime cost of an ischemic stroke is $175,000*- 1.5% absolute risk reduction of stroke (50% of 3% incidence)- Represents expected cost savings of $2,650 per procedure
Estimated from Credit Suisse TAVI estimates (Jan 2015)*Stroke.1996; 27: 1459-1466
Current Devices in Trials
SENTINEL TRIGUARD EMBRELLA
Competitive AdvantagesOPTIMAL SOLUTION SPECIFICATIONS
Minimally Sized Catheter 6 French 9 French 6 French
Easy Access Point(s) Radial Femoral Radial, UlnarBrachial
Aortic Arch Coverage (3 Arteries) BCA, LCCA BCA, LCCALSA
BCA, LCCAPartial LSA
Ability to Capture Debris ✔ ✖ ✖
Convenient Imaging of Position RadiopaqueMarkers
Contrast Agent Only
Contrast Agent Only
Reduce # of Cerebral Lesions - 65% -50% +80%
Reduces Volume of Cerebral Lesion -57% -44% -46%
Improve Neurological Outcomes Lower Ataxia Some Non-significant
Not Yet Studied
Procedural Success 94% 89% 93%
Hurdles for Creating a Solution
- Etiology of stroke is not clearly understood following TAVI (and other procedures) - Calcified debris; Native valve tissue; Thrombus
- Potentially large trial to demonstrate reduced stroke incidence may be needed if effect size of solution is not high (~75%)
- Value ($) of surrogate benefits are unclear- Reduced DW-MRI # of lesions & lesion volumes- Reduced neurocognitive deficits
Similar Risk amongst Procedures
- Percutaneous Coronary Intervention- Coronary Artery Bypass Graft- Atrial Fibrillation Ablation- Surgical AVR
Creating a platform solution will be difficult but highly valuable
Thank You!
Appendix
A1. Study Device
4 valve sizes (18-29 mm annular range)
18Fr delivery system
A2. Access Routes