Post on 14-Apr-2017
transcript
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