ECHO 2013 / Transcatheter Aortic and Mitral Valve Replacement The Future is Now 2
.pdf
TAVR Procedures
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TAVR |
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$1.8 Billion |
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09-15 CAGR |
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Thousands of Procedures |
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Percentage |
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77 |
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US |
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63 |
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OUS |
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25 |
120% |
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+43% |
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20 |
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50 |
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36 |
15 |
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24 |
8 |
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52 |
33% |
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2 |
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16 |
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35 |
43 |
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8 |
0.7 |
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28 |
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US |
22 |
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0 |
15 |
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OUS |
8 |
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2009 |
2010 |
2011 |
2012 |
2013 |
2014 |
2015 |
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Source: JP Morgan
TAVR Categories
(risk is a continuum)
Operable AS patients
Too Sick
Inoperable
High Risk
Low-Intermediate Risk
90% |
10% Approved Indications |
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Who Is Too Sick for TAVR?
Patients in whom the presence of multiple comorbidities, especially frailty, overwhelm the likelihood of functional recovery despite successful TAVR
TAVR |
Medical |
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therapy |
Porcelain aorta |
Severe COPD |
Dementia |
Severe frailty |
Hostile chest |
Liver cirrhosis |
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RIMA/LIMA anatomy |
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43
Transcatheter AVR
Post Commercial
Approval
Challenges of Commercialization
•Training operators on new technology
Shorten the learning curve
Standardized training program
•Identifying sites
Case volume
Heart Team
Infrastructure concerns
Political and geographical concerns
•Regulatory and reimbursement issues
•Educating referring physicians to increase referral volume
Who Should Do TAVR?
•Only well trained qualified individuals
•This should be done as a team
Not a single operator procedure
Focus needs to be on catheter skills
Surgical skills must be available
Best served by having multiple expertise
•IC/Surgeons
•Echo, anesthesia, nursing
•Team is ideally a formal structure
Alignment of interests and incentives
What‟s so special about a TAVR program?
•Unique and still evolving technology
Program vs. procedure
•Procedural environment
Hybrid Cath Lab and/or OR
Operator expertise
Intermingling of Cath lab and OR staff
•Unique patient population
Elderly
•Sensory/cognitive deficits
•Frail, multiple co-morbid conditions
•Intense family involvement
Require expertise in clinical management of aortic stenosis, as well as geriatric care
How to Form the Team?
•Find interested motivated individuals
„cutting edge‟
Generally earlier in career
•Focus on treating valve/structural disease
Not TAVR vs. sAVR, TA vs. TF
•Align organization and incentives
All benefit from treating patients
Allows unbiased decisions
TAVR Commercial Sites Trained
156 New Commercial Sites Trained
Excludes PARTNER sites; as of 9/26/12
TAVR Commercial Sites