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ECHO 2013 / Transcatheter Aortic and Mitral Valve Replacement The Future is Now 2

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TAVR Procedures

 

TAVR

 

 

 

$1.8 Billion

 

09-15 CAGR

 

Thousands of Procedures

 

 

 

Percentage

 

 

 

 

 

 

 

 

 

 

 

 

 

77

 

 

US

 

 

 

 

63

 

 

 

 

 

 

 

 

 

 

 

OUS

 

 

 

 

 

25

120%

 

 

 

+43%

 

 

 

 

 

 

 

 

20

 

 

 

 

 

50

 

 

 

 

 

 

 

 

 

 

 

 

 

36

15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

24

8

 

 

52

33%

 

 

 

2

 

 

 

 

 

 

16

 

35

43

 

 

 

8

0.7

 

28

 

 

 

US

22

 

 

 

 

0

15

 

 

 

 

 

 

 

 

 

 

 

 

OUS

8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2009

2010

2011

2012

2013

2014

2015

 

Source: JP Morgan

TAVR Categories

(risk is a continuum)

Operable AS patients

Too Sick

Inoperable

High Risk

Low-Intermediate Risk

90%

10% Approved Indications

 

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

 

therapy

Porcelain aorta

Severe COPD

Dementia

Severe frailty

Hostile chest

Liver cirrhosis

 

 

RIMA/LIMA anatomy

 

 

 

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