Robert C. Welsh, MD, FRCPCProfessor of Medicine, University of Alberta

Zone Clinical Department Head, Cardiac Sciences

The Expansion of TAVI Patient Indications.Is Open AVR Soon To Be Replaced?

Inspiring Innovation and KnowledgeLeaders in Patient Care

2010

2011

2012

2013

2014

2015

2016

Published

Upcoming

LowIntermedi

ateHigh Extreme

NOTION

PARTNER 3US Evolut R

LR

PARTNER 2A

SURTAVI

PARTNER 1A

Corevalve US HR

PARTNER 1B

Corevalve US ER

REPRISE 3

Symptomatic AS: SAVR Risk

SALUS (stopped)

PORTICO IDE

Medtronic CoreValve/Evolut R

Edwards Sapien/Sapien XT/S3

Boston Lotus

Direct Flow Medical Direct Flow

Abbott Vascular Portico

PARTNER 2 S3i

UK TAVI

Any available TAVR system

2017

2018

2019

2017

REBOOT

CHOICE

PARTNER 2 S3

Investigational devices

SOLVE-TAV

Pipeline of TAVR trials across the spectrum of

aortic stenosis

SCOPE 1

Symetis Acurate Neo

SCOPE 2

NOTION 22020

2021

AS with no

symptoms

TAVR UNLOAD

EARLY TAVR

PARTNER 2B

RCT, randomised controlled trialCapodanno D, Leon MB. EuroIntervention 2016; 12:Y51–5; Clinicaltrials.gov

STS Data base

Prohibitive Risk

High RiskIntermediate

RiskLow Risk

Score STS >8% STS 4-8% STS<4%

Percent SAVR 6% 14% 80%

In-hospital Mortality

11.8% 5.1% 1.4%

Strategy TAVI only Option

TAVI Dominant

TAVI Dominant

?TAVI=SAVR

PARTNER 2A:Adverse events (30 days)

7.9

10.49.1

5.5

8.5

1.3

5

43.4

26.4

6.1 6.9

3.1

0

5

10

15

20

25

30

35

40

45

50

Major Vasc Comp Life ThreateningBleed

New Afib Stroke Pacemaker Acute KidneyInjury

TAVI Column1 SAVR

Leon MB et al. NEJM 2016

P<0.001

P<0.001

P=0.57

P=0.17

P=0.006

P<0.001%

Events (%) 30 Days 1 Year

TAVR Surgery TAVR Surgery

Death

All-cause 1.1 4.0 7.4 13.0

Cardiovascular 0.9 3.1 4.5 8.1

Neurological Events

Disabling Stroke 1.0 4.4 2.3 5.9

All Stroke 2.7 6.1 4.6 8.2

All-cause Death and Disabling Stroke

2.0 8.0 8.4 16.6

Unadjusted Clinical EventsAt 30 Days and 1 Year (AT)

What outcomes do you expect with an intermediate STS Score Risk STS score if you receive

open surgical AVR?

In-hospital Outcome Expected risk

Mortality 6.3%

Morbidity or Mortality 36.4%

Risk of long hospitalization 19%

Disability Stroke 2.4%

Prolonged Ventilation 22.3%

Deep Sternal Wound Infection 0.3%

Renal Failure 13.5%

TAVR Guidelines (2017)The New AHA/ACC Focused Update

ACA, American College of Cardiology; AHA, American Heart AssociationNishimura RA, et al. J Am Coll Cardiol. 2017; 70:252–289

Nordic Aortic Valve Intervention (NOTION) Trial

Objective:To compare TAVR vs. SAVR in patients ≥ 70 years eligible for surgery

(all-comers population/consecutive recruitment)

Primary outcome:Composite rate of all-cause mortality, stroke or myocardial infarction

at 1 year (VARC II-defined)

Secondary

outcomes:

Safety and efficacy (NYHA), echocardiographic outcomes (VARC II-

defined)

Design: Prospective, multicenter, non-blinded, randomized trial

Enrollment period: December 2009 - April 2013

ITT TAVR

n=145

ATT TAVR

n=142

Implanted TAVR

n=139

All randomized

N=280

Died prior to

procedure n=3

Crossover

TAVR to SAVR

n=1

Crossover

SAVR to TAVR

n=1

Crossover

TAVR to SAVR

n=3

ITT SAVR

n=135

ATT SAVR

n=134

Implanted SAVR

n=135

Died prior to

procedure n=1

Not implanted

n=2

Trial Flow

Baseline Characteristics

Characteristic, % or mean ± SDTAVR

n=145

SAVR

n=135p-value

Age (yrs) 79.2 ± 4.9 79.0 ± 4.7 0.71

Male 53.8 52.6 0.84

STS score 2.9 ± 1.6 3.1 ± 1.7 0.30

STS score < 4% 83.4 80.0 0.46

Logistic EuroSCORE I 8.4 ± 4.0 8.9 ± 5.5 0.38

NYHA class III or IV 48.6 45.5 0.61

All-Cause Mortality, Stroke, or MI

All-Cause Mortality, Stroke, or MI:STS<4%

Aortic Valve Performance

Reflections on TAVR in Symptomatic Low-Risk Severe Aortic Valve Stenosis Patients

Patient factors

1. Age at time of implant

2. Coexisting medical conditions

3. Patient preference

TAVR team factors

1. Experience and outcomes

2. Process of care

Health Economics

1. Health system perspective

2. Patient perspective

Medical and Technical Advances

Favors TAVI Favors SAVR

Risk of surgical mortality or morbidity ≥ intermediate +

Advanced age, frailty, limited mobility +

Small annulus requiring a small valve +

Longevity unlikely (minimum 2 years) +

Mediastinal anatomy unfavorable for surgery* +

Aortic root anatomy unfavorable for TAVI** +

Advanced atrio-ventricular block, especially RBBB +

Non-femoral access required +

Congenital bicuspid valve +

Risk of coronary obstruction or coronary access concerns +

Concomitant conditions requiring surgery (e.g. multivalve disease) +

Aortic aneurysm or dissection +

Endocarditis +

*Porcelain aorta, prior thoracotomy, patent grafts, hostile root **inadequate or excessive calcification, annulus size out of range, coronary obstruction risk

Conditions that should be considered by a multidisciplinary Heart Team when determining the recommendation for

transcatheter or surgical aortic valve replacement.

Canadian Cardiovascular Society Position Statement for Transcatheter Aortic Valve Implantation (TAVI)

The VolumeOutcome

Association

Operator Volumes for TAVI

‘…individual operator experience is paramount to a successful program. Therefore, it is important to preserve adequate exposure as either primary or secondary TAVI operator to a minimum of 50 cases annually’.

Low Volume Medium High Very High

# Cases/Center 0-50 51-100 101-200 >201

# Total Operators (maximum)

2 2 - 3 3-4 4 or more

# Cases per operator(minimum)

25-50 50 50 50

Table 1. Annual Institutional and Operator Requirements based on TAVI Volumes

Canadian Cardiovascular Society Position Statement for Transcatheter Aortic Valve Implantation (TAVI)

Aortic Valve Replacement Costs

(days) TAVI Mini AVR Open AVRICU LOS 1.9 3.3 2.4

Ward LOS - 6.6 5.5

Total LOS 1.9 9.9 7.9

Mazankowski Alberta Heart Institute – local costs unpublished data

TAVI Mini AVR Open AVR

Age (years) 86.7 - -

YTD Volumes 51 112 14

Med Surg Cost $23 500 $8093 $7735

ICU Cost $2778 $7733 $5385

Ward Cost - $4188 $3490

Total $26 278 $20 014 $16 610

Cost Per Day Datao CVICU: $2,343.40/elapsed Day (BAS)o CCU: $1,462.28/elapsed Day (BAS)o CV Ward: $634.55/elapsed Day (BAS)

*Current fiscal year data.

Aortic Valve Replacement CostsPatients referred for TAVI

TAVI Mini AVR Open AVR

Age (years) 86.7 77.9 77.0

Med Surg Cost $23 500 $8093 $7735

ICU Cost $2778 $8905 $10309

Ward Cost - $5072 $5584

Total $26 278 $22 070 $23 628

Mazankowski Alberta Heart Institute – local costs unpublished data

Risk of Thrombotic and Bleeding Events According to Time After Transcatheter Aortic Valve Implantation

Blue dotted line indicates the risk of a cerebrovascular event, red dotted line indicates the risk of bleedingVranckx P, et al. Eur Heart J. 2017 [Epub ahead of print] DOI: 10.1093/eurheartj/ehx390

Conclusions

Prohibitive Risk

HighRisk

Intermediate Risk

Low Risk

Score STS >8% STS 4-8% STS<4%

Percent SAVR 6% 14% 80%

In-hospital Mortality

11.8% 5.1% 1.4%

Strategy TAVI TAVI Dominant TAVI Dominant ?TAVI=SAVR

Robert C. Welsh, MD, FRCPCProfessor of Medicine, University of Alberta

Zone Clinical Department Head, Cardiac Sciences

TAVR in Low-Medium Risk Patients with Aortic Stenosis

Inspiring Innovation and KnowledgeLeaders in Patient Care