Gerald Yong MBBS (Hons) FRACP FSCAI

Interventional Cardiologist

Royal Perth Hospital

Western Australia

4th APCASH – 7th September 2013

5 Important Lessons

Learnt From Australia

Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial

Interest /arrangement or affiliation with the organization(s) listed below

Affiliation/Financial Relationship Company

Grant/ Research Support:

Consulting Fees/Honoraria: Edwards Lifesciences

(consultant & proctor)

Major Stock Shareholder/Equity Interest:

Royalty Income:

Ownership/Founder:

Salary:

Intellectual Property Rights:

Other Financial Benefit:

TAVR Program in Australia

Began in August 2008

Currently incorporates

Edwards SAPIEN / XT

Medtronic CoreValve

Boston-Scientific Lotus

Edwards SAPIEN / XT

Medtronic CoreValve

BSC Lotus

0

100

200

300

400

500

600

700

800

900

Edwards SAPIEN / XT

Medtronics CoreValve

BSC Lotus

1503 TAVR performed

Data till 1 Aug 2013

Access Routes Used

81%

12%

5%

2%

Transfemoral

Transapical

Transaortic

Transubclavian

Valve sizes used

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Edwards SAPIEN / XT

Medtronics CoreValve

BSC Lotus

31mm

29mm

26mm

23mm

Clinical Trials

SOURCE-ANZ

- 2008-2010

SOLACE-AU

- 2012-current

ANZ CoreValve Trial

- 2008-current

REPRISE I

- 2011-12

REPRISE II

- 2012-13

SOURCE-

ANZ TF

(N=67)

SOURCE-

ANZ TA

(N=62)

ANZ

CoreValve

(Interim)

(N=441)

REPRISE I

(N=11)

Characteristics

Age (years) 83.7 81.7 83.9 83.0

Female (%) 34.3% 61.3% 44.9% 100%

Logistic EuroScore 26.8% 28.8% 17.3% 9.5%

Procedural Success 92.4% 87.1% 98.2% 100%

30-day Outcomes

Mortality 6.0% 9.6% 3.7% 0

Major stroke 3.0% 4.8% 3.5% 9.1%

Life threatening

bleeding

6.6% 18.2%

Major vascular

complication

4.5% 3.2% 4.1% 9.1%

Acute kidney injury 13.4% 17.7% 0

PPM 1.5% 8.1% 28.6% 36.3%

1 year Mortality 11% 18% 12% 0

VARC meta-analysis Euro-Sentinel

Registry

SOURCE-XT ADVANCE

CoreValve

N & Valve type 3,619

- ESV 1,903

- MCV 1,186

4,571

- ESV 2,604

- MCV 1,943

2,700

- All SAPIEN XT

1,015

- All CoreValve

Time Period Publications

Jan 2011-Oct 2011

Jan 2011 – Jun

2013

Jun 2010 - Oct

2011

Mar 2010 – Jul

2011

Age 81.5 81.4 81.3 81.1

Logistic

EuroScore

22.8% 20.2% 20.5% 19.4%

30 day Mortality 7.8% 7.4% 6.3 4.5%

30 day Stroke 5.7% 1.8% 2.8 4.5%

1 year Mortality 22.1% N/A 19.5 17.9%

TAVI – Contemporary Results

Genereux, P., et al. J Am Coll Cardiol. 2012;59:2317-26 Di Mario, C., et al. EuroIntervention. 2012;

Edwards SAPIEN / XT

Medtronic CoreValve

BSC Lotus

WA FIRST TRANSFEMORAL TAVR

WA TAVR Program Experience

(149 patients, 151 procedures)

CoreValve SAPIEN / XT

Transfemoral 36 85 121

Transapical - 20

30 Transaortic 0 9

Transubclavian 1 -

TOTAL 37 114

WA TAVR Program

Procedural Success

Procedural success – 98.0%

3 failures

1x TF SAPIEN – failure to advance 24Fr sheath

1x TF SAPIEN XT – embolised valve converted to SAVR

1x TA SAPIEN – apical tear procedural death

TOTAL Transfemoral Hybrid

Characteristics

Age (years) 85.3 85.6 84.2

Female (%) 40.7% 40.8% 40.1%

Logistic EuroScore 23.8% 23.1% 27.1%

Procedural Success 98.0% 98.3% 96.7%

30-day Outcomes

Mortality 4.7% 2.0% 16.7%

Major stroke1 2.4% 2.0% 4.3%

Life threatening

bleeding1 8.8% 8.8% 8.7%

Major vascular

complication1 8.8% 8.8% 8.7%

Acute kidney injury1 8.0% 6.9% 13.0%

PPM1 17.6% 16.7% 17.7%

1 year Mortality1 14.8% 10.1% 35.8%

1 Based on patients to 2012 (N=125)

LESSONS LEARNT ON:

PATIENT SELECTION

Current TAVR Eligibility According to

Operative Risk

STS <4%

>8%

4-8%

Inoperable Low Risk Moderate

Risk

High

Risk

PA

RT

NE

R 2

SU

RTA

VI

PA

RT

NE

R 1

A

US

Core

Valv

e

H

igh R

isk

PA

RT

NE

R 1

B

US

Core

Valv

e

E

xtr

em

e R

isk

75% 10% 15% % AVR

Volume

Risk

TRIALS

FUTILE REASONABLE NEED DATA IRRESPONSIBLE & RECKLESS

SOURCE – Leon & Kodali

Risk Scores

Independent Predictors of Early Mortality in patients without Non-Fatal major complications (Full Model):

Variable Hazard Ratio p value Fit-statistic

Liver disease 3.098 [1.07, 8.39] 0.036 823.96

Serum creatinine 1.09 [1.03, 1.15] 0.003 823.09

Coagulopathy 3.47 [1.24, 9.70] 0.017 822.34

MMSE 1.07 [1.01, 1.13] 0.023 819.95

BMI 1.06[1.01, 1.11] 0.018 819.39

Male sex 2.09 [1.23, 3.54] 0.006 817.77

Baseline STS risk

score 1.08 [1.03, 1.13] 0.0008 813.99

* Lower F-statistic means a higher contribution to early mortality

Frailty

Syndrome of multisystem impairment

associated with aging that results in

decreased physiologic reserve and

increased vulnerability to stressors.

Fried J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3)

Frailty Domain Measure Frailty Score

Slowness

15 foot walk gait speed (m/s) Quartiles (0-3)

Weakness Grip strength (kg) Gender based quartiles

(0-3)

Wasting and

malnutrition

Serum albumin (g/dl) Quartiles (0-3)

Inactivity Katz ADLs (dress, bath, transfer,

feed, toilet, continence)

Any dependence=3,

Independence=0

Mental Faculty MMSE

Frailty Components

Kappetein, A. P., et al. J Am Coll Cardiol. 2012;60:1438-54 Stortecky, S., et al. JACC Cardiovasc Interv. 2012;5:489-96

Frailty predicts long term outcome

Stortecky, S., et al. JACC Cardiovasc Interv. 2012;5:489-96

Review of symptoms & indication for intervention

History and comorbidities

Objective functional assessment

Katz ADL assessment

Lowton & Brody instrumented ADL assessment

Canadian Study of Health and Aging Frailty assessment

Mini Mental State Examination

Formal assessment by geriatrics physician in bordeline

cases (ADL<6/6, iADL<6/8, MMSE<26/30)

Expectations – patient and family

Assess patient wish for intervention

Complete Global Clinical Assessment

2009-10 2011 2012

Age (years) 84.5 85.5 85.8

Logistic EuroScore 23.8% 23.0% 21.7%

30-day Mortality 5.6% 7.7%% 5.7%

Length of Stay 9.0 6.7 5.4

The IDEAL TAVR Patient

Elderly

High surgical risk

BUT…

LESSONS LEARNT IN:

VALVE SIZING

Predictors of Paravalvular Regurgitation

Severe calcification – Agaston calcium score on CT

Low implantation depth

Markers of valve undersizing

Small cover index

Large annulus

“Prosthesis / annulus mismatch”

Athappan, G., et al. J Am Coll Cardiol. 2013;61:1585-95

Traditional Imaging for Annulus Sizing

MSCT Assessment of Annulus

• Mean Diameter as Average of Smallest & Largest Diameters • Mean Diameter as Annular Circumference / π • Mean Diameter as √ ( 4x Annular Area / π )

• Annular Area

• Annular Circumference

Willson et al, JACC 2012

Multimodality Imaging with 3D TEE or MSCT

important in sizing

Preventing Para-Valvular AR

% oversizing % undersizing 10-15% 0

Adapted from Thierry Lefevre; London Valves, 2012

TTE Annulus 19mm

TEE Annulus (at procedure)

- 19mm

CT

- CSA – 460mm2

- Perimetry – 81mm

- Dmin – 20mm

- Dmax – 29mm

Annulus / LVOT calcified

16% Oversizing

26mm SAPIEN XT

Underfilled balloon by 2ml

Post-dilate – fully-filled

deployment balloon

Final Result

LESSONS LEARNT IN:

COMPLICATIONS

Be Prepared for All Emergencies

Pre-defined & discussed protocol....

What to do when BP falls

What to do if peripheral

perforation

What to do if pre-closure fail

What to do if coronary occlusion

What to do if severe AR from

valve malposition

Bail out equipment list... And

know where to find them...

Etc...

Hypotension

Consider circumstances

At sheath insertion / removal

Peripheral perforation

Early angiography

After stiff wire passage to LV

Severe MR; Tamponade

Echo

Post-BAV

Severe AR; Tamponade

Echo, Aortogram

Post-THV deployment

Severe AR (valvular / paravalvular); Coronary occlusion; Tamponade

Echo & Aortogram, then coronary angiogram

Hypotension Post-TAVI

• Post-TF TAVI

• Good valve position &

function

• Heparin reversed

• 18 F sheath removed

• Preclosure completed

• Abrupt fall in sBP to 60mmHg

OCCLUSION BALLOON COVERED STENTS

Hypotension post-TAVI

• Post-TF TAVI

• Heparin reversed with

protamine

• 18Fr Sheath removed

successfully & hemostasis

confirmed

10 minutes post sheath removal

• Severe hypotension

• CVP

LESSONS LEARNT IN

TEAM WORK

Interventional cardiology Cardiac surgery

Cardiac Imaging

Cardiac Anesthetist Vascular Surgery

Cardiac cathlab

Hybrid OR

Wards – ICU / CCU /

Cadiac / CTS ward

TAVR Program

Geriartrician Nephrologist

Intensivist

Program Co-ordinator

Need for Multi-Disciplinary Team Involvement

Conclusions

Well-established TAVR programs in Australia since 2008

Despite no formal regulatory approval for use of TAVR

Results are comparable to contemporary international

outcomes

30-day mortality 4-8%

30-day stroke

Patient selection important contributor to outcomes

Risk profile bordering on intermediate risk

My personal lessons learnt in running

WA TAVR Program

Patient selection important

Co-morbidities

Frailty

Paravalvular regurgitation is an important limitation of TAVR

Proper device sizing is important step to reducing incidence

Meticulous attention to procedural details is important,

especially well developed plan to treat complications

Multidisciplinary team-work in patient selection and

management of this group of high risk patients with low

reserve is extremely important

THANK YOU… POST TAVR #100

18TH APRIL 2012