Triển vọng can thiệp bệnh van tim qua đường ống thông cho người châu á bước tiếp theo là gì và đâu là giới hạn

PARTNER Placement of Aortic Transcatheter Valves Study Design N = 179 N = 358 Inoperable Standard Therapy ASSESSMENT: Transfemoral Access Not In Study TF TAVR Primary Endpoint:

Perspectives of Transcatheter Aortic Valve Implantation in Asia: What are the next steps

and what are the limitations?

Paul Chiam Cardiologist Adjunct Associate Professor National University of Singapore

Mount Elizabeth Hospital Singapore

Patient with severe AS

Rejected for surgery (extreme risk)

No other options

Circulation 2002

Medtronic CoreValve Edwards Sapien XT valve

Both achieved European CE mark 2007

PARTNER (Placement of Aortic

Transcatheter Valves) Study Design

N = 179

N = 358

Inoperable

Standard Therapy

ASSESSMENT:

Transfemoral Access

Not In Study

TF TAVR

Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality

and Repeat Hospitalization (Superiority)

Symptomatic Severe Aortic Stenosis

ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened

Transapical (TA) Transfemoral (TF)

1:1 Randomization 1:1 Randomization

P (log rank) < 0.0001

All cause mortality

Cohort B (inoperable)

All-Cause Mortality (ITT)

Crossover Patients Censored at Crossover

Median Survival

11.1 Months

29.7 Months

p (log rank) < 0.0001

PARTNER (Placement of Aortic

Transcatheter Valves) Study Design

N = 179

N = 358

Inoperable

Standard Therapy

ASSESSMENT:

Transfemoral Access

Not In Study

TF TAVR

Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality

and Repeat Hospitalization (Superiority)

Symptomatic Severe Aortic Stenosis

ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened

Transapical (TA) Transfemoral (TF)

1:1 Randomization 1:1 Randomization

0 0.1 0.2 0.3 0.4 0.5

TAVR AVR

P (log rank) = 0.62

Cohort A –

High risk

348 287 250 228 211 176 139 TAVR

All-Cause Mortality or Strokes (ITT)

No at Risk

HR [95% CI] = 0.98 [0.79, 1.21]

No at Risk

Pivotal Trial Design

1 TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal

All Stroke

16

Echocardiographic Findings

TAVR had significantly better valve performance over SAVR at all follow-up visits (P<0.001)

NYHA Class

18

• We found that survival at 1 and 2 years was

superior in patients that underwent transcatheter

replacement with CoreValve

Conclusion

ACC 2016 | Chicago | April 2, 2016

Transcatheter or Surgical Aortic Valve

with Aortic Stenosis:

Final Results from the PARTNER 2A Trial

Randomized Patients

n = 2032

Symptomatic Severe Aortic Stenosis

ASSESSMENT by Heart Valve Team

TA/TAo TAVR (n = 236)

Surgical AVR (n = 246)

Primary Endpoint (ITT)

All-Cause Mortality or Disabling Stroke

Months from Procedure

TF Primary Endpoint (AT)

All-Cause Mortality or Disabling Stroke

The PARTNER 2A Trial

Conclusions

In intermediate-risk patients with symptomatic severe

aortic stenosis,

• TAVR using SAPIEN XT and surgery were similar

for the all-cause mortality or disabling stroke at 2 years

• In the transfemoral subgroup (76% of patients), TAVR

reduced all-cause mortality or disabling stroke (p = 0.05)

Published online 1 st April 2016

Edwards Sapien valve Patient alive and well at 7.5 years – now 84 years old NYHA class I-II; mean valve gradient 18 mmHg

Valve-in-valve TAVI

FDA and CE mark approved indication

Valve in valve TAVI case

• 80 year male

• Previous AVR 1998 - Medtronic Freestyle bioprosthesis

• TIA Dec 2012

• PPM (DDD) April 2008

• EP ablation for SVT Oct 2012

• PCI/DESx2 m-dLAD Nov 2013

• Cardiac failure, NYHA III

• Na ~ 130 (dilutional hyponatraemia)

• Echo: LVEF 45%, severe bioprosthetic AR

• Procedure under LA and sedation

• At 1 month post:

• NYHA I-II, Na 140

• Echo: LVEF 45%, trivial AR

New (Improved) Devices

• Sapien 3

• Lower profile sheath (14F expandable sheath)

• External skirt to reduce paravalvular leaks

Susheel Kodali, MD

on behalf of The PARTNER Trial Investigators

Clinical and Echocardiographic

Outcomes at 30 Days with the SAPIEN 3 TAVR System in Inoperable, High-Risk and Intermediate-Risk AS Patients

Conclusions (1)

• In high-risk and inoperable patients (S3HR), the SAPIEN 3 TAVR system demonstrated low mortality and stroke and excellent clinical outcomes at 30 days:

– Mortality: 2.2% (TF 1.6%, TA/TAo 5.4%)

– Disabling Stroke: 0.9%

• In intermediate-risk patients (S3i), SAPIEN 3 was associated with strikingly low mortality and strokes at 30 days:

– Mortality: 1.1% (TF 1.1%, TA/TAo 1.6%)

– Disabling Stroke: 1.0%

• Boston Lotus valve

• Fully recapturable

• External skirt to reduce paravalvular leaks

Bovine Pericardium

Long-Term Proven material

Locking Mechanism

• CoreValve Evolut R

• Lower profile sheath (14F equivalent)  reduces vascular injury

• Recapturable

Early Procedural Results

From the CoreValve Evolut R CE Study

Source: Meredith IT, et al Early Results from the CoreValve Evolut R CE Study 295] Presented at the Annual Meeting of the American College of Cardiology March

[2101-14, 2015; Medtronic data on file

INTERNATIONAL

* Percentages obtained from Kaplan Meier estimates

Source: Meredith IT, et al Early Results from the CoreValve Evolut R CE Study [2101-295] Presented at the Annual Meeting of

the American College of Cardiology March 14, 2015

30-Day Outcomes

Hayashida K et al Circ Cardiovasc Interv 2013;6:284-91

• TAVR for pure AR feasible in selected patients

• Higher risk of valve embolization

• Increased need for use of 2 CoreValves

CoreValve implantation Pure severe AR due to a

flail leaflet (previous endocarditis)

Survived 3 years post TAVI

Sapien XT valve Patient well at 3 years

NYHA 1

57 year female

Collapsed in Japan Tracheostomy

SLE – platelet 20K

On steroids

29mm Sapien XT valve via TA approach in a 33mm mitral bioprosthesis

NYHA 1 at 24 months with trivial MR

Which patients should we consider for

TAVR

• Inoperable patients with severe AS and life

expectancy > 1 year

• High surgical risk patients

• INTERMEDIATE surgical risk patients

• Degenerated surgical bioprosthesis

What are the next steps for Asia

• Educate non-interventional cardiologists / internists

on the results of TAVI

• Changing mind set of cardiologists/ internists to

move away from surgery first option  consider TAVI and surgery as equal options (except in LOW risk

patients)

• Training of centres of excellence to perform TAVI

• Establish a “multidisciplinary heart team” in such

centres

What are the next steps for Asia

• Increased research to determine if there are any

particular groups of Asians at increased risk for TAVI

or have poorer outcomes

• Which valves produce good / better outcomes in

Asians

What are the limitations

• Vast geography of Asia

• A significant proportion of the Asian population live

in rural villages with poor access to health care

• TAVI centres only in major cities

• Many centres have low volumes  cases infrequent and thus have limited experience

What are the limitations

• No universal health coverage in most Asian countries

• Private health insurance lacking in many Asian

countries

• Cost of the device

• Currently approx USD 30,000 !

•  biggest single limiting factor inhibiting the growth

of TAVI in Asia

Conclusion

• TAVR is the standard of care for inoperable patients

with severe AS and may be SUPERIOR to AVR in risk and intermediate risk patients

high-• Durable clinical and hemodynamic results in Asians

Thank you

paulchiam@heartvascularcentre.com

www.heartvascularcentre.com