top 10 advances in transcatheter valve therapy 2018 · the future of transcatheter heart valves...

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Samin K Sharma, MD, FACC, FSCAI Senior VP for Operation & Quality, Mount Sinai Heart Director Interventional Cardiology, Mount Sinai Health System Anandi Lal Sharma Professor of Medicine in Cardiology President Mount Sinai Heart Network Mount Sinai Hospital, NY COI: Speaker bureau for Abbott, BSC, CSI, Abiomed, Top 10 Advances in Transcatheter Valve Therapy 2018

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Page 1: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Samin K Sharma, MD, FACC, FSCAI

Senior VP for Operation & Quality, Mount Sinai Heart

Director Interventional Cardiology, Mount Sinai Health System

Anandi Lal Sharma Professor of Medicine in Cardiology

President Mount Sinai Heart Network

Mount Sinai Hospital, NY

COI: Speaker bureau for Abbott, BSC, CSI, Abiomed,

Top 10 Advances in Transcatheter Valve Therapy 2018

Page 2: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

The Future of Transcatheter Heart Valves Aortic Valve

Medtronic CoreValve

Mitral Valve

Edwards Sapien XT

Tricuspid Valve

Edwards Perimount Magna

Pulmonic Valve

Medtronic Melody Valve

Page 3: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

The Andersen Stent-Valve (1989)

Page 4: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Father of Transcatheter Valve Therapy

Percutaneous Valve Technologies (PVT)

Aortic Heart Valve

Bovine pericardium / Stainless steel stent

Polyurethane

23mm max diameter

24F

Alain Cribier

Page 5: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

15 min post-TAVR

April 16, 2002; FIM-TAVR; Rouen, FR

Alain Cribier

Page 6: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Reasons for selection of the study

Revolutionary / significant observation

Widespread acceptance

Change in clinical practice

Top 10 Advances in Transcatheter Valve Therapy 2018

Page 7: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

1.

2.

3.

4.

5.

6.

7.

8.

9.

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

Page 8: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Trends in U.S. In-Hospital Mortality After

Isolated Tricuspid Valve Surgery, 2003 to 2014

Asmarats et al., J Am Coll Cardiol 2018;71:2935

Page 9: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards
Page 10: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Transcatheter Tricuspid Landscape

Asmarats et al., J Am Coll Cardiol 2018;71:2935

Coaptation Devices Suture Annuloplasty

Ring Annuloplasty

Transcatheter Tricuspid Valve Replacement

Heterotopic Caval Valve Implant

Page 11: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards
Page 12: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

TriValve Registry: Patient Stratification According to

Procedural Success

Besler et al., J Am Coll Cardiol Intv 2018;11:1119

Assessment of tricuspid valve coaptation gap

n=117

Coaptation gap <7.2 mm

n=95

Coaptation gap >7.2 mm

n=22

Main TR jet

central/anteroseptal

n=78

Main TR jet

central/anteroseptal

n=78

Main TR jet

central/anteroseptal

n=78

Main TR jet

central/anteroseptal

n=78

Main TR jet

central/anteroseptal

n=78

Main TR jet

central/anteroseptal

n=78

Main TR jet

central/anteroseptal

n=78

Main TR jet

central/anteroseptal

n=78

Page 13: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

TRILUMINATE Trial: TriClip System

Page 14: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

TRILUMINATE TriClip Study

▪ Prospective, single-arm, multicenter feasibility study

▪ At least 85 patients in 15 centers (4 in US 35 patients:

Mount Sinai, Henry Ford, Abbott Northwestern, Cedar Sinai)

▪ Moderate or greater TR in NYHA II, III, ambulatory IV

▪ Follow-up to 3 years

Primary Endpoint: TR reduction > 1 grade at 30d

Secondary Endpoint: Cardiac mortality at 30d

Page 15: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Summary of Ongoing and Future Studies on

Transcatheter Therapies for Tricuspid Regurgitation

Page 16: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Proposed Algorithm for Transcatheter Tricuspid Valve Device

Selection Based on Mechanism & Patho-anatomy of TR

Asmarats et al., J Am Coll Cardiol 2018;71:2935

Page 17: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

1.

2.

3.

4.

5.

6.

7.

8.

9. Sentinel Cerebral Protection Device during TAVR

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

Page 18: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Sources of Debris During TAVR: Strokes

TAVR DEVICES

Foreign

material

NATIVE HEART

Myocardium

TRANSVERSE ARCH

Arterial wall, calcific

and atherosclerotic

material

ASCENDING ARCH

Arterial wall, calcific

and atherosclerotic

material

STENOTIC VALVE

Leaflet tissue and

calcific deposits

Page 19: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

TAVR & Stroke: Often Underreported

~4% Average Stroke RateContemporary TAVR studies have shown an average

of 4% stroke rate

>9% with Routine Neurologist

AssessmentStudies using routine discharge exams by

neurologists show higher clinical stroke rates

TM

TM T

M

TM

TM

TM

TM

Page 20: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Findings from the SENTINEL IDE Trial Together with Real World Outcomes

from Ulm, Erasmus and Cedars Sinai Medical Centers Demonstrate Consistent

Reductions in Stroke Among Nearly 2,400 Patients

1Kapadia S, et al. J Am Coll Cardiol 2017;69:367–77; 2Seeger J et al. 2017. JACC Cardiovasc Interv. 10(22)2297-2303; 3van Mieghem N. presented at

TVT 2018; 4Chakarvarty T. presented at TVT 2018

Page 21: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards
Page 22: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Histopathology of the Proximal Filter

Seeger et al., J Am Coll Cardiol Intv 2018;11:1683

Histopathology of the Distal Filter

Page 23: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Particle Size by Histomorphometry in the

Proximal and Distal Filter in Relation to Valve Type

Seeger et al., J Am Coll Cardiol Intv 2018;11:1683

Histomorphometry – Particle Size –

Proximal FilterHistomorphometry – Particle Size –

Distal Filter

Page 24: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

1.

2.

3.

4.

5.

6.

7.

8. Antithrombotic Therapy post TAVR

9. Sentinel Cerebral Protection Device during TAVR

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

Page 25: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

What Antithrombotic Treatment After TAVR/TAVI?

Thrombo-embolic

Risk

Bleeding

RiskOAC-based

strategy(VKA or NOAC)

SAPT (ASA or Clopidogrel alone)

DAPT (ASA+Clopidogrel)

Mortality Structural Valve

Deterioration

AT+ AT-

Page 26: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Bioprosthetic Valve Dysfunction• in mean gradient (MG) ≥ 10 mmHg or new MG ≥ 20mmHg

• Prevalence of 4.5% post-TAVR

Makkar et al., N Engl J Med

2015;373:2015

Del Trigo et al, J Am Coll

Cardiol 2016;67:644

Page 27: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Anti-Thrombotic Treatment After TAVR:

Insights from the

FRANCE-TAVI Registry

Page 28: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

FRANCE-TAVI Registry: Flow Chart

Collet JP, ESC 2018

Page 29: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

France-TAVI Registry: KM Curves According

to Anticoagulation

Overtchouck et al., J AM Coll Cardiol Aug 22, 2018 Epub

Page 30: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

France-TAVI Registry: Correlates to

Bioprosthetic Valve Dysfunction (BVD)

Overtchouck et al., J AM Coll Cardiol Aug 22, 2018 Epub

N=2555m=20

P-valueAdj. OR 95% CI upper 95% CI lower

BMI 0.002 1.05 1.02 1.09

Prior TAVR 0.025 2.96 1.15 7.64

Moderate/severe renal failure 0.034 1.46 1.03 2.08

Non-femoral access 0.049 0.53 0.28 1.02

Prosthesis ≤23 mm <0.001 3.43 2.41 4.89

OAC at discharge 0.005 0.54 0.35 0.82

Page 31: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

France-TAVI Registry: Post-TAVR Antithrombotic

Strategy Flowchart

Overtchouck et al., J AM Coll Cardiol Aug 22, 2018 Epub

Page 32: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Major Ongoing Trials of Anti-thrombotics in TAVR/TAVI

Treatment Comparison Number of

Patients

NVAF Status

GALILEO RIVA vs DAPT/SAPT 1520 Excluded Enrolment

completed

ATLANTIS VKA vs Apixaban

DAPT/SAPT vs Apixaban

1510 Included

(stratified)

Enrolment almost

done

ENVISAGE EDOXABAN 1400 only Ongoing

POPULAR VKA vs VKA+clopi

DAPT vs ASA

1510 Included and

stratified

Ongoing

AVATAR VKA vs VKA+APT 170 Included

(stratified)

Ongoing

AUREA VKA vs DAPT 124 Excluded Ongoing

Page 33: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Trial completed enrollment as of April 2018

August 2018, DSMB recommended

to halt the study follow-up due to

safety concerns; Higher mortality?

Page 34: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

What Do Guidelines Recommend?

• 2017 AHA/ACC Focused Update Guidelines for the management

of valvular heart disease

\\

• 2017 ESC/EACTS Guidelines for the management of valvular

heart disease

New!

New!

Page 35: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

1.

2.

3.

4.

5.

6.

7. TAVR for Pure Aortic Regurgitation

8. Antithrombotic Therapy post TAVR

9. Sentinel Cerebral Protection Device during TAVR

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

Page 36: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Pure Aortic Regurgitation Current Challenges for TAVR

Franzone et al., J Am Coll Cardiol Intv 2016;9:2308

This Pathology Presents Unique Technical Challenges for Current TAVI Systems

Page 37: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards
Page 38: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Procedural Data

Yoon et al., J Am Coll Cardiol 2017;70:2752

Page 39: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Procedural and Clinical Outcomes

Yoon et al., J Am Coll Cardiol 2017;70:2752

Page 40: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

TAVR for Native Aortic Valve Regurgitation

Yoon et al., J Am Coll Cardiol 2017;70:2752

Outcomes According to DevicesMortality and Post-Procedural Aortic

Regurgitation

Page 41: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Self-Expabdable

ACURATE TA

Bioprosthesis

JenaValve™ Prosthesis

Kemfert et al., Eur J Cardiothoracic 2011;40:761

Engager™ Aortic

Transcatheter Valve

Sündermann et al., Eur J

Cardiothoracic 2012;42:e48Wendt et al., J Am Coll

Cardiol Intv 2014;7:1159

Transcatheter Aortic Valves for Pure AI

Page 42: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

1.

2.

3.

4.

5.

6. Emerging TAVR Indications: LFLG, ViV, BAV, EARLY, UNLOAD

7. TAVR for Pure Aortic Regurgitation

8. Antithrombotic Therapy post TAVR

9. Sentinel Cerebral Protection Device during TAVR

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

Page 43: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Emerging Indications of TAVR

Pt with moderate to severe AS

Bicuspid ASViV Bioprosthetic

Degenration

Alternate Access:

Axillary

Venacaval

Carotid

Moderate AS with

CHF

LFLG AS

Early TAVR in

asymptomatic

severe AS

Page 44: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Proposed Decision Tree Algorithm for Patients Presenting with

Classic

(EF <50%) Low-Flow, Low-Gradient AS

Généreux P, J Am Coll Cardiol 2018;71:1309

FAVOR TAVR if AS

deemed severe

By MDCT Ca2+

♀ ≥1,200, ♂ ≥2,000

EOA <1 cm2, MG <40 mmHg, and LVEF <50%

Dobutamine stress echocardiogram

Increase SV ≥20%

MG ≥40 mmHg

EOA ≤1.0 cm2

Increase SV ≥20%

MG <40 mmHg

EOA >1.0 cm2

Increase SV <20%

(no contractile

Reserve)

Ture severe ASPseudo severe AS

Heart team risk

assessment

Medical therapy vs.

consider enrollment in

TAVR-unload trial

Intermediate, high, or

extreme risk

TAVR

Low risk for SAVR

TAVR vs. SAVR pending low-risk trials results

Favor TAVR if noninferior

Page 45: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards
Page 46: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

TOPAS-TAVI: Mortality Rates (N=287)

Ribeiro et al., J Am Coll Cardiol 2018;71:1297

0

10

20

30

40

30 Days 1 Year 2 Years

3.8

20.1

32.3

%

• Mean LVEF - 30 ± 10 mmHg

• Transvalvular gradient - 25 ± 7 mmHg

• Median STS Risk Score – 7.7%

• Multivariable analysis for death:

o COPD – p=0.02

o Lower hemoglobin values – p<0.001

o Moderate-severe AR post-TAVR

Page 47: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Cumulative Late Outcomes at 2 Yrs Follow-Up

(N=287)

Ribeiro et al., J Am Coll Cardiol 2018;71:1297

0

10

20

30

40

50

3.8 4.2

0.7

9.8

3.5

24.7

18.8

39.0

MI Stroke Endocarditis PPM PPM-defib Rehosp Cardiac Global

for HF death death

%

Page 48: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Clinical Outcomes and LV Changes Following TAVR in

Patients with LFLG-AS

Ribeiro et al., J Am Coll Cardiol 2018;71:1297

Page 49: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards
Page 50: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Ribeiro et al., Eur Heart J 2018;39:687

Predictors of Coronary

Obstruction

Clinical Presentation and

Management

Distribution of Distance Between Virtual

Tanscatheter Ring at a Size of the

Implanted Device

K-M Survival Curve at 1-Year Follow-Up

of Pts Undergoing TAVI for Degenerated

Bioprostesis Valve

Page 51: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards
Page 52: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Kaplan-Meier Curves for All-Cause Mortality

According to Early- and New-Generation Devices

Yoon et al., J Am Coll Cardiol 2017;69:2579

Early-Generation Device New-Generation Device

Page 53: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Procedural Outcomes in Bicuspid and Tricuspid

AS with Early- and New-Generation Devices

Yoon et al., J Am Coll Cardiol 2017;69:2579

0

5

10

15

20

25

Conversionto surgery

SecondValve

Implantation

Paravalvularleak

Absence ofdevice

success

NewPacemaker

2.5

7.2

15.9

21.6

14.7

0.32.2

10.3

13.1 13.7

%

p=0.02

p=0.72

p=0.005

p=0.03

p=0.003

Early-Generation Device

Sapien XT CoreValve

0

5

10

15

20

25

Conversionto surgery

SecondValve

Implantation

Paravalvularleak

Absence ofdevice

success

NewPacemaker

1.3 1.32.7

4.9

16.4

0.0 0.41.8 2.2

17.8

%

p=0.25

p=0.69

p=0.13p=0.53

p=0.62

New-Generation Device

Sapien 3 Lotus Evolut R

Bicuspid AS Tricuspid AS

Page 54: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

EARLY TAVR Trial: ACC/AHA and ESC/EACTS Guidelines

Nishimura et al., J Am Coll Cardiol 2017;70:252; Baumgartner et al., Eur Heart J (2017) 00, 1-53

Asymptomatic Severe AS

MG ≥40 mmHg, AVA ≤1.0 cm2 and EF >50%

Exercise Testing (ACC/AHA Class lla)

PV ≥5 m/s (ACC/AHA) or ≥5.5 m/s (ESC):

Class lla

PV progression ≥0.3 m/s/year: ACC/AHA llb

and ESC Class lla

Severe SPH >60: ESC Class lla

Repeatedly markedly elevated BNP:

ESC Class lla

Exercise Imaging (ACC/AHA Class lla)

Increase in MG with exercise by >20 mmHg

ESC Class llb

Limiting Symptoms

Angina

Syncope

Dyspnea

Decrease exercise

tolerance

Abnormal SBP

response (drop or

<20 mmHg rise)

ACC/AHA Class l

ESC Class l

ACC/AHA Class lla

ESC Class lla

If Stress Test and Stress Echo Normal:

Clinical and Echo Follow-Up 6 months (ESC) and 6-12 months ACC/AHA Class l

+ -+

Page 55: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

EARLY TAVR Trial: Flow Chart

AsymptomaticNegative stress test OR medical history

1:1 Randomization

Transfemoral

TAVR

Clinical

Surveillance

Primary Endpoint2 yr composite of all-cause mortality, all stroke,

and unplanned cardiovascular hospitalization

Asymptomatic, Severe Aortic Stenosis

Screening/Stress TestInclusion/exclusion criteria, treadmill stress test

SymptomaticPositive stress test

RegistryCommercial AVR (TAVR or

SAVR), Clinical Trial (e.g.

PARTNER 3 Trial), etc.

PI: Philippe Généreux, MD

Chair: Martin B. Leon, MD

NCT03042104

Page 56: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

TAVR UNLOAD Trial Design

Steiner et al., J Am Coll Cardiol 2017;70:3026

TAVR UNLOAD (n=600)

LVEF <50%, NYHA 2-4, optima HF therapy (OHFT),

Moderate AS, NT-proBNP >1500 pg/ml

1:1 Randomization

OHFT OHFT and TAVR

Follow-up at 1, 6, and 12 months

Primary endpoints include death, disabling stroke,

hospitalization for HF, aortic disease, or stroke,

Quality of Life

Key inclusion Criteria:

• NYHA class ≥2

• NT-proBNP >1500 pg/ml or hospitalization for HF within the

last year

• Appropriate guideline-directed HF medical therapy (as

tolerated) for ≥3 months

• LVEF <50%, but >20%

• Anatomically suitable for SAPIEN 3

Moderate AS confirmed by the echo core lab and defined as:

• Mean transaortic gradient (MG) ≥20 mmHg and <40 mmHg and

aortic valve area (AVA) >1.0 cm2 and ≤1.5 cm2 at rest

OR

• MG ≥20 mmHg and <40 mmHg and AVA >1.0 cm2 at rest AND

MG <40 mmHg and AVA >1.0 cm2 with low dose dobutamine

stress echo

• MG <20 mmHg, if other parameters consistent with mod AS

according to echo core lab

Key Exclusion Criteria:

• LVEF <20% or inotropic support

• Recent CRT, revascularization, or in need of revascularization

• Prosthetic valve stenosis, bicuspid valve, associated severe

MR

• Severe RV dysfunction, COPD, or CKD, liver cirrhosis, GI

bleeding

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Vascular Access of the Future?

Page 58: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

1.

2.

3.

4.

5. TMVR Trials: MITRAL, GLOBAL Registry, APOLLO, TENDYNE

6. Emerging TAVR Indications: ViV, LFLG, BAV, EARLY, UNLOAD

7. TAVR for Pure Aortic Regurgitation

8. Antithrombotic Therapy post TAVR

9. Sentinel Cerebral Protection Device during TAVR

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

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Mitral Valve Replacement Devices Landscape

In Trials

FIM CasesIn Development

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TMVR: Early Clinical Experience

Human Experience 52 cases 12 cases 23 cases 38 cases 20 cases

First Implant October-2013 June-2012 February-2014 September-2014 January-2014

Longest Patient F/U 2 year+ 1 year+ 2 years+ 2 years+ 2 years+

Patient Population Clinically Significant Severe MR and High Risk Surgical Candidates, NYHA II-IV

FMR Etiology 86% (n=22) 64% (n=11) 100% (n=13) 73% (n=15) 54% (n=11)

Successful Deployment 21/23 9/11 10/13 14/15 9/11

30-Day Mortality 1/23 5/11 5/13 2/15 3/11

30-Day Rehosp 3/23 Data not available Data not available 1/14 Data not available

MR Grade 0 at F/U 19/19 Data not available 8/9 13/14 Data not available

Abbott

Tendyne

Edwards

CardiAQ

Edwards

Fortis

Medtronic

TwelveNeovasc

CE approval study

CE approval study

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Intrepid Twelve Valve: APOLLO Trial • Circular inner stent to house the valve plus a outer fixation ring to engage the mitral

annular anatomy.

• The outer fixation ring is designed to accommodate the dynamic variability of the native

mitral annulus while isolating the inner valve assembly throughout the cardiac cycle.

• A flexible brim is attached to the atrial end of the fixation ring which facilitates imaging

during the procedure.Valve Characteristics

Implant Shape Circular

Construction

Self-expanding nitinol

Frame, outer and inner polyester fabric skirt

Inner valve structure of 27 mm (orifice area 2.4

cm2

Outer diameter 43, 46 or 50 mm

Leaflet Trileaflet Bovine Pericardium

Catheter Size OD 35 Fr

Access Site T-Apical

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MITRAL Trial

90 patients extremely high surgical risk (STS PROM >15% or M&M >50%)

SAPIEN XT SAPIEN 3Inclusion Criteria

NYHA II or greater

Native MV (MAC)n=30

Valve-in-Ringn=30

Valve-in-Valven=30

Severe MS (MVA ≤1.5 cm2)

Severe MR + Moderate MS

Severe MS (MVA ≤1.5 cm2)

At least Moderate-Severe MR

Severe MS (MVA ≤1.5 cm2)

At least Moderate-Severe MR

Results of MViV at AHA

Nov 13, 2017

Guerrero M, TCT 2017

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Guerrero M, TCT 2017

MITRAL Trial: ViR Procedural Outcomes

100% Transseptal Access

OutcomesIn-Hospital

n=30

30 Days

n=29*

All-Cause Mortality 6% 6.8%

Cardiovascular death 3% 3.4%

Non-Cardiac death 3% 3.4%

* Last implant 10-3-17 (POD # 28 at time of this presentation)Data not yet adjudicated, may be subject to change.

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MITRAL Trial: MAC Procedural Outcomes

Guerrero M, TCT 2017

50% Transseptal or TA(TS=14, TA=1)

Difficult anatomy for TS=1

50% Transatrial (n=15)Risk of LVOTO=3

Risk of embolization=6

Both=6

OutcomesIn-Hospital

n=30

30 Days

n=26*

All-Cause Mortality

16.7%Transeptal=1

Transapical=1

Transatrial=3

19.2%

Cardiovascular death 3.3% 3.8%

Non-Cardiac death13.3% MOF=4

15.3%

* 3 patients treated in October 2017 (POD # 13, 21 and 27 at time of this presentation)

1 patient withdrew consent while being discharged after successful transatrial TMVR

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Objective

• We aimed to evaluate and compare the procedural and clinical outcomes of patients

undergoing TMVR for degenerated bioprostheses (valve-in-valve [ViV]),

failed annuloplasty rings (valve-in-rings [ViR]) and severe MAC (valve-in-MAC [ViMAC])

Outcomes of TMVR for Degenerated

Biprostheses, Failed Annuloplasty Rings

and Mitral Annular Calcification

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Yoon SH, ESC 2018

Procedural Outcomes

Overall

(n = 521)

ViV

(n = 322)

ViR

(n = 141)

ViMAC

(n = 58)P value

Conversion to surgery, % 2.3 0.9 2.8 8.6 0.004

Valve embolization, % 1.7 0.9 1.4 6.9 0.01

LV perforation, % 0.8 1.2 0.0 0.0 0.58

Need for second valve, % 5.4 2.5 12.1 5.2 < 0.001

LVOT obstruction, % 7.1 2.2 5.0 39.7 < 0.001

Technical Success *, % 87.1 94.4 80.9 62.1 < 0.001

* Absence of procedural mortality; successful access, delivery; and retrieval of the device delivery

system; successful deployment and correct positioning of the first intended device; freedom from

emergent surgery or reintervention

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Yoon SH, ESC 2018

Clinical Outcomes at 30-Days

0

20

40

60

80

Proceduralsuccess

Death at 30Days

Stroke Bleeding Major vasccompl

AKI (Stage 2or 3)

73.6

6.22.2 2.2 1.6

4.3

58.2

9.9

0.0

6.43.5

9.2

41.4

34.5

3.4 3.46.9

12.1

%

p<0.001

p=0.03

p=0.05p=0.07

p=0.15

p<0.001

ViV (n=322)

ViR (n=141)

ViMAC (n=58)

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Yoon SH, ESC 2018

All-Cause Mortality According to TMVR

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Yoon SH, ESC 2018

Landmark Analysis of All-Cause Mortality

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1.

2.

3.

4. TAVR Valve Choice Trials: CHOICE, SOLVE-TAVI

5. TMVR Trials: MITRAL, MAC Registry, APOLLO, TENDYNE

6. Emerging TAVR Indications: ViV, LFLG, BAV, EARLY, UNLOAD

7. TAVR for Pure Aortic Regurgitation

8. Antithrombotic Therapy post TAVR

9. Sentinel Cerebral Protection Device during TAVR

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

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CHOICE Trial: Study Flowchart241 Transfemoral TAVR patients enrolled and randomized

Balloon-expandable valve

(Edwards Sapien XT, n=121)

Self-expandable valve

(Medtronic CoreValve, n=120)

Alive = 116

Dead = 5

LTFU = 0

Withdrawal = 0

Alive = 111

Dead = 6

LTUF = 1

Withdrawal = 2

30 Days

1 Year

Alive = 100

Dead = 21

LTFU = 0

Withdrawal = 0

Alive = 102

Dead = 15

LTUF = 0

Withdrawal = 3

100% Clinical follow-up 97% Clinical follow-up

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CHOICE Trial: Clinical Outcomes at 1 Year

Abdel-Wahab et al., J Am Coll Cardiol 2015;66:791

0

20

40

60

17.4

5.8 7.4

1411.6

3.4

23.4

10.712.8

3.4

12.8 14.5 12.0

0.0

27.9

6.8

%

Death Stroke HF repeat Bleeding Major vasc Valve New PPM MACCE

hosp life threatening compl thrombosis

p=0.37

p=0.36

p=0.22

p=0.12

p=1.00p=0.85

p=0.19

p=0.54

Balloon-Expandable Valve (n=121)

Self-Expandable Valve (n=117)

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A 2x2 Randomized Trial of Self-Expandable vs Balloon-Expandable Valves

and General vs Local Anesthesia in Patients Undergoing Transcatheter Aortic Valve Implantation

SOLVE-TAV

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SOLVE-TAVI Program

Thiele H, TCT 2018

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Primary Endpoint – Valve Strategy

Thiele H, TCT 2018

All-cause mortality, stroke, moderate or severe prosthetic valve regurgitation,

permanent pacemaker implantation at 30 days

0

10

20

30

40

50

Evolut R Sapien 3

Rate difference -1.14

90%CI -8.15 – 5.87

Pequivalence=0.02

Psuperiority=0.83

27.2%26.1%

%

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Endpoints – Valve Strategy

Individual Components Primary Endpoint

Thiele H, TCT 2018

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Secondary Endpoints – Valve Strategy

Evolut R

(n=219)

Sapien 3

(n=219)

Rate difference Pequivalence Psuperiority

Device time, min 63 ± 32 64 ± 43 0.80

Total procedural time, min 118 ± 48 117 ± 52 0.40

Cardiovascular mortality, n (%) 1/216 (0.5) 4/218 (1.8) 1.37 (-2.27 ─ 5.01) <0.001 0.37

Hospital stay, days 9 ± 7 9 ± 7 0.97

VARC-2 criteria:

Device success, n (%) 203/216 (94.0) 200/218 (91.7) -2.24 (-6.91 ─ 2.43) 0.002 0.46

Early safety, n (%) 24/217 (11.1) 33/219 (15.1) 4.01 (-1.57 ─ 9.59) 0.03 0.26

Clinical efficacy, n (%) 74/216 (34.3) 80/217 (36.9) 2.61 (-4.94 ─ 10.15) 0.05 0.61

Time-related safety, n (%) 41/217 (18.9) 58/219 (26.5) 7.59 (0.91-14.27) 0.27 0.07

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Primary Endpoint – Anesthesia Strategy

All-cause mortality, stroke, myocardial infarction,

infection requiring antibiotic treatment, acute kidney injury at 30 days

2725.5

0

10

20

30

40

50

Local anesthesia General anesthesia

Rate difference -1.52

90%CI -8.47 – 5.42

Pequivalence=0.02

Psuperiority=0.74

27.0%25.5%

%

Thiele H, TCT 2018

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Situations Where You Favor One Valve Over Another?A Clinicians Perspective: Most of AS are suitable for either valve

Evolut R

• Dense sub-annular calcium

• Intolerant to rapid pacing (↓↓EF)

• TAVR in SAVR (ViV)

• Ileo-femorals 5-6mm size

• Hypertrophied septum (HOCM)

• Subclavian approach

Sapien 3

• Ante-grade approaches

• Very large annulus >31-33mm

• Horizontal Aorta >60 degrees

• Concerns about PPM

• Pt with extensive CAD or prior PCIs

• Low coronary heights/ small SOV

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1.

2.

3. Coronary Angiography post TAVR

4. TAVR Valve Choice Trials: CHOICE, SOLVE-TAVI

5. TMVR Trials: MITRAL, MAC Registry, APOLLO, TENDYNE

6. Emerging TAVR Indications: ViV, LFLG, BAV, EARLY, UNLOAD

7. TAVR for Pure Aortic Regurgitation

8. Antithrombotic Therapy post TAVR

9. Sentinel Cerebral Protection Device during TAVR

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

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• There is a high prevalence of CAD in patients with severe aortic

stenosis who undergo TAVR

• As TAVR expands to lower risk patients, progressive CAD will

necessitate future coronary angiography & PCI

• Few data describing the feasibility of coronary re-access post TAVR

have been reported

Background

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Published Overview of CAG/PCI after TAVR ProceduresZivelonghi C, et al. Am J Cardiol 2017;120:625–31.

Htun WW, et al. Catheter Cardiovasc Interv 2017; Oct 8 [Epub ahead of print]

Allali A, et al. Cardiovasc Revasc Med 2016;17:391–8.

Boukantar M, et al. J Interv Cardiol 2017;30:56–62.

Chakravarty T, et al. J Am Coll Cardiol 2016;67:951–60.

Greenberg G, et al. J Invasive Cardiol 2013;25:361–3.

Murarka S, et al. Indian Heart J 2015;67:476–9.

Jackson M, et al. Cardiovasc Revasc Med 2017 Jul 31 [E-pub ahead of print]

Harhash A, et al. STEMI after TAVR: procedural challenge and

catastrophic outcome. J Am Coll Cardiol Intv 2016;9:1412–3.

Khan A, et al. Percutaneous coronary intervention after transcatheter aortic valve replacement:

approach and challenges. J Am Coll

Cardiol 2016;68:432–3.

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Methods and Objectives

• A systematic review identified all published

peer reviewed articles describing coronary

angiography and PCI post TAVR

• We assessed proportion of patients who

had selective coronary angiography and

successful PCI, grouped by self-expanding

valve and balloon-expandable valve

devices

• We aim to propose a practical algorithm for

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Self-Expanding Valve

Yudi, Sharma and Kini et al., J Am Coll Cardiol 2018;71:1360

Various Dimensions of Self-Expanding

Valves

Self-Expanding Valves and Coronary

Access

Location of the coronary ostium in relation to valve frame

Depicts closest diamonds that can be used to access the

coronary ostium

Annular plane

An optimally positioned self-expanding valve (A)

would make coronary access potentially easier

than one with a higher implant (B)

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Yudi, Sharma and Kini et al., J Am Coll Cardiol 2018;71:1360

Self-Expanding Valve and Coronary Access if Ostia

Lines Up with Commissural Post

Annular planeLocation of the coronary ostium in relation to valve frame

Depicts closest diamonds that can be used to access the coronary ostium

(A)The commissural post

of a self-expandable valve

is 26 mm in height.

(B)Depending on the

height of coronary ostia, a

different catheter and

approach is necessary for

coronary reaccess, when

the ostium faces the side

of the commissural post.

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Yudi, Sharma and Kini et al., J Am Coll Cardiol 2018;71:1360

Balloon-Expandable Valves

Features and Dimensions Balloon-Expandable Valve and Coronary

Ostia Based on Depth of Implant

Location of the coronary ostium in relation to valve frame

Annular plane

(A) Would make coronary access potentially easier than

one with a higher implant (B), where the coronary ostium

will be located below the seal skirt. Tall native leaflet or

bulky calcium at the leaflet tip may further increase

difficulty of coronary access in a high valve implant.

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Yudi, Sharma and Kini et al., J Am Coll Cardiol 2018;71:1360

Summary of Factors Impacting Coronary Access

and Imaging Evaluation After TAVR

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Algorithm for Coronary Angiogram Post-TAVR

with a Self-Expanding Valve

Yudi, Sharma and Kini et al., J Am Coll Cardiol 2018.71:1360

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Algorithm for PCI Post-TAVR with a Self-Expanding Valve

Yudi, Sharma and Kini et al., J Am Coll Cardiol 2018;71:1360

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Algorithm for Coronary Angiogram Post-TAVR with a

Balloon-Expandable Valve

Yudi, Sharma and Kini et al., J Am Coll Cardiol 2018;71:1360

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Algorithm for PCI Post-TAVR with a Balloon-Expandable

Valve

Yudi, Sharma and Kini et al., J Am Coll Cardiol 2018;71:1360

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1.

2. TAVR for Low Surgical Risk AS

3. Coronary Angiography post TAVR

4. TAVR Valve Choice Trials: CHOICE, SOLVE-TAVI

5. TMVR Trials: MITRAL, MAC Registry, APOLLO, TENDYNE

6. Emerging TAVR Indications: ViV, LFLG, BAV, EARLY, UNLOAD

7. TAVR for Pure Aortic Regurgitation

8. Antithrombotic Therapy post TAVR

9. Sentinel Cerebral Protection Device during TAVR

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

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PARTNER Trial Cohort B:

Inoperable Extreme Risk

Makkar et al., NEJM 2012;366:1696

Rate of Death (N=358)

20%

CoreValve Extreme Risk:

No Randomization1 Year Mortality (N=487)

Popma et al, JACC 2014;63:1972

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PARTNER Trial Cohort A:

Primary Endpoints at 3-Yr

Kodali et al., NEJM 2012;366:1686

Death from Any Cause

Major drawback:

ES TAVR had 2x the

Stroke rates vs. SAVR

TAVR SAVR

Death from Any Cause

CoreValve Trial High Risk:

Primary Endpoints at 3-Yr

Deeb et al., JACC 2016;67:2565

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SURTAVI Trial: Primary Endpoint at 2 Years

Reardon et al., NEJM 2017;376:1321

PARTNER 2A Trial: Primary Endpoint at 2 Years

Leon M et al. NEJM 2016;374:1609

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Serruys et al., EuroIntervention 2018;14:877

SURTAVI Trial: Outcomes of Patients in the SAVR and

TAVI Groups Among the Three Strata of STS PROM

0

5

10

15

1.5

5.5

11.1

3.8 4.2

7.8

Death Stroke

STS <3% STS ≥3% - <5% STS ≥5%

(n=131) (n=480) (n=253)

%

TAVI

0

5

10

15

5.7 5.3

9.18.2

6.8 6.5

Death Stroke

STS <3% STS ≥3% - <5% STS ≥5%

(n=123) (n=405) (n=268)

%

SAVR

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Study Design

Waksman et al., J Am Coll Cardiol 2018;72:2095

Prospective TAVR Cohort Historical Control SAVR Cohort

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In-Hospital Procedural-Related Complications

Waksman et al., J Am Coll Cardiol 2018;72:2095

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TAVR in Low-Risk Patients: Clinical Outcomes

Waksman et al., J Am Coll Cardiol 2018;72:2095

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The PARTNER 3 Trial:

Study Design

1:1 Randomization

(n=1228)

TF - TAVR

(SAPIEN 3)

Surgery

(Bioprosthetic Valve)

Follow-up: 30 days, 6 mos, 1 year and annually through 10 years

CT Imaging Sub-Study (n=200)

Low Risk ASSESSMENT by Heart Team(STS < 3%, TF only)

Symptomatic Severe Calcific Aortic Stenosis

PRIMARY ENDPOINT:

Composite of all-cause mortality, all strokes, or

re-hospitalization at 1 year post-procedure

Bicuspid Valves

(n=100)

ViV (AV and MV)

(n=100)

PARTNER 3

Registries

Alternative Access (n=100)

(TA/TAo/Subclavian)

Actigraphy/QoL Sub-Study (n=100)

CT Imaging Sub-Study (n=200)

Actigraphy/QoL Sub-Study (n=100)

Results in ACC 2019

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Medtronic TAVR in Low Risk PatientsTrial Design & leaflet Sub-study

▪ Patient Population: Low Risk Cohort

▪ Determined by Heart Team to be low surgical risk

▪ Primary Endpoint:

▪ Safety: Death, all stroke, life-threatening bleed, major vascular

complications or AKI at 30 days

▪ Efficacy: Death or major stroke at 2 yrs

▪ Sample Size: ~1200 Subjects

▪ Follow-up Evaluations:

▪ 30-days, 6-month , 18-month, and

1 through for 5 years

▪ Number of Sites: Up to 80 sites

Results in ACC 2019

Page 105: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Choice of TAVR vs Surgical AVR in Patients with

Severe Symptomatic AS

Nishimura et al., J Am Coll Cardiol 2017;70:252

TAVR

(Class I)

Page 106: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

1. MitraClip for FMR: MITRA-FR, COAPT2. TAVR for Low Surgical Risk AS

3. Coronary Angiography post TAVR

4. TAVR Valve Choice Trials: CHOICE, SOLVE-TAVI

5. TMVR Trials: MITRAL, MAC Registry, APOLLO, TENDYNE

6. Emerging TAVR Indications: ViV, LFLG, BAV, EARLY, UNLOAD

7. TAVR for Pure Aortic Regurgitation

8. Antithrombotic Therapy post TAVR

9. Sentinel Cerebral Protection Device during TAVR

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

Page 107: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

General Principles of Therapy for MR

Primary

No Medical Therapy(Diuretics pallative)

Surgery for symptoms

or LV dysfunction(Repair > Replacement)

Consider prophylactic repair for

low risk with long term survival

Secondary

Medical Therapy first(BB,ACE/ARB, Aldactone, Diuretics)

CRT(Repair > Replacement)

Surgery only in highly selected pts

with CHF(Class 3/4 symptomatic and

acceptable surgical risk)

FMR

MitraClip is approved for

prohibitive surgical risk

Primary MR

?

DMRDMR

Page 108: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards
Page 109: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

MITRA FR Study Design

Objective: To evaluate the clinical efficacy of

percutaneous mitral valve repair in addition to medical

treatment in patients with heart failure and severe

functional/secondary mitral regurgitation versus

medical treatment alone.

Primary Endpoint “Composite”: All-cause Deaths or

Unplanned rehospitalization for heart failure at 12

months

Page 110: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

MITRA FR: Enrollment, Randomization, and Follow-Up

Obadia et al., N Engl J Med Aug. 27, 2018 Epub

Page 111: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

MITRA FR: Prespecified Secondary Endpoints

Obadia et al., N Engl J Med Aug. 27, 2018 Epub

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MITRA-FR: Clinical Outcomes at 12 Months

Obadia et al., N Engl J Med Aug. 27, 2018 Epub

0

20

40

60

80

PrimaryEndpoint

Death Unplanned HFhosp

MACE

54.6

24.3

48.756.6

51.3

22.4

47.451.3

p=0.53

p=NS

%

Intervention group (n=152) Control group (n=152)

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MITRA FR: Kaplan-Meier Estimates of Survival

Without a Primary Outcomes Event

Obadia et al., N Engl J Med Aug. 27, 2018 Epub

Primary Composite Endpoint: All-cause Death and

Unplanned HF Hospitalization

Page 114: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

The COAPT Trial

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous

Therapy for Heart Failure Patients with Functional Mitral Regurgitation

A parallel-controlled, open-label, multicenter trial in ~610 patients with

heart failure and moderate-to-severe (3+) or severe (4+) secondary MR

who remained symptomatic despite maximally-tolerated GDMT

Randomize 1:1*

GDMT aloneN=305

MitraClip + GDMTN=305

*Stratified by cardiomyopathy etiology

(ischemic vs. non-ischemic) and site

Stone GW, TCT 2018

Primary endpoint: Rate of HF re-hospitalization at 24months

Secondary endpoints: Device related comp, mortality, need for

LVAD/transplant, QOL, NYHA Class

Page 115: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Primary Effectiveness EndpointAll Hospitalizations for HF within 24 months

HR (95% CI] = 0.53 [0.40-0.70]

P<0.001

0

50

100

150

200

250

300

0

MitraClip + GDMT (n=160)

GDMT alone (n=283)

35.8

67.9

Cu

mu

lati

ve

HF

Ho

sp

italizati

on

s (

n)

Time After Randomization (Months)

3 6 9 12 15 18 21 24

Stone et al., N Engl J Med Sept. 23, 2018 Epub

NNT (24 mo) = 3.1 [95% CI 1.9, 8.2]

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Primary Safety EndpointFreedom from Device-Related Complications within 12 Months

MitraClip procedure attempted N=293

Device-related complications 9 (3.4%)

- Single leaflet device attachment 2 (0.7%)

- Device embolization 1 (0.3%)

- Endocarditis requiring surgery 0 (0.0%)

- Mitral stenosis requiring surgery 0 (0.0%)

- Left ventricular assist device implant 3 (1.2%)

- Heart transplant 2 (0.8%)

- Any device-related complication requiring

non-elective CV surgery1 (0.3%)

*KM estimate; **Calculated from Z test with Greenwood’s method of estimated variance against a pre-

specified objective performance goal of 88%

50%

60%

70%

80%

90%

100%

88% OPC

94.8% [95% LCL]

P<0.001

Stone et al., N Engl J Med Sept. 23, 2018 Epub

96.6%*

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All-Cause MortalityA

ll-C

au

se M

ort

ality

(%

)

0%

20%

40%

60%

80%

100%

Time After Randomization (Months)

0 3 6 9 12 15 18 21 24

46.1%

29.1%

HR [95% CI] =

0.62 [0.46-0.82]

P<0.001

MitraClip + GDMT (n=302)

GDMT alone (n=312)

NNT (24 mo) =

5.9 [95% CI 3.9, 11.7]

Stone et al., N Engl J Med Sept. 23, 2018 Epub

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Death or HF Hospitalization

Stone et al., N Engl J Med Sept. 23, 2018 Epub

MitraClip + GDMT

GDMT alone

All-c

au

se M

ort

ality

or

HF

Ho

sp

ita

liza

tio

n (

%)

0%

20%

40%

60%

80%

100%

Time After Randomization (Months)

0 3 6 9 12 15 18 21 24

67.9%

45.7%

HR [95% CI] = 0.57 [0.45-0.71]

P<0.001

NNT (24 mo) =

4.5 [95% CI 3.3, 7.2]

Page 119: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

0

20

40

60

80

29.1

45.7

2.8 4.4 4.7 2.9 4.4 3.0 1.4

46.1

67.9

4.3 5.1 6.53.3

9.57.1

3.6

Adverse Events Within 24-Months

Stone et al., N Engl J Med Sept. 23, 2018 Epub

All-cause Death or HF PCI or Stroke MI New CRT LVAD or LVAD Heart

death hosp CABG implant heart transplant transplant

MitraClip + GDMT (n=302) GDMT alone (n=312)

p<0.001

p=0.12

p=0.02p=0.01

p=0.75

p=0.62p=0.93

p=0.32

p<0.001

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Why are the COAPT Results so Different from

MITRA-FR? Possible ReasonsMITRA-FR (n=304) COAPT (n=614)

Severe MR entry criteria

Severe FMR by EU guidelines:

EROA >20 mm2 or RV >30

mL/beat

Severe FMR by US guidelines:

EROA >30 mm2 or RV >45

mL/beat

EROA (mean ± SD) 31 ± 10 mm2 41 ± 15 mm2

LVEDV (mean ± SD) 135 ± 35 mL/m2 101 ± 34 mL/m2

GDMT at baseline and FU

Receiving HF meds at baseline

– allowed variable adjustment

in each group during follow-up

per “real-world” practice

CEC confirmed pts were failing

maximally-tolerated GDMT at

baseline – few major changes

during follow-up

Acute results: No clip/≥3+ MR 9% / 9% 5% / 5%

Procedural complications* 14.6% 8.5%

12-mo MitraClip ≥3+ MR 17% 5%

Page 121: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Conclusions• In pts with HF and moderate-to-severe or severe secondary

MR who remained symptomatic despite maximally-tolerated

GDMT, transcatheter mitral leaflet approximation with the

MitraClip was safe, provided durable reduction in MR,

reduced the rate of HF hospitalizations, and improved

survival, quality-of-life and functional capacity during 24-

month follow-up

• As such, the MitraClip is the first therapy shown to improve

the prognosis of patients with HF by reducing secondary

MR due to LV dysfunction

WE expect MitraClip soon to become ACC Class I

indication for FMR after GDMT (just like CRT)

Page 122: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

1. MitraClip for FMR: MITRA-FR, COAPT

2. TAVR for Low Surgical Risk AS

3. Coronary Angiography post TAVR

4. TAVR Valve Choice Trials: CHOICE, SOLVE-TAVI

5. TMVR Trials: MITRAL, MAC Registry, APOLLO, TENDYNE

6. Emerging TAVR Indications: ViV, LFLG, BAV, EARLY, UNLOAD

7. TAVR for Pure Aortic Regurgitation

8. Antithrombotic Therapy post TAVR

9. Sentinel Cerebral Protection Device during TAVR

10. Tricuspid Valve Intervention: TRILUMINATE

Top 10 Advances in Transcatheter Valve Therapy 2018

Page 123: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Reasons for selection of the articles Revolutionary / significant observation

Widespread acceptance

Change in clinical practice

Final result → BETTER INTERVENTION & PT’s SURVIVAL

TMVR for MAC, AC for TAVR, MITRA-FR:

TMVR, TTVR, BAV, ViV, TOPAS, SOLVE-TAVI:

Sentinel CPS, AR TAVR, CAG postTAVR :

COAPT in FMR, TAVR Low risk:

Top 10 Advances in Transcatheter Valve Therapy 2018

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Cumulative TAVR Procedures: TVT Registry 2012 to 2014

TAVR in USAProcedural Performance and Outcome of TAVR since FDA Approval

65% 35%

2018: ≈5000 TAVR per month in USA

Page 125: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

There is a Range of TAVR Mortality in US

Practice

Risk Adjustment:

Using variables from

the previously

developed TVT in-

hospital mortality

model.

Edwards et al., JAMA, Epub March 9, 2016

Page 126: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

TAVR Complications: Transfemoral Population

JD Carroll, ACC 2016

In-Hospital Outcomes - Volume

P Value for Association

Unadjusted = <0.0001

Adjusted = 0.1494

P Value for Association

Unadjusted = <0.0001

Adjusted = <0.0001

P Value for Association

Unadjusted = <0.0001

Adjusted = <0.0001

Unadjusted

Adjusted

Unadjusted

Adjusted

Unadjusted

Adjusted

Mortality Vascular complications Bleeding Complications

CVA complications

Page 127: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Growth in TAVR Procedures at MSH

2013 to 2017Major complication: N = 4 7 12 10 8

10 %

N

Length of Stay in Days: 7.8 7.4 6.3 4.9 4.7

O/E Mortality Ratio: 1.32 1.96 1.64 0.69 0.74

Page 128: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Excellent TAVR Volume & Outcomes 2017N=306 (55% Evolut-R CoreValve, 45% SAPIEN 3)

78% Conscious Sedation; 22% GA

82% Perc Femoral; 11% Cutdown Iliac, 6% Subclavian, 1% Direct Aortic

%

MSH DataTVT Registry

Page 129: Top 10 Advances in Transcatheter Valve Therapy 2018 · The Future of Transcatheter Heart Valves Aortic Valve Medtronic CoreValve Mitral Valve Edwards Sapien XT Tricuspid Valve Edwards

Excellent Growth in MitraClip Procedures at MSH

2013 to 2017In-Hospital Death: N = - 0 1 2 4

N FDA approval

in Oct 25, 2013

0

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www.ccclivecases.org

Watch our monthly live webcasts from our new and improved website!

www.ccclivecases.org

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