Michael J. Reardon, M.D., FACC, FACSProfessor of Cardiothoracic SurgeryAllison Family Distinguished Chair of Cardiovascular ResearchHouston Methodist DeBakey Heart & Vascular Center

Transcatheter Valve Therapies in 2020: A Surgeon’s Perspective

REQUIREDI Michael J. Reardon, M.D

Consultant:

Medtronic

Boston Scientific

Agenda

Understand the dataWhat are the knowledge gapsWho should be considered for TAVR in 2020

Extreme Risk

DONE

DONE

FDA Approved

HIGH RISK

DONE

DONE

FDA Approved

Intermediate risk

DONE

DONE

FDA Approved

High and Intermediate risk

TAVR vs. AVR must show equivalent or better

mortality

hemodynamics

morbidity

quality of life

durability

patient acceptance

TAVR ties/wins

TAVR wins

TAVR wins

TAVR wins

Unknown Unknown

TAVR ties/winsStrokeHemodynamicsAtrial fibrillationTransfusions

Surgery winsPVLPacers for SEV

High risk age 84Intermediate risk age 80/81

Low risk

Primary Endpoints

Valves Used

Mean ageSex

STS PROM

Primary Endpoint Outcomes

1 Year All-cause Mortality

KM Curves

Stroke

Embolic Protection Devices Were Not Allowed

KM Curves

Rehospitalization

KM Curves

Death, Stroke, Hospitalization

Conclusions

This applies to the population tested!Know the trial data!

Low Risk

DONE

DONE

FDA Approved

2017 Up Date

Rick A. Nishimura, MD, MACC, FAHA, Co-Chair, Catherine M. Otto, MD, FACC, FAHA, Co-Chair, Robert O. Bonow, MD, MACC, FAHA, Blase A. Carabello, MD, FACC, John P. Erwin III, MD, FACC, FAHA, Lee A. Fleisher, MD, FACC, FAHA, Hani Jneid, MD, FACC, FAHA, FSCA, Michael J. Mack, MD, FACC, Christopher J. McLeod, MBChB, PhD, FACC, FAHA, Patrick T. O’Gara, MD, MACC, FAHA, Vera H. Rigolin,, MD, FACC, Thoralf M. Sundt III, MD, FACC, Annemarie Thompson, MD, 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease, Circulation. 2017;135:e1159–e1195.

70220

74048 74408 74830 7368770228

69885

28948 30772 30159 30432 2892526426

25513

18466 1861318548

18157 1773316182

15929

19146 2068021543

22007

22238 2225522322

3660 3983 4158 4234 4791 536561214666

894616106

24908

38276

51303

58657

0

10000

20000

30000

40000

50000

60000

70000

80000

2012 2013 2014 2015 2016 2017 2018Total of all SAVRS (includes Bentalls) Isolated AVR SAVR + CABG SAVR Other Bentalls TAVR

The Aortic Valve “Universe” in the USA

Linked TVT and STS Data. From the STS/ACC TVT Steering CommitteeRepresents approx. 93% and 97% of SAVR and TAVR respectively

Presented By Joe Bavaria MD at EACTS 2019

Pacemaker

Trial DifferencesTrial Differences

0%

20%

40%

60%

80%

100%

0 10 20 30 40 50 60 70

Perm

anen

t Pa

cem

aker

# Implanted TAVR Patients

95% Control limitAverage99.8% Control limit

Presented by Dr. Gada at TCT 2019

Site-level Variation and Predictors of PPIVariability in 30-Day PPI Rate by Center

Remember the S curve and find a RAO

projection

Hemodynamics

Trial Differences

That is the dataWhat are the knowledge gaps?

Who was excluded?

Bicuspid ValvesPartner 3 Syntax > 32Evolut Syntax > 22

Who was excluded after local heart team approval?

520/1,520 (34%) screen failed 255/1,723 (14.8%) screen failed

Age?

Mean ageSex

STS PROM

7% were < 65 years

6% were < 65 years1.3% were < 60 years

Safety is the key difference in outcomes in both trials with most of the benefit in the first month

0.0000

0.0005

0.0010

0.0015

0.0020

0.0025

0.0030

0.0035

0.0040

0 30 60 90 120 150 180 210 240 270 300 330 360

Inst

anta

neo

us

Haz

ard

Mo

rtal

ity

Time (Days)

High Risk TAVR High Risk SAVR

Intermediate Risk TAVR Intermediate Risk SAVR

Low Risk TAVR Low Risk SAVR

Causes of Death Risk of death lower in low-risk patients

Presented by Dr. Ramlawi at AATS 2019

Nu

mb

er o

f Pa

tien

ts

31

43

11

2

0

2

4

6

8

10

TAVRN=3

SAVRN=8

TAVRN=6

SAVRN=1

TAVRN=5

SAVRN=8

0–30 Days 31–120 121–365

Technical Repair Failure Complications(Linked to Death)

No Recovery Other

5

2

1

3

1

4

Causes of Death Hierarchical Causes of Death –Low Risk

Presented by Dr. Ramlawi at AATS 2019

Sievers HH, Schmidtke C. A classification system for the bicuspid aortic valve from 304 surgical specimens., J ThoracCardiovasc Surg. 2007 May;133(5):1226-33.

Bicuspid Valves

Sievers HH, Schmidtke C. A classification system for the bicuspid aortic valve from 304 surgical specimens., J Thorac Cardiovasc Surg. 2007 May;133(5):1226-33.

Prevalence of Bicuspid Valve Disease

1 Ward. Heart, 2000; 2. Roberts. AJC, 2012; 3. Zhao, Z.-G. et al. Nat. Rev. Cardiol, 2014. 4. Wang, J of Heart Valve Disease, 2017; 5. Jilaihawi, Catheter Cardiovasc Interv. 2016.

Prevalence of Bicuspid Valve Disease inUS SAVR Patients by Age (n = 1,725) 2

44, 39%

55, 4%

63, 55%

638, 51%

78,22%

3, 18%

9, 8%

546,44%

269,78%

14,82%

0%

20%

40%

60%

80%

100%

21 - 50 51 - 79 80 - 89 ≥ 90

Unicuspid Bicuspid Tricuspid

Prevalence of Bicuspid Valve Disease inTAVR Patients by Country3

6.7% 6.6% 4.5%2.7% 1.6%

0%

10%

20%

30%

40%

50%

Poland(n = 417)

France(n = 417)

Italy(n = 468)

Germany(n = 1,395)

USA(n = 7,710)

Makkar et al: JAMA 2019;321:2193-202

Data from STS/ACC TVT Registry. 92.236 patients treated with the third-generation balloon-expandable Sapien 3 from 2015-2018

Makkar et al: JAMA 2019;321:2193-202

Procedural Outcomes

Makkar et al: JAMA 2019;321:2193-202

30-day Outcomes

Makkar et al: JAMA 2019;321:2193-202

1-Year mortality

Makkar et al: JAMA 2019;321:2193-202

1-Year stroke

Makkar et al: JAMA 2019;321:2193-202

Paravalvular Leak

Hemodynamics

Patient Prosthesis Mismatch

CoreValve High Risk Trial

CoreValve High Risk

7.413.3

6.812.8

1620.4

1

1.1

1.5

2.53.8

10.2

0

10

20

30

40

Large Medium Small Large Medium Small

Moderate PPM Severe PPM

TAVR SAVR

P=0.031

P=0.070

Perc

enta

ge P

PM

Hemodynamics30-day PPM by Annular Size

Presented by Dr. Mumtaz at TVT 2019

Low Risk

Herrmann HC, Daneshvar SA, Fonarow GC, Stebbins A, Vemulapalli S, Desai ND, Malenka DJ, Thourani VH, RymerJ, Kosinski AS.,Prosthesis-Patient Mismatch in Patients Undergoing Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry., J Am Coll Cardiol. 2018 Dec 4;72(22):2701-2711

Pibarot P, Clavel MA., Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement: It Is Neither Rare Nor Benign., J Am Coll Cardiol. 2018 Dec 4;72(22):2712-2716.

Evolut Low Risk PPM

Fallon JM, DeSimone JP, Brennan JM, O'Brien S, Thibault DP, DiScipio AW, Pibarot P, Jacobs JP, Malenka DJ., The

Incidence and Consequence of Prosthesis-Patient Mismatch After Surgical Aortic Valve Replacement.,Ann

Thorac Surg. 2018 Jul;106(1):14-22.

STS SURGICAL PPM

JACC Cardiovasc Imaging. 2018 Jun 8. pii: S1936-878X(18)30358-9. doi: 10.1016/j.jcmg.2018.04.010. [Epub ahead of print]

Sapien 3 mean EOA 1.66

Evolut mean EOA 2.01

Balloon Expanded

Self-Expanding

30 Day PPM

0

10

20

30

40

50

60

70

Evolut TAVR Partner TAVR

30 Day PPM

Severe

Moderate

9.9%

1.1%

53.8%

8.3%

GORLIN R, McMILLAN IK, MEDD WE, MATTHEWS MB, DALEY R., Dynamics of the circulation in aortic valvular disease., Am J Med. 1955 Jun;18(6):855-70

Hemodynamics

Rahimtoola, S .The Problem of Valve Prosthesis-Patient

Mismatch. Circulation, Vol. 58, No 1, July 1978;20-24Grossman Text, Hemodynamics Chapter

Normal Flow

High Flow

DurabilityMechanical vs.Biologic

Randomized trials

Circulation 2013;128:1372-80

50 – 65 years old – no survival difference

Shared decision making

Nishimura RA, Otto CM, Bonow RO, et al. 2017AHA/ACC focused update of the 2014 AHA/ACCguideline for the management of patients withvalvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J AmColl Cardiol. 2017;70(2):252-289.

Tissue vs. mechanical

Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J AmColl Cardiol. 2017;70(2):252-289.

Early Failures of Surgical Valves

TAVR Durability

THV degeneration = ≥ 20 mmHG after30 days and/or at least moderate AR, without endocarditis

CHU Rouen239 pts from 2002-2011 (> 5 years FU)

Freedom from either reoperation, or if asymp,echo mean valve gradient >40 mmHg or severe AR (effective ROA > 0.3cm2)

Among survivors, none withMG >40 and only 1 pt with severe AR resulting in ViVprocedure

High Risk 5-year

High Risk 5-year

INTERMEDIATE RISK ADDED

0

10000

20000

30000

40000

50000

60000

1 2 3 4

TAVR

SAVR

SAVR/CAB

17544

18090 17507

15910

18384

28857

29829 30265 28493

25580

43548

51998

LOW RISK ADDED

0

10000

20000

30000

40000

50000

60000

70000

80000

90000

1 2 3 4

TAVR

SAVR

SAVR/CAB

17544

18090 17507

15910

18384

28857

29829 30265 28493

25580

43548

80076

Under Diagnosis

The most common abnormalities were aortic sclerosis (34%),

mitral regurgitation (22%), and aortic regurgitation (15%). Aortic

stenosis was present in 1.3%. The likelihood of undiagnosed

VHD was two-fold higher in the two most deprived

socioeconomic quintiles than in the most affluent quintile, and

three-fold higher in individuals with atrial fibrillation

Enrolled 2500 individuals aged

≥65 years from a primary care

population and screened for

undiagnosed VHD using

transthoracic echocardiography.

Newly identified (predominantly

mild) VHD was detected in 51%

of participants.

Clinically significant valve

disease will double by 2050 in

the UK

Under Diagnosis

THE HEART TEAM DISCUSSION

• 90 and above = High Risk

– TAVR

• 80 = Intermediate to High Risk

– 10 year valve is all they will ever need

• 70 = Low to Intermediate Risk

– Likely will require a VIV, start with the largest platform

• 60 = Shared decision making

– “Kicking the can”• PPM vs PPM

• Coronary Access• Durability

How do we choose?

TAVR vs. AVR must show equivalent or better

mortality

hemodynamics

morbidity

quality of life

durability

patient acceptance

AgeLife spanAnatomyChoice

Conclusions – From the surgeon’s perspective

Demand for TAVR will increase

Number of TAVRs will increase

Surgery will not go away but become more complex and a good surgeon will become even more valuable to the best programs

Understand the dataLove your surgeon

Thank You