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9/17/2016 1 Aortic Stenosis: When Will Surgery ALWAYS Be a Better Option in 2016 September 17, 2016 Ahmet Kilic, MD Associate Professor of Surgery Educational Objectives At the conclusion of this activity, learners should be able to: 1. To describe the role of surgery in patients with aortic stenosis. 2. To describe the role of transcatheter aortic valve replacement in patients with aortic stenosis. 3. To delineate the risks and benefits of when surgical valve replacement is better than transcatheter aortic valve replacement. 2

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Aortic Stenosis: When Will Surgery ALWAYS Be a Better Option in 2016

September 17, 2016

Ahmet Kilic, MDAssociate Professor of Surgery

Educational Objectives

At the conclusion of this activity, learners should be able to:

1. To describe the role of surgery in patients with aortic stenosis.

2. To describe the role of transcatheter aortic valve replacement in patients with aortic stenosis.

3. To delineate the risks and benefits of when surgical valve replacement is better than transcatheter aortic valve replacement.

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Speaker Disclosure

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Baxter International (speaker)

HeartWare (travel)

St. Jude Medical (consultant/speaker)

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Aortic Stenosis:

Symptomatic (angina, syncope, dyspnea, heart failure)

Asymptomatic

Severe (mean ≥ 50 mm Hg, AVA ≤ 1.0 cm2)

Aortic Regurgitation:

Severe (3+ to 4+) aortic insufficiency in the presence ofsymptoms, left ventricular dilation, or impaired left ventricular function.

Isolated Aortic Valve ReplacementWhen to intervene?

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Aortic StenosisSymptomatic - Survival

Angina and Syncope – 3 years

Dyspnea – 2 years

Heart Failure – 1.5 years

Aortic StenosisACC / AHA Classification

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Aortic Valve ReplacementOptions

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Patient Selection

• Open Surgical AVR‒ Full Sternotomy‒ Mini Sternotomy

• TAVR‒ Transileofemoral ‒ Transapical‒ Left subclavian‒ Direct aortic‒ “Alternative alternative”

• Carotid• Cavo-aortic

Aortic Stenosis: TAVR vs (s)AVR

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So why not TAVR everyone ? Conversely, why not surgery for everyone?

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Anatomy

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Anatomy: Bicupsid valve

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Anatomy: Annulus

• Too large annulus‒ Aortic aneurysm

• Too small annulus‒ Need for root enlargement

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Surgical techniques of posterior aortic root enlargement reported so far (Nick's-white arrow, Nuñez's-black arrow, Manouquian's-black plus black dotted arrows). NCC,noncoronary cusp; LCC, left coronary cusp; RCC, right coronary cusp; AML, anterior mitral leaflet.

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Anatomy: Coronary obstruction

• Height of coronary to annulus

• Inappropriate Sinus reserve• Heavy calcifications• Aortic root rupture

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Anatomy: Transcatheter access route

• Inappropriate access vessels‒ Transfemoral‒ Direct aortic‒ Subclavian

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1

3

4

2

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Anatomy: Access

Anatomy: Access

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Anatomy: Access

Anatomy: Access – tortuosity

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Anatomy: Borderline and Tortuous

Anatomy: No ileofemoral access

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Anatomy: Aortic Angulation

Long sheath to avoid perforating the aorta

Abdominal Aorta Angulation

Anatomy: Aortic Angulation

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Whole Aorta and Iliacs Tortuosity

Anatomy: Aortic Angulation

Anatomy: Aortic Pathology

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Subclavian Access

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Transapical Approach

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Anatomy: Pre-operative planning

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Manenti et al. Computed tomography in aid to direct aortic access Ann Thorac Surg 2013;95:1137.

• Computed tomography‒ Anatomy

• Length of ascending aorta• Aortic annulus to brachiocephalic trunk

• Sternomanubrium to right rib cage• Calcified plaques• Lung lesions, pleura, pericardium, mediastinum,

supra-aortic valves‒ Size of aortic annulus

Patient Prosthesis Mismatch

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Concomitant Procedures

• Mitral valve

• Tricuspid valve

• Anti-arrhythmia

• Coronary revascularization

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Infection

• Need to debride all infected tissue in endocarditis‒ Aortic root abscess

• Prosthetic valve endocarditis

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Risk-adjusted estimates of explant for structural valve dysfunction (SVD) by competing risk analysis. For this figure, the patient was assumed to be a man in New York Heart functional class III, undergoing first valve replacement, and not undergoing con...

Michael K Banbury, Delos M Cosgrove III, Jennifer A White, Eugene H Blackstone, Robert W M. Frater, J.Edward OkiesAge and valve size effect on the long-term durability of the Carpentier-Edwards aortic pericardial bioprosthesis . The Annals of Thoracic Surgery, Volume 72, Issue 3, 2001, 753–757

Age

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Age: Case Example

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What’s the long view: Long term follow-up

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Bileaflet mechanical valve replacement: an assessment of outcomes with 30 years of follow-up.Saito S, Tsukui H, Iwasa S, Umehara N, Tomioka H, Aomi S, Yamazaki K. Interact Cardiovasc Thorac Surg. 2016 Jun 23. pii: ivw196. [Epub ahead of print]

TAVR Candidacy

InoperableInoperable

PARTNER I TRIAL

Symptomatic Severe Aortic Stenosis1057 Total Patients Enrolled

Symptomatic Severe Aortic Stenosis1057 Total Patients Enrolled

n = 699 High-RiskHigh-Risk

STS > 10; Predicted Mortality > 15% Predicted death, serious morbidity > 50%

Extreme Risk

Extreme Risk

CoreValve US Pivotal Trial

Symptomatic Severe Aortic Stenosis1381 Total Patients Enrolled

Symptomatic Severe Aortic Stenosis1381 Total Patients Enrolled

High-RiskHigh-Risk

Predicted Mortality > 15% Predicted death, serious morbidity > 50%

n = 487

n = 358

TAVR v SAVR

TAVR v SAVR

TAVR v Standard Tx

TAVR v Performance Goal

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TAVR Candidacy

LOW INTERMED HIGH INOPERABLE

SA

PIE

NS

AV

RC

OR

E

STS > 8EuroScore > 6

STS 4-8EuroScore 3-5

STS 0-3EuroScore 0-2

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Aortic Stenosis: TAVR vs (s)AVR

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Financial Burden: Aortic Valves

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J Am Coll Cardiol. 2016 Jan 5;67(1):29-38. doi: 10.1016/j.jacc.2015.10.046. Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement.. Reynolds MR1, Lei Y2, Wang K3, Chinnakondepalli K3, Vilain KA3, Magnuson EA4, Galper BZ5, Meduri CU6, Arnold SV4, Baron SJ4, Reardon MJ7, Adams DH8, Popma JJ9, Cohen DJ4; CoreValve US High Risk Pivotal Trial Investigators.

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Inpatient Mortality after aortic valve replacement

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Heart Valve Team

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Increasing referral of patients for TAVR that are too well

Increasing referral of patients for TAVR that are too sick

Appropriate Case Selection – Risk Assessment Predicted risk of mortality AND morbidity Frailty Assessments Clinical Futility Technical Challenges

Integral involvement of the Heart valve team

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Heart Valve Team

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Appropriate Patient – Intervention Matching

Importance of Clinical Trials

PARTNER II TrialSURTAVI Trial

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Valve bad …..Me Surgeon ….. Me replace with new

one……

What do surgeons really think of TAVR……

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Fig 1. Valve design features: button holes. Button holes allow correct axial-rotational positioning in the native aortic root. (LC = left coronary; NC = noncoronary; RC = right coronary.)

Thierry A. Folliguet, François Laborde, Konstantinos Zannis, Gabriel Ghorayeb, Axel Haverich, Malakh Shrestha

Sutureless Perceval Aortic Valve Replacement: Results of Two European Centers

The Annals of Thoracic Surgery, Volume 93, Issue 5, 2012, 1483–1488

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Conclusions for Aortic Stenosis: When Will Surgery ALWAYS Be a Better Option in 2016

• Low risk patients• Intermediate risk patients – Need longer term follow-up• Infective endocarditis • Adverse anatomy

‒ Bicuspid‒ Annulus‒ Coronary height / blood flow‒ Sinus reserve

• Concomitant ‒ Valvular‒ Coronary revascularization

53Reardon AATS 2014

Conclusions for Aortic Stenosis: When Will Surgery ALWAYS Be a Better Option in 2016

• Bioprosthetic valve performance and durability will improve.

• Mechanical valves have excellent long term outcomes.

• There will always be clinical scenarios when surgery will outperform transcatheter therapies.

• Surgical valve replacement, just like TAVR, will continue to evolve and adapt

• Our understanding for the role of appropriate patient selection for BOTH transcatheter and surgical aortic valve replacement will continue to evolve

• The structural heart disease – team based approach will improve patient outcomes.

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Thank You