Frontiers In The Treatment of

Aortic Valve Disease

Association of Physician Assistants

In Cardiothoracic and Vascular Surgery

April 7, 2018

Benjamin A. Burroughs, PA-C, M.S.Chief Physician Assistant

Division of Cardiac SurgeryHenry Ford Hospital

Detroit, Michigan

Disclosures

• I have none.

Aortic Stenosis

Natural History Overview…

What Causes Aortic Stenosis in Adults?

More CommonLess Common

4

Images courtesy of John Webb, MD at St. Paul’s Hospital and Renu Virmani, MD at the CVPath Institute

Age-Related Calcific Aortic

Stenosis

Congenital Abnormality

RheumaticFever

Population at Risk for Aortic Stenosis is Increasing

5

▪ Aortic Stenosis is estimated to be

prevalent with 12.4% of the population

over the age of 75.2

▪ The elderly population will more than

double between now and the year 2050,

to 80 million.3

▪ 80% of adults with symptomatic aortic

stenosis are male4

Approx. 2.5 Million People in the U.S.

Over the Age of 75 suffer from this

disease.1

ELDERLY AVERAGE ANNUAL GROWTH RATE:

1910 to 2030

2.6%

3.1%

2.4%2.2%

1.3%

2.8%

0.0%

1.0%

2.0%

3.0%

4.0%

1910-1930 1930-1950 1950-1970 1970-1990 1990-2010 2010-2030

1. U.S. Census Bureau, Population Division. June 2015; 2. Ruben L.J.et al. Heart. 2000;84:211-21; 3. U.S. Census Bureau Statistical Brief. May 1995;

4. Ramaraj R, Sorrell VL. Br Med J 2008;336: 550–5.

Definition Valve Hemodynamics

High-gradient severe

aortic stenosis

▪ Aortic jet velocity ≥ 4 m/s or mean gradient ≥ 40 mmHg

▪ Or aortic valve area index ≤ 0.6 cm2/m2

Low-flow/low-gradient with

reduced left ventricular

ejection fraction

▪ Resting aortic jet velocity < 4m/s or mean gradient < 40 mmHg

▪ Dobutamine stress echocardiography shows aortic valve area ≤ 1.0

cm2 with aortic jet velocity ≥ 4m/s at any flow rate

▪ Left ventricular ejection fraction < 50%

Low-gradient with

normal left ventricular

ejection fraction or

paradoxical low-flow

▪ Aortic jet velocity < 4m/s or mean gradient < 40 mmHg

▪ Indexed aortic valve area ≤ 0.6 cm2/m2

▪ Stroke volume index < 35 mL/m2 measured when patient is

normotensive (systolic blood pressure < 140 mmHg)

▪ Left ventricular ejection fraction ≥ 50%

Patients with severe aortic stenosis typicallyhave an aortic valve area ≤ 1.0 cm2

Symptoms:

Dyspnea or decreased exercise tolerance, heart failure, angina, syncope and presyncope

Definition of Severe Aortic Stenosis

6

2014

Valvular

Disease

Guidelines

AHA / ACC

9. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537.

Aortic Stenosis Is Life-Threatening and Progresses Rapidly

➢Survival after onset of

symptoms is 50% at two years

and 20% at five years.1

➢“…valve surgery is appropriate

with even mild symptoms.”2

7

Sources

1) Catherine M. Otto. Valve Disease: Timing of aortic valve surgery. Heart. 2000;84:211-218.

2) Catherine M. Otto. Valvular aortic stenosis disease severity and timing of intervention. AMJC. 2006;47:2141-51.

Chart: Ross et al. Aortic stenosis. Circ.1968;38 (Suppl 1):61-7.

Aortic Valve Stenosis: Echo Findings

• Leaflet changes: Thickening, Calcification, Mobility

• Left ventricular hypertrophy

• Valve gradient / Valve area

8

ECHO – Short Access View

The Evolution of TAVR as a Disruptive Technology:

• Increasingly growing population of patients with severe AS.

• As medicine evolves, people live longer with more co-morbid diseases.

• Making traditional SAVR higher risk, and at times not possible.

• Large push for less invasive treatment options.

• Balloon Aortic Valvuloplsty - developed in 1985. Initially showed promise, however, restenosis rate was at 80% within the first year.

• Leading to the concept and ultimately the birth of TAVR. Now considered a medical breakthrough in the treatment of Aortic Stenosis.

Alain CribierFirst human transcatheter valve replacement (2002)

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PARTNER Trial

• TAVI with significant ↓ in mortality compared

with standard therapy: 30.7% vs. 50.7%, p <

0.001; death or hospitalization: 42.5% vs. 71.6%,

p < 0.001

• Major vascular complications at 1 year: 16.8% vs.

2.2%, major bleeding: 22.3% vs. 11.2%, (p <

0.001); major strokes: 7.8% vs. 3.9%, p = 0.18

• Landmark trial – demonstrates utility of TAVI

in the management of patients with high or

prohibitive surgical risk severe aortic stenosis

Patients at high or prohibitive risk for surgery randomized to transcatheter aortic

valve implantation (TAVI) or standard therapy and followed for 1 year.

Results

Leon MB, et al. N Engl J Med 2010;Sep 22:[Epub]

(p < 0.001)

TAVI

(n = 179)

All-cause mortality at 1

year

0

50

100

%

30.7

50.7

(p < 0.001)

16.8

2.2

50

Major vascular

complications at 1 year

Standard

therapy

(n = 179)

0

100

%

Approved Devices

• Medtronic Corevalve – Self Expanding Nitonal Valve

• Corevalve

• Evolut R

• Evolut Pro

• Sapien balloon expandable platform

• Sapien

• Sapien XT

• Sapien 3

Additional Trials

• Corevalve Trial – High risk / in-operable. TAVR vs. Surgical Aortic Valve Replacement.

• Surtavi – (Corevalve) intermediate risk / low risk randomized Trials TAVR vs. Surgical Aortic Valve Replacement.

• Partner 2 Trial – Intermediate Risk Registry – Sapien XT/S3.

• Partner 3 Trial – Randomized Low Risk – Sapien 3 vs. Surgical AVR

• Valve in Valve Registry

• Bicuspid Valve Registry

• EARLY TAVR – Asymptomatic patients- TAVR vs medical management

Edwards Sapien Valve

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Valve size 20 mm 23 mm 26 mm 29 mm

Native annulus size by TEE 16 – 19 mm 18 – 22 mm 21 – 25 mm 24 – 28 mm

Native annulus area (CT) 273 – 345 mm2 338 – 430 mm2 430 – 546 mm2 540 – 683 mm2

Area-derived diameter (CT) 18.6 – 21 mm 20.7 – 23.4 mm 23.4 – 26.4 mm 26.2 – 29.5 mm

Medtronic Corvalve

Smaller Sheath Sizes

Low mortality and stroke ratesPatient selection, procedural techniques, device evolution

Edwards eSheathintroducer set

Improved vascular accessLower profile devices expands treatment possibilities

Increased treatment range Larger and smaller valves

RetroFlex 3 introducer sheath

22F 16F

NovaFlex+delivery system

RetroFlex 3delivery system

SAPIEN valve23 mm and 26 mm

SAPIEN XT valve23 mm, 26 mm, 29 mm

SAPIEN 3 valve20 mm, 23 mm, 26 mm, 29 mm

Edwards Commander delivery system

Edwards eSheathintroducer set*

14F

*Only used with 20 mm,23 mm,26 mm valve sizes

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Heart Murmur = Aortic Stenosis = TAVR!!!

Henry Ford TAVR Volume

44

105

153

210 213

275

0

50

100

150

200

250

300

2012 2013 2014 2015 2016 2017

#

#

Early TAVR Approaches

Alternative Access for TAVR

Carotid

Transcaval

Subclavian/

Percutaneous axillary

Thoracic / Extra-thoracic

Suprasternal notch

Transapical

Direct Aortic

32

66

103

164 167

223

716

6 3 3 23 2

199

1 1

1725 24 26 26

1016 20

2 7 30

50

100

150

200

250

2012 (n=44) 2013 (n=108) 2014 (n=153) 2015 (n=210) 2016 (n=213) 2017 (n=275)

HFH TAVR Volume by Approach

transfemoral transapical transaortic transcaval transcarotid antegrade axillary

Trans-Caval Approach: Rationale

Halabi…Lederman. JACC 2013;61(16):1745Greenbaum…Lederman. JACC 2014;64(1)

◼Ilio-femoral veins –

Larger, more compliant

Lower pressure system

◼Aorto-caval fistulas from ruptured AAA often

not immediately life threatening

◼IVC is usually close to aorta without significant

intervening structures

Transcaval Physiology

Transcaval aortic access for TAVR>400 patients, 5 valve types, >50 centers , 3 continents as of Jul17

Halabi .. Lederman, JACC, 2013Greenbaum, O’Neill .. Lederman, JACC, 2014

Greenbaum, Babaliaros.. Lederman, JACC, 2017

Electrified wire cross-inginto aortic snare

Amplatzer muscular VSD occluder 8mm

Final Angiogram

Introducer sheath from femoral vein into aorta

Angiogram

CT-based plan

Trans-Caval Closure Technique

Trans-Caval Approach: First Patient

• 76 year old female s/p AVR, Ascending aortic aneurysm repair with a Dacron Graft.

• Developed significant degeneration / AI of her bio-prosthetic valve.

• Significant tortuous calcific femoral / illiac disease – Bilateral Illiac Stents.

• Attempted Trans-Apical TAVR – Unsuccessful due to significant epicardial fat, poor tissue.

• Done in collaboration with the NIH at Henry Ford Hospital.

• Approximately 3 months later, with the development of advanced technology, through the NIH, she successfully underwent the world’s first Trans-Caval TAVR at Henry Ford Hospital on July 3, 2013.

“Youtube.com”

Search: TCT Adam Greenbaum 2016

Watch Recorded Trans-Caval Case

Trans-Carotid Approach

• Patients considered candidates for TC TAVR if by CT scan they had common carotid arteries ≥6.0mm in diameter without significant calcification or tortuosity.

• All candidates undergo carotid duplex scanning. Those with significant unilateral disease (>50%) are considered candidates if the stenotic side is suitable for valve delivery. Attention to the amount of stenosis of the ipsilateral external carotid artery, as well as bilateral vertebral artery flow is considered.

• All cases are performed without shunting, EEG monitoring, or cerebral oximetry.

Aortic Insufficiency - ? TAVR

• Off label

• Lack of thickened, sclerotic, calcified valve leaflets for catheter valves to adhere to .

• Medtronic CoreValve due to dimensions / aortic wall tension.

A.I. – Device Choices

Case: S.D.

• 69 year old female with PMH of chronic a-fib, hypothyroidism, depression, MV repair/CABG in 1994, stage D ICMP s/p DT LVAD in April 2013

• Admitted 1/14/18 with evidence of hemolysis with presumed pump thrombosis.

• Difficult OR course in 2013 due to significant mediastinal adhesions, therefore sub costal approach recommended for LVAD exchange however,

• Echo 1/23/18 with moderate to severe AI, moderate MR and moderate to severe TR

• Structural heart consulted for transcatheter aortic valve replacement for AI.

TAVR for Aortic Insufficiency

Corevalve Evolut R

BASILICABioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic

Coronary Artery obstruction during transcatheter aortic valve replacement

References

1. Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007, 2014 internal estimates 2. Freed 2010, Iung 2007, Pellikka 2005; 2014 internal estimates 3. Das P. European Heart Journal. 2005;26:1309-13134. Lester SJ et al. CHEST 1998;113(4):1109-1114.5. Otto CM. Timing of aortic valve surgery. Heart. 2000;84:211-218 6. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537.7. Dumesnil et al. European Heart Journal 2010; 31, 281-289.8. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537.9. National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). 2012.10. Leon M et al. New England Journal of Medicine 2010 October 21;363(17):1597-1607.11. Nishimura RA et al. JACC. 2014. doi: 10.1016/j.jacc.2014.02.537.12. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4004491

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Thank You!!