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NY STATE NPA 33rd Annual ConferenceTAVR & Structural Heart

UpdateOctober 21, 2017Rose Hansen DNPStructural Heart CoordinatorGates Vascular Institute, Buffalo NY

TAVR Update: Objectives

1. Understand Aortic Stenosis disease process, prognosis and prevalence

2. Explore treatment options: TAVR, SAVR, BAV

3. Define new TAVR trends: Low Risk Patients, Carotid protection

4. Understand Patient Screening Process and Selection

5. Understand TAVR Program Challenges and Structural Heart Expansion

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Structural Heart Update: Objectives

Mitral Stenosis Prognosis and treatment options

Mitral Regurgitation prognosis and treatment options

Transcatheter Mitral Repair with Mitraclip for Severe Degenerative Mitral regurgitation

Explore FDA Approved Watchman device for patients with Atrial Fib at high risk for CVA and Bleeding

Cryptogenic Stroke associated with PFO/ASD may benefit from Closure

HOCM treatment with Alcohol Septal Ablation

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TAVR for Aortic Stenosis

Age-related calcific aortic stenosis

Symptoms of Aortic Stenosis Shortness of breath

Angina

Fatigue

Syncope or Presyncope

Other Rapid or irregular heartbeat

Palpitations

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The symptoms of aortic disease are commonly misunderstood by patients as ‘normal’ signs of aging.5

Many patients initially appear asymptomatic, but on closer examination up to37% exhibit symptoms.6

Sandy Severe Aortic

Stenosis (Actual Patient)

5. Das P. European Heart Journal. 2005;26:1309-1313; 6 . Lester SJ et al. CHEST 1998;113(4):1109-1114.

Population at Risk for Aortic Stenosis is Increasing

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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%

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.

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Severe Aortic Stenosis Is a Life Threatening Rapidly Progressing Disease Process

After the onset of symptoms, patients with severe aortic stenosishave a survival rate as low as 50% at 2 years and 20% at 5 years without aortic valve replacement2

The PARTNER Trial demonstrated that 50% of inoperable patients died within 1 year without a valve replacement

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Otto, CM, 2000

5-YEAR SURVIVAL(Distant Metastasis)

3 4

12

2328 30

0

5

10

15

20

25

30

35

severeinoperable

AS*

lung cancer colorectalcancer

breast cancer ovariancancer

prostatecancer

Sur

viva

l (%

)

Severe aortic stenosis has a worse prognosis than many metastatic cancers

8*Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic

p

5-year survival of breast cancer, lung cancer, prostate cancer, ovarian cancer and severe inoperable aortic stenosis

*

2014 AHA/ACC Valvular Heart Disease Guidelines

Symptomatic Severe Aortic Stenosis

Stage Definition Valve Hemodynamics Hemodynamic Consequences

D: Symptomatic Severe Aortic Stenosis

D1 High-gradient Aortic jet velocity ≥ 4m/s or meangradient ≥ 40 mmHg

Or aortic valve area index ≤ 0.6 cm2/m2

Left ventricular diastolic dysfunction Left ventricular hypertrophy Pulmonary hypertension may be present

D2 Low-flow/low-gradient with reduced leftventricular ejectionfraction

Resting aortic jet velocity < 4m/s ormean gradient < 40 mmHg

Dobutamine stress echocardiographyshows aortic valve area ≤ 1.0 cm2 with aortic jet velocity ≥ 4m/s at any flow rate

Left ventricular diastolic dysfunction Left ventricular hypertrophy Left ventricular ejection fraction <

50%

D3 Low-gradient with normal left ventricular ejection fraction orparadoxicallow-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)

Increased left ventricular relative wall thickness

Small left ventricular chamber with low stroke volume

Restrictive diastolic filling Left ventricular ejection fraction ≥

50%

NYHA Class II Symptoms include: Dyspnea, decreased exercise tolerance, CHF, angina, presyncope & syncopePatients with severe aortic stenosis typically have an aortic valve area ≤ 1.0 cm2

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A collaborative treatment decision

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Patient with severe aortic

stenosis identifiedby referring

physician

1

Patient referred tovalve clinic

2

Additional testing

completed

3

Multidisciplinaryreview and

treatment decisionby Heart Team

4

Treatmentrecommendations

reviewed with referringphysician, patient

and patient’s family

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Devising a treatment plan is a collaborative process

Ultimate treatment choice is a collaborative decision between the

physicians, patient and patient’s family.

TAVR Pre-Operative Workup 2D Echo

Right & Left Heart Cath 100cc IV Contrast

CTA Torso (70cc IV contrast)

PFTs

Carotid Doppler

Chest-X-Ray

EKG

Lab work/MRSA swab

(TEE optional)

Functional Assessment

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TAVR Pre-Operative Workup

Clinic Visit 2-3 times prior

CT Surgery Consult

CT Surgery Consult Second Opinion (Separate Date)

Vascular Surgery Consult

Anesthesia Consult

Consult for all other co-morbidities Renal, Oncology, Neurology, Dental, PT, OT, ect

Discussed in a multidisciplinary forum and deemed candidate for TAVR/SAVR If not a candidate: BAV or Palliative care

TAVR Workup is extensive and geared to obtain mandatory registry reported data. 30 day and 1 year reports.

TRANSCATHETER AORTIC VALVE REPLACEMENT

TAVR

Alain Cribier: First human transcatheter valve replacement (2002)

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Standard therapy includes medical management and BAV

ORIGINAL PARTNER Trial Significant reduction in mortality for inoperable patients with patients with the SAPIEN valve

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Of the 358patients 94% of patients in the

standard therapy group died within

5 years

21.8%absolute reduction

in mortality at 5 years

71.8%

Months

HR [95% CI] = 0.50 [0.39, 0.65]p (log rank) < 0.0001

93.6%

All-

Cau

se M

orta

lity

(%)

0 12 24 36 48 60

100

80

60

40

20

0

Standard Rx (n = 179)TAVR (n = 179)

50.7%

30.7%

All-cause mortalityinoperable cohort

The PARTNER II Trial: Intermediate-risk

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Intermediate-risk symptomatic severe aortic stenosisIntermediate-risk symptomatic severe aortic stenosis

Transapical (TA)/Transaortic (TAo)Transapical (TA)/Transaortic (TAo)Transfemoral (TF)Transfemoral (TF)

PARTNER II S3i( n = 1078 )

TA / TAo TAVRSAPIEN 3 valveTA / TAo TAVRSAPIEN 3 valve

TF TAVRSAPIEN 3 valve

TF TAVRSAPIEN 3 valve

Intermediate-risk assessment by Heart Valve Team

PARTNER IIA( n = 2032 )

Assessmenttransfemoral access

NoYeYes

1:1 Randomization

1:1 Randomization

Transapical (TA)/Transaortic (TAo)Transapical (TA)/Transaortic (TAo)Transfemoral (TF)Transfemoral (TF)

TA TAVR

SAPIEN XT

valve

TA TAVR

SAPIEN XT

valve

Surgical

AVR

Surgical

AVRvsvs

TA/TAoTAVR

SAPIEN XT

valve

TA/TAoTAVR

SAPIEN XT

valve

Surgical

AVR

Surgical

AVRvsvs

Assessment for optimalvalve delivery access

1:1 Randomization

1:1 Randomization

The most robust, rigorous study in more than 3,000 intermediate-risk patientsThe most robust, rigorous study in more than 3,000 intermediate-risk patients

Disabling Stroke*

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Months from procedure

Dis

ablin

g st

roke

(%

)

0

10

20

30

40

2.3%

5.9%

1.0%

4.4%

0 3 6 9 12

TAVR with SAPIEN 3 valve

Surgery (PIIA)

1077 1033 1008 884 953

806 778 764

*The PARTNER II trial intermediate-risk cohort unadjusted clinical event rates.

SAPIEN 3 TAVR

944 825

Number at risk:Surgery

1.0%

4.4%

Leon M et al. New England Journal of Medicine 2016

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Over 150,000 patients treated worldwide

Over 50,000 patients treated in the United States

Treating patients in Over 65 countries

Backed by unprecedented outcomes and real world results INTERMEDIATE RISK TAVR APPROVAL 8/2016

19 *As of February 2016

Gates Vascular InstituteTAVR Program

TAVR First Case 1/11/12 >675 TAVRs to date Edwards Medtronic Boston Scientific

Research:Partner3, Reprise3

Transfemoral (Percutaneous 2012) MAC~ 1/1/2015

Alternate Approach 2013 >85 cases Transapical/Direct Aortic/Axillary/Subclavian

Carotid Approach=14

• Valve in Valve, ESRD HD, Bicuspid Valves

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99 years old 5 weeks post TAVR

What Else is New in the TAVR World Embolic Debris During TAVR

23 Giustino, et al 2016

Claret Sentinel Carotid Protection forStroke Prevention during TAVRFDA Approved 8/2017

24Giustino, et al 2016

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LOW RISK Patients STS <3%May Now be Eligible for TAVR

Partner 3 Trial 1:1 Randomization to TAVR or SAVR

Bicuspid TAVR Registry pending

Early TAVR TRIAL for Asymptomatic patients

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Minimally Invasive and Minimalist Approach

Performed in Hybrid Cath Lab

Conscious Sedation MAC

Percutaneous, No Cutdown

No Swan

No Art Line

No Foley

No ICU (for select patients)

Shorter LOS

Less readmission

Better Outcomes26

STRUCTURAL HEART Mitral Stenosis

Severe NYHA Class CHF symptoms

Poor prognosis

Surgery high Risk due to calcification

FDA Approval of TAVR in Mitral position ina previous place surgical valve 2017

Native TMVR in trial

Balloon Mitral Valvotomy Palliative

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STRUCTURAL HEART Mitral Regurgitation and Mitraclip

Severe degenerative Mitral Regurgitation is a progressive disease leading to CHF and functional decline

Diagnosis with TEE Right and Left Heart Cath

For inoperable or high risk patients transcatheter percutaneous transeptal Mitral Valve Repair with MitraClip can decease Severe MR

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STRUCTURAL HEART LAAO WATCHMAN DEVICE

Atrial Fibrillation treatment includes anticoagulation for prevention of left atrial appendage thrombus increasing stroke risk.

For Patients at high risk for Bleeding a percutaneous LAA occluder device WATCHMAN may be inserted to reduce risk

Preoperative Warfarin, TEE and

General anesthesia, Cath Lab or EP Lab

Follow up Registry Reporting x4

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STRUCTURAL HEART Cryptogenic CVA with PFO/ASD

PFO/ASD Prevalence in 25% of population

Cause shunting of right to left turbulence clotting and embolic events

Causes left to right ishunting ncreasing the right atrial pressures and PHTN

2017 approval of ASD/PFO Closure in presence of cryptogenic stroke

Diagnosis Bubble study echo, transcranial doppler,

Rule out atrial fib holter monitor and hypercoagulable studies

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11

Maria

103 years old 4 weeks post

TAVR

STRUCTURAL HEART Hypertrophic Obstructive

Cardiomyopathy HOCM is an enlargement of the left ventricular outflow

tract Symptoms mimic Aortic Stenosis increae risk of Sudden

death, familial Diagnosis 2D Echo/ Cardiac MRI & Left heart Cath Treatment: Surgical Myectomy Open Heart Surgery Alcohol Septal ablation is performed in the Cath lab

under general anesthesia Induces an infarct to the upper septal wall reducing the

septum Requires ICU and post op pain management Recommend AICD 32

Structural Heart Summary

Patients with Mitral Stenosis have limited treatment options and can be extremely symptomatic.

Severe Mitral Regurgitation has a poor prognosis and limited treatment options

Transcatheter Repair with Mitraclip is an effective option for high risk patients with Severe Mitral regurgitation

Watchman device is an appropriate option for patients with Atrial Fib at high risk for CVA and Bleeding

Patients with Cryptogenic Stroke and PFO/ASD may benefit from FDA Approved Closure

HOCM increases risk of Sudden death an may be treated with Alcohol Septal Ablation

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TAVR Summary

Aortic stenosis is prevalant in elderly populations and has a poor prognosis if left untreated

TAVR is effective treatment for High risk and Inoperable patients

TAVR is effective treatment in Intermediate Risk Patients

ALL Aortic Stenosis Patients Should Be Evaluated By the Heart Team: Low Risk Patients should be offered Trial

CVA Protection is Available for at Risk patients

Minimalist approach provides less complications and Shorter LOS

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Questions? Thank You!Rhansen@Daemen.edu

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.Giustino, Gennaro, Cerebral Embolic Protection During TAVR. JACC

Intervention DOI: 10.1016/j.jacc.2016.12.0025. 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.Abbott Vascular Everest Trial MitraClip13 Boston Scientific Watchman13. St Jude Amplatzer PFO/ASD Closure

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