TAVR SPRING 2017 - Bryan Health...4/13/2017 Nithin P G 1 Matthew Johnson, MD TAVR SPRING 2017 The...

4/13/2017

Nithin P G 1

Matthew Johnson, MD

TAVR SPRING 2017The evolution of TAVR

Disclosers

None

Evolution of the Balloon-Expandable Transcatheter Valves

* Sheath compatibility for a 23 mm valve

2002

Cribier

2006

SAPIEN

2009

SAPIEN XT

2013

SAPIEN 3

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Introduction

AV

R

High risk for

surgery

Complications30-40% do not undergo Sx

•Advanced age

•LV dysfunction

•Multiple co-morbidities

•Pt. preference

•Physician assessment

“Symptomatic Severe Aortic

Stenosis” Prohibitive risk

Inoperability

•~3% mortality (STS, EuroSCORE)

•~2% Stroke

•~11% prolonged ventilation

•Organ failure

•Thromboembolic Complications

•Bleeding

•Prosthetic valve DysfunctionJ. Am. Coll. Cardiol. 2012;59;1200-1254

Indications 2012

• A Symptomatic severe calcific Aortic Stenosis [trileaflet] who

have aortic and vascular anatomy suitable for TAVR and a

predicted survival >12 months, and who have a prohibitive

surgical risk as defined by an estimated 50% or greater risk of

mortality or irreversible morbidity at 30 days or other factors such as frailty, prior radiation therapy, porcelain aorta, and severe hepatic

or pulmonary disease.

• TAVR is a reasonable alternative to surgical AVR in patients at

high surgical risk (PARTNER Trial Criteria: STS >8)

J. Am. Coll. Cardiol. 2012;59;1200-1254

Indications

Patient selection in clinical trials

Logistic EuroSCORE >20% or STS Score > 10.

J. Am. Coll. Cardiol. 2012;59;1200-1254

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Indications

J. Am. Coll. Cardiol. 2012;59;1200-1254

Requisites

• ‘Heart team’ approach– Specific team leader

– Close communication

– ‘Preplanning procedure’

• Large cathlabs/ ‘hybrid’ rooms– Fluoroscopic imaging

– TEE capabilities

– GA/ CPB

– Vascular intervention

– Urgent AVR, CABG, Vascular complications

• Anesthesia

– Conscious sedation/ GA

– CPB facility

– Hemodynamic monitoring

and management

Work up

• Pre-anesthetic work up

• Cardiothoracic evaluation [access, AVR, risk assessment]

• Imaging– AS severity, morphology, calcification, annular size and shape

– Aortic root, annulus to coronary ostia (>8mm), Atheroma burden, calcification

– Other valvular disease, sub aortic obstruction

– LV function

– Vascular anatomy from access site to annulus

– Cerebro vascular imaging

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Work upRole of imaging in pre-procedural and post procedural assessment

J. Am. Coll. Cardiol. 2012;59;1200-1254

Transcatheter Aortic Valve

Intervention

Procedure & Hardware

Procedure & Hardware• LA + Conscious sedation/ GA, hemodynamic stability [ SBP~120 mm

Hg / MAP >75 mm Hg]

• Vascular access

– Sites

• Transfemoral

• Transapical

– Left ant. thoracotomy

– More direct, shorter catheter

– Septal hypertrophy

– Ascendra2, Sapien valve

• Transaortic

– Upper partial sternotomy

– Mini-sternotomy 2/3 RICS

– Aorta 5 cm above valve

– Less painful, familiar approach

– Manipulation of ascending aorta

• Subclavian

Percutaneous

or Cut-down

technique

J. Am. Coll. Cardiol. 2012;59;1200-1254

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• Pacing leads – Trans venous or epicardial

• Anticoagulation

– Large sheaths

– Heparin [ACT>300]

• Intra-procedural TEE

– Guidewire placement

– Valve placement

• Stable position

• No coronary obstruction

• No interference with mitral valve function

• No conduction system impingement

• No overhanging native aortic leaflets

• Avoidance of aortic root complications (rupture & dissection)

– Post deployment assessment [MR, AR]

TEE- Mid esophageal

long axis view

J. Am. Coll. Cardiol. 2012;59;1200-1254

Procedure & Hardware‘Sapien XT’ device ‘CoreValve’ device

Self expandable

Nitinol frame

Porcine

Pericardial

Tissue

European Heart Journal (2011) 32, 140–147

Cardiol Clin 29 (2011) 211–222

•Superior hemodynamics

•Lower risk for PPM

Procedure & HardwarePressure tracings before and after TAVR


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Post-Operative Care & Monitoring

• Immediate or early extubation, early mobilization

• Adequate analgesia, control postoperative hypertension,

monitor for any bleed

• Monitor vital parameters including fluid balance, renal status,

and AV conduction system.

• Pre-discharge TTE, DAPT,Coumadin vs NOAC

J. Am. Coll. Cardiol. 2012;59;1200-1254

Complications & Management

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Left main stem compromise with semi-occlusive displacement of

calcified nodule from aortic valve.

Treated with CPB� device explantation � AVR

Also PCI/CABG

Cardiol Clin 29 (2011) 211–222

J. Am. Coll. Cardiol. 2012;59;1200-1254


• Incidence of CHB requiring permanent pacemaker implantation has been higher with the CoreValve (19.2% to 42.5%) than with the Sapien valve (1.8% to 8.5%) [larger profile and extension low into the LVOT

• Occurrence of CHB/LBBB

– BAV 46%

– Balloon/prosthesis positioning &wire-crossing of the aortic valve 25%

– Prosthesis expansion 29%.

• Pre-existing RBBB risk factor for CHB

J. Am. Coll. Cardiol. 2012;59;1200-1254


Aortic Regurgitation

•Typically paravalvular mild or

mild-moderate severity

•Most of AR disappears or reduces

at 1 yr follow-up [13% absent, 80%

mild AR]

J. Am. Coll. Cardiol. 2012;

59;1200-1254

Cardiol Clin 29 (2011) 211–222

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Paravalvular AR

Central valvular AR

Post-deployment balloon dilation, rapid RV

pacing for stabilization, ‘valve in valve’

implantation

Usually self-limited, Gentle probing of leaflets

with a soft wire or catheter

Delivery of a 2nd TAVR device, ‘valve in valve’

J. Am. Coll. Cardiol. 2012;59;1200-1254

Complications & Management Rapid Pacing for stabilization

‘Valve in Valve’ Implantation

Reduction

of diastole

Cardiol Clin 29

(2011) 211–222


Causes of hypotension after TAVI

•Vascular complications—iliac rupture

•Ventricular rupture

•Acute valve dysfunction

•Coronary artery obstruction

•Multiple rapid pacing episodes in pts with poor LV function

•‘Suicidal’ LV in severe LVH [After removing AV obstruction LV

decompresses to such an extent that the subvalvular hypertrophy

obstructs outflow] treated with fluids & avoiding diuretics

Cardiol Clin 29 (2011) 211–222 J. Am. Coll. Cardiol. 2012;59;1200-1254

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Significant annular rupture

Ventricular perforation

•Pericardial drainage, auto-transfusion

•Conversion to open surgical closure

Device malposition

Device embolization

Overlapping ‘valve in valve’

Urgent endovascular/ surgical

management

Major ischemic stroke

Minor ischemic stroke

Hemorrhagic stroke

Catheter-based, mechanical embolic retrieval

Aspirin, anticoagulants

Anticoagulation reversal, coagulopathy correction

J. Am. Coll. Cardiol. 2012;59;1200-1254


Atrial fibrillationRate control/ rhythm control via

pharmacological or electrical

cardioversion

Shock, low cardiac output

Major bleeding

Vascular complications

•Careful systemic pressure management,

inotropic support, IABP, or CPB

•Hemodynamic support, blood transfusion

•Urgent endovascular repair/surgery

J. Am. Coll. Cardiol. 2012;59;1200-1254

Transcatheter Aortic Valve

Intervention

Review of evidence

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Review of Evidence

Registry data

•Age> 80 years

•EuroSCORE [> 23 ‘Sapien’, >16 ‘CoreValve’]

•Route of implantation no difference in procedural success rate b/w

TF & TA accesses

•Major bleeding more in TA vs. more vascular complications in TF

J. Am. Coll. Cardiol. 2012;59;1200-1254

Review of EvidencePARTNER Trial Design

Cohort A

84 yrs

N=699

Cohort B

83 yrs

N=358

J. Am. Coll. Cardiol. 2012;59;1200-1254www.nejm.org

Background

• Based on randomized trials with first generation devices,

transcatheter aortic valve replacement (TAVR) has been

incorporated into the treatment strategy for high-risk and

inoperable patients with severe AS.

• Procedural complications remain a concern with TAVR,

including stroke, vascular complications, paravalvular leak

(PVL) and conduction disturbances.

• Addressing these limitations will support TAVR use in lower

risk populations.

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Evolution of the Balloon-Expandable Transcatheter Valves

* Sheath compatibility for a 23 mm valve

2002

Cribier

2006

SAPIEN

2009

SAPIEN XT

2013

SAPIEN 3

SAPIEN 3 Transcatheter Heart ValveDistinguishing Features

Bovine pericardial

tissue

Outer skirt to reduce PVL

Low frame height

Enhanced frame geometry for

ultra-low delivery profile

SAPIEN 3 Commander Delivery SystemDistinguishing Features

• Accurate positioning

Fine control of valve positioning Distal flex

SAPIEN 3 Valve Size 20 mm 23 mm 26 mm 29 mm

Expandable Sheath 14F 14F 14F 16F

Minimum Access Vessel Diameter 5.5 mm 5.5 mm 5.5 mm 6.0 mm

• Improved coaxial alignment

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The PARTNER II ProgramPurpose

To evaluate the safety and efficacy of the SAPIEN 3

transcatheter heart valve system at 30 days in

inoperable, high-risk, and intermediate-risk patients.

Intermediate Risk

Operable(PII S3i)

High Risk Operable /

Inoperable (PII S3HR)

Symptomatic Severe Aortic Stenosis

ASSESSMENT by Heart Valve Team

n = 1076

Patients

n = 583

Patients

ASSESSMENT:

Optimal Valve

Delivery Access

ASSESSMENT:

Optimal Valve

Delivery Access

SAPIEN 3

2 Single Arm Non-Randomized

Historical-Controlled Studies

Transfemoral (TF)

TF TAVR

SAPIEN 3TAA TAVR

SAPIEN 3

Transapical /

Transaortic (TA/TAo)

TF TAVR

SAPIEN 3

PI A

SAPIEN

PII A

SAVR

Transfemoral (TF)

TAA TAVR

SAPIEN 3

Transapical /

Transaortic (TA/TAo)

The PARTNER II S3 TrialStudy Design

Key Inclusion Criteria

• Risk determined by STS score and heart team:

– High Risk / Inoperable (S3HR): STS score > 8 or heart team

determination

– Intermediate Risk (S3i): STS score between 4 and 8 or heart

team determination

• Severe aortic stenosis determined by echocardiography:

– Valve area < 0.8 cm2 or Valve area index < 0.5 cm2/m2 and mean

gradient > 40mmHg or peak velocity > 4 m/s

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Key Exclusion Criteria

• MI within one month

• Bicuspid aortic valve

• Severe aortic regurgitation

• Prior prosthetic valve in any position

• Untreated significant CAD (S3HR only)

• LVEF < 20%

• Stroke or TIA within 6 months

• Upper GI bleed within 3 months

• Creatinine > 3.0 or dialysis

• Estimated life expectancy< 24 months

Study Methodology

• All patients presented on a screening call for approval prior to

implant.

• 3D imaging of annulus (CT or 3D TEE) recommended for S3HR and

required for majority of S3i with core lab analysis prior to implant.

• All patients evaluated by a neurologist at baseline and at follow-up

time points.

• Primary Analysis: As treated patients

• S3HR and S3i combined for echocardiographic analyses (valve

implant patients).

Study Flow: S3HR & S3i30 Day Patient Status

0 Withdrawal

3 LTFU

13 Deaths

0 Withdrawal

5 LTFU

12 Deaths

S3HR S3i

n = 583n = 583

n = 570

SAPIEN 3

n = 570

SAPIEN 3

567 / 570 or 99.5% follow-upvisits performed at 30 Days 567 / 570 or 99.5% follow-upvisits performed at 30 Days

n = 1076n = 1076

n = 1064

SAPIEN 3

n = 1064

SAPIEN 3

1059 / 1064 or 99.5% follow-upvisits performed at 30 Days

1059 / 1064 or 99.5% follow-upvisits performed at 30 Days

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Baseline Patient CharacteristicsS3HR Patients

Average STS =

8.6%(Median 8.4%)

N = 583Average Age =

82.6yrs

Baseline Patient CharacteristicsS3i Patients

Average STS =

5.3%(Median 5.2%)

N = 1076Average Age =

81.9yrs

Baseline Patient CharacteristicsDemographics

Characteristic (%)S3HR(n=583)

S3i(n=1076)

NYHA Class III or IV 90.1 72.6

Previous CABG 33.1 28.0

Previous CVA 11.0 8.9

Peripheral Vascular Disease 35.2 28.3

Diabetes 34.5 34.1

COPD - O2 Dependent 11.7 5.0

CKD - Creat. ≥ 2mg/dL 12.0 7.5

Atrial Fibrillation 43.7 36.0

Permanent Pacemaker 16.3 13.2

Frailty 30.9 8.6

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Baseline Echocardiography

CharacteristicS3HR(n=583)

S3i(n=1076)

AV Area - cm2 (mean ± SD) 0.67 ± 0.18 0.70 ± 0.17

Annulus Diam. - cm (mean ± SD) 2.2 ± 0.2 2.2 ± 0.2

AV Gradient - mmHg (mean ± SD) 45.5 ± 14.3 46.3 ± 12.7

LV Ejection Fraction (%) 56.4 ± 14.8 58.6 ± 13.3

Mod-Severe MR (%) 3.0 2.3

Procedural Factors

S3HR(n=583)

S3i(n=1076)

Post-Dilatation (%) 14.8 11.3

>1 Valve Implanted (%) 0.9 0.4

Valve Embolization (%) 0.2 0.1

IABP During Procedure (%) 0.5 0.4

Cardiopulmonary Bypass (%) 1.2 0.6

Conscious Sedation (%) 13 17

Median LOS – Days (Min, Max) 5 (1, 33) 4 (1, 64)

Mortality and Stroke: S3HRAt 30 Days (As Treated Patients)

% O:E = 0.26

(STS 8.6%)

Mortality Stroke

%

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Mortality and Stroke: S3iAt 30 Days (As Treated Patients)

O:E = 0.21

(STS 5.3%)

Mortality Stroke

% %

Transfemoral Transapical / Transaortic

%

Mortality: S3HR & S3iAt 30 Days (As Treated Patients)

491 947 92 125

All-Cause Mortality at 30 DaysSAPIEN Valves (As Treated Patients)

175 344 240 271 282 583 491 1072 947

SAPIEN SXT SAPIEN 3

PARTNER I and II Trials

Overall and TF Patients

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104 125 94 92 125

SAPIEN SAPIEN XT SAPIEN 3

Nested Registries

All-Cause Mortality at 30 DaysSAPIEN Valves (As Treated Patients)


TA/TAo Patients

StrokesAt 30 Days (As Treated Patients)

Events (%)

S3HROverall(n=583)

S3HRTF

(n=491)

S3HRTA/TAo(n=92)

S3iOverall(n=1076)

S3iTF

(n=951)

S3iTA/TAo(n=125)

All 1.54 1.63 1.09 2.60 2.42 4.00

Disabling* 0.86 0.81 1.09 1.02 0.95 1.60

Non-Disabling 0.69 0.81 0 1.58 1.47 2.40

TIA 0.69 0.61 1.09 0.37 0.42 0

*CEC adjudicated or Modified Rankin Score ≥ 2 at 30 days

All Strokes at 30 DaysSAPIEN Valves



Neurologist evaluations (pre- and post)

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Other Clinical EventsAt 30 Days (As Treated Patients)

Events (%)

S3HROverall(n=583)

S3HRTF

(n=491)

S3HRTA/TAo(n=92)

S3iOverall(n=1076)

S3iTF

(n=951)

S3iTA/TAo(n=125)

Major Vascular Comps. 5.0 5.3 3.3 5.6 5.9 3.2

Bleeding - Life Threatening 6.3 5.5 10.9 5.4 4.4 12.9

Annular Rupture 0.3 0.2 1.1 0.2 0.2 0

Myocardial Infarctions 0.5 0.4 1.1 0.3 0.3 0

Coronary Obstruction 0.2 0 1.1 0.4 0.4 0

Acute Kidney Injury 1.0 0.8 2.2 0.5 0.3 1.6

New Permanent Pacemaker 13.0 13.2 12.0 10.1 10.4 7.2

Aortic Valve Re-intervention 1.0 0.8 2.2 0.7 0.8 0

Endocarditis 0.2 0.2 0 0.1 0.1 0

%

Baseline 30 Days

90%

73%

13%6%

583 10495501075

I

II

III

IV

NYHA Functional ClassAt 30 Days (As Treated Patients)

Echo Findings: S3HR & S3iAortic Valve Area (Valve Implant Patients)

No. of EchosOverall 1546 1461

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0.69

1.67

0.75

1.90

0.70

1.74

0.63

1.46

0.62

1.22

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

2

Baseline 30 Days

Va

lve A

rea

(cm

²)

Overall

29 mm

26 mm

23 mm

20 mm


Echo Findings: S3HR & S3iAortic Valve Area (Valve Implant Patients)


Echo Findings: S3HR & S3iMean Gradients (Valve Implant Patients)

46.0

11.3

50.1

16.7

47.6

13.0

45.5

10.8

43.9

9.1

0.0

10.0

20.0

30.0

40.0

50.0

60.0

Baseline 30 Days

Gra

die

nt

(mm

Hg

)

Overall

20 mm

23 mm

26 mm

29 mm

No. of Echos

Echo Findings: S3HR & S3iMean Gradients (Valve Implant Patients)

Overall 1602 1531

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Paravalvular Leak: S3HR & S3i(Valve Implant Patients)

1504No. of Echos

0.1%

Moderate/Severe PVL at 30 DaysSAPIEN Valves



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Conclusions (1)

• In high-risk and inoperable patients (S3HR), the SAPIEN 3

TAVR system demonstrated low mortality and stroke and

excellent clinical outcomes at 30 days:

– Mortality: 2.2% (TF 1.6%, TA/TAo 5.4%)

– Disabling Stroke: 0.9%

• In intermediate-risk patients (S3i), SAPIEN 3 was

associated with strikingly low mortality and strokes at 30

days:

– Mortality: 1.1% (TF 1.1%, TA/TAo 1.6%)

– Disabling Stroke: 1.0%

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Conclusions (2)

• Other important clinical findings with SAPIEN 3

(both S3HR & S3i) include:

– Major vascular complications: ~5%

– Annular rupture: ~0.2%

– Coronary obstruction: ~0.3%

– New pacemakers: ~10%

• Significant paravalvular regurgitation with SAPIEN 3 (both

S3HR & S3i) was rare:

– Severe: 0.1%

– Moderate: 3.7%

Implications

• The rapid evolution of balloon-expandable TAVR,

both procedural developments and technical

enhancements, represented in the SAPIEN 3 clinical

and echo results, indicates at least parity with the

best surgical outcomes in comparable patients.

• SAPIEN 3 TAVR should now be considered as an

alternative to surgery, even in lower risk patients with

aortic stenosis.

Thank YouThank YouThank YouThank You

TAVR SPRING 2017 - Bryan Health...4/13/2017 Nithin P G 1 Matthew Johnson, MD TAVR SPRING 2017 The...

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