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TAVRPutting the Swagger back in Mick Jagger

Wayne S. Hwang MD FACCInterventional Cardiology

Director, Cardiac Catheterization LaboratoryVirginia Mason Medical Center

© 2014 Virginia Mason Medical Center

No disclosures of relevance

2

INCIDENCE

3

US ESTIMATESAortic Stenosis 1.5 millionSevere 500,000Symptomatic 250,000

ETIOLOGY

• CALCIFIC BICUSPID RHEUMATIC

• Age > 70 Age < 70 Worldwide

4

CALCIFIC AORTIC STENOSIS

5

Symptoms of aortic stenosis

▪ Shortness of breath

▪ Syncope or presyncope

▪ Angina

▪ Fatigue

▪ Difficulty when exercising

▪ Swollen ankles and feet

▪ Rapid or irregular heartbeat

▪ Palpitations (an uncomfortable awarenessof heart beating rapidly or irregularly)

Age-related calcific

aortic stenosis

3. Das P. European Heart Journal. 2005;26:1309-1313;

4. Lester SJ et al. CHEST 1998;113(4):1109-1114.

The symptoms of aortic disease are commonly misunderstood by patients

as ‘normal’ signs of aging.3

Many patients initially appear asymptomatic,

but on closer examination up to 37% exhibit symptoms.4

6

PATHOPHYSIOLOGY

7

CO

LVH

DiastolicDysfunction

Myocardialischemia

8

Severe aortic stenosis is life threatening and treatment is critical

9

100

80

60

40

20

0 0 40 50 6070 Age, years

Surv

ival

, %

Onset severe symptoms

Average survival, y

Angina

Syncope

Failure

0 2 4 6

Latentperiod

(Increasing obstruction,myocardial overload)

Adult average course with valvular aortic stenosis

5. Otto CM. Timing of aortic valve surgery. Heart. 2000;84:211-218

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

5-YEAR SURVIVAL

(Distant Metastasis)

3 4

12

23

2830

0

5

10

15

20

25

30

35

severeinoperable AS*

lung cancer colorectalcancer

breast cancer ovarian cancer prostatecancer

Su

rviv

al (%

)

Severe aortic stenosis has a worse prognosis than many metastatic cancers

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

5-year survival of breast cancer, lung cancer, prostate cancer,

ovarian cancer and severe inoperable aortic stenosis

10

Can we manage Aortic Stenosis with medications? … No. It is a mechanical problem.

• Vasodilators (NTG) are potentially dangerous, although may be useful in acutely decompensated AS with CHF, in ICU setting.

• Afterload reducing agents (ACEi, ARB) benefit is unclear

- traditionally has been relatively contraindicated

- ACEi has not prevented progression of AS severity in clinical trials

- An observational study suggested improved survival and lower CV events

- Not a specific recommendation, but its use for AS related co-morbidities ok

• Diuretics cautiously

• Digoxin if CHF present

• Re-establish / maintain Sinus rhythm

• Treating symptoms, NOT the underlying disease

What about “plain old” balloon aortic valvuloplasty?

- Palliative procedure- Bridge to sAVR or TAVR- Frail patients, very old- Compromised clinical

status from concurrent CAD and/or other extracardiac co-morbidities

why?- Fracture of calcific nodules- Commissural splitting- Annular stretching

BENEFITS OF AVR

1. Improved survival

2. Relief of symptoms

3. Increased ejection fraction

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“Gold Standard”. Surgical AVR (sAVR) works, but its big surgery. Many are not even candidates

few willingly sign up..

Enter: PERCUTANEOUS Aortic Valve Replacement• novel concept of implanting an artificial valve within the structure of

the originally heavily diseased valve, while beating, using currently proven catheter techniques without need for general anesthesia or even a Foley catheter, performed within 45 minutes, and walks home the next day.

Early Opposition -• It Can’t be done - Impossible!

• Too Dangerous and unpredictable!

• Valve can’t be stented open !

• Durability unpredictable!

First proof of concept – Cadaver procedure

• A. Cribier, Rouen 1994

Demonstrated ability to deploy a PALMAZ STENT in the aortic position and contributed to appropriate stent dimensions.

Alain Cribier: First human transcatheter valve replacement (2002)

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Transfemoral procedural animation

20

Continuously Improving Processes

Procedural• Conscious sedation >> General Anesthesia• Cath lab > Hybrid OR• No central line or Swan catheter or even radial arterial lines often• Transthoracic ECHO >> Transesophageal ECHO • Percutaneous suture management for large bore arterial catheters >> surgical cutdown

POST Procedural Care Pathways• Remove lines ASAP• If appropriate, non-ICU (ie telemetry bed) recovery• Early ambulation encouraged• Echo in am, follow up labs, telemetry review – if all ok discharge

TAVR VALVES• CORE VALVE SAPIEN

• SELF EXPANDING BALOON EXPANDABLE

22

LOTUS VALVE

23

TAVR Access options – historical evolution

26

27

28

29

PARTNER 1: HIGH RISK

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PARTNER 2: INTERMEDIATE

31

PARTNER 2: TRANSFEMORAL

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SUMMARY SLIDE TO DATE: STS score breakdown

PROHIBITIVE RISK(STS > 15%)

Partner 1BCoreValve Extreme

TAVR > Medical therapy

HIGH RISK(STS >8%)

10% of total pts Partner 1ACoreValve High

TAVR = SAVR

INTERMEDIATE RISK(STS 3-8%)

25% of total pts Partner 2A, S3iSURTAVI, UK TAVI

TAVR = SAVR*Transfemoral: TAVR > SAVR

LOW RISK(STS <3%)

65% of total pts PARTNER 3 LRCoreValve LRNOTION All Comers

TAVR > SAVR

LOW RISK TAVR - summary of latest trials

• PARTNER 3 (Edwards Lifesciences)

• EVOLUT LOW RISK TRIAL. (Medtronic)

Primary Endpoint

0 3 6 9 12

496 475 467 462 456454 408 390 381 377

Number at risk:

TAVRSurgery

Months after Procedure

451374

TAVRSurgery

Psuperiority= 0.001

HR [95% CI] =

0.54 [0.37, 0.79]

Death

, S

troke, or

Rehosp

(%)

Pnon-inferiority< 0.001

Upper 95% CI of

risk diff = -2.5%

8.5%9.3%

15.1%

4.2%

0

10

20

Leon MB, Mack MJ. PARTNER 3: transcatheter or surgical aortic valve replacement in low risk patients with aortic stenosis. Presented at ACC 2019; March 2019; New Orleans, LA

All-Cause Mortality

All-

Cause M

ort

alit

y (

%)

494 494 493 492454 445 438 433 431

488427

Months from ProcedureNumber at risk:

1.0%1.1% 2.5%

0

10

0.4%

20HR [95% CI] =

0.41 [0.14, 1.17]

496TAVRSurgery

P = 0.09

0 3 6 9 12

TAVRSurgery

Leon MB, Mack MJ. PARTNER 3: transcatheter or surgical aortic valve replacement in low risk patients with aortic stenosis. Presented at ACC 2019; March 2019; New Orleans, LA

All Stroke

All

Str

oke (

%)

491 491 489 487454 435 427 423 421

484417

Months from ProcedureNumber at risk:

HR [95% CI] =

0.38 [0.15, 1.00]

496TAVRSurgery

1.2%

2.4% 3.1%

P = 0.04

0

10

20

0.6%0 3 6 9 12

TAVRSurgery

Leon MB, Mack MJ. PARTNER 3: transcatheter or surgical aortic valve replacement in low risk patients with aortic stenosis. Presented at ACC 2019; March 2019; New Orleans, LA

Death or Disabling Stroke

Death

or

Dis

ablin

g S

troke (

%)

494 494 493 491454 444 436 432 430

488426

Months from ProcedureNumber at risk:

HR [95% CI] =

0.34 [0.12, 0.97]

496TAVRSurgery

1.0%

2.9%1.3%

P = 0.03

0

10

20

0.4%0 3 6 9 12

TAVRSurgery

Leon MB, Mack MJ. PARTNER 3: transcatheter or surgical aortic valve replacement in low risk patients with aortic stenosis. Presented at ACC 2019; March 2019; New Orleans, LA

Primary Endpoint - Subgroup Analysis

Subgroup TAVR Surgery Diff [95% CI] P-value*

Overall 8.5 15.1 -6.6 [-10.8, -2.5]

Age

≤ 74 (n=516)

> 74 (n=434)

10.6

5.8

14.9

15.3

-4.3 [-10.1, 1.5]

-9.5 [-15.3, -3.7]0.21

Sex

Female (n=292)

Male (n=658)

8.1

8.7

18.5

13.8

-10.4 [-18.3, -2.5]

-5.1 [-9.9, -0.3]0.27

STS Score

≤ 1.8 (n=464)

> 1.8 (n=486)

9.1

8.0

15.7

14.5

-6.7 [-12.6, -0.7]

-6.5 [-12.2, -0.8]0.98

LV Ejection Fraction

≤ 65 (n=384)

> 65 (n=524)

9.6

8.0

17.2

12.4

-7.6 [-14.5, -0.7]

-4.4 [-9.6, 0.7]0.48

NYHA Class

I/II (n=687)

III/IV (n=263)

6.8

12.3

14.5

16.9

-7.8 [-12.4, -3.2]

-4.7 [-13.5, 4.1]0.54

Atrial Fibrillation

No (n=786)

Yes (n=163)

7.9

11.6

14.0

20.3

-6.1 [-10.5, -1.7]

-8.7 [-19.9, 2.5]0.67

KCCQ Overall Summary Score

≤ 70 (n=407)

> 70 (n=536)

10.5

6.5

19.9

11.2

-9.4 [-16.5, -2.4]

-4.6 [-9.4, 0.2]0.27

-20% 20%-10% 10%0 TAVR Better Surgery Better →

Event rates are KM estimates (%)

* P-value is for interaction

Leon MB, Mack MJ. PARTNER 3: transcatheter or surgical aortic

valve replacement in low risk patients with aortic stenosis.

Presented at ACC 2019; March 2019; New Orleans, LA

The PARTNER 3 TrialConclusions (1)

In a population of severe symptomatic aortic stenosis patients who

were at low surgical risk, SAPIEN 3 TAVR compared to surgery:

• Demonstrated superiority in the primary endpoint and 6 pre-

specified secondary endpoints, after first achieving non-inferiority

• Significantly reduced the primary endpoint of death, stroke, or

rehospitalization by 46% at 1-year.

▪ Components of the primary endpoint favored SAPIEN 3 TAVR,

both at 30 days and 1 year

▪ Multiple sensitivity analyses confirmed robustness of the

primary endpoint findings

The PARTNER 3 TrialConclusions (2)

• Secondary endpoints adjusted for multiple comparisons

indicated that SAPIEN 3 TAVR reduced new-onset AF, index

hospitalization days, and a measure of poor treatment outcome

(death or low KCCQ score at 30 days).

• Other secondary endpoint analyses also showed reduced

bleeding after SAPIEN 3 TAVR and no differences in the need

for new permanent pacemakers, major vascular complications,

coronary obstruction, and mod-severe PVR.

The PARTNER 3 TrialConclusions (3)

• SAPIEN 3 TAVR had more rapid post-procedure

improvement in patient-oriented functional indices, including

NYHA class, 6-minute walking distance, and KCCQ scores.

• SAPIEN 3 TAVR allowed 95.8% of patients to return home or

to self-care, compared to only 73.1% for surgery.

TAVR ISSUES

• Paravalvular leak (PVL): aortic regurgitation

• Permanent pacemaker

• Long term durability

• BICUSPID VALVES

• Coronary access post TAVR

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PARTNER 3 PVL

44

CONDUCTION ABNORMALITIES

45

PACEMAKER REQUIREMENT

46

PACEMAKER

47

What about Bicuspid Valves?- They were excluded from the randomized trials

With newer generation devices, even BICUSPID AS outcomes are much improved with lower adverse events

NOT all bicuspid valves will be best suited by TAVR. Individualized assessment needed.

Confidence in Durability of TAVR vs SAVR at 6 years

VALVE IN VALVE (when initial SAVR fails)

• Bioprosthetic TAVR Valve in Valve

• valve

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SUMMARY OF CURRENT STATE

TRANSCATHETER SURGERY

AORTIC STENOSIS Everyone Non-TAVR candidatesMechanical ValvesConcurrent procedures

AORTIC REGURGITATION Ongoing trials Everyone

Multidisciplinary Team is crucial

• Valve Cardiologist

• Interventional Cardiologist/Structural Interventionalist

• Cardiothoracic Surgeon with transcatheter training

• CV Anesthesiologist

• Radiologist / CT

• Heart Failure specialist

• MD Consultants

• Dedicated Valve coordinator *

• Cath lab / OR staff,

• RN leadership, cath lab/OR/CCU/telemetry

• Administration buy in and support

meet weekly or bi-weekly, review cases objectively transparently, review outcomes and quality assessment

Case 1

• 93 y/o very functional F, independently living

• Short of breath

• Chest pain new

• Atrial fibrillation chronic on OAC

• Echo severe aortic stenosis (peak vel 5.0m/s, mean gradient 61mmHg, AVA 0.65)

a) Medical therapyb) BAVc) Coronary angiogram then TAVRd) CTS consultation for sAVR

Case 1, continued

• 1/8/18 Cath - 95% Circumflex - stented/DES RCA 90% - stented/DES

• 1/16/18 TAVR

• 1/17/18 Discharged

• 1/17/20 most recent clinic visit - asymptomatic cardiac status, last echo normal TAVR appearance, no paravalvular leak, LVEF 70.

Case 2

• 57 y/o M

• Severe aortic insufficiency/moderate aortic stenosis

• h/o bioprosthetic 27mm AVR for severe aortic regurgitation (bicuspid) 9/25/03

• HFrEF acute systolic CHF, LVEF 19 in cardiogenic shock, shock liver on inotropes

• h/o CAD - RCA PCI

• Severe PAD, s/p iliofemoral and fem-fem bypass, bilateral CIA occlusions.

• Atrial fibrillation new

• Newly diagnosed Hodgkins lymphoma – felt to be curable.

a) Medical therapyb) BAVc) Coronary angiogram then TAVRd) CTS consultation for re-do sAVR

Case 2, continued

• Cath – stable disease, patency of previous stents

• Valve-in-Valve TAVR - L. axillary approach , 26mm Sapien 3

• 6 mo later - echo: LVEF 51 (from 19), normal Valve in valve appearance of TAVR, trivial paravalvular AI.

• Hodgkin’s cured

Case 3

• 65 y/o patient

• Symptomatic severe aortic stenosis

• Ascending aortic aneurysm, 4cm

• 1 vessel CAD (circumflex/Obtuse marginal)

a) sAVR (and leave aneurysm alone)b) TAVR now and follow – if either TAVR deteriorates over time and/or

aneurysm becomes >5.5, then can sAVR/root replacement

Case 4

• 75 y/o M, non-diabetic

• Typical angina CCS III

• Exertional dyspnea HFpEF NYHA class II-III

• Severe aortic stenosis

• Severe multivessel CAD (focal LAD, CX, RPDA stenosis).

a) Medical therapyb) Multivessel PCI, then TAVRc) TAVR, then multivessel PCId) CABG/sAVR

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