3-pollak patient selection in tavr · 2018-11-11 · 9/17/2016 2 ©2016 mfmer | slide-3 outline -...

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©2016 MFMER | slide-1

Patient Selection in TAVR:How We Continue to Improve

Peter Pollak MDDirector of Structural Heart Disease & Intervention

Mayo Clinic Florida


Disclosures

• Financial – None

• Off-label - None

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Outline - TAVR Lessons

• Risk assessment• Frailty• Invasive Hemodynamics• Management of Coronary Disease• Value of CT Imaging

• Valve sizing• Access selection• Procedural Planning

• Valve-in-Valve TAVR


The only constant in life is change

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TAVR Background


Nobody Wants Surgery

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©2016 MFMER | slide-715 min post-TAVI

April 16, 2002, FIM-TAVI, Transseptal


F.I.M. Balloon Aortic Valvuloplasty1985

1993-1994

Post-mortem studies of intra-valvular stenting

« Percutaneous Valve Technology » (prototypes)

1999 Animal implantations (sheep)

2000 F.I.M. THV implantation2002

Feasibility Studies (antegrade)2002-03

Edwards Lifesciences2004

International TF and TA Feasibility Studies

2005-07

PARTNER US Pivotal2008-09FDA Approval - SAPIEN

Nov 2011

FDA Approval - CoreValveJan 2014

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6.3%5.2%

3.7%4.5%

3.5%

1.6%

0%

5%

10%

15%

20%

PARTNER I B (TF) PARTNER I A (All) PARTNER I A (TF) PARTNER II B (TF) PARTNER II B (TF) PARTNER II HR (TF)

All-Cause Mortality at 30 Days (As Treated Patients)

175 344 240 271 282 491

SAPIEN ValveSAPIEN XT

ValveSAPIEN 3 Valve

PARTNER I Trial and PARTNER II TrialOverall and TF Patients


CoreValve 1 Year Mortality

24.3%

17.9%

14.2%

6.7%

COREVALVE EXTREME RISK

ADVANCE REGISTRY

COREVALVE HIGH RISK

COREVALVE EVOLUTR

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TAVR Lessons LearnedLessons from the TAVR experience

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Patient AssessmentValue of the Team


2014 Guidelines for TAVR

Recommendations COR LOETAVR is recommended in patients who meet an indication for AVR for AS who have a prohibitive surgical risk and a predicted post-TAVR survival >12 months

I B

TAVR is a reasonable alternative to surgical AVR for AS in patients who meet an indication for AVR and who have high surgical risk

IIa B

TAVR is not recommended in patients in whom the existing comorbidities would preclude the expected benefit from correction of AS

III: No Benefit

B

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Low Risk(All criteria)

Intermediate Risk (any 1 criteria)

High Risk (any 1 criteria)

Prohibitive Risk(any 1 criteria)

STS PROM <4% 4% to 8% >8% Predicted risk with surgery of death or major morbidity (all-cause) >50% at 1y Frailty None 1 index (mild) 2+

Organ system compromise

None 1 ≤2 3+

Procedure-specific

None Possible Possible Severe

Risk Assessment

2014 ACC/AHA Valvular Heart Disease Guidelines


©2015 MFMER |

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©2015 MFMER |

slide-17


TAVR Saves Lives

©2011 MFMER |

3138928-18

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Not Everyone Benefits

Kodali et al 2012

©2016 MFMER | slide-20Lindman JACC Card Int July 2014

TAVR and Futility

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Complex decisions in complex patients


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Components of Frailty Score

Frailty domain Measure Frailty score

Slowness 15-ft walk gait speed (m/s)

Quartiles (0–3)

Weakness Grip strength (kg)

Sex-based quartiles (0–3)

Wasting andmalnutrition

Serum albumin (g/dL)

Quartiles (0–3)

Inactivity Katz activities of daily living

Any dependence = 3Independent = 0

Green et al: JACC Intv 5:974, 2012


Kaplan-Meier Survival Estimates Stratified by Frailty Score

Green et al: JACC Intv 5:974, 2012

0.2

0.4

0.6

0.8

1.0

0 150 300

Days

Frailty score >5Frailty score ≤5P=0.01S

urvi

val p

roba

bilit

y

No. at riskScore >5Score ≤5

76 65 6083 77 76

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©2016 MFMER | slide-27Studenski et al. JAMA.2011; 305:50-8

Gait Speed and SurvivalPooled data from over 34,000 patients


2014 Valvular Heart Disease Guideline

Invasive Hemodynamic Assessment

Recommendations COR LOECardiac catheterization for hemodynamic assessment is recommended in symptomaticpatients when noninvasive tests are inconclusive or when there is a discrepancybetween the findings on noninvasive testing and physical examination regarding severity of the valve lesion

I C

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LHC with Hemodynamic Study

Mean PA: 54 mmHg Non-obstructive CAD with large 1st Septal Perforator


LHC with Hemodynamic Study

Mean PA: 54 mmHg Non-obstructive CAD with large 1st Septal Perforator

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©2016 MFMER | slide-31Circulation 2013;128:1349-53

Aortic Valve

SVR


Invasive Hemodynamics with SNP

Mean Gradient 30 mmHgModerate AS

Mean Gradient 52 mmHgSevere AS

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Procedural PlanningValue of CT Imaging


Vascular Access for TAVR

©2011 MFMER |

3138928-34

Di Mario EuroIntervention 2013Holmes JAMA 2015

56%

69%72%

80%

92%

40%

60%

80%

100%

US TVToverall

UK France US TVT Q42014

Germany

Percent Transfemoral

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Sheath Size Matters

Hayashida JACC CI 2011


Edwards Lifesciences: Sapien Valve

Balloon Expandable

22F 16F 14F

Relative Sheath Size

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©2016 MFMER | slide-37Abdel-Wahab Int. Card. Review Summer 2015

Classic Evolut R

Medtronic CoreValve

Nitinol Self-expanding Valve

18F 14F


Sheath Outer Diameters (in mm)

8.9 9.9 8.0 8.967.3

Sapien XT Sapien S3CoreValve

Riberio et al Prog. Card. Diseases 2014 583-595

23/26 29 23/26 29All Sizes

Valve Size

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Half of TAVR Patients have significant CAD

0%

20%

40%

60%

80%

100%

Prevalence of CAD


Mimic CABG: Treat every lesion >50%

Evolution of CAD management in TAVR

Functional Revascularization: Treat every ischemic lesion

Minimalism: Treat only proximal severe epicardial stenosis

Nihilism: Treat only symptomatic severe proximal stenoses

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CT Scans on octogenarians will find things

Mayo Clin Proc. June 2014;89(6):747-753

67% had potentially pathologic IF

99% had incidental findings (IF)


$-

$50,000

$100,000

$150,000

$200,000

$250,000

$300,000

ACE-I forCHF

CABG forLMCAD

Renal TXP BB for CHF Statins ICD Afib Ablation TAVR Dialysis PCI stableCAD

LVAD

Cost per QALY

Money Matters

Pollak, Mack, Holmes Prog. Card. Dis. 2014;56:610-8

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Permanent Pacemakers by valve type


Conduction System & Aortic Annulus

©2011 MFME

Bagur et al JACC CI 2012;5:540-51

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Predictors of New Permanent Pacemaker

©2011 MFMESiontis et al JACC 2015;65:313

1.01

1.62

2.54

2.89

3.49

1

2

3

4

LBBB LAHB MCV vs. ESV RBBB IntraOp AVB

Relative Risk of new PPM


Implant Depth and Pacemakers

13.3%

21.1%

<6MM >6MM

New PPM

Petronio et al JACC Int 2015

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New Permanent Pacemaker(published rates)

11%13%

0%

10%

20%

30%

40%

50%

CoreValve EvolutR Sapien S3


Annular Ruptures in TAVR

No Annular Ruptures with CoreValve unless post-dilated

No Annular Ruptures in 491 PARTNER II High Risk S3 Implants

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Predictors of Aortic Root Rupture

6.03

8.76

9.00

0 1 2 3 4 5 6 7 8 9 10

LVOT Calficication

Oversizing >20%

Balloon Post-Dilation

Odds Ratio – Univariate Analysis

Barbanti Circ 2013


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Avoiding Coronary Obstruction


Valve-in-Valve TAVRA New Way to Replace and Old Valve

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There is an app for that…


All-Cause Mortality with Valve-in-Valve TAVR

3.07

2.04

2.25

1 1.5 2 2.5 3 3.5

Stenotic Lesion

Valve <21mm

Trans-Apical

Relative Risk

Dvir D.et al. JAMA 2014; 312:162-170

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Valve Thrombosis

Drs. Nkomo and Pislaru, Mayo Clinic CV Update 2015


Summary Points

• Complex Patients in rapidly evolving field

• Not everyone benefits• Improved risk & Frailty assessment• Invasive hemodynamics helpful

• CT Imaging valuable• Valve sizing and selection• Patient anatomical considerations

• Vessel sizing

• Valve-in-Valve TAVR • Importance of thrombus

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Thank you!

[email protected]@DrPeterPollak

Questions?

3-pollak patient selection in tavr · 2018-11-11 · 9/17/2016 2 ©2016 mfmer | slide-3 outline -...

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