Transcatheter AVRTranscatheter AVREstablished and Emerging Established and Emerging

IndicationsIndications

Paul Sorajja, MDDirector, Center for Valve and Structural Heart DiseaseMinneapolis Heart InstituteAbbott Northwestern HospitalDisclosures: proctoring, consulting with Abbott Vascular

83 year-old man83 year-old man

What would you do next?What would you do next?

Heart failureHeart failurePrior CVAPrior CVAHx CABGHx CABG

Patients in needPatients in need

1/3 had symptomatic AS but no 1/3 had symptomatic AS but no operationoperation

Bach DS et al., Circ CV Qual Out 2009Bach DS et al., Circ CV Qual Out 2009

Michigan surveyMichigan survey369 patients 369 patients

Age (years)

Osnabrugge RL, et al. JACC 2013;13:2079-2Osnabrugge RL, et al. JACC 2013;13:2079-2Nkomo et al. Lancet, 2006;368:1005-11Nkomo et al. Lancet, 2006;368:1005-11

Prevalence ~3.4%Prevalence ~3.4%

75% symptomatic75% symptomatic

102,558 high-risk or 102,558 high-risk or

inoperableinoperable

9,189 added annually9,189 added annually

AllAll

MitralMitral

AorticAortic

Burden of Aortic StenosisBurden of Aortic StenosisU.S. and CanadaU.S. and Canada

Transcatheter AVRTranscatheter AVR

Inoperable PatientsInoperable Patients

p<0.0001p<0.0001

Standard RxStandard Rx

TAVRTAVR

All-cause mortality (%)All-cause mortality (%)

MonthsMonths

00

2020

4040

6060

8080

100100

NNT to save one life: 5NNT to save one life: 5

50.750.7

30.730.7

Leon et al., NEJM 2010Leon et al., NEJM 2010

High Surgical RiskHigh Surgical Risk

0

10

20

30

40

50

60

0 6 12 18 24 30 36

Dea

th f

rom

Any

Cau

se (

%)

Months

Hazard ratio, 0.90 (95% CI, 0.71-1.15)P=0.41

Surgery

TAVR

Adams D, et al. N Engl J Med 2014Adams D, et al. N Engl J Med 2014Kodali S, et al. N Engl J Med 2011Kodali S, et al. N Engl J Med 2011

Available TAVRAvailable TAVR

LabelingLabeling

• Symptomatic severe ASSymptomatic severe AS

• Inoperable (I) or High-risk (IIa)Inoperable (I) or High-risk (IIa)

• 18 to 29 mm (but use CT area)18 to 29 mm (but use CT area)

ResearchResearch

• Intermediate risk (3 to 8%)Intermediate risk (3 to 8%)

• New valves and new approachesNew valves and new approaches

Invasive MedicineInvasive Medicine

The New GenerationThe New Generation

Active lifestyleActive lifestyleLike less invasiveLike less invasive

InnovativeInnovative

- Walter Lillehei- Walter Lillehei

What mankind can What mankind can dream, research and dream, research and

technology can technology can achieveachieve

Abbott Northwestern HospitalAbbott Northwestern HospitalMHI Center for Valve and SHDMHI Center for Valve and SHD

November 12, 2013: First mitral valve-in-valve therapy using an Edwards Sapien prosthesis in the U.S.

December 11, 2013: First worldwide treatment of obstructive hypertrophic cardiomyopathy with the MitraClip device

January 25, 2014: First commercial implant of a Medtronic CoreValve in the U.S.

July 1, 2014: Establishment of a SHD interventional fellowship

August 13, 2014: First successful therapy with MitraClip in the U.S. performed independently of industry clinical support

September 23, 2014: 250th case of transcatheter aortic valve implantation performed at Abbott Northwestern Hospital

Key pointKey point

Think of transcatheter Think of transcatheter valve therapy for any high valve therapy for any high

risk patientrisk patient