By Paul Sorajja, MD. The efficacy and safety of transcatheter valve replacement in high-risk, non-operable patients is leading to new valve therapy options for a broader pateint population. "The options we have today to fix problems without opening the chest would have been unimaginable 10 years ago."
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Transcatheter Aortic Valve Replacement (TAVR): Established and Emerging Indications
1. Transcatheter AVRTranscatheter AVR
Established and EmergingEstablished and Emerging
IndicationsIndications
Paul Sorajja, MD
Director, Center for Valve and Structural Heart Disease
Minneapolis Heart Institute
Abbott Northwestern Hospital
Disclosures: proctoring, consulting with Abbott Vascular
2. 83 year-old man83 year-old man
What would you do next?What would you do next?
Heart failureHeart failure
Prior CVAPrior CVA
Hx CABGHx CABG
3. Patients in needPatients in need
1/3 had symptomatic AS but no1/3 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 survey
369 patients369 patients
4. Age (years)
Osnabrugge RL, et al. JACC 2013;13:2079-2Osnabrugge RL, et al. JACC 2013;13:2079-2
Nkomo 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 or102,558 high-risk or
inoperableinoperable
9,189 added annually9,189 added annually
AllAll
MitralMitral
AorticAortic
Burden of Aortic StenosisBurden of Aortic Stenosis
U.S. and CanadaU.S. and Canada
7. 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
8. High Surgical RiskHigh Surgical Risk
0
10
20
30
40
50
60
0 6 12 18 24 30 36
DeathfromAnyCause(%)
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 2014
Kodali S, et al. N Engl J Med 2011Kodali S, et al. N Engl J Med 2011
9. 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
11. The New GenerationThe New Generation
Active lifestyleActive lifestyle
Like less invasiveLike less invasive
InnovativeInnovative
12.
13.
14. - Walter Lillehei- Walter Lillehei
What mankind canWhat mankind can
dream, research anddream, research and
technology cantechnology can
achieveachieve
15. Abbott Northwestern HospitalAbbott Northwestern Hospital
MHI 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
16. Key pointKey point
Think of transcatheterThink of transcatheter
valve therapy for any highvalve therapy for any high
risk patientrisk patient
Notes de l'éditeur
Flail mitral eclip in 88 yo
In the US, there also is a large number of pts with severe sx AS who are not undergoing open surgery
This was a survey of
In this report, like the EuroHeart survey, 1/3
Cited morbidity, pt refusal; few pts actually saw surgeon
IS THERE DATA ON IMPROVED ACCESS ONCE TAVR BECAME AVAILABLE IN EU?
Focus of this slide is on REGURGITANT DISEASE...
Mitral regurgitation is the most common type of heart valve insufficiency in the US
Prevalence increases with increasing age, from 0.5% for 18-44 yr olds rising to 9.3% for ≥75 year olds (p&lt;.0001)
Add 30 day mortality and long-term survival
Valve in valve mitral
And the trend for latest and greatest in medicine is to go smaller and less invasive
So they appreciate it when we can be innovative and do things with less intrusion