Prospettive nell’utilizzo Prospettive nell’utilizzo delle valvole percutanee: delle valvole percutanee: oltre la stenosi valvolare oltre la stenosi valvolare aortica degenerativa aortica degenerativa Luca Testa, MD, PhD Luca Testa, MD, PhD Istituto Clinico S. Ambrogio Istituto Clinico S. Ambrogio Milano Milano
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Prospettive nell’utilizzo delle valvole percutanee: oltre la stenosi valvolare aortica degenerativa Luca Testa, MD, PhD Istituto Clinico S. Ambrogio Milano.
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Prospettive nell’utilizzo delle valvole Prospettive nell’utilizzo delle valvole percutanee:percutanee:
oltre la stenosi valvolare aortica oltre la stenosi valvolare aortica degenerativadegenerativa
Luca Testa, MD, PhDLuca Testa, MD, PhDIstituto Clinico S. AmbrogioIstituto Clinico S. Ambrogio
MilanoMilano
FIRST IN PIG; May 1, 1989
Dr. Henning Rud AndersenPIONEERED Concept
First Successful Percutaneous Aortic Valve Replacement
Alain Cribier
April 16, 2002
Day 8 post-implantation
Severe AS should be treated with AVRSevere AS should be treated with AVR
Ross J, BranwaldE. Aortic Stenosis. Circulation1968; 38(suppl5);61-7
At least 30-40% Of Cardiologists’ AS Patients Go Untreated
At least 30-40% Of Cardiologists’ AS Patients Go UntreatedSevere Symptomatic Aortic StenosisPercent of Cardiology Patients Treated
No AVR
AVR
Aortic Stenosis: the unmet need and the oppurtunity to make difference with
technology
US population >65 37M US Census, 2005
Prevalence rate ~4% Cardiovascular Health Study
Prevalence ~1.5M Calculation
Operable AS (%) 20% L.E.K. Consulting estimate
Addressable patients
~300K
Annual AVR patients
~60K HRI
Calculation
•~25% of those who would benefit from AVR actually get it
•More appropriate application of
guidelines could lead to lower excess morbidity/mortality
Approximately 200,000 surgical aortic valve replacements performed Approximately 200,000 surgical aortic valve replacements performed annually in U.S., the majority are bioprostheses.annually in U.S., the majority are bioprostheses.
With a life expectancy of 10-20 years, and implantation of bioprosthetic With a life expectancy of 10-20 years, and implantation of bioprosthetic valves in younger patients, it is expected that there will be a significant valves in younger patients, it is expected that there will be a significant increase in the number of patients requiring redo surgery for failed increase in the number of patients requiring redo surgery for failed bioprostheses.bioprostheses.
•Calcium deposition at sites of greatest leaflet flexion Calcium deposition at sites of greatest leaflet flexion and stress: basal and commissural and stress: basal and commissural attachment pointsattachment points
High implant, low left coronary ostia,High implant, low left coronary ostia,long leaflet with bulky calcified noduleslong leaflet with bulky calcified nodules
Acute left main occlusionAcute left main occlusion
Left Main protection during highest risk Transcatheter Aortic Valve-in-Valve procedure. A proof-of-concept Multicenter Registry. Testa L et al. Eurointervention 2015, in press
Is that all????
What have we learned?What have we learned?
AR vs AS -1 month,23%vs5.9%, OR 4.22 (3.03-8.28), p<0.001
-12 months, 31%vs19%, HR 2.1 (1.5-4.41), p<0.001
AS vs AS + AR - 1 month, 5.9%vs10%, p=0.2
- 12 months, 19%vs17.6%, p=0.1
AR vs AS+AR - 1 month: 23%vs10%, OR 2.2 (1.1-4.8), p=0.05
• The need for long term follow ups (in an The need for long term follow ups (in an octuagenarians population….)octuagenarians population….)
• The challenge in patients at lower surgical riskThe challenge in patients at lower surgical risk• The availability of a fully retrievable prosthesisThe availability of a fully retrievable prosthesis• To minimize the rate of PAVRTo minimize the rate of PAVR• To minimize the rate of conduction disturbances To minimize the rate of conduction disturbances
(cost burden of PM implantation…)(cost burden of PM implantation…)• The integration in an evolving scenario with The integration in an evolving scenario with
newer prosthesis newer prosthesis
Conclusions
• Patient selection is particularly critical when moving outside the GL/on label indication
• CT angiography is nowadays gold-standard
• TAVI is a “team sport”.
• Hybrid or not the “Lab” must be ready to quickly react to complications
Rome, IT
Oxford, UK
Milan, IT
Anzio (RM), IT
Thanks for your Thanks for your attentionattention