Upload
prudence-warren
View
215
Download
1
Tags:
Embed Size (px)
Citation preview
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
US prevalence of aortic stenosis
Sources:C.M. Otto. Valve Disease: Timing of Aortic Valve Surgery. Heart 2000: (84) 211-217
US Census Bureau, Population Estimates Program, July 1 2005
LEK, Project Helium Analysis, November 10, 2005
Health Research International. US Opportunities in Heart Valve Disease Management, July 2005
Stainless Steel vs. NitinolBalloon Expandable vs. Self
ExpandingBovine vs. Porcine pericardial tissue
ABPS nitinol frame and nitinol membrane leaflet
DAT self expanding nitinol stent
ATS Enable self expanding nitinol stent (left); Entrata stainless steel balloon expandable stent (right)
“Newly” available devices…..
Is that all????
Surgical Bioprosthetic Cardiac Surgical Bioprosthetic Cardiac Valves BackgroundValves Background
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.
Bioprosthesis TypesBioprosthesis Types
Way of failure….Way of failure….
Leaflet tissue deterioration:Leaflet tissue deterioration:
•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
•Leaflet wear and/or tearLeaflet wear and/or tear
•In situ thrombosisIn situ thrombosis
•Infective endocarditisInfective endocarditis
•Pannus formation (inflammatory tissue, richPannus formation (inflammatory tissue, rich
•in fibroblasts, at the host–graft interface)in fibroblasts, at the host–graft interface)
Paravalvular regurgitationParavalvular regurgitation
Prosthesis‐patient mismatchProsthesis‐patient mismatch
What have we learned?What have we learned?
Regurgitation has a better outcome
What have we learned?What have we learned?
Large sizes have a better outcome
What have we learned?What have we learned?
Quality of life is significantly improved
What have we learned?What have we learned?
Self-Expandable seems to be a better choice
What do we fear?What do we fear?
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
- 12 months 31%vs 17.6%, HR 1.88 (1.5-3.9), p=0.01
AR vs AS -1 month,15.3%vs4%, OR 4.01 (2.4-7.66), p<0.001
-12 months, 19.2%vs6%, HR 3.1 (2.09-8.22), p<0.001
AS vs AS + AR - 1 month, 4%vs6.4%, p=0.2
- 12 months, 6%vs10%, p=0.1
AR vs AS+AR - 1 month: 15.3%vs6.4%, p=0.1
- 12 months 19.2%vs10%, p=0.1
What have we learned?What have we learned?
What is ahead?What is ahead?
• 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
Luca Testa, MD, PhDLuca Testa, MD, [email protected]@gmail.com