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, PhDluctes@gmail.comluctes@gmail.com