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The Future of Percutaneous Valve Therapies
Dr. Jan Kovac, MUDr., FACC, FESC
Cardiology Division, Glenfield Hospital
University of Leicester NHS Trust, Leicester UK
Presenter Disclosure:None
Interventional Cardiology ‘Credo’
“Anything a cardiac
surgeon can do,
an interventional
cardiologist can do
as well or better
percutaneously”
AH Gershlick, 2003
Percutaneous Valve Therapies in 2006
1. Percutaneous aortic valve replacement (AS,AI)
PVT, Corevalve, Pananigua, 3F, Corazone…
2. Percutaneous therapy of mitral regurgitation
leaflet fixation
coronary sinus techniques
transventricular techniques
3. Pulmonary valve replacement (P.Bohnhoffer)
The standard for critical AS RX is Surgical AVR
Mechanical
Homograft
Tissue
Ross
Stentless
Actuarial and "actual" freedom from valve-related morbidity or
mortality after AVR and MVR
Ikonomidis, J. S. et al.; J Thorac Cardiovasc Surg 2003;126:2022-2031
Mortality in Aortic Valve Replacement
n = 1.984
%mortality
Burr et al.: Annals of Thor Surg, 1995, 60, S264-269
Aortic valve replacement
Refused for Surgery
Euro Heart Survey on Valvular Heart Disease (5001 Patients)
32 % did not undergo surgery !
Iung B. and al, Eur. Heart Journal 2003 : 24, 1231-1243
Diseases desperate grown,
By desperate appliances are reliev’d,
Or not at all”
(Hamlet Act IV)
Prosthetic Aortic Valve Functions
1. Allow normal LVOT function
2. Restore anulus flexibility
3. Conserve sinus motion and sinus flow dynamics
4. Ensure physiological orientation of trileaflet valve
5. Do better than current valves
First Clinical Percutaneous Aortic Valve
Alain Cribier - 16/4/02
• Equine pericardial valve
sewn on 23mm BES;
• PVT acquired by Edwards
1/04
Percutaneous Aortic Valve Replacement
Designs/Trials
1. PVT-Edwards-Cribier
2. COREVALVE
3. Panaguia
4. 3F
5. SORIN
6. CORAZONE
7. SADRA Medical
8. ValveXchange
9. Direct Flow
• Tricuspid valve, equine pericardium
• Stainless steel stent frame
• 22mm Numed ballon catheter
• Original crimper device
• Compatible with 24-Fr sheath
Cribier Edwards AV Implant
Cribier PVT Trials Inclusion Criteria
Patients >70 years of age
Aortic valve area < 0.7 cm²
Aortic annulus diameter: 19-23 mm
Dyspnoea NYHA class IV
At extremely high risk for open heart surgery and formally
declined by two cardiac surgeons for surgical valve
replacement
Alan Cribier-Edwards PVT Rouen Experience
Alan Cribier-Edwards PVT RECAST Experience
CoreValve’s Self-Expanding
Prosthesis

HIGHER PART : increases
quality of fixation and axes the
system

MIDDLE PART : is
constrained to avoid coronaries
(no rotational positioning) and
carries the valve

LOWER PART: High radial
force of the frame pushes aside
the calcified leaflets and avoids
recoil and para-valvular leaks
A pericardium porcine tissue valve
Fixed to the frame in a surgical
manner with PTFE sutures
CoreValve Study
Results
Phase 1&2: July 2004-Dec 2005 (28 patients)
100
90
80
70
60
50
40
30
20
10
0
Clinical succes
In hospital
death
Convertion
to Surgery
Phase 1
Phase 2
Phase 2 Clinical Study
7 European Investigative Centers
Patient type:
High-risk/non-surgical candidates
Euroscore higher than 20
Trial initiated: December 2005
Primary endpoints:Acute safety and efficacy
Long-term outcomes
Leicester 2006
3F Transapical Antegrade Aortic Valve Implant
Thin Film Nanotechnology eNitinol
MembranePercValve™
Aortic Valve Calcification
CORAZON percutaneous
aortic valve system
flexible multilumen central catheter
(navigable)
soft tip for placement into left ventricle
and a balloon for occluding the LV
outflow tract
below the aortic valve
expandable central lumen with
temporary aortic valve enabling beating
heart aortic valve treatment
aortic isolation of treatment area using
a compliant bell designed to conform to
the shape of aortic valve cusps
balanced solution inflow and aspiration
CORAZON percutaneous aortic valve system
Percutaneous Mitral Valve Therapies
Percutaneous Mitral Repair Technologies
Percutaneous Transvenous Mitral
Reshaping/Annuloplasty through the
Coronary Sinus Straightening, Stent based
Reshaping/Annuloplasty through the
Ventricle
Percutaneous/Transatrial edge to edge
(E2E or Alfieri) repair
Plicating Left Atrial/Ventricular Tissue
anchors
Percutaneous Mitral E2E Repair
EVEREST I
Endovascular Valve Edge to edge REpair pair
STudy
EVEREST I
Endovascular Valve Edge to edge REpair pair
STudy
Freedom from surgery to date 35/47 = 74%
•No clip deployed (n=5) for insufficient MR reduction
•Operations: 4 repairs, 1 intended replacement after
clip deployment (n=7)
•Reasons:
•1 device malfunction
•4 partial detachments
•Timing (days): 1, 3, 36, 40, 50, 110, 133
•Surgery:
•5 repairs, 2 replacement (1 intended; 1 failed repair)
•Concomitant ASD repair (6), MAZE (1), CABG (1)
•2 progressive MR
EVEREST II Study Design
EVEREST II Study Design
Prospective, randomized, multicenter study
Control: surgical mitral valve repair/ replacement
Patients randomized 2:1
37 centers in US and Canada
Primary Effectiveness Endpoint
Freedom from surgery, death, and moderate to severe (3+)
or severe (4+) mitral regurgitation at 12 months.
Primary Safety Endpoint
Freedom from MAE at one month
Placement of a percutaneous stitch in
the free edge(s) of the mitral leaflets,
Edwards LilfeSciences
Step 1
Step 2
Step 3
Mitral Annuloplasty Therapies
Viking
Edwards PTMA
Stent based anchors
connected by a tether
Anchors at the CS ostium
and AIV
Time delay contracting
tether
Cinches the mitral annulus,
increases mitral leaflet
coaptation
CarillonTM, Cardiac Dimensions
Viacor
Straightens the coronary
sinus
 Anteriorly displaces P2
 Begins with a “diagnostic”
OTW procedure
 Implant placed OTW
within a 7 Fr sheath
 Implant tethered to a hub
in the infraclavicular
fossa

Quantum Cor RF
Tip of probe is smaller to conform to
annulus shape
8 electrodes (~1.5x2mm)
Delivery of RF energy to electrodes
is computer-controlled by maximum
temperatures sensed by adjacent
thermocouples
Combined percutaneous MV Treatment
… a bow tie always need a collar
Is Percutaneous Mitral Replacement Possible?
For Cardiac Surgeons..
"In times of change, the learners inherit the Earth,
while the learned find themselves beautifully equipped
to deal with a world that no longer exists."
Eric Hoffer
Not quite….for a while
UK/ Leicester Perspective
1. Aortic valve COREVALVE 18 F Trial (2006)
2. EVEREST III Trial (pending EVEREST II, end 2006)
3. Compassionate Use ??
Very early days
120-130 aortic and mitral implants worldwide
Does not stand up to surgical therapy at the moment
New skills needed for interventionist-TOE/ICE
Old skills refreshed (transseptal, PTMV, CS)
Teamwork (blurring boundaries interventionist/ surgeon)
Will it ultimately work?
S.Oesterle….the Beauty of Stardom
No R+D but r+D
no Venture Capitalist able to fund >1000 $/patient clinical
Trial, quality assurance, manufacturing, regulatory issues,
distribution
“Make a better mousetrap and world will beat path to your
door ”
Waldo Emerson
I don’t skate where the puck is.
I skate, to where the puck is going.
Wayne Gretzky
NHL All Star 81-99