interventional techniques
DESCRIPTION
TRANSCRIPT
Dr. Jan Kovac, MUDr., FACC, FESC
Cardiology Division, Glenfield Hospital
University of Leicester NHS Trust, Leicester UK
The Future of Percutaneous Valve The Future of Percutaneous Valve Therapies Therapies
Presenter Disclosure:None
Interventional Cardiology ‘Credo’Interventional Cardiology ‘Credo’
“Anything a cardiac
surgeon can do,
an interventional
cardiologist can do
as well or better
percutaneously”
AH Gershlick, 2003
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)
Percutaneous Valve Therapies in 2006Percutaneous Valve Therapies in 2006
The standard for critical AS RX is Surgical The standard for critical AS RX is Surgical AVRAVR
RossHomograft
Mechanical StentlessTissue
Ikonomidis, J. S. et al.; J Thorac Cardiovasc Surg 2003;126:2022-2031
Actuarial and "actual" freedom from valve-related Actuarial and "actual" freedom from valve-related morbidity or mortality after AVR and MVRmorbidity or mortality after AVR and MVR
Mortality in Aortic Valve ReplacementMortality in Aortic Valve Replacementn = 1.984n = 1.984
%mortality%mortality
Burr et al.: Annals of Thor Surg, 1995, 60, S264-269
Aortic valve replacementAortic valve replacement
Refused for SurgeryRefused for SurgeryEuro Heart Survey on Valvular Heart Disease (5001 Euro Heart Survey on Valvular Heart Disease (5001
Patients)Patients)
Iung B. and al, Eur. Heart Journal 2003 : 24, 1231-1243
32 % did not undergo surgery !32 % did not undergo surgery !
Diseases desperate grown, By desperate appliances are reliev’d,Or not at all”(Hamlet Act IV)
Prosthetic Aortic Valve FunctionsProsthetic 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 ValveFirst Clinical Percutaneous Aortic ValveAlain Cribier - 16/4/02Alain Cribier - 16/4/02
• Equine pericardial valveEquine pericardial valve sewn on 23mm BES;sewn on 23mm BES;
• PVT acquired by EdwardsPVT acquired by Edwards 1/041/04
Percutaneous Aortic Valve ReplacementPercutaneous Aortic Valve ReplacementDesigns/TrialsDesigns/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 ImplantCribier Edwards AV Implant
Patients >70 years of age Aortic valve area < 0.7 cm²Aortic annulus diameter: 19-23 mmDyspnoea NYHA class IV
At extremely high risk for open heart surgery and formally declined by two cardiac surgeons for surgical valve replacement
Cribier PVT Trials Inclusion CriteriaCribier PVT Trials Inclusion Criteria
Alan Cribier-Edwards PVT Rouen Experience
Alan Cribier-Edwards PVT RECAST Experience
CoreValve’s Self-Expanding CoreValve’s Self-Expanding ProsthesisProsthesis
A pericardium porcine tissue valveA pericardium porcine tissue valve
Fixed to the frame in a surgical Fixed to the frame in a surgical manner with PTFE suturesmanner with PTFE sutures
HIGHER PARTHIGHER PART : increases : increases quality of fixation and axes the quality of fixation and axes the systemsystem
MIDDLE PART :MIDDLE PART : is is constrained to avoid coronaries constrained to avoid coronaries (no rotational positioning) and (no rotational positioning) and carries the valve carries the valve
LOWER PART:LOWER PART: High radial High radial force of the frame pushes aside force of the frame pushes aside the calcified leaflets and avoids the calcified leaflets and avoids recoil andrecoil and para-valvular leaks para-valvular leaks
CoreValve StudyCoreValve StudyResultsResults
0
10
20
30
40
50
60
70
80
90
100Clinical succesClinical succes
In hospitalIn hospital deathdeath
ConvertionConvertion to Surgeryto Surgery
Phase 1Phase 1 Phase 2Phase 2
Phase 1&2: Phase 1&2: July 2004-Dec 2005 (28 patientsJuly 2004-Dec 2005 (28 patients))
Phase 2 Clinical StudyPhase 2 Clinical Study
7 European Investigative CentersPatient type: High-risk/non-surgical candidates Euroscore higher than 20Trial initiated: December 2005Primary endpoints:Acute safety and efficacyLong-term outcomesLeicester 2006
3F Transapical Antegrade Aortic Valve 3F Transapical Antegrade Aortic Valve ImplantImplant
Thin Film Nanotechnology Thin Film Nanotechnology eeNitinol Nitinol MembranePercValve™MembranePercValve™
Aortic Valve CalcificationAortic 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 tractbelow 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 Transvenous Mitral Reshaping/Annuloplasty through the Coronary Sinus Straightening, Stent basedReshaping/Annuloplasty through the VentriclePercutaneous/Transatrial edge to edge(E2E or Alfieri) repairPlicating Left Atrial/Ventricular Tissue anchors
Percutaneous Mitral Repair Technologies
Percutaneous Mitral E2E RepairPercutaneous Mitral E2E Repair
EVEREST IEndovascular 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 IEndovascular Valve Edge to edge REpair pair STudy
EVEREST II Study DesignEVEREST II Study DesignProspective, randomized, multicenter studyControl: surgical mitral valve repair/ replacementPatients randomized 2:137 centers in US and Canada
Primary Effectiveness EndpointFreedom from surgery, death, and moderate to severe (3+) or severe (4+) mitral regurgitation at 12 months.
Primary Safety EndpointFreedom from MAE at one month
Placement of a percutaneous stitch inthe free edge(s) of the mitral leaflets,
Edwards LilfeSciences
Step 1
Step 3
Step 2
Mitral Annuloplasty TherapiesMitral Annuloplasty Therapies
Edwards PTMA Viking
Stent based anchors connected by a tetherAnchors at the CS ostium and AIVTime delay contracting tetherCinches the mitral annulus, increases mitral leaflet coaptation
CarillonTM, Cardiac Dimensions
ViacorViacor
Straightens the coronarysinus Anteriorly displaces P2 Begins with a “diagnostic”OTW procedure Implant placed OTWwithin a 7 Fr sheath Implant tethered to a hubin the infraclavicularfossa
Quantum Cor RFQuantum Cor RF
Tip of probe is smaller to conform Tip of probe is smaller to conform to to annulus shapeannulus shape8 electrodes (~1.5x2mm)8 electrodes (~1.5x2mm)Delivery of RF energy to Delivery of RF energy to electrodes is computer-electrodes is computer-controlled by maximum controlled by maximum temperatures sensed by adjacent temperatures sensed by adjacent thermocouplesthermocouples
Combined percutaneous MV Treatment
… a bow tie always need a collar
Is Percutaneous Mitral Replacement Is Percutaneous Mitral Replacement Possible?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 PerspectiveUK/ Leicester Perspective
1. Aortic valve COREVALVE 18 F Trial (2006)
2. EVEREST III Trial (pending EVEREST II, end 2006)
3. Compassionate Use ??
Very early daysVery 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 GretzkyNHL All Star 81-99