how to build a tavi team
TRANSCRIPT
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Alain Cribier, MDCharles Nicolle Hospital, University of Rouen, France
How to build a TAVI Team
TAVI Summit, Seoul, Korea, September 3rd, 2011
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DisclosureDisclosure
Consultant and involved in theConsultant and involved in theTraining / Proctoring program forTraining / Proctoring program for
Edwards Lifesciences Edwards Lifesciences
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Growing interest in the medical community
• > 40 000 treated Pts worldwide• Improved and satisfactory immediate and mid-
term results in high risk patients
CE mark2007
Edwards Sapienballoon expandable
CoreValveself expandable
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Near all operators are willing to learn and apply this technique
• Who should do these procedures ?
This raises several questions:This raises several questions:
• Which centers should be open ?• How to get prepared and organized?• How to get trained?
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Multiple new issues for the physicians
• Caring with unusually sick patients and choosing the best therapeutic option
• Returning to basics (crossing aortic valve)• Creating a cohesive multi-disciplinary team
• Learning new interventional and surgical procedures (new devices, larges introducers,new technical modalities)
• Facing new specific complications
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European Statement - 2008
European Heart Journal (2008) 29, 1463European Heart Journal (2008) 29, 1463--14701470
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Should be concerned high volume and experienced centers for both AVR and interventional cardiology
• AVR > 200 per year• PCI > 600 per year
With expertise in structural heart disease intervention and high-risk valvular surgery
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Each step is crucial to achieve a safe procedure
Staff and Team preparation
Equipement, imaging modalities
Patient Screening
Pre-implantation valvotomy
Valve positioning and delivery
Large sheath insertion
Devices retrieval
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High quality imaging matters
• Ideally: Hybrid room for all procedures
• If hybrid room not available: Cath-Lab adapted to meet surgical sterility Operating room with validated mobile
C-arm for the transapical approach
GENERAL ELECTRIC: OEC 9800 & 9900ZIEHM: Vision R & FDPHILIPS: BV PulseraSIEMENS: Artis U
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Key factors for a successful procedure
Patient selection
Aortic valve assessmentanatomy, calcium distribution
valve sizingSelection of access
Vascular imaging
THV positioningand delivery
Technique of BAVand RVP
Prevention and treatment of complications
Multiple Disciplinary
Approach
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Close cooperation of teamspecialists in valve disease
SuccessfulSuccessfulTHV ProgramTHV Program
Cardiac surgeonCardiac surgeon CardiologistCardiologist
Nurses Nurses TechniciansTechnicians
EchocardiographistEchocardiographist
RadiologistRadiologist
AnesthesiologistAnesthesiologist
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Each procedural step mattersEach procedural step mattersArterial accessArterial access
FEMORAL APICAL
FEMORAL
SUB-CLAVIAN
Percutaneous?Arterial cut-down?Lateral sternotomy
General or localAnesthesia?
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Each procedural step mattersEach procedural step mattersBallon preBallon pre--dilatationdilatation
--Crossing the valve; wire selection and preshapingCrossing the valve; wire selection and preshaping--Balloon selection, preparation and positioningBalloon selection, preparation and positioning--Rapid ventricular pacingRapid ventricular pacing--Simultaneous aortogram (validation of THV size) Simultaneous aortogram (validation of THV size)
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Each procedural step mattersEach procedural step mattersPreparation and use of Preparation and use of
introducers and delivery systemsintroducers and delivery systems
NovaFlex (TF)NovaFlex (TF)
Ascendra (TA)Ascendra (TA)
CoreValveCoreValvedelivery systemdelivery system
EDWARDSEDWARDS COREVALVECOREVALVE
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Each procedural step mattersEach procedural step mattersTHV positioning and delivery THV positioning and delivery
EACH DETAIL MATTERS !EACH DETAIL MATTERS !
EDWARDSEDWARDS
TransfemoralTransfemoral TransapicalTransapical TransfemoralTransfemoral
COREVALVECOREVALVE
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Prevention and treatment of complications
Be prepared to manage the complications
OTHER SEVERE COMPLICATIONSOTHER SEVERE COMPLICATIONSPOSSIBILITY OF CONVERSION TO SURGERY POSSIBILITY OF CONVERSION TO SURGERY
TAMPONADE:Pericardial drainageVASCULAR complications:
- Aorta balloon occlusion- Covered /non covered stents- Surgical repair
CORO. OcclusionCORO. OcclusionStentingStentingCardiac assistanceCardiac assistance
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Organize POST-implantation phase
- In-hospital management- Compliance to Registries(ideally with a research nurse)- Organize the follow-up
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Training is the KEY !
•• Acquiring basic, then advanced device specific skills•• Acquiring knowledge of valve disease (clinical, catheterization techniques, imaging)•• Working in a sterile environment•• Understanding the equipment•• Anticipating and treating complications
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Training sessions organized by both companies
COREVALVE- Switzerland
(2 per month)
- On-site
EDWARDS- Rouen-France
( 1 or 2 per month)
- Leipzig-Germany(1 or 2 per month)
-Nyon-Switzerland-Vancouver- Canada- New-York- USA
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• Simulators• Didactic• Cases
review• Hands on• Live cases
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Learning CurveSeveral levels of learning
Patient screeningSelection of access
Technical skillPrevention / treatement of complications
The impact of the learning curve onthe safety of TAVI has been fully demonstrated
The learning curve is permanent from
one case to the other
It has to re-start after each
technological advancement
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• Organized by both companies• Clinical assistance for the first cases• After re-assessment of each patient’s
screening• Ideally > 2 cases/day (pre-selected cases)• Same 2 operators (main + assistant)• Proctored cases:
- 4 to 6 for Edwards - 15 for Corevalve
• Certification
On site-proctoring
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Optimal training of the team
Valve crimpingSpecific training of nurses
by the compagny’s clinical specialists
Assistance for the first 10 cases
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Start of certified centers
• Start with optimal cases (ex:good femoral access, no EF depression)
• Short delay after on site proctoring• Same two trained operator
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The TAVI Team Summary
• Importance of physician and staff trainingvalidating training and proctoring programs
• Dedicated cath-labs and / or hybrid ORwith optimal imaging capabilities
• Interventional vs surgical operatorsno competition, no fight, optimal partnership
Team work for screening and procedures
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- Even though results are good in experienced teams, there is a learning curve and training/proctoring is crucial
Conclusions
- TAVI should be used in selected centers with experience of valvular disease
- Training and personal preparation of the operators and their team, patient’s selection and cooperative work are crucial for the success and the future of the procedure