Tavi
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TAVI procedures with combined Sapien and CoreValve prosthesis:
early experience in a single Center
Gian Luca Martinelli MDCV Surgery Dept.
S Anna Hospital – Catanzaro - Italy
Yes
Femoral Access
Evaluation Y/N
Femoral Access
Evaluation Y/N
Yes No No
Not in Study
Transfemoral VS
1:1 Randomization
1:1 Randomization
1:1 Randomization
Transfemoral
Medical Management ControlVS
Cohort B
Yes
No
AVR Control
Trans apical
AVR Control
OPERABLEASSESMENT
VS
Cohort A ~650 pts ~350 pts
Yes
Femoral Access
Evaluation Y/N
Femoral Access
Evaluation Y/N
Yes No No
Not in Study
Transfemoral VS
1:1 Randomization
1:1 Randomization
1:1 Randomization
Transfemoral
Medical Management ControlVS
Cohort B
Yes
No
AVR Control
Trans apical
AVR Control
OPERABLEASSESMENT
VS
Cohort A ~650 pts ~350 pts
• Fully enrolled. • 1st results by Q4-2010
PARTNER IDEThe world’s first and only prospective, multicenter, randomized clinical trial to
compare transcatheter heart valve replacement to conventional AVR and medicalmanagement.
Primary endpoint: one year survival plus extensive 5-year follow-up
Indications to TAVI procedure at S.Anna Hospital
Symptomatic Severe Aortic Stenosis
• Operative High Risk scores ( logES > 20%)
• Controindications to open surgery
• More recently, age over 80.
129129 patients were submitted to TAVIprocedure between 2010/2011
Patients CharacteristicsVariable TAVI ( N= 129)
Age, y 80,4 ± 5.5
Female gender, n(%) 76( 58.4%)
NYHA class 3.2 ± 0.5
IMA n(%) 58(45%)
Neurological dysfuction or stroke n(%) 36(28%)
Chronic Kidney failure n(%) 29(23%)
COPD n(%) 60(47%)
Liver cirrosis 10(8%)
Previous open heart surgery n(%) 9 (6.9)
Previous PCI n(%) 13 (10.7)
Previous PMK implantation n(%) 14(11%)
Atrial Fibrillation, n(%) 5(4%)
Logistic Euroscore, % 22.3 ± 11
VASCULAR ACCESSSapien100 and CoreValve 29
75% of cases in general anesthesia
Transfemoral 98
Transaortic 3
Transapical 28
Early results
• Global In-hospital Mortality : 13/129 (10.1%)
• 5 related to the procedure (aortic dissection, anulus rupture, occlusion of right coronary, 2 embolizations)
• 2 Low Cardiac output
• 2 ARDS
• 2 MOF
• 1 ICH
• 1 GI bleeding
Early results according to vascular access
• In-hospital Mortality (TF approach): 5/98 (5.1%)• mean LogES: 20.4. ± 12.8%
• mean LogES ( death group) 35.3 ± 28.3%
• In-hospital Mortality (TA approach): 7/28 (25%)• mean LogES: 26.1 ± 14.4%
• mean LogES ( death group) 38.7 ± 18.5%
Perioperative Complications
• 5 cases of conversion to AVR ( only 1 death): • 1 Embolization into the Aorta
• 2 Embolization into the Ventricular Cavity
• 1 Residual Severe AR
• 1 Rupture on Non Coronary Sinus
• IMA 2 pts (1.5%)
• Stroke: 2 pts (1.5%)
• Major Vascular complication: 6 pts (4.6%)
• Minor Vascular complications: 6 pts (4.6%)
• Acute Renal Failure (VARC) 9 pts (6.9%)
• PMK implantation 8 pts ( 6.2%)
SURVIVAL (Kaplan-Meyer Method)Follow-up: 9.9 ± 7 mth
Late Death: 9 pts1 Cardiac related8 Non Cardiac related
2 late reoperations:1 endocarditisSevere AR in valve in valve with bioprosthetic failure
9.5 + 3.1
EF>50
30>EF>50
EF<30
EF>50
30>EF>50
EF<30
EF>50
30>EF>50
EF<30
At Fup, only 1 pt has more than AR > 2
p<0.01
p=0.2p<0.01
p=0.3
p<0.01p=0.2
p<0.01
p=0.1
Goal of the procedure
Reduction of AR after 30 min
Valve in Valve
Treatment of AR>2+ after procedure
• Valve in valve
• BAV
• Repositioning of prosthesis
• AVR
Prosthesis Embolization
Embolia in ventricolo (spina)
Prosthesis Embolization
Prosthesis Embolization
Coronary occlusion
Coronary occlusion
Successful THV PROGRAM
Patient-Focused Multidisciplinary Heart ValveTeam Approach
RadiologistRadiologist
EchocardiographistEchocardiographist
CardiologistCardiologistCardiac SurgeonCardiac Surgeon
AnesthesiologistAnesthesiologist
Excellent Visualization
Patient Selection
Patient Management
Procedure Planning
Hybrid Suite
TAVI is an approachto the patient….
not just a procedure
Conclusion
THANK YOU
Late Endocarditis
Treatment of bioproshesis degeneration: the role of TAVI
Role of TAVI in isolated AR
Eco pre e post impianto di Attanasio su centricity redux di TD
Multidisciplinary Imaging Approach
Between Dec 2010 and Jan 2012
325 patients were treated for isolated AS.
129129 patients were submitted to TAVIprocedure
Sapient XT(77.5%)
CoreValve(22.5%)
TF
TA
TAo
TF
TAo
75% in general anesthesia
Operative Data70
28
2
28
1