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Tavi
1. TAVI procedures with combined
Sapien and CoreValve prosthesis:
early experience in a single Center
Gian Luca Martinelli MD
CV Surgery Dept.
S Anna Hospital – Catanzaro - Italy
2.
3. PARTNER IDE
The world’s first and only prospective, multicenter, randomized clinical trial to
compare transcatheter heart valve replacement to conventional AVR and medical
management.
OPERABLE
Yes ASSESMENT No
Cohort A ~650 pts Cohort B ~350 pts
Femoral Femoral
Access Access
Yes Evaluation No Yes Evaluation No
Y/N Y/N
Not in Study
1:1 1:1 1:1
Randomization Randomization Randomization
Trans AVR Trans AVR Trans Medical Management
VS VS VS
femoral Control apical Control femoral Control
Primary endpoint: one year survival plus extensive 5-year follow-up
• Fully enrolled.
• 1st results by Q4-2010
4. 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.
129 patients were submitted to TAVI
procedure between 2010/2011
6. VASCULAR ACCESS
Sapien100 and CoreValve 29
75% of cases in general anesthesia
Transaortic 3
Transapical 28
Transfemoral 98
7. 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
8. 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%
9. 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%)
10. SURVIVAL (Kaplan-Meyer Method)
Follow-up: 9.9 ± 7 mth
Late Death: 9 pts
1 Cardiac related
8 Non Cardiac related
2 late reoperations:
1 endocarditis
Severe AR in valve in
valve with bioprosthetic
failure
11. p<0.01
p<0.01
p=0.2
p=0.3
9.5 + 3.1
p<0.01
p=0.1
EF>50
EF>50 EF>50 p<0.01
p=0.2
30>EF>50
30>EF>50 30>EF>50
EF<30
EF<30 EF<30
At Fup, only 1 pt has more than AR > 2
