1) The document describes the early experience of a single center performing TAVI procedures using both the Sapien and CoreValve prostheses between 2010-2011. 129 high-risk patients with severe aortic stenosis underwent the TAVI procedure. 2) In-hospital mortality was 10.1% overall, with lower mortality for transfemoral (5.1%) compared to transapical (25%) access. Complications included conversion to surgery, stroke, vascular issues, and renal failure. 3) At 9.9 month follow up, late mortality was 9 additional patients from non-cardiac causes. Survival was better for those with higher ejection fraction and without other comorbidities. The

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

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

5. Patients Characteristics
Variable 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

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

12. Goal of the procedure

13. Reduction of AR after 30 min

14. Valve in Valve

15. Treatment of AR>2+ after procedure
• Valve in valve
• BAV
• Repositioning of
prosthesis
• AVR

16. Prosthesis Embolization

17. Embolia in ventricolo (spina)

18. Prosthesis Embolization

19. Prosthesis Embolization

20. Coronary occlusion

21. Coronary occlusion

22. Patient-Focused Multidisciplinary Heart Valve
Team Approach
Radiologist
Patient
Selection
Anesthesiologist Echocardiographist
Successful
Patient THV Excellent
Management Visualization
PROGRAM
Procedure
Planning
Cardiac Surgeon Cardiologist
Hybrid Suite

23. Conclusion
TAVI is an approach
to the patient….
not just a procedure

24. THANK YOU

25. Late Endocarditis

26. Treatment of bioproshesis
degeneration: the role of TAVI

27. Role of TAVI in isolated AR

28. Eco pre e post impianto di Attanasio
su centricity redux di TD

29. Multidisciplinary Imaging Approach

30. Between Dec 2010 and Jan 2012
325 patients were treated for isolated AS.
129 patients were submitted to TAVI
procedure

31. Operative Data
TF 70
Sapient XT TA 28
(77.5%) 2
TAo
CoreValve TF 28
(22.5%) TAo 1
75% in general anesthesia