1. Alberto Repossini, Thierry A Folliguet
A Multicenter Propensity-score Analysis Of 991 Patients With Severe Aortic Stenosis And Intermediate-high Risk Profile: Conventional Surgery versus SuturelessValves versus TAVR
Claudio Muneretto, Ottavio Alfieri, Michele De Bonis, Roberto Di Bartolomeo,
Gianluigi Bisleri, Carlo Savini, Gianluca Folesani, Lorenzo Di Bacco, Manfredo Rambaldini, Juan Pablo Maureira, FrancoisLaborde, Maurizio Tespili,
Alberto Repossini, Thierry A Folliguet
Universityof Brescia MedicalSchool,, Italy, San Raffaele University Hospital, Italy,
Universityof Bologna, Italy,Azienda Ospedaliera Carlo Poma, Italy, CHU de Nancy, France, InstitutMutualiste Montsouris, France, Ospedale Bolognini di Seriate, Italy, CentreHospital-UniversitaireBrabois ILCV, France

2. Background
Surgery(SVR) is still the gold standard in the treatment of severe aortic stenosis
TAVR has proved as an effective alternative in inoperable or high risk patients.
Recent trend to extend the use of TAVR in patients with intermediate risk profile
Sutureless valve recently become a valuable tool to reduce invasiveness, aortic cross-clamp and CPB time
DivisionofCardiacSurgery–Universityof Brescia MedicalSchool

4. DivisionofCardiacSurgery–Universityof Brescia MedicalSchool

5. STS/ACC TVT Registry

6. AVR
AVR
AVR
AVR

7. Study population 163 matched Patients AVR (Group 1) 55 patients
255 Consecutive patientswith severe aortic valve stenosis
163
matched
Patients
AVR
(Group 1)
55 patients
PERCEVAL
(Group 2)
53 patients
TAVR
(Group 3)
55 patients

9. Study Design 1:1:1propensity score matching
991 intermediate-high risk patients with severe aortic valve stenoses
conventional surgery vs sutureless valve vs TAVR
8 European centers
1:1:1propensity score matching

10. Post-Match population intermediate-high risk patients
612
intermediate-high risk patients
Group 1:
Surgical AVR
204 pts
Group 2:
Sutureless valve
204 pts
Group 3:
TAVR
204 pts
DivisionofCardiacSurgery–Universityof Brescia MedicalSchool

11. Post-Match population
AVR
(204 pts)
n (%)
Sutureless
(204pts)
TAVR
p-value
AGE (yrs)
80±3
79±4
80±2
0.07 EF
54,7±5,1
55,1±7,3
54,6±6,8
0.1
EuroSCORE I log
19,2±7,4
18,9±5,9
19,5±6,7
0.34
STS score
8,3±4,4
7,9±3,2
8,2±4,2
0.2
BMI
26,8±3,2
27,1±2,8
26,9±5,3
0.52
FEMALE GENDER
98 (48%)
105 (51,4%)
91 (44,6%)
0.08
HYPERTENSION
135 (66,1%%)
138 (67,6%)
129 (63,2%)
0.35
DYSLIPIDEMIA
48 (23,5%)
45 (22%)
51 (25%)
0.56
COPD
54 (26,4%)
49 (24%)
56 (27,4%)
0.53
PREVIOUS PCI
19 (9,3%)
24 (12%)
27 (13,2%)
0,32
PREVIOUS AMI
17 (8,5%)
12 (6%)
15 (7,5%)
0.22
CAD
49 (24,0%)
42 (20,6%)
53 (25,9%)
0.18
CVA
22 (10,7%)
25 (12,2%)
28 (13,6%)
0.65
PAD
46 (22,6%)
40 (19,6%)
43 (21%)
0.7
DIABETES
57 (28%)
62 (30,3%)
0.11
NYHA III-IV
125 (61,2%)
130 (64%)
137 (67,1%)
0.14
CRF
37 (18,1%)
31 (15,2%)
44 (21,6%)
0.09
REDO
16 (7,8%)
30 (14,7%)
0.056

12. Primary Endpoints Secondary Endpoints
All-cause 30 days mortality
Overall survival at 24 months
Secondary Endpoints
Composite Endpoint (MACCE) according to VARC criteria including AR ≥ Grade II at 24 months
DivisionofCardiacSurgery – Universityof Brescia MedicalSchool

13. Preoperative Ao Gradient/Area (ECHO)
P=NS
P=0.01
P=NS
Division of Cardiac Surgery – University of Brescia Medical School

14. INTRA-OPERATIVE DATA
p<0.001
p<0.001
p<0.001
DivisionofCardiacSurgery – Universityof Brescia MedicalSchool

15. POST-OPERATIVE Gradient/AR

16. IN-HOSPITAL OUTCOME

17. MACCE AT F-UP (VARC)
p<0.001
p=0.028
p=0.055

18. p<0.001
TAVR vs SUTURELESS
OverallSurvival
TAVR vs AVR p<0.001

19. FREEDOM FROM MACCE (including AR ≥ 2)

20. CoxRegressionAnalysis
OverallSurvival
(HR: 2.5; CI )
Division of Cardiac Surgery – University of Brescia Medical School

21. Conclusions
Patients with severe aortic stenosis and intermediate risk profile undergoing TAVR showed a significant worse outcome when compared with conventional surgery and sutureless valve
At the multivariate analysis TAVR was identified as an independent predictor of death (HR 2.5)
The deliberate use of TAVR in this specific subset of patients shoud be restricted in further, independent CRTs
TAVR
Division of Cardiac Surgery – University of Brescia Medical School

22. Thanks Participating Centers
Universityof Brescia MedicalSchool, Italy,
San Raffaele University Hospital, Milan, Italy,
Universityof Bologna, Italy,
Azienda Ospedaliera Carlo Poma, Mantova, Italy,
CHU Nancy, France,
InstitutMutualiste Montsouris, Paris, France,
Ospedale Bolognini Seriate, Italy,
Centre Hospital-UniversitaireBrabois ILCV, Vandoeuvreles Nancy, France

23. All-cause30-days mortality
All-cause 1-year mortality

24. All-causedeath
Stroke or TIA
All–causedeath and Stroke or TIA

27. Meanlogistic EURO Score
TV TAVI
TA TAVI
AVR without CABG
AVR with CABG
AGE > 75
86.3%
84.0%
33.3%
44.9%
Meanlogistic EURO Score
25.9%
24.5%
8.8%
11%
9985 conventional AVR patients (with or withoutassociated CABG) and TAVI patients (TransVascular/TransApical)
Surgical AVR hasoptimalresults in everyriskcategory

28. Incidence of post-operative complicationhigher in TAVI group
Higherincidence of paravalvularleak, in particular in TAVI
transvalvulargroup
TAVR may be an alternative only in high riskpatients with contraindications for surgery

29. EARLY POST-OPERATIVE
AVR
SUTURELESS
TAVR
P-VALUE
BLEEDING REQUIRING REVISION
6 (3%)
10 (4,8%)
0 (0%)
0.008
ANAEMIA REQUIRING AT LEAST 2 UNITS OF RBC
116 (57%)
73 (35,7%)
67 (32,8%)
<0.001
ACUTE RENAL FAILURE
30 (14,7%)
11 (5,3%)
24 (11,7%)
0.007
CVVH
7 (3,4%)
3 (1,5%)
12 (5,8%)
0.06
STROKE
6 (2,9%)
4 (1,9%)
0.6
PERIPHERAL VASCULAR COMPLICATIONS
20 (9,8%)
PM IMPLANTATION
8 (3,9%)
30 (14.7%)
HOSPITAL MORTALITY
20 (9.8%)
0.005
Division of Cardiac Surgery – University of Brescia Medical School

30. DivisionofCardiacSurgery–Universityof Brescia MedicalSchool