alberto repossini, thierry a folliguet
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A Multicenter Propensity-score Analysis Of 991 Patients With
Severe Aortic Stenosis And Intermediate-high Risk Profile: Conventional Surgery versus
SuturelessValves versus TAVRClaudio 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
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
DivisionofCardiacSurgery–Universityof Brescia MedicalSchool
STS/ACC TVT Registry
AVR
AVR
AVR
AVR
Study population255 Consecutive patientswith severe aortic valve stenosis
PERCEVAL(Group 2)
53 patients
AVR(Group 1)
55 patients
TAVR(Group 3)
55 patients
163matchedPatients
991 intermediate-high risk patients with severe aortic valve stenoses
conventional surgery vs sutureless valve vs TAVR8 European centers
1:1:1propensity score matching
Study Design
Post-Match population612
intermediate-high risk patients
Group 1:Surgical AVR
204 pts
Group 3:TAVR
204 pts
Group 2:Sutureless
valve204 pts
DivisionofCardiacSurgery–Universityof Brescia MedicalSchool
Post-Match populationAVR
(204 pts)
n (%)
Sutureless(204pts)
n (%)
TAVR(204 pts)
n (%)
p-value
AGE (yrs) 80±3 79±4 80±2 0.07EF 54,7±5,1 55,1±7,3 54,6±6,8 0.1EuroSCORE I log 19,2±7,4 18,9±5,9 19,5±6,7 0.34STS score 8,3±4,4 7,9±3,2 8,2±4,2 0.2BMI 26,8±3,2 27,1±2,8 26,9±5,3 0.52FEMALE GENDER 98 (48%) 105 (51,4%) 91 (44,6%) 0.08HYPERTENSION 135 (66,1%%) 138 (67,6%) 129 (63,2%) 0.35DYSLIPIDEMIA 48 (23,5%) 45 (22%) 51 (25%) 0.56COPD 54 (26,4%) 49 (24%) 56 (27,4%) 0.53PREVIOUS PCI 19 (9,3%) 24 (12%) 27 (13,2%) 0,32PREVIOUS AMI 17 (8,5%) 12 (6%) 15 (7,5%) 0.22CAD 49 (24,0%) 42 (20,6%) 53 (25,9%) 0.18CVA 22 (10,7%) 25 (12,2%) 28 (13,6%) 0.65PAD 46 (22,6%) 40 (19,6%) 43 (21%) 0.7DIABETES 54 (26,4%) 57 (28%) 62 (30,3%) 0.11NYHA III-IV 125 (61,2%) 130 (64%) 137 (67,1%) 0.14CRF 37 (18,1%) 31 (15,2%) 44 (21,6%) 0.09REDO 25 (12,2%) 16 (7,8%) 30 (14,7%) 0.056
DivisionofCardiacSurgery – Universityof Brescia MedicalSchool
All-cause 30 days mortality Overall survival at 24 months
Primary Endpoints
Composite Endpoint (MACCE) according to VARC criteria including AR ≥ Grade II at 24 months
Secondary Endpoints
Preoperative Ao Gradient/Area (ECHO)
Division of Cardiac Surgery – University of Brescia Medical School
P=0.01
Peak Gra-dient
Mean Gradient
0102030405060708090
AVRSuture-lessTAVR
mmHgP=NS
AVR Sutureless TAVR0
0.2
0.4
0.6
0.8
Ao Valve Areacm2
P=NS
INTRA-OPERATIVE DATA
DivisionofCardiacSurgery – Universityof Brescia MedicalSchool
p<0.001
p<0.001
CPB CROSS-CLAMP0
20
40
60
80
AVR SUTURELESS
AVR SUTURELESS TAVR19212325
Prostheses Size (mm)p<0.001
POST-OPERATIVE Gradient/AR
AVR PERCEVAL TAVR0
5
10
15
20
25
post-op PEAK GRADIENT (mmHg)p=0,01
AVR PERCEVAL TAVI 0
5
10
15
20
25
post-op MEAN GRADIENT (mmHg)
p=NS
AVR PERCEVAL TAVR0%1%2%3%4%5%6%7%8%9%
10%
AR ≥Grade II
p=0,028
p<0.001
IN-HOSPITAL OUTCOME
BLEED
ING
TRANSF
USION
ACUTE R
ENAL F
AILURE
CVVH
STROKE
VASCULA
R COMPLIC
PM IM
PLANTA
TION
HOSPITA
L MORTA
LITY
0
10
20
30
40
50
60
AVR SUTURELESS TAVR
p<0.001
p=0.005
p<0.001
p=0.008
p=0.007
MACCE AT F-UP (VARC)
0%1%2%3%4%5%6%7%8%9%
10%
AVR Sutureless TAVR
p=0.028
p<0.001
p=0.055
p<0.001TAVR vs SUTURELESS
TAVR vs AVR p<0.001
OverallSurvival
FREE
DOM
FRO
M M
ACCE
(inc
ludi
ng A
R ≥
2)
Division of Cardiac Surgery – University of Brescia Medical School
CoxRegressionAnalysisOverallSurvival
(HR: 2.5; CI 1.1-4.2)
Conclusions
Division of Cardiac Surgery – University of Brescia Medical School
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 CRTsTAVR
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
All-cause30-days mortality
All-cause 1-year mortality
All-causedeath
Stroke or TIA
All–causedeath and Stroke or TIA
9985 conventional AVR patients (with or withoutassociated
CABG) and 3875 TAVI patients (TransVascular/TransApical)
Surgical AVR hasoptimalresults in everyriskcategory
TV TAVI TA TAVIAVR
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%
• 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
Division of Cardiac Surgery – University of Brescia Medical School
EARLY POST-OPERATIVEAVR 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
STROKE6 (2,9%) 4 (1,9%) 7 (3,4%) 0.6
PERIPHERAL VASCULAR COMPLICATIONS 0 (0%) 0 (0%) 20 (9,8%) <0.001
PM IMPLANTATION 8 (3,9%) 20 (9,8%) 30 (14.7%) <0.001
HOSPITAL MORTALITY 7 (3,4%) 12 (5,8%) 20 (9.8%) 0.005
DivisionofCardiacSurgery–Universityof Brescia MedicalSchool
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