Alberto Repossini, Thierry A Folliguet

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Presentation transcript:

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

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 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

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

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

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

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

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

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

POST-OPERATIVE Gradient/AR

IN-HOSPITAL OUTCOME

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

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

FREEDOM FROM MACCE (including AR ≥ 2)

CoxRegressionAnalysis OverallSurvival (HR: 2.5; CI 1.1-4.2) Division of Cardiac Surgery – University of Brescia Medical School

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

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

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 3875 TAVI patients (TransVascular/TransApical) Surgical AVR hasoptimalresults in everyriskcategory

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

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

DivisionofCardiacSurgery–Universityof Brescia MedicalSchool