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Transcatheter Versus Rapid Deployment Suturelss Bioprosthesis: Real Wolrd Outcomes In Octuagenarians At Intermediate Risk
Claudio Muneretto1, Lorenzo Di Bacco1, Fabrizio Rosati1, Roberto Di Bartolomeo2, Manfredo Rambaldini3, Francois Laborde4, Maurizio Tespili5, Alberto Repossini1, Thierry Folliguet6, Alexandre Metras7, Louis Labrousse7, Gianluigi Bisleri8.
1Division of Cardiac Surgery, University of Brescia Medical School, Brescia, Italy, 2Division of Cardiac Surgery, University of Bologna Medical School, Bologna, Italy, 3Division of Cardiac Surgery, Azienda Ospedaliera Carlo Poma, Mantova, Italy, 4Division of Cardiac Surgery, Institut Mutualiste Montsouris, Paris, France, 5Division of Cardiology, Ospedale Bolognini, Seriate, Bergamo, Italy, 6Division of Cardiac Surgery, CHU de Nancy, Nancy, France, 7Division of Cardiac Surgery, CHU Bordeaux, Hopital Haut-Leveque, Pessac - Bordeaux, France, 8Division of Cardiac Surgery, Queen's University, Kingston, ON, Canada.
OBJECTIVE: The use of transcatheter aortic valve replacement (TAVR) has been validated in patients at extremely high-risk or contraindicated to conventional cardiac surgery and more recently there has been a trend to extend TAVR also in patients with intermediate risk profile. In this specific subset of patients Rapid Deployment Sutureless Valves (RDSV) are becoming a valuable tool for surgeons. Aim of this study was to investigate the clinical outcomes of octuagenarians patients with severe aortic stenosis and intermediate-high risk treated either by means RDSV or TAVR in a multicenter evaluation.
METHODS: Among 397 consecutive patients with severe aortic stenosis and intermediate-high risk profile (STS-PROM 4-10% and Logistic Euroscore I 10-20%), a propensity-score analysis was performed based on the therapeutical strategy: RDSV (Group 1,G1, n=112) and TAVR (Group 2,G2, n=112). Primary end-points were short-term (30 days) mortality as well as overall survival at 24 months follow-up; secondary end-point was survival free from a composite end-point of MACCEs (defined as cardiac-related mortality, myocardial infarction, cerebrovascular accidents and major haemorrhagic events) and periprosthetic regurgitation>2.
RESULTS: Reported 30-days mortality was significantly higher in TAVR group (G1=2.7% vs G2=9.8 %; p=0.050) as well as post-procedural PM implantation (G1= 5.4% vs G2= 16.1%, p=0.016) and peripheral vascular complications (G1=0% vs G2= 10.7%, p<0.001 ). No significant difference in early reoperation for early device failure (G1= 1.8% vs G2= 2.6%, p=0836). At 24 months follow-up, overall survival (G1= 86.6±6.1% vs G2=66.6±6.8%; p=0.032), and the survival free from the composite end-point of MACCEs and periprosthetic regurgitation (G1=71.4±8.1% vs G2=49.8±9.1%; p<0.001) were significantly better in patients undergoing RDSV valves than those undergoing TAVR. Multivariate Cox regression analysis identified TAVR as independent risk factor for overall mortality (HR=2.7,CI=1.2-7.1,p=0.044).
CONCLUSIONS: The use of TAVR in elderly patients with intermediate risk profile was associated with a significant higher incidence of perioperative complications (as postoperative PM implantation and peripheral vessels complications). TAVR significantly decreased survival at mid-term when compared to Rapid deployment sutureless valves. TAVR approach in this subset of patients should be carefully evaluated in further independent prospective randomized trials.
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