• Bern-Rotterdam-Munich Propensity Analysis: SVR vs. TAVR in >3500 Patients

    Sunday February 24, 2013 2-30 to 2-40 pm Consulting- Medtronic CoreValve Peter Juni Stephan Windecker Bindu Kalesan Thierry Carrel Rotterdam Patrick Serruys Arie Pieter Kappetein Nicolas van Mieghem Stuart Head Peter de Jaegere Munich Nicolo Piazza Sabine Bleiziffer Ruediger Lange TAVI – 782 SAVR – 2884 2856 patients excluded based on propensity scores TAVI 377 SAVR 2479 810 matched patients TAVI – 405 SAVR - 405 510 matched patients (STS scores 3-8%) 300 patients excluded based on STS score <3% and >8% TAVI 255 patients analyzed (Lost to follow-up 3) SAVR 255 patients analyzed (Lost to follow-up 8) Median STS – 4.3% STS scores PS Matched TAVI Cohort Below STS 4 – 46% Above STS 8 – 15% Between STS 3-8 – 62% Between STS 4-8 – 39% (n=782) SAVR (n=2884) Age [yrs.] (SD) Logistic EuroSCORE (%) 81 (7) 70 (11) 21 (14) 9 (9) Baseline CharacteristicsBefore Matching Female gender (%) 457 (58) 1106 (38) Pulmonary hypertension 187 (24) 315 (11) Creatinine [mg/dl] (SD) 1.21 (0.7) 1.06 (0.6) (n=255) SAVR (n=255) Age [yrs.] (SD) Logistic EuroSCORE (%) 81 (6) 80 (5) 17 (9) 18 (12) Baseline CharacteristicsAfter MatchingSTS 3-8% Female gender (%) 156 (61) 151 (59) Pulmonary hypertension 52 (20) 57 (22) Creatinine [mg/dl] (SD) 1.16 (0.8) 1.10 (0.7) 95% confidence interval 30-day cumulative mortality 1-year cumulative mortality Stratified analyses for all-cause 1-year mortality Similar 30-day and 1-year all-cause mortality outcomes between propensity matched TAVI and SAVR cohorts (STS 3-8%) Females appear to have a survival benefit with TAVI as compared to SAVR ASSESSMENT by Heart Valve Team Two Parallel Randomized Trials +3 Nested Registries n=2000 Randomized Patients n=500 Randomized Patients TAO Registry Yes 6-7mm 6-7mm Registry Implications of selecting European TAVI patients using the logistic EuroSCORE? Implications of SURTAVI and PARTNER II trials using STS scores? Have we appropriately designed the PARTNER II and SURTAVI trial using a STS score with a lower cut-off value of 4%? JenaValve and Symetis CE mark trials have enrolled patients with mean STS scores of 6-8%. Is a STS score between 6-8% considered high or intermediate surgical risk? STS 2.81% Logistic EuroSCORE II 4.81% X

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