• Are we ready to perform TAVI in Intermediate Risk Patients?

    Heart Center University Bonn , Bonn, Germany Stanford University, School of Medicine, Stanford, California CRT 2013 Washinton DC, February 28, 2013 Are we ready to perform TAVI in Intermediate Risk Patients? Consulting- Medtronic CoreValve, Boston Scientific Corporation, Cordis Corporation, Johnson and Johnson and Abbott Vascular Honoraria- Boston Scientific Corporation and Biosensors International Stocks, Stock Options, other ownership interest- Medtronic CoreValve and Biosensors International Off-Label- Off-label use of stents and valve prosthesis Better TAVR Outcomes in Lower Risk Patients N=420 patients (105 per quartile) Lange JACC 2012;59-280–7) “Risk Creep” Favors TAVR Preferentially Top 33% Surgical Risk STS = 4 Top 7% Surgical Risk STS > 8 Inoperable 20-50K Extreme Risk “Cohort C” Two-thirds of patients will remain optimal surgical candidates STS PROM < 4% 30-Day Mortality < 2-4% PARTNER IIA SURTAVI Intermediate ˜ 26% PARTNER B CoreValve Extreme Risk PARTNER A CoreValve High Risk Futility Identifying Patient Risk EuroPCR 2012 Mean EuroSCORE in CoreValve ADVANCE Study varied by Country (p-value < 0.001) Munich and BERMUDA Triangle Studies Beyond Risk Models Intermediate Risk Trials Lange, R. et al, JACC 2012 “TAVI and Lower Surgical Risk Patients.” Intermediate Patients- Munich Study BERn – MUnich - rotterDAm TVT 2011 TAVI – 782 (21.3%) SAVR – 2884 (87.7%) 2882 patients excluded based on propensity score TAVI – 390 (49.9%) SAVR – 2492 (86.4%) Propensity score matched patients n = 784 TAVI - 392 SAVR- 392 Lost to follow-up- 4 (1.0%) Lost to follow-up- 15 (3.8%) 392 analysed 392 analysed BERMUDA Triangle Study 4-8% STS – 152 patients 3-8% STS – 255 patients TAVI (n=255) SAVR (n=255) 7.9% 7.1% BERMUDA Triangle Study TAVI (n=255) SAVR (n=255) 18.8% 17.0% BERMUDA Triangle Study Patients with severe aortic stenosis and an intermediate surgical risk have a similar overall mortality at 30 days and 1 years irrespective of the treatment (TAVI or SAVR) It appears that there is a difference in clinical outcomes between men and women The efficacy of TAVI in intermediate risk populations and the differences in outcomes between men and women warrants further evaluation in the context of randomized control trials BERMUDA Triangle Study BERMUDA Triangle Study Beyond Risk Models Intermediate Risk Trials Frailty Impairment in multiple systems that leads to a decline in homeostatic reserve and resiliency Charlson Co-Morbidities Two or more medical conditions Disability ADL IADLs Difficulty or dependency in daily living 5.7% 21.5% 46.2% Variables Included in Various Risk Models Dewey J Thor CV Surgery 2008; 135-180 Frailty is not represented in any of the commonly used risk scores STS has begun collecting 5-meter gait speed as a measure of frailty EuroSCORE II has added “Poor mobility” defined as severe impairment of mobility secondary to musculoskeletal or neurological dysfunction -Utility v. Futility Current risk stratification methods are not sufficient to stratify frailty Complete assessment includes -Frailty -Disability -Co-Morbidity Important interactions with pulmonary disease and cognitive function We still have work to do to to find the risk index Interplay of Frailty-Disability-Co-Morbidity BERMUDA Triangle Study Beyond Risk Models Intermediate Risk Trials Patient Selection Enrolling approximately 2,500 Subjects randomized 1-1 to TAVI and SAVR in up to 75 European, Canadian, and US centers. CoreValve SURTAVI Trial ASSESSMENT by Heart Valve Team Two Parallel Randomized Trials +5 Nested Registries n=2000 Randomized Patients n=500 Randomized Patients TAO Registry Yes 6-7mm 6-7mm Registry 29 mm valve Registry PARTNER II Trial TCT 2012 Although we have reasons to believe that Intermediate Risk patients will profit from TAVI outcome, we will need randomized data (Partner II, SURTAVI) to definitely extend and recommend TAVI in Intermediate Risk patients Future risk models/scores will need to contemplate frailty, disability and co-morbidities Additional “issues” need to be resolved such as procedural complications, durability of valves etc…

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