Abstract 13294: Outcomes of Patients with Severe Aortic Stenosis at High Surgical Risk Evaluated in a Clinical Trial of Trans-Catheter Aortic Valve Replacement
Background: Patient populations with severe aortic stenosis (AS) are at high surgical risk (STS score >10% or Logistic EuroSCORE >20%). Transcatheter-aortic valve replacement (T-AVR) has emerged as a less invasive treatment for these patients.
Aim: To assess the outcome and predictors of mortality for patients referred for T-AVR.
Methods: From April 2007 to May 2011, a cohort of 900 patients with severe AS were evaluated as candidates for T-AVR. This cohort was divided into three groups: I, medical arm 595 (66.1%) treated medically 241 (26.7%) or by balloon aortic valvuloplasty (BAV) 354 (39.3%); II, surgical arm 146 (16.2%); and III, T-AVR 159 (17.6%). Patients were followed clinically by telephone or office visit.
Results: The surgical group had a lower mean age, STS and logistic EuroSCOREs, and incidence of NYHA class IV. The medical/BAV group had significantly higher BNP levels and lower ejection fraction (Table). Mortality rate in the medical/BAV group was 46.6% (n=277) at median (25th, 75th interquartile range) follow-up of 206 (76-411) days; 26.7% (n=39) in the surgical group at median follow-up of 628 (211-911) days; and 30.8% (n=49) in the T-AVR group at median follow-up of 399 (167-669) days. The median time from screening to mortality was 151, 73, and 164 days in the medical/BAV, surgical, and T-AVR groups, respectively. In the medical/BAV group, multivariate adjustment analysis identified renal failure HR 2 (p=0.001), pulmonary pressure HR 1.02 (p=0.002) and aortic systolic pressure HR 0.98 (p=0.03) as independent predictors for mortality. In the surgical group NYHA class IV (HR-2.1, p=0.03) was associated with mortality. In the T-AVR the STS score (HR-1.1, p=0.01) and renal failure (HR- 2.3, p=0.03) were associated with mortality.
Conclusion: Patients with severe AS treated medical/BAV have poor prognoses. Both surgical aortic valve replacement and T-AVR are good treatment options for these high-risk patients.
- © 2011 by American Heart Association, Inc.