Abstract 4625: Predictors of Outcomes in Patients With Severe Symptomatic Aortic Stenosis Who Were Not Eligible to Participate in a Clinical Trial Evaluation of Percutaneous Aortic Valve Replacement
Background: Percutaneous aortic valve replacement (PAVR) is currently being evaluated in clinical trials for pts with severe aortic stenosis (AS) who are considered high-risk surgical candidates. However, many pts are not eligible to participate in such trials.
Methods: Our study consisted of 188 pts with severe AS who were referred to participate in a clinical trial of PAVR and were deferred based on the protocol inclusion/exclusion criteria, who were then treated medically or by balloon aortic valvuloplasty (BAV). Pts were followed by telephone contact or office visits.
Results: The mean age was 81.5±8.8 years. 106 (56.3%) were female, 164 (87.2%) were hypertensive, 64 (34.0%) had diabetes, 84 (44.7%) had renal failure and 61 (32.4%) had prior MI. The mean STS score was 12.8±7.3% and mean EuroSCORE was 41.3±22.8%. Mean CRP level was 17.7±30.0 mg/dl. The mean ejection fraction was 48.5±17.4%, mean aortic valve area 0.74±0.19cm2, mean gradient 40.8±14.7 mmHg, and mean cardiac output was 4.23±1.34%. During median follow-up of 327.5 days [146.2–577], the mortality rate was 71 (37.7%), with 31 (43.6%) cardiac deaths, 21 (33.8%) non-cardiac, and 15 (21.2%) were unknown. The median time from screening to death was 64.5 days [19.0–167.2]. There was significant correlation between STS score and EuroScore r=0.61, p<0.001. In univariate analysis, renal failure, prior MI, EuroSCORE, and lower EF were significantly associated with mortality. After multivariate adjustment analysis, renal failure, diabetes, and lower EF were identified as risk factors significantly associated with mortality. Renal failure had the strongest association with HR 2.5, 95% CI 1.3–4.6, p=0.004. (Table⇓)
Conclusion: The mortality of pts with severe symptomatic AS who are not eligible for PAVR procedures, and are treated medically or by BAV, are high. Renal failure was identified as the strongest predictor for mortality.