BACKGROUND: Outcome of transcatheter aortic valve implantation (TAVI) for high risk aortic stenosis patients is at least equivalent to surgical replacement. Lower risk patients were not enrolled into earlier clinical trials, however they are already being treated by TAVI despite a lack of data regarding the safety and efficacy in these patients. Our aim was to assess the safety and efficacy of TAVI in low risk patients.
METHODS: Patients undergoing TAVI at the Tel-Aviv, Rabin (Beilinson) or Sheba Medical Centers during 2008-2014 were enrolled (n=1349). Adverse events and procedural outcomes were adjudicated according to VARC-2 definitions. Patients were stratified according to STS score as High (STS ≥8, n=279, 21%), Intermediate (STS 4-8; n=494, 37%) or Low risk (STS <4; n=576, 42%).
RESULTS: Low-risk patients were younger and more likely to be males compared to intermediate- and high-risk patients. Baseline characteristics differed between the groups with higher rates of prior CABG, stroke, PVD, renal failure, COPD and frailty scores among high-risk patients. As compared with intermediate and high-risk patients, low-risk patients were more likely to undergo TAVI via the transfemoral route (72% vs. 88% vs. 95%, p<0.0001) and under conscious sedation (59% vs. 72% vs. 81%, <0.0001). Interestingly, there were no significant differences in the rates of procedural complications apart from bleeding. Both short- and long-term mortality (Figure) were significantly lower for intermediate- and even more, for low-risk patients as compared to high-risk patients (p<0.001). Lower mortality for intermediate (HR 0.44, 95%CI 0.29-0.67) and low risk patients (HR 0.27, 95% CI 0.17-0.43) was maintained also after multivariable adjustment.
CONCLUSIONS: TAVI for intermediate and low risk patients is safe and associated with improved outcome as compared with high risk patients. These data support the hypothesis that TAVI may achieve results comparable to surgical AVR also in lower risk patients.
