TAVI with a self-expanding bioprosthesis in high-risk severe aortic stenosis resulted in a 5-year all-cause mortality rate of 50.7% (95% CI 46.7-54.5%) and continued valve durability.
Observational (n=1,015)
Yes
Does TAVI with a self-expanding bioprosthesis provide long-term safety and durability in high-risk patients with severe aortic stenosis?
In high-risk elderly patients with severe aortic stenosis, TAVI with a self-expanding bioprosthesis showed sustained haemodynamic performance and low rates of valve dysfunction at 5 years.
AIMS: The ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis in real-world patients with symptomatic, severe aortic stenosis at high surgical risk for valve replacement. METHODS AND RESULTS: Study participants were enrolled from 44 experienced centres in 12 countries. Patient eligibility, treatment approach, and choice of anaesthesia were determined by the local Heart Team. The study was 100% monitored, and adverse events were adjudicated by an independent clinical events committee using Valve Academic Research Consortium (VARC-1) criteria. There were 1015 patients enrolled with 996 attempted TAVI procedures. Mean age was 81 years, and mean logistic EuroSCORE was 19.3 ± 12.3%. Five-year follow-up was available on 465 (46.7%) patients. At 5 years, the rate of all-cause mortality was 50.7% (95% confidence interval: 46.7%, 54.5%), and the rate of major stroke was 5.4%. Haemodynamic measures remained consistent for paired patients with a mean aortic valve gradient of 8.8 ± 4.4 mmHg (n = 198) and an effective orifice area of 1.7 ± 0.4 cm2 (n = 123). Aortic regurgitation (AR) decreased over time and among paired patients dropped from 12.8% to 8.0% moderate AR at 5 years (n = 125). Of the 860 patients with echocardiographic data or a reintervention after 30 days, there were 22 (2.6%) patients meeting the VARC-2 criteria for valve dysfunction and 10 (1.2%) patients with a reintervention >30 days. CONCLUSION: Five-year results in real-world, elderly, high-risk patients undergoing TAVI with a self-expanding bioprosthesis provided evidence for continued valve durability with low rates of reinterventions and haemodynamic valve dysfunction. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01074658.
Gerckens et al. (2017) conducted an observational in symptomatic, severe aortic stenosis (n=1,015). Transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis was evaluated on all-cause mortality (95% CI 46.7%, 54.5%). TAVI with a self-expanding bioprosthesis in high-risk severe aortic stenosis resulted in a 5-year all-cause mortality rate of 50.7% (95% CI 46.7-54.5%) and continued valve durability.
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