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Balloon-expandable better than self-expanding transcatheter heart valves

Presented by
Dr Eric Van Belle, CHU Lille, France
AHA 2019
Dr Eric Van Belle (CHU Lille, France) presented the FRANCE-TAVI nationwide registry study, which attempted to determine the impact of transcatheter heart valve (THV) design (balloon-expandable [BE] or self-expanding [SE]) on the risk of paravalvular regurgitation (PVR), intrahospital mortality, and 2-year mortality [1]. The authors concluded that BE-THV had fewer complications.

In this registry-based, multicentre, prospective, open, non-randomised study, 12,141 patients with native aortic stenosis received either BE-THV (n=8,038) or SE-THV (n=4,103). Follow-up was available for all patients (median 20 months, interquartile range 14-30). Co-primary outcomes of this study were the occurrence of ≥moderate PVR and/or in-hospital mortality, as well as 2-year all-cause mortality.

For the presented matched-propensity analyses, 25 clinical, anatomical, and procedural variables, coupled with the date of the procedure (within 3 months) were used to score patients either treated with BE-THV (n=3,910) or SE-THV (n=3,910). The results showed that ≥moderate PVR and/or in-hospital mortality was higher in patients who received SE-THV (19.8%) compared with BE-THV (11.9%; relative risk [RR] 1.68; 95% CI 1.46-1.91; P<0.0001). The individual components of the composite outcome were both also higher in SE-THV patients: ≥moderate PVR (15.5% vs 8.3%; RR 1.90; 95% CI 1.63-2.22; P<0.0001) and in-hospital mortality (5.6% vs 4.2%; RR 1.34; 95% CI 1.07-1.66; P=0.01). All-cause mortality at 2 years was higher in patients treated with SE-THV than in patients treated with BE-THV (29.8% vs 26.6%; HR 1.17; 95% CI 1.06-1.29; P=0.003). The authors concluded that use of SE-THV was associated with a higher risk of PVR and higher in-hospital and 2-year mortality as compared with BE-THV.

1. Van Belle E, et al. Balloon-Expandable versus Self-Expandable TAVR on Paravalvular Regurgitation and 2-Year Mortality: A Propensity-Matched Comparison From the FRANCE-TAVI Registry. LBS04, AHA Scientific Sessions 2019, 14-18 November, Philadelphia, USA.

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