Highlights from

AHA 2019

American Heart Association’s Scientific Sessions

Philadelphia, USA 16 - 18 November 2019

Balloon-expandable Better than Self-expanding Transcatheter Heart Valves

Dr Eric Van Belle (Institute Coeur Poumon - 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] and 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.

The investigators included 12,141 patients in undergoing BE-THV (n=8,038) or SE-THV (n=4,103) for native aortic stenosis. Long-term mortality status was available in all patients (median 20 months, interquartile range, 14-30). Patients treated with BE-THV (n = 3,910) were successfully matched 1:1 with 3,910 patients treated with SE-THV by using propensity-score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first co-primary outcome was the occurrence of PVR ≥ moderate and/or in-hospital mortality. The second co-primary outcome was 2-year all-cause mortality.

In matched-propensity analyses, the incidence of the first co-primary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk [RR] 1.68; 95% CI 1.46-1.91; P<0.0001). Each component of the outcome was also higher in SE-THV patients: PVR ≥ moderate (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). During follow-up, all-cause mortality occurred in 899 patients treated with SE-THV (2-year mortality was 29.8%) and in 801 patients treated with BE-THV (2-year mortality was 26.6%; HR 1.17; 95% CI 1.06-1.29; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. 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 in the current analysis.

This propensity-score matched comparison of 7,820 patients with native aortic stenosis undergoing TAVR based on the nationwide FRANCE-TAVI registry reports that use of SE-THV was associated with higher risk of PVR, PVR and/or in-hospital mortality, and 2-year mortality as compared with use of BE-THV. Furthermore, the association of THV type with 2-year mortality remained after multivariable adjustment including PVR severity and other periprocedural events. This study confirms the need for a randomised clinical study sufficiently powered to compare the efficacy of the SE and BE-THV head-to-head and the need to simplify and optimise the grading of PVR and its long-term clinical impact.

  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. Session LBS04. American Heart Association Annual Scientific Sessions (AHA 2019), 14-18 November, Philadelphia, PA, USA.

Top image: @ iStockPhoto: Noctiluxx

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