Article Text
Abstract
Aim Contemporary data comparing early versus newer generation transcatheter heart valve (THV) devices in routine clinical practice are lacking. We sought to compare the safety and efficacy of early versus newer generation THVs in unselected patients undergoing transcatheter aortic valve implantation (TAVI).
Methods and results We performed a propensity score matched analysis of patients undergoing transfemoral TAVI at a single centre with early versus newer generation devices between 2007 and 2016. Patients were matched for balloon-expandable versus self-expandable valves and Society of Thoracic Surgeons score. The primary end point was the Valve Academic Research Consortium (VARC)-2 early safety composite end point at 30 days. Among the 391 matched pairs, no differences between early (21.2%) and newer generation (20.8%) THVs regarding the early safety composite end point (HR 0.98, 95% CI 0.72 to 1.33, P=0.88) were observed. The rates of valve embolisation (0.8% vs 4.2%, P=0.005), bleeding events (24.8% vs 32.0%, P=0.028) and moderate-to-severe paravalvular regurgitation (PVR) (3.1% vs 12.1%, P<0.001) were lower among patients receiving newer generation devices. Conversely, patients treated with early generation THVs less frequently experienced annulus rupture (0% vs 2.0%, P=0.008).
Conclusion Newer compared with early generation THV devices were associated with a lower rate of valve embolisation, PVR and bleeding events.
- valvular disease
- aortic valve disease
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Footnotes
Funding TP has received research grants to the institution from Edwards Lifesciences, Symetis, and Biotronik. SW has received research grants to the institution from Bravo, Boston Scientific and Terumo. LR has received research grants to the institution from Abbott Vascular. All other authors have nothing to disclose.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Cantonal Ethics Committee of Bern.
Provenance and peer review Not commissioned; externally peer reviewed.