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. 2018 Jan 20;5(1):e000695.
doi: 10.1136/openhrt-2017-000695. eCollection 2018.

Early versus newer generation devices for transcatheter aortic valve implantation in routine clinical practice: a propensity score matched analysis

Thomas Pilgrim  1 , Joe K T Lee  1 , Crochan J O'Sullivan  2 , Stefan Stortecky  1 , Sara Ariotti  1 , Anna Franzone  1 , Jonas Lanz  1 , Dik Heg  3 , Masahiko Asami  1 , Fabien Praz  1 , George C M Siontis  1 , René Vollenbroich  1 , Lorenz Räber  1 , Marco Valgimigli  1 , Eva Roost  4 , Stephan Windecker  1
Affiliations

Early versus newer generation devices for transcatheter aortic valve implantation in routine clinical practice: a propensity score matched analysis

Thomas Pilgrim et al. Open Heart. .

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.

Keywords: aortic valve disease; valvular disease.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow diagram of patients included into the propensity score matched analysis. *Patient censored at last scheduled or unscheduled contact. BSC, Boston Scientific; TAVI, transcatheter aortic valve implantation; THV, transcatheter heart valve.
Figure 2
Figure 2
Kaplan-Meier estimates of the VARC-2 early composite safety outcome. The blue line relates to the newer generation TAVI devices; the black line relates to the early generation TAVI devices. TAVI, transcatheter aortic valve implantation; VARC, Valve Academic Research Consortium.
Figure 3
Figure 3
Kaplan-Meier estimates of the VARC-2 early composite safety outcome landmark analysis between 0 and 3 days and 4 and 30 days. The blue line relates to the newer generation TAVI devices; the black line relates to the early generation TAVI devices. TAVI, transcatheter aortic valve implantation; VARC, Valve Academic Research Consortium.
Figure 4
Figure 4
Stratified analysis for the VARC-2 early composite safety outcome. eGFR, estimated glomerular filtration rate; LVEF, left ventricular ejection fraction; TAVI, transcatheter aortic valve implantation; VARC, Valve Academic Research Consortium.
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