January 1, 2018Open Access
Early versus newer generation devices for transcatheter aortic valve implantation in routine clinical practice: a propensity score matched analysis
Key Result
Newer generation transcatheter heart valves showed no difference in the 30-day early safety composite endpoint compared to early generation devices (HR 0.98; 95% CI 0.72-1.33; P=0.88).
Study Design
Type
Observational (n=782)
Multicenter
No
Structured PICO
Do newer generation transcatheter heart valve devices improve safety and efficacy compared to early generation devices in patients undergoing TAVI?
P
Population
782 propensity-matched patients undergoing transfemoral TAVI at a single center between 2007 and 2016, evaluated for 30-day outcomes.
E
Exposure
Newer generation transcatheter heart valve (THV) devices
C
Comparator
Early generation transcatheter heart valve (THV) devices (propensity score matched for balloon-expandable versus self-expandable valves and Society of Thoracic Surgeons score)
O
Outcome
Valve Academic Research Consortium (VARC)-2 early safety composite end point at 30 dayscomposite
While overall 30-day safety composite outcomes were similar, newer generation TAVI devices demonstrated reduced rates of valve embolization, paravalvular regurgitation, and bleeding, albeit with a slight increase in annulus rupture compared to early generation devices.
Main Result
Hazard Ratio: 0.98 (95% CI 0.72–1.33)
Absolute Event Rate: 20.8% vs 21.2%
p-value: p=0.88
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.