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Comparative Study
. 2016 Nov 17;5(11):e004088.
doi: 10.1161/JAHA.116.004088.

Repositionable Versus Balloon-Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis

Thomas Pilgrim  1 , Stefan Stortecky  1 , Fabian Nietlispach  2 , Dik Heg  3 , David Tueller  4 , Stefan Toggweiler  5 , Enrico Ferrari  6   7 , Stéphane Noble  8 , Francesco Maisano  2 , Raban Jeger  9 , Marco Roffi  8 , Jürg Grünenfelder  10 , Christoph Huber  11 , Peter Wenaweser  12   13 , Stephan Windecker  1
Affiliations
Comparative Study

Repositionable Versus Balloon-Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis

Thomas Pilgrim et al. J Am Heart Assoc. .

Abstract

Background: The safety and effectiveness of the fully repositionable LOTUS valve system as compared with the balloon-expandable Edwards SAPIEN 3 prosthesis for the treatment of aortic stenosis has not been evaluated to date.

Methods and results: All patients undergoing transcatheter aortic valve implantation with the Edwards SAPIEN 3 or the LOTUS valve system were included into the Swiss Transcatheter Aortic Valve Implantation Registry. An adjusted analysis was performed to compare the early clinical safety outcome according to the Valve Academic Research Consortium-2 definition. Between February 2014 and September 2015, 140 and 815 patients were treated with the LOTUS and the Edwards SAPIEN 3 valve, respectively. There was no difference in crude and adjusted analyses of the early safety outcome between patients treated with LOTUS (14.3%) and those treated with Edwards SAPIEN 3 (14.6%) (crude hazard ratio, 0.97; 95% CI, 0.61-1.56 [P=0.915]; adjusted hazard ratio, 1.03; 95% CI, 0.64-1.67 [P=0.909]). More than mild aortic regurgitation was <2% for both devices. A total of 34.3% of patients treated with LOTUS and 14.1% of patients treated with Edwards SAPIEN 3 required a permanent pacemaker (HR, 2.76; 95% CI, 1.97-3.87 [P<0.001]).

Conclusions: The repositionable LOTUS valve system and the balloon-expandable Edwards SAPIEN 3 prosthesis appeared comparable in regard to the Valve Academic Research Consortium-2 early safety outcome, and the rates of more than mild aortic regurgitation were exceedingly low for both devices. The need for new permanent pacemaker implantation was more frequent among patients treated with the LOTUS valve.

Keywords: aortic valve regurgitation; newer‐generation devices; permanent pacemaker; transcatheter aortic valve replacement.

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Figures

Figure 1
Figure 1
Kaplan–Meier estimates of the Valve Academic Research Consortium 2 (VARC2) early safety composite outcome at 30 days. The blue line relates to the LOTUS valve system; the red line relates to the Edwards SAPIEN 3 valve. HR indicates hazard ratio.
Figure 2
Figure 2
Bar graph of estimated and observed mortality at 30 days. Society of Thoracic Surgeons (STS) risk scores were used to estimate mortality at 30 days.
Figure 3
Figure 3
Kaplan–Meier estimates for permanent pacemaker implantation within 30 days. The blue line relates to the LOTUS valve system; the red line relates to the Edwards SAPIEN 3 valve. HR indicates hazard ratio.
Figure 4
Figure 4
Stratified analysis for the Valve Academic Research Consortium 2 Early Composite Safety Outcome (based on crude hazard ratios). LVEF indicates left ventricular ejection fraction; STS, Society of Thoracic Surgeons.
See this image and copyright information in PMC

References

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