October 26, 2016Open Access
Repositionable Versus Balloon‐Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis
Key Result
The repositionable LOTUS valve system showed comparable 30-day early safety outcomes to the balloon-expandable Edwards SAPIEN 3 prosthesis (14.3% vs 14.6%, adjusted HR 1.03) in patients with severe aortic stenosis.
Study Design
Type
Cohort (n=955)
Multicenter
Yes
Structured PICO
Does the fully repositionable LOTUS valve system improve early clinical safety outcomes compared to the balloon-expandable Edwards SAPIEN 3 prosthesis in patients with aortic stenosis undergoing TAVI?
P
Population
955 patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with either the LOTUS or Edwards SAPIEN 3 valve, followed for 30 days.
I
Intervention
Fully repositionable LOTUS valve system
C
Comparator
Balloon-expandable Edwards SAPIEN 3 prosthesis
O
Outcome
Early clinical safety outcome according to the Valve Academic Research Consortium-2 definitionsafety
The repositionable LOTUS valve and balloon-expandable Edwards SAPIEN 3 valve demonstrate comparable early safety and low rates of aortic regurgitation, though the LOTUS valve is associated with a significantly higher need for permanent pacemaker implantation.
Main Result
Hazard Ratio: 1.03 (95% CI 0.64–1.67)
Absolute Event Rate: 14.3% vs 14.6%
p-value: p=0.909
Limitations
- No random allocation to treatment
- Limited number of patients included in the analysis
- Duration of follow-up did not extend beyond 30 days
- Differences in balloon valvuloplasty prior to device implantation may have confounded the clinical results
- Implantation depth and oversizing were not prospectively documented
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.