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

Abstract

BackgroundThe 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 ResultsAll 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]).ConclusionsThe 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.

Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis

“…Indeed, major vascular and access-related complications were observed in 10.3% of patients receiving the CoreValve and 9.8% of patients receiving the Evolut R (HR adj 1.01, 95% CI: 0.94-1.08) in the present analysis. However, the rate of major vascular complications in our Evolut R patient series (9.8%) is comparable with the rate of vascular complications reported in the Evolut R CE mark trial (8.7%) 2 as well as in a recent publication from the Swiss TAVI registry in which the rate of major vascular complications was 9.3% for the Edwards SAPIEN 3 (815 cases) and 7.2% for the Lotus™ valve (140 cases) (Boston Scientific, Marlborough, MA, USA) 14 . A detailed and thorough comparison of vascular access-site complication rates would demand analyses adjusting for anatomical factors such as calcification and tortuosity of the vasculature, the type of access to the vessel and the use of different closure devices.…”

Comparative analysis of balloon- versus mechanically-expandable transcatheter heart valves considering landing zone calcification

“…Both THVs yield good procedural and functional as well as comparable clinical outcomes in a real-world patient population. This is in line with previous data comparing both devices [32,33]. However, our study is the first that shows an impact of landing zone calcification on the risk of PVL for both THVs.…”

One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3

“…Although the mean of mean pressure gradients was low throughout the first year (12 mmHg), a considerable proportion of patients (9%) exhibited elevated gradients at 1 year. Other groups have reported even higher rates of patient-prosthesis mismatch (24%) mostly due to elevated gradients with the S3-THV [22]. In this analysis, patients experiencing elevated gradients displayed no significant difference in outcome in terms of mortality, stroke rates or worsening of symptoms.…”