Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Valve

Abstract

This analysis represents the largest published series on use of the LOTUS valve. Outcomes using this valve are excellent. In-hospital mortality is very low. Complication rates are low, and the LOTUS valve improves on first-generation valves, particularly with regard to residual aortic regurgitation.

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

“…In the Swiss TAVI registry, moderate or severe aortic regurgitation was documented in 0.7% and 1.2% of patients treated with LOTUS and Edwards SAPIEN 3, respectively. Our findings are consistent with the Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance (REPRISE) II study and the UK LOTUS registry, reporting moderate or severe aortic regurgitation in 1% and 0.8% of patients, respectively . Reduction of paravalvular aortic regurgitation results from a combination of both, the full repositionability of the LOTUS valve allowing for an assessment of the result prior to deployment, and the prosthesis design with an adaptive seal in the distal portion and an outer sleeve .…”

“…Rates of permanent pacemaker implantation amounted to 34% among patients treated with the LOTUS valve, and were 2‐ to 3‐fold higher compared with patients treated with the Edwards SAPIEN 3 prosthesis. Comparable rates of AV conductance disturbances and permanent pacemaker implantation have been consistently reported in the REPRISE II study (28.6%) and the UK LOTUS registry (31.8%) . The effect of permanent pacemaker implantation after TAVI on long‐term outcomes remains a matter of debate .…”

Conduction disturbances after transcatheter aortic valve implantation procedures – predictors and management

“…Overstretch of valve annulus or LVOT of ≥ 10% was identified as a strong independent predictor of the need for PPM implantation [44]. A similar PPM implantation frequency was reported by Rampat et al in the LOTUS UK registry [45]. Due to a relatively high rate of conduction disturbances accompanying the first generation of TAVI prostheses, the decrease in this complication rate was one of the reasons for the introduction of improved valves.…”

Transcatheter Aortic Valve Replacement in Low-Risk Patients Within the Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment Study

“…In addition, TAVR technology has evolved rapidly with incremental improvements in clinical outcomes and reductions in TAVRrelated complications (paravalvular aortic regurgitation, conduction disturbance, etc), and several additional devices are under development that promise to further mitigate the current limitations of TAVR. [16][17][18] Results of the PARTNER 2 trial, using both Sapien XT and Sapien 3 valves, have been promising in intermediate-risk patients and have supported the recent United States Food and Drug Administration investigational device exemptions for clinical trials of TAVR in low-risk AS patients using the Edwards Sapien 3 (NCT02675114) and Medtronic CoreValve Evolut R (NCT02701283) transcatheter valve platforms. Until definitive data emerge from these trials, clarifying the comparative effectiveness of transcatheter and surgical aortic valve replacement in low-risk patients, SAVR remains the standard of care for low-risk patients with symptomatic severe AS.…”