German Study Compares Transfemoral TAVR With Boston Scientific's Lotus Device Versus Edwards' Sapien 3
June 12, 2017—Principal investigator Jochen Wöhrle, MD, at the University of Ulm in Ulm, Germany, led a single-center investigation comparing the 30-day, 12-month, and 24-month outcomes of transcatheter aortic valve replacement (TAVR) with the repositionable and retrievable Lotus device (Boston Scientific Corporation) versus the balloon-expandable Edwards Sapien 3 device (Edwards Lifesciences) in patients undergoing transfemoral TAVR procedures
The study, titled Coronary and Structural Interventions Ulm—Transcatheter Aortic Valve Replacement, or CSI–Ulm-TAVR, was published by Julia Seeger, MD, et al online ahead of print in Circulation: Cardiovascular Interventions.
The investigators concluded that procedures with the Lotus and the Sapien 3 TAVR devices were associated with similar 30-day, 12-month, and 24-month clinical outcomes; however, the need for permanent pacemaker implantation was significantly higher with the repositionable Lotus device.
As summarized in Circulation: Cardiovascular Interventions, the investigators at the University of Ulm enrolled 537 patients, with 202 patients receiving the Lotus and 335 patients receiving the Sapien 3. The primary endpoint was all-cause mortality or disabling stroke within 12 months.
They found no residual moderate or severe aortic regurgitation. The rate of mild aortic regurgitation was lower with the repositionable and retrievable Lotus valve compared with the Sapien 3.
The rate of pacemaker implantation was significantly higher with the Lotus valve compared with the Sapien 3 valve (36.1% vs 14.9%; P < .01). The Valve Academic Research Consortium-2 early safety endpoint at 30 days was 7.4% for Lotus and Sapien 3 with no difference in all-cause mortality (1.9% vs 1.8%; P = .87), rate of disabling stroke (1.5% vs 2.1%; P = .62), or major vascular complications (2.9% vs 2.4%; P = .69).
The primary endpoint at 12 months was similar between groups. In a propensity score–matched comparison, there was no difference in the primary endpoint within 12 months (15.5% vs 18.6%; P = .69) and 24 months (21.9% vs 26.4%; P = .49), reported the investigators in Circulation: Cardiovascular Interventions.