Boston Scientific has since retired the Lotus Edge THV
A study of transcatheter aortic valve replacement (TAVR) procedures with the Lotus Edge transcatheter heart valve (THV) in 18 European centers yielded satisfactory short-term safety and efficacy, favorable hemodynamic results and low rates of paravalvular leak (PVL) in patients with complex anatomy. However, the rate of new permanent pacemaker (PPM) implantations remained high, according to the study, which was published Monday in JACC: Cardiovascular Interventions.
The paper was initially accepted for publication on Sept. 29. Less than 2 months later, on Nov. 17, Boston Scientific announced that it would begin a voluntary global recall of the Lotus Edge Aortic Valve System, retiring the entire family of THVs, because of delivery system issues.
The results of the REPRISE III trial led to U.S. Food and Drug Administration approval of the Lotus Edge in TAVR for high-surgical-risk patients in April 2019.
Xavier Armario, MD, of Galway University Hospital, Ireland, and co-investigators, reported the first European commercial experience using the Lotus Edge THV in TAVR in the paper, which appears in the Jan. 25 issue of JACC: Cardiovascular Interventions. They conducted a multicenter retrospective analysis of TAVR patients receiving the Lotus Edge THV. They examined short-term outcomes, using Valve Academic Research Consortium-2 (VARC-2) definitions.
They studied a total of 286 patients who underwent TAVR using the Lotus Edge THV between April and November 2019 at 18 European centers. Patients had a mean age of 81.2 years with a mean Society of Thoracic Surgeons (STS) score of 5.2%.
Nearly half demonstrated complex anatomy, prior to their TAVR, which was defined as having at least one of the following: severe aortic valve calcification, moderate to severe left ventricular outflow tract calcification, bicuspid aortic valve morphology, degenerated surgical biological prosthesis, or pure aortic valve regurgitation.
Mean aortic valve gradient was 11.9 mmHg, with a mean aortic valve area of 1.9 cm2. Moderate PVL occurred in 2.0% of patients, with none having severe. New requirement for permanent pacemaker (PPM) was 30.8% in PPM-naïve patients. Stroke occurred in 3.5% of patients at 30 days. Death occurred in 2.4% of patients at 30 days.
Stefan Toggweiler, MD, of Luzerner Kantonsspital, Lucerne, Switzerland, wrote an accompanying editorial to the study. He states that these published data demonstrate acceptable short-term outcomes in patients with complex anatomy. With its Acurate neo line of THVs, Boston Scientific seemed primed to offer two valves with complementary strengths and weaknesses.
However, in the case of the Lotus family of valves, after numerous delivery system issues and recalls, the complexities of delivering a THV mechanically turned out to be a too great a hurdle for Boston Scientific to overcome.
Several authors report having relationships with Boston Scientific and other device manufacturers, including the senior and corresponding author, Darren Mylotte, MB BCh, MD, PhD, who reported being a consultant for Medtronic, Boston Scientific, and Microport. The editorialist, Toggweiler, who was not part of the study, reported having been a proctor for Boston Scientific, Medtronic, Biosensors/New Valve Technology, and Abbott Vascular; having been a consultant for Carag, Medira, Boston Scientific, Medtronic, Biosensors/ New Valve Technology, and Abbott Vascular; having received institutional research grants from Boston Scientific and Fumedica; and holding equity in Hi-D Imaging.
Armario X, Rosseel L, Kharbanda R, et al. Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience. JACC Cardiovasc Interv 2021;14:172–81.
Toggweiler S. The LOTUS Edge Is Up for a Challenge. JACC Cardiovasc Interv 2021;14:182–4.