While Edwards Lifesciences and Medtronic slugged it out at ACC 2014 with studies comparing their TAVI (transcatheter aortic valve implantation)offerings, Boston Scientific draws our attention to new data presented at the event that says its own Lotus™ Valve System continued to demonstrate impressive performance at three months.
The Lotus™ Valve System consists of a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. According to Boston Scientific, its low-profile delivery system and introducer sheath are designed to enable predictable and precise placement, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant. The device also employs a unique Adaptive Seal™ feature designed to minimize the incidence of paravalvular regurgitation, which has proven to be a predictor of mortality, a factor that makes this set of study data particularly meaningful.
The REPRISE II clinical trial, evaluated the Lotus™ Valve System in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement. REPRISE II is an ongoing prospective, single-arm study that has enrolled 120 patients at 14 sites in Australia, France, Germany and the U.K. An additional 130 patients will be enrolled in an extension of the study at 16 sites in Australia and Europe. Enrolment in this extension of REPRISE II is expected to be complete in April 2014.
The data were presented at ACC 2014 by Professor Ian Meredith, director of MonashHeart at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial.
Safety and efficacy outcomes were demonstrated out to three months with 85 percent of patients having no paravalvular aortic regurgitation. At 90 days 85.4 percent of patients had no paravalvular aortic regurgitation as assessed by an independent core lab. Furthermore, while 2.1% of cases resulted in moderate paravalvular aortic regurgitation ( with mild regurgitation in 12.5% of patients) there were no severe incidences in any patient at 90 days. While it’s impossible to read across directly to data supplied in the Sapien XT/CoreValve study, also presented at the congress, these figures are modestly better than either of those valves, albeit they were assessed angiographically immediately post-procedure.
30-day mean aortic valve pressure gradient of 18 mmHg, the primary device performance endpoint, was met as the 30-day mean aortic valve pressure gradient of 11.5±5.2 mm Hg was significantly (P<0.001) less than the performance goal. At 90 days, the mean aortic valve pressure gradient remained low and stable at 11.5±5.4 mm Hg.
All-cause mortality at 90 days was 5 percent and there were no instances of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve or ectopic valve placement occurred.
The disabling stroke rate at 90 days was 2.5 percent.
Source: Boston Scientific Corporation, PR Newswire