Medtronic plc’s Evolut Low-Risk trial continued to show non-inferiority of transcatheter aortic valve replacement to surgical aortic valve replacement in terms of death or disabling stroke at five years in a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session in Chicago on March 30.
Medtronic plc released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli.
In what undoubtedly came as a response to Medtronic plc’s recently reported Small Annuli Randomized to Evolut or SAPIEN Trial trial results that showed a decisive advantage for its Evolut transcatheter aortic valve replacement system in patients with a small aortic annulus, Edwards Lifesciences Corp. reported the results from an analysis of data from its Placement of Aortic Transcatheter Valve trials of the Sapien 3 valves showing “excellent clinical outcomes and valve durability irrespective of the patient’s annulus size or sex.”
Medtronic plc reported data from a head-to-head trial backing its Evolut TAVR system against competitor Edwards Lifesciences Corp.’s Sapien platform, and the data showed particular promise of the Evolut in patients with a small aortic annulus, which would appear to be most beneficial for women in particular.
Surgical aortic valve replacement (SAVR) devices are widely believed to be considerably more durable than transcatheter aortic valve replacement (TAVR) devices, but five-year data for Medtronic plc’s Corevalve Evolut, presented this week at the Cardiovascular Research Technologies Conference in Washington, seem to suggest that TAVR devices are closing that gap.
Transcatheter aortic valve replacement (TAVR) continues to grow, so it is little surprise that the 2022 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting featured multiple presentations about TAVR-related devices and outcomes. The American College of Cardiology/American Heart Association’s latest guidelines recommends TAVR for patients over age 80 and surgery for those under age 65. Those in the middle can go either way, depending on comorbidities and patient preferences.
It has long been known that patients recover more quickly from transcatheter aortic valve replacement (TAVR) than from open-heart surgery for valve replacement (SAVR) and results at two years looked good, too, with very similar outcomes. The question remained what happens in the longer term?
Two-year results from the Evolut Low Risk Trial show Medtronic plc’s Evolut transcatheter aortic valve replacement (TAVR) is noninferior to open-heart surgery in younger, healthier aortic stenosis patients. Moreover, the Evolut cohort fared better on certain critical events. Specifically, two-year rates of all-cause mortality or disabling stroke were 4.3% for TAVR patients vs. 6.3% for those undergoing surgical aortic valve repair (SAVR).
Medtronic plc reported positive interim results on the first 171 patients implanted with Evolut transaortic valve replacement (TAVR) devices in its OPTIMIZE PRO clinical trial. The postmarket, prospective, multicenter study is assessing procedural outcomes, including pacemaker rate, associated with in-procedure techniques and post-procedure TAVR care pathways when using the self-expanding, supra-annular Evolut Pro and Pro+ TAVR systems in patients with symptomatic severe aortic stenosis.
The history of TAVR devices is evolutionary as much as it is revolutionary, or that is at least the take-away from an Oct. 15 virtual session comparing the Acurate Neo device by Boston Scientific Corp., of Marlborough, Mass., with the Corevalve Evolut R by Dublin-based Medtronic plc.
