Medtronic, a global leader in heart valve therapies, recently announced new data presented at the 30th Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation. During the meeting, investigators—including McGowan Institute for Regenerative Medicine affiliated faculty member Thomas Gleason, MD, the Ronald V. Pellegrini Endowed Professor of Cardiothoracic Surgery and Chief, Division of Cardiac Surgery of the University of Pittsburgh School of Medicine, Co-Director of the Heart and Vascular Institute at UPMC, Director of the Center for Thoracic Aortic Disease, Co-Director of the Center for Heart Valve Disease, and member of the Center for Vascular Remodeling and Regeneration at Pitt—presented the longest-term data to-date from the CoreValve U.S. Pivotal Trial
The longest-term follow-up data ever presented from the randomized trial showed that patients implanted with Medtronic’s CoreValve(TM) System experienced excellent valve durability out to five years with low severe hemodynamic structural valve deterioration (0.8 percent) compared to patients who received a surgical aortic valve replacement (SAVR) (1.8 percent). Of the 750 patients (391 transcatheter aortic valve replacement (TAVR); 359 SAVR) followed out to five years, patients treated with the CoreValve System showed similar outcomes compared to surgery for the primary endpoint of all-cause mortality 55.3 percent versus 55.4 percent; p=0.50). Additionally, rates were similar for major stroke (12.3 percent versus 13.2 percent; p=0.49) at five years.
“These were early CoreValve patients, some of the first patients to receive the therapy, and it’s reassuring to see that the CoreValve System has proven to be durable out to five years,” said Dr. Gleason, who presented the data at the meeting. “As the technology and heart team experience continues to improve, this longer-term follow-up data is an encouraging indicator for TAVR patients in the future. Earlier concerns regarding the durability of TAVR are certainly tempered by these mid-term data.”