Medtronic today unveiled new insights from a pooled analysis of high and intermediate risk patients from the CoreValve/Evolut program, showing a lower occurrence in structural valve deterioration (SVD) in patients with severe aortic stenosis (AS) at high or intermediate surgical risk undergoing supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) compared to surgery. The data were presented as a late-breaking clinical trial at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22).

To compare SVD rates between randomized patients who underwent TAVR and surgery, 1,484 intermediate risk (792 TAVR, 692 SAVR) and 615 high risk (336 TAVR, 279 SAVR) patients were evaluated for SVD. In patients with symptomatic severe AS at intermediate or high surgical risk, the 5-year rate of SVD was 4.38% in patients undergoing surgery, versus 2.57% in patients undergoing TAVR (P=0.0095). The risk of death and rehospitalization for aortic valve disease or heart failure approximately doubles in patients that develop SVD, according to the pooled analysis.

The analysis also showed a higher risk of developing SVD in younger patients, women, and patients with a higher body surface area (BSA). To date, only CoreValve and Evolut transcatheter aortic valve replacement systems are shown in randomized clinical trials to out-perform surgery in valve durability at 5 years.

“As TAVR is being used among a wider patient population, valve durability is becoming more important to clinicians when selecting a treatment option. Patients need a valve that can accommodate their activity levels while remaining hemodynamically stable for years to come,” said Michael J. Reardon, M.D., professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center, principal investigator in the SURTAVI trial. “These outcomes confirm what clinicians have long believed about Evolut and CoreValve and allow for greater confidence in the strength of the platform regardless of patient’s overall surgical risk.”

The Medtronic TAVR technologies, which includes the Evolut™ R, Evolut™ PRO, Evolut™ PRO+, and newest-generation Evolut™ FX systems, are indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low).                                                                      

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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