Dive Brief:
- Edwards Lifesciences said Wednesday its transcatheter aortic valve replacement (TAVR) device is similarly effective in patients with small and large aortic annuli.
- Earlier this year, Medtronic linked its TAVR device to a lower rate of valve dysfunction than Edwards’ rival product in people with small annuli. Edwards pushed back on the findings at the time. The company has now used a medical conference, New York Valves 2024: The Structural Heart Summit, to present data in support of its position.
- An analysis of more than 1,300 patients treated with Edwards’ Sapien 3 device showed clinical outcomes and valve durability after five years were comparable in small and large aortic annuli. The aortic annulus is a fibrous ring around the heart’s valve.
Dive Insight:
Medtronic presented data from its head-to-head clinical trial in people with small annuli, most of whom are women, as evidence that its Evolut valve should be the preferred product in the subpopulation. Edwards said clinical trial data and real-world evidence on Sapien 3 paint a different picture. Wall Street analysts were also critical of the data.
On Wednesday, Edwards set out the case for using its device in people with small annuli at the event in New York.
The analysis looked at outcomes in people enrolled in a Sapien 3 registry and randomized clinical trial. After five years, the rate of all-cause death, disabling stroke or heart failure hospitalization was similar in people with small and large annuli, causing the study to hit its primary endpoint. The rate of all-cause death was numerically lower in people with small annuli.
Outcomes were similar in females with small and large annuli. The rates of aortic valve reintervention and bioprosthetic valve failure were statistically no higher in people with small rather than large annuli. Quality of life one and five years after treatment were similar in the two cohorts.
The presentation also looked at whether the rate of prosthesis-patient mismatch and mean gradient after 30 days affects outcomes in people with small annuli. Prosthesis-patient mismatch refers to when the valve is too small for the body. Mean gradient is a measure of aortic stenosis severity.
Some studies have found 30-day mean gradients and mismatch rates are higher in patients treated with balloon-expandable valves such as Sapien than self-expanding products such as Medtronic’s Evolut. The Edwards analysis suggests such differences may be irrelevant to long-term health outcomes. There was no significant link between five-year outcomes and the mean gradient or mismatch rate after 30 days.
The analysis is the latest in the back-and-forth between Edwards and Medtronic over this patient population. On an earnings call in May, Medtronic CEO Geoff Martha said the company was “seeing early signs from many loyal Sapien users that they expect to increase their usage of Medtronic valves.”
Edwards’ defense is built on the idea that multiple factors, not just the area where Medtronic may have an edge, inform valve choice.
