Two major players are vying for women’s hearts, but it’s not as romantic as it sounds.
After Medtronic put forward a head-to-head study in April showing its transcatheter aortic valve replacement implant had fewer complications within one year among patients with a small aortic annulus—the fibrous ring where the artery connects to the heart’s left ventricle, and a group that primarily includes women—TAVR rival Edwards Lifesciences has now responded with five-year data demonstrating similar safety rates for its valve regardless of the size of a patient’s annulus or their sex.
Edwards’ analysis pulled together more than 1,350 patients from two of its PARTNER trials who received its Sapien 3 implant, including people who took the transcatheter route while having low or intermediate risks for undergoing open heart surgery.
One of the main differences between Edwards’ Sapien and Medtronic’s Evolut TAVR systems—the two most commonly used implants of their type—is how they are deployed. Each is folded and flattened down to fit through the patient’s arteries as it’s threaded into the heart; once placed in the landing zone of the annulus, Sapien is pushed open by the inflation of a balloon, while Evolut’s frame uses spring forces to expand by itself.
According to Medtronic, this allows its valve to conform to the shape of the ring and apply consistent outward pressure. Its trial, known as SMART, followed 716 patients across all risk categories, about 87% of whom were women. The results were presented at the annual meeting of the American College of Cardiology in Atlanta and published in The New England Journal of Medicine.
While Evolut performed on par with Sapien in terms of clinical safety—showing statistically similar one-year rates of patient deaths, disabling strokes or rehospitalizations for heart failure—the rate of valve dysfunction was significantly lower, at 9.4% compared to 41.6%, including cases of structural valve deterioration and calcification as well as the development of blood clots or bacterial infections.
Valve dysfunction was also defined by higher average differences in blood pressure on opposite sides of the valve, including 20 mmHg or more as measured by a noninvasive echocardiogram, as well as reported mismatches between the size of the implant and the heart’s anatomy.
Edwards’ analysis examined average pressure gradients and prosthesis-patient mismatch rates logged at the 30-day mark and then looked to see whether those translated into poorer outcomes over five years.
The company said researchers found no statistical association between clinical outcomes—including valve reinterventions, disabling stroke and death—and mismatches or average gradients over 20 mmHg. Valve durability rates were also similar between patients with small versus large annuli.
“This important dataset highlights the risk of relying on a singular hemodynamic parameter such as mean gradient as a surrogate for valve dysfunction,” said lead investigator Rebecca Hahn, M.D., a professor of medicine at Columbia University Irving Medical Center and director of interventional echocardiography at the Columbia Structural Heart & Valve Center, who presented the results as a late-breaking study at New York Valves 2024, formerly known as the TVT structural heart conference.
“When selecting the best treatment option, we must evaluate measures that matter to patients such as death, disabling stroke, quality of life and reintervention,” Hahn said in an Edwards statement. “These are important findings for clinicians in determining the best treatment for patients.”
Patients with severe valve disease and a smaller annulus have historically carried higher risks of implant impairment following a TAVR procedure. Medtronic has estimated that about 40% of all TAVR patients worldwide may have a small aortic annulus, as well as about 35% of patients who receive a Sapien valve in the U.S.—and that while women may statistically have longer life expectancies, they typically see higher rates of death versus men after an aortic stenosis diagnosis.
In addition, a Medtronic survey this year found older women face gaps in awareness and screening for aortic stenosis.
“The PARTNER series of robust pivotal trials, all of which included FDA oversight, rigorously followed more than 12,000 patients treated with Edwards Sapien valves rendering them excellent data from which to examine the totality of factors that contribute to valve durability and performance,” said Larry Wood, president of Edwards’ TAVR and surgical structural heart group. “These data are reassuring for patients and clinicians—particularly women who are more likely to receive a smaller valve—that the Sapien platform offers excellent survival and very low reintervention rates at five years.”
Meanwhile at New York Valves 2024, Medtronic provided a late-breaking update from its SMART trial, with a secondary analysis that broke down dysfunction rates by patients’ annulus size, which ranged among participants from 270 mm2 to 430 mm2.
Over the same one-year period, the study showed fewer cases of valve dysfunction with Evolut compared to Sapien—with a 45% absolute difference on the smaller side of the median annulus area, at 386 mm2, and a 19% gap on the comparatively larger side.
Editor's note: This story has been updated with Medtronic's announcement from New York Valves.