Intra-annular TAVR valves from Edwards Lifesciences and Abbott deliver similar 1-year outcomes
The intra-annular transcatheter aortic valve replacement (TAVR) valves from Edwards Lifesciences and Abbott are associated with comparable clinical outcomes after one year, according to new data published in JACC: Cardiovascular Interventions.[1] However, the authors noted, there were still some key differences between the two devices.
Intra-annular TAVR valves are designed to be positioned inside a patient’s native aortic annulus as opposed to above the annulus. Researchers focused on patients treated with either the balloon-expandable Sapien 3 Ultra TAVR valve from Edwards Lifesciences or the self-expanding Navitor TAVR valve from Abbott. The U.S. Food and Drug Administration has approved both valves for treating symptomatic, severe aortic stenosis.
“Over recent years, various studies have compared different TAVR platforms to investigate the potential benefits of specific device types,” wrote first author Stefano Cannata, MD, an interventional cardiologist with the Mediterranean Institute for Transplantation and Advanced Specialized Therapies in Italy, and colleagues. “The NAVULTRA registry is the first study to report outcomes in patients undergoing TAVR who received intra-annular self-expanding or balloon-expandable devices.”
Overall, the study included data from nearly 4,000 TAVR patients who underwent TAVR from November 2018 to April 2024. While 56% of patients were treated with the Sapien 3 Ultra valve, the other 44% were treated with the Navitor valve.
Abbott's Navitor TAVR valve. Image taken during TCT 2023.
Before propensity score matching, patients treated with the Navitor tended to be slightly older than Sapien 3 Ultra patients. This group was also more likely to be female and presented with a higher Society of Thoracic Surgeons Predicted Risk of Mortality score. After propensity score matching, researchers were left with 1,363 matched pairs of comparable patients.
Procedural complications, including in-hospital mortality, were rare for all patients included in this analysis, and there were no significant differences in the two groups. Patients treated with the Navitor valve, however, were associated with a significantly longer mean hospitalization time—4 days vs. 3.4 days—and higher rates of new left bundle branch block and new permanent pacemaker implantation (PPI).
Cannata et al. noted that the Navitor valve was associated with a significantly higher device success rate than the Sapien 3 Ultra—91.2% vs. 87%. On the other hand, an early safety endpoint that included freedom from all-cause mortality, stroke, major bleeding events, vascular complications, access-related complications, cardiac structural complications, severe acute kidney injury, moderate or severe aortic regurgitation, PPI and device-related surgeries or interventions was seen in a much higher percentage of patients treated with the Sapien 3 Ultra valve (82.6%) than patients treated with the Navitor valve (73.9%).
At 30 days, meanwhile, there were no significant differences in the rates of all-cause mortality, stroke or repeat hospitalization for heart failure following treatment. Most of those outcomes were also similar after one year, though there was one notable exception: heart failure hospitalization were seen in 4.6% of patients treated with the Navitor valve compared to 2.8% of patients treated with the Sapien 3 Ultra.
This head-to-head comparison also included echocardiographic findings. The Sapien 3 Ultra TAVR valve was consistently linked to lower rates of paravalvular leak, but it was also associated with higher residual transprosthetic gradients and a larger effective orifice area.
“These findings warrant further investigation in dedicated randomized clinical trials that directly compare the two intra-annular devices,” the group concluded.
Click here for the full analysis in JACC: Cardiovascular Interventions, an American College of Cardiology journal.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.