A comparison of two latest-generation self-expanding and balloon-expandable transcatheter aortic valve implantation (TAVI) systems has found comparable rates of all-cause mortality and heart failure hospitalisation between the two devices, but a higher rate of disabling stroke with the self-expanding device.
One-year findings from the OPERA-TAVI registry, an investigator-initiated, multicentre registry looking at the latest iteration Evolut (Medtronic) self-expanding platform alongside the Sapien 3 (Edwards Lifesciences) balloon-expandable TAVI platform, were presented at PCR London Valves (19–21 November, London, UK) by Giuliano Costa (AOU Policlinico “G Rodolico–San Marco”, Catania, Italy). The findings were published simultaneously in EuroIntervention.
“Over the past decade different iterations of the most-used balloon-expandable Sapien 3 platform and self-expandable CoreValve Evolut platform have been introduced to clinical practice, leading to a marked improvement in procedural results,” Costa told PCR London Valves attendees.
The most recent randomised comparison of the two platforms, from the SOLVE-TAVI trial, showed broadly comparable rates of all-cause death, cardiovascular death, valve regurgitation and permanent pacemaker implantation between the self-expanding and balloon-expandable systems, Costa explained, though at one year the trialists did find a higher rate of stroke among patients receiving a balloon expandable device.
The OPERA-TAVI registry reflects real-world usage of the two platforms, and includes newer iterations of the two devices—Evolut PRO and Evolut PRO+ as well as Sapien 3 Ultra. A total of 1,897 consecutive patients were enrolled in the study at 15 centres in Europe and North America, treated between September 2017 and January 2022.
Patients who had received either of the devices were propensity matched into 587 pairs based upon clinical and anatomical characteristics, Costa explained, and detailed that the make-up of the two groups was well balanced, with a median age of 82 years in both groups.
Primary endpoints were one-year all-cause death, disabling stroke and heart failure hospitalisation, with secondary endpoints including the single components of the primary endpoint. Investigators also sought to probe the difference between the two devices in five pre-specified subgroups of patients, including leaflet or left ventricular outflow tract (LVOT) calcification, annulus dimensions, aortic angulation or leaflet morphology.
The primary endpoint occurred in 14% of patients who received the self-expanding device, Costa reported, compared to 11.9% of patients implanted with the balloon-expandable platform, with analysis of the single endpoint components showing the biggest disparity being in the rate of disabling stroke, which stood at 2.6% in the self-expanding TAVI group and 0.4% amongst patients receiving the balloon-expandable TAVI device.
“Of note, these results were consistent across all the five prespecified subgroups of patients,” Costa said. “Similar results were recorded in patients with moderate-to-severe leaflet or left ventricular outflow tract calcification, patients with bicuspid native valves, patients with horizontal aorta, and patients with annulus diameter below 23mm.”
“[Evolut] Pro and [Sapien] Ultra devices showed similar clinical efficacy in real-world TAVI practice including challenging anatomical subsets,” Costa concluded. “But, Pro had high rates of disabling stroke, and this was mainly related to the index procedure.”
Commenting on the findings of the study, co-author Marco Barbanti (AOU Policlinico “G Rodolico–San Marco”, Catania, Italy) highlights to Cardiovascular News that statistical bias could remain despite extensive statistical adjustments. “The issue of stroke remains highly debated and only randomised studies will provide a definite answer,” he adds.
