Dedicated Devices for Aortic Regurgitation Supported by Meta-analysis

NEW YORK, NY—For patients with pure native aortic regurgitation (AR) who are undergoing TAVI, use of devices tailored to treat the AR seems to provide superior outcomes compared with off-label use of valves developed to treat aortic stenosis, a meta-analysis indicates.

Dedicated devices came with a higher rate of device success and lower rates of all-cause mortality, moderate-severe residual AR, reintervention, and embolization/migration in pooled results from 19 studies, Sahar Samimi, MD (Houston Methodist, TX), reported last week here at New York Valves 2024, previously known as the TVT meeting.

Use of transcatheter heart valves with features specific to treatment of AR, including the Trilogy system (JenaValve) and the J-Valve system (JC Medical), has “demonstrated promising results” for patients with AR and high surgical risk, Samimi said.

“These findings,” she added, “support the hypothesis that using dedicated devices is preferable to off-label devices for native aortic valve regurgitation.”

Though SAVR is the established treatment for severe AR accompanied by symptoms, an LVEF of 55% or lower, or an LV end-systolic diameter greater than 50 mm, about three-quarters of afflicted patients don’t undergo surgery within the first year, Samimi said. Without treatment, he noted, severe AR is associated with an annual mortality rate exceeding 10%.

TAVI is another option for these patients, but aortic annulus dilation, the absence of calcium, and a “suction effect” stemming from the severe aortic regurgitant jet present challenges for use of transcatheter valves developed initially to treat aortic stenosis, which rely on calcium for anchoring.

Newer valves, including the Trilogy and the J-Valve, have been developed to address some of these issues, with positive results. The single-arm ALIGN-AR trial of the Trilogy system, for instance, met safety and efficacy goals and demonstrated improvements in NYHA functional class and quality of life in patients with symptomatic AR and high surgical risk.

Samimi and her colleagues set out to compare use of dedicated devices with use of off-label TAVI valves by pooling data from 19 studies. There was a total of 1,203 patients (median age 74.4), with 54% treated with off-label devices and the remainder treated with either the Trilogy or the J-Valve system. Mean STS score was 6.7%, and mean EuroSCORE was 19.9%.

The primary outcome of interest was 30-day all-cause mortality, with a higher rate observed among patients treated with off-label versus dedicated devices (about 11% vs 3%; P < 0.01). Use of off-label valves also was associated with higher rates of moderate-severe residual AR (about 8% vs 1%; P < 0.01), reintervention (about 8% vs 2.5%; P = 0.04), and embolization/migration (about 11% vs 2%; P < 0.01), as well as a lower rate of 30-day device success (82% vs 93%).

There were no significant differences between groups in stroke, major bleeding, vascular complications, or pacemaker implantation, although that last outcome was numerically greater in the off-label group, Samimi reported.

She acknowledged that the analysis was limited in that the included studies did not involve head-to-head comparisons of the off-label and dedicated devices and were observational in nature, with all of the shortcomings inherent to those types of analyses.

Nevertheless, Jubin Joseph, MD, PhD (Keck School of Medicine of USC, Los Angeles, CA), moderator of the session at which Samimi presented the results, told TCTMD that the study “highlights a need for the availability of dedicated devices to help treat these patients that we see in clinical practice.

“We have clearly demonstrated that it’s technically possible to treat these patients with off-label use of the commercially available devices designed for aortic stenosis, . . . but looking at these retrospective analyses, the complication rate with dedicated devices is much lower and it appears to be safer, albeit with the limitations that they’re likely to be different patient populations,” he said. “But the differences are really marked.”

The main issue is that the TAVI valves designed to treat aortic stenosis depend on calcification to anchor the device, prevent embolization, and get a good seal to avoid leaks, but the valve leaflets in pure AR are not calcified, Joseph stressed. “When we’re using off-label devices in aortic regurgitation, we have to significantly oversize to try and anchor the valve to reduce complications.”

Dedicated devices like the Trilogy and the J-Valve, on the other hand, use additional anchoring onto the valve leaflets to provide a safer and more stable deployment in the setting of AR.

The results of this meta-analysis build on data from ALIGN-AR, showing “that we’re able to achieve good outcomes in patients with severe aortic regurgitation treated with dedicated devices,” Joseph said, noting that the Trilogy and the J-Valve are not currently available in the US.

“I think this meta-analysis, taken together with the published data, really pushes the need for a commercially available dedicated device for aortic regurgitation to try and help reduce complications for patients and improve procedural outcomes,” he said.