Dedicated devices for the treatment of aortic regurgitation supported by a meta-analysis

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

According to pooled results from 19 studies, Sahar Samimi, MD (Houston Methodist, Texas), dedicated devices had higher success rates and lower rates of all-cause mortality, moderate-severe residual AR, reintervention, and embolization/migration. last week here at New York Valves 2024, formerly known as the TVT meet.

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

“These findings,” she added, “support the hypothesis that the use of dedicated devices is superior to unregistered devices in the setting of native aortic regurgitation.”

Although SAVR is an established treatment for severe AR that is accompanied by symptoms, an LVEF of 55% or less, or an LV end-systolic diameter greater than 50 mm, approximately three-quarters of patients do not undergo surgery within the first year. Samimi said. He noted that without treatment, severe AR is associated with an annual mortality rate of more than 10%.

TAVI is another option for these patients, but aortic annulus dilatation, lack of calcium, and the “suction effect” resulting from the high aortic regurgitation jet pose challenges in the use of transcatheter valves initially developed for the treatment of aortic stenosis that rely on calcium for treatment. anchoring.

Newer valves, including Trilogy and J-Valve, have been developed to address some of these issues with positive results. One-armed ALIGN-AR for example, the Trilogy System study 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 the use of dedicated devices with the use of unregistered TAVI valves by pooling data from 19 studies. A total of 1,203 patients participated (median age 74.4), of which 54% were treated with devices not in accordance with the manufacturer’s recommendations and the remainder were treated with the Trilogy or J-Valve system. The average STS score was 6.7% and the average EuroSCORE score was 19.9%.

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

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

It acknowledged that the analysis was limited because the included studies did not involve direct comparisons of unregistered and dedicated devices and were observational in nature, with all the shortcomings inherent in this type of analysis.

Nevertheless, Dr. Jubin Joseph (Keck School of Medicine of USC, Los Angeles, California), moderator of the session in which Samimi presented the results, told TCTMD that the study “underscores the need for dedicated devices to be available to help treat these patients we encounter in clinical practice.

“We have clearly demonstrated that it is technically possible to treat these patients with commercially available devices designed to treat aortic stenosis outside the manufacturer’s instructions. . . However, looking at these retrospective analyses, the complication rate with dedicated devices is much lower and appears safer, although with some limitations due to the fact that these are different patient populations,” he said. “But the differences are really stark.”

The main problem is that TAVI valves intended to treat aortic stenosis depend on calcification to anchor the device, prevent embolization and provide a good seal to avoid leakage, but the valve leaflets in pure AR are not calcified, Joseph emphasized. “When we use devices that do not meet the manufacturer’s recommendations for aortic regurgitation, we have to significantly oversize the valve to try to anchor the valve and reduce the risk of complications.”

On the other hand, dedicated devices such as Trilogy and J-Valve use additional attachment to the valve leaflets to provide safer and more stable deployment for AR.

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

“I think this meta-analysis, combined with published data, really highlights the need for a commercially available, dedicated device for the treatment of aortic regurgitation that could help reduce patient complications and improve procedural outcomes,” he said.