ALIGN AR: ‘Intuitive’ TAVR system safe, effective for severe aortic regurgitation
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Key takeaways:
- A novel TAVR system was safe and effective for adults with severe aortic regurgitation who are not surgical candidates.
- Patients reported quality of life and functional status improvements at 1 year.
SAN FRANCISCO — New 1-year data show a novel system for transcatheter aortic valve replacement was safe and effective for adults with symptomatic severe aortic regurgitation at high surgical risk, a speaker reported at TCT 2023.
TAVR for patients with severe aortic regurgitation has been off-label and often presents procedural challenges and risk for poorer outcomes. The new TAVR system (Trilogy, JenaValve) features locators that “clip” onto native leaflets, forming a natural seal and stable securement for patients with severe aortic regurgitation who are not candidates for surgical aortic valve replacement, Vinod H. Thourani, MD, FACC, chair of the department of cardiovascular surgery for Piedmont Healthcare in Atlanta, said during a press conference. The Trilogy system received a CE mark in May 2021 for the treatment of aortic regurgitation and aortic stenosis and is not yet commercially available in the U.S.
“It is a unique valve system with three locators ... that are able to be rotated, allowing complete alignment with the three cusps of the native aortic valve,” Thourani said.
In the nonblinded, single-arm ALIGN AR trial, Thourani and colleagues analyzed 30-day safety data from 180 adults with symptomatic moderate to severe aortic regurgitation ( 3+) at high surgical risk. Researchers also assessed the 1-year primary efficacy outcome for all-cause mortality in a separate group of 180 patients.
Researchers found that TAVR using the Trilogy system met the 30-day performance goal for safety outcomes (26.7%; upper one-sided 97.5% CI, 34.1%, beating performance goal of 40.5%; P for noninferiority < .0001), as well as the 12-month performance goal for the efficacy outcome of all-cause mortality (7.8%; upper one-sided 97.5% CI, 12.3%, beating performance goal of 25%; P for noninferiority < .0001).
Thourani said the rate of new pacemaker implantation was 30% for the first 60 patients enrolled in ALIGN AR, falling to 14% for the last one-third of patients enrolled.
“There was a large learning curve that we had at the beginning of the trial, which occurred during the COVID-19 pandemic,” Thourani said. “You can see the pacemaker rate improved when we look at enrollment by tertiles.”
At 1 year, just 7.8% of patients had mild paravalvular regurgitation and 92.2% had none or trace.
“This is some of the best-in-class [results] for paravalvular regurgitation ever shown with a transcatheter heart valve prosthesis,” Thourani said. Thourani also noted significant improvements in left ventricular and systolic diameters and LV mass regression.
Patients also reported sustained improvement in quality of life and HF functional status measures through 1 year, Thourani said.
“In a population of symptomatic patients with moderate to severe or severe [aortic regurgitation] at high surgical risk who underwent TAVR using the Trilogy system, we showed that we achieved safety outcomes that met the 30-day performance goal and the efficacy outcome for all-cause mortality at 12-month performance goal,” Thourani said.
Additional analysis will occur annually through 5 years, Thourani said.
In a Q&A session after the press conference, Thourani called the pacemaker implantation rate in ALIGN AR “very respectable” for a patient population with no other options, noting that the rate improved as operators made changes to how the valve was implanted.
“It takes about one or two valves to get used to it. ... It is unbelievably intuitive,” Thourani said. “It is a very useable valve, very easy to teach. For the most part, it is as easy as a balloon-expandable valve, so I do think it is translatable to a larger patient population.”
“[Aortic regurgitation] is a forgotten disease,” Thourani said. “It is staggering, the number of these patients. Once we open this up, we will see this proliferation of disease management for something we previously have ignored.”
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Thourani VH, et al. Late-breaking clinical trials: Session I, in collaboration with The New England Journal of Medicine. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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