Transcatheter aortic valve implantation (TAVI) using the JenaValve Trilogy system met its primary safety and efficacy endpoints in the first real-world test of the novel valve in high-risk patients with severe aortic regurgitation (AR).
Technical success, defined as a mean gradient less than 20 mm Hg and a greater than 1 grade reduction in AR, was achieved in all 45 consecutive patients treated at six German centers.
“AR patients ineligible or at high risk for surgery were previously without treatment options and now our results can give confidence to treat these patients with a lifesaving procedure,” said Alexander Tamm, MD, during a hotline session at EuroPCR 2022 , held in Paris and online.
He noted that the JenaValve Trilogy (JenaValve Technology) is the only transcatheter heart valve in the world approved for the treatment of AR and aortic stenosis, earning CE Mark approval for both indications last year.
The JenaValve ALIGN-AR pivotal trial is ongoing in the United States, so patients with severe AR who are ineligible for surgery are currently treated with medical therapy, a left ventricular assist device, or off-label TAVI.
The new results confirm those reported by the investigators last year at PCR London Valves in 10 high-risk AR patients ineligible for surgery, in whom the JenaValve device was implanted under a compassionate-use protocol.
Several iterations of the JenaValve have surfaced over the years. But what sets the JenaValve Trilogy system apart is that it features three unique locators that align the prosthesis with the native cusps of the valve, Hamm explained. This ensures correct commissural alignment but, unlike other TAVI valves used for aortic stenosis, it allows the valve to be anchored in pure AR patients with noncalcified valves.
In the study, the 45 patients (mean age, 77 years; 40% female) presented with moderate-severe or severe AR and a mean EuroSCORE II of 7.1%. Over half (58%) had an ejection fraction of 50% or less, 71% were in functional NYHA class III or IV, and 29% had previous cardiac surgery.
All cases were performed via transfemoral access and 82% were under conscious sedation. The valve size was 27 mm in 60%, 25 mm in 31% and 23 mm in 9%. Post-dilatation was used in two cases.
The median procedure time was 77 minutes, mean fluoroscopy time 19 minutes, and mean contrast dose 180.58 mL, Hamm reported.
There was one major vascular complication and three minor bleeding events; there were no conversions to open surgery.
At discharge, the average aortic valve gradient was low at 4.04 mm Hg and the aortic valve area large at 2.62 cm2.
Most importantly, no patient had moderate or severe paravalvular regurgitation and 91% had no AR or just trace AR at discharge (55.5% none, 35.5% trace, and 9% mild), Hamm said
During a discussion of the results, however, audience members called out the 23% pacemaker rate and observed that data presented just the day before at EuroPCR showed no new pacemakers in TAVI patients treated for aortic stenosis (AS).
“Of course, 20% seems high but it is a different population,” Hamm responded. He also pointed out that the pacemaker rate for off-label TAVI trials in pure AR is between 10% and over 40% and was around 12% for surgery in pure AR in a recent meta-analysis.
“These patients have a higher possibility of conduction disturbances and this is challenging, but we have to deal with that,” Hamm said.
Discussant Ganesh Manoharan, MD, Royal Victoria Hospital, Belfast, Ireland, remarked: “Great presentation; thank you for keeping this technology alive because I think it’s got some cool features to it.”
He went on to ask whether the investigators oversize the valve for regurgitant patients, and if this could explain a change in pacemaker rates between cyanotic and regurgitant patients.
“Part of that is maybe the population is different and part of that is also because of the calcium in the base of the sinuses, that the valve is implanted a little bit higher, as in AR, where it’s very soft tissue,” he said. “It goes very deep into the annulus and so maybe is producing more conduction disturbances.
Another audience member said the JenaValve Trilogy is an excellent valve but that additional sizes are needed, observing that in his experience treating more than 100 pure AR patients with no calcium, the annulus size is way above what was treated.
Hamm agreed that the annular measurement in AR patients is big and said this is a challenge for the company to manufacture a valve that can exceed its current limits.
Tamm reports honoraria or consultation fees from Edwards Lifesciences, JenaValve, and Medtronic. Manoharan reports consultation fee/honoraria/speaker’s bureau participation for Medtronic and Abbott Vascular.
EuroPCR 2022: Congress of European Association of Percutaneous Cardiovascular Interventions. Presented May 18, 2022.