Two studies offered new insights into the transcatheter heart valve (THV) system used in transcatheter aortic valve replacement (TAVR) in patients with aortic regurgitation (AR).
Irvine, California-based JenaValve’s Trilogy won FDA approval in March for the treatment of patients with symptomatic, severe aortic regurgitation (ssAR) at high or greater risk for surgical aortic valve replacement (SAVR). The company launched the system in April.
Trilogy became the first and only transcatheter device approved in the U.S. with a dedicated indication for this patient population. The valve features locator technology that ensures commissural alignment. This allows the valve to attach to the native leaflets for secure anchoring. The locators go within the native cusps and resist ventricular migration.
JenaValve’s technology also features a self-expanding nitinol frame and porcine pericardial tissue with Jasmine proprietary tissue treatment. Trilogy has a large, open-cell design to enable future coronary access.
Findings shared at New York Valves included outcomes from the ALIGN-AR study. The company also shared outcomes related to the use of Trilogy in left ventricular assist device (LVAD) patients.
“The data presented at New York Valves reflect the expanding depth of clinical evidence and growing real-world experience with the Trilogy System,” said Dr. Duane Pinto, chief medical officer of JenaValve. “The ALIGN‑AR findings reinforce that AR is a distinct disease that demands distinct thinking, while the LVAD results bring us closer to addressing one of the most urgent unmet needs in structural heart disease.”
More on the findings shared by JenaValve
In the first presentation, Dr. James McCabe of Beth Israel Deaconess Medical Center presented data on pacemaker implantation rates after a TAVR procedure in patients with AR.
Key findings indicated that predictors of pacemaker implantation in TAVR for AR reflect the disease’s unique pathophysiology as it progresses. This compares to factors like oversizing that are typically implicated in aortic stenosis (AS), JenaValve says.
“The ALIGN-AR data continue to reveal important distinctions in how AR patients present and respond to TAVR. Understanding the drivers of pacemaker implantation reinforces that AR imposes unique physiological demands, AR is a distinct entity separate from AS, and our clinical management must evolve to reflect this reality,” said Dr. McCabe.
Dr. Ravi Ramana of Heart Care Centers of Illinois shared the second set of findings. Raman served as national principal investigator for the prospective JENA-VAD registry. The analysis evaluated expanded access of Trilogy in LVAD patients.
JenaValve said the registry examined outcomes in patients with continuous-flow LVADs and significant AR treated with Trilogy. It says patients with LVADs who develop significant AR face poor clinical outcomes and very limited treatment options.
In 28 LVAD patients treated under expanded access, Trilogy demonstrated high procedural success. It also delivered low 30-day mortality with no major complications. One-year mortality came in at 7.3%. Findings complement the ongoing prospective JENA-VAD registry, an FDA investigational device exemption (IDE) study.
“Patients with LVADs and clinically significant AR represent one of the most vulnerable and underserved populations in structural heart disease. This data is encouraging, demonstrating that treatment with a dedicated AR device is feasible in this setting and was achieved with low complication rates despite significant disease complexity. These findings begin to lay the foundation for a much-needed option for these patients,” said Dr. Ramana.
